ABSTRACT
OBJECTIVE: To observe the effect of Butylphthalide soft capsules on improving cognitive function, activity of daily living, and dementia-related factors of elderly patients with Parkinson's disease dementia (PDD) during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: The clinical data of 126 elderly patients with PDD admitted to the Second Affiliated Hospital of Zhengzhou University during the COVID-19 pandemic were analyzed retrospectively. Patients were assigned to a control group (conventional clinical treatment, n=50) and a research group (conventional clinical treatment combined with Butylphthalide soft capsules, n=76). The clinical response, clinical symptoms, cognitive function, activity of daily living (ADL), cerebral blood flow velocity, serum inflammatory factors, oxidative stress indices, neurotrophic factors, dementia-related factors, and drug safety were analyzed and compared between the two groups. RESULTS: The overall response rate was significantly higher in the research group than in the control group (97.37% vs. 84.00%, P=0.017). After treatment, the clinical symptom-based scores and levels of serum inflammatory factors, malondialdehyde, and Parkinson disease protein 7 were significantly lower in the research group than in the control group (all P<0.001); the cognitive function and ADL scores, cerebral blood flow velocities, and levels of catalase, glutathione peroxidase, superoxide dismutase, neurotrophic factors, and neurotrophin-3 were significantly higher in the research group (all P<0.001). The incidence of adverse reactions was comparable between the two groups (4.00% vs. 6.58%, P=0.825). CONCLUSION: Butylphthalide soft capsules have a definite effect and good safety in elderly patients with PDD during the COVID-19 pandemic.
ABSTRACT
ObjectiveTo comprehensively assess the clinical value of Duliang soft capsules in the treatment of migraine with wind-cold blood stasis syndrome， and to provide guidance for national medical decision-making， clinical drug promotion， and pharmaceutical services. MethodThe evaluation of Duliang soft capsules' clinical value was conducted in accordance with the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs （Trial Version， 2021） using a combination of qualitative and quantitative methods. Utilizing the CSC v2.0 software， this study conducted a comprehensive clinical evaluation of Duliang soft capsules across the "6+1" dimensions， including safety pre- and post-market launch， effectiveness in treating migraine， economy （cost-effectiveness）， and innovation， suitability， accessibility， and traditional Chinese medicine （TCM） characteristics in both its technology and clinical applications. ResultSafety： Duliang soft capsules were found to have good safety based on evidence from known adverse reactions （spontaneous reporting system （SRS） data， literature data， etc.）， pre-marketing toxicological research， and post-marketing drug monitoring. Effectiveness： A meta-analysis indicated that the combination of Duliang soft capsules and western medicine was more effective than Western medicine alone in the treatment of migraine. The product's effectiveness was rated as "Best" based on the quality and value of the evidence. Economy： Duliang soft capsules are moderately priced and categorized as a Type B medical insurance product. Economic research indicated that the combination of Western medicine and Duliang soft capsules was more cost-effective than Western medicine alone. The product's economy was rated as "Better". Innovation： Duliang soft capsules， with Angelicae Dahuricae Radix and Chuanxiong Rhizoma as the main components， hold one invention patent and have been awarded the China Patent Excellence Award. The pharmaceutical company has introduced innovative extraction （CO2 supercritical extraction technology） and formulation （soft capsule） processes. The product's innovation was rated as "Better". Suitability： A questionnaire survey on Duliang soft capsules showed that it was well-suited for both patients and healthcare professionals. The product received a comprehensive assessment of suitability through the "Evaluation of Chinese Patent Medicine Information Services". The product's suitability was rated as "Best". Accessibility： Duliang soft capsules are moderately priced， making them accessible and affordable. The product's accessibility was rated as "Good" based on evidence from these three aspects. TCM characteristics： The formulation of Duliang soft capsules can be traced back to WANG Qiu's Selected Formulas from the Praiseworthy Studio （Shi Zhai Bai Yi Xuan Fang） from the Song Dynasty， and it was documented in ZHANG Jiebin's The Complete Works of Zhang Jing-yue （Jing Yue Quan Shu） as "Duliangwan". The product has been extensively studied with over 2000 clinical cases since its market launch， and its TCM characteristics were rated as outstanding with sufficient evidence. ConclusionThe comprehensive clinical value evaluation of Duliang soft capsules demonstrated its high effectiveness， suitability， and accessibility， and outstanding TCM characteristics. The product's safety， economy， and innovation received good ratings. In summary， Duliang soft capsules exhibited significant clinical value and outstanding TCM characteristics， the evidence was sufficient， and the result was confirmed， providing crucial references for clinical decision-making and pharmaceutical management.
ABSTRACT
Lixuwang~® Xuesaitong Soft Capsules(referred to as "Xuesaitong Soft Capsules") have the effects of promoting blood circulation, resolving blood stasis, and dredging meridians and collaterals. They are widely used in the prevention and treatment of cardiovascular and cerebrovascular diseases in clinical practice. Through years of clinical observation, they have shown significant efficacy in ischemic stroke, coronary heart disease, and other diseases, and have been recommended by multiple guidelines, consensus statements, and monographs. Based on the summary of clinical application experience by doctors and existing evidence-based research, following the Technical Specifications for Consensus Development of Chinese Patent Medicine by Clinical Experts issued by Standardization Office of the Chinese Association of Traditional Chinese Medicine, a nominal group method was used to reach 19 recommended opinions/consensus suggestions. This document proposes the timing of medication, syndrome differentiation for medication, therapeutic effects, dosage and administration, treatment duration, economic considerations, and safety considerations in the use of Xuesaitong Soft Capsules for the treatment of ischemic stroke and angina pectoris in coronary heart disease. It is intended for doctors in internal medicine, encephalopathy(neurology), cardiovascular medicine, geriatrics, emergency medicine, general practice, and traditional Chinese medicine departments of various medical institutions, as well as pharmacists in hospitals and pharmacies, as a medication reference when using Xuesaitong Soft Capsules. It is hoped that the widespread application of this consensus can improve the clinical efficacy of Xuesaitong Soft Capsules in the treatment of ischemic stroke and coronary heart disease, promote rational drug use, and reduce medication risks. This consensus has been reviewed and published by the China Association of Traditional Chinese Medicine, with the identification number GS/CACM 323-2023.
Subject(s)
Coronary Disease , Drugs, Chinese Herbal , Ischemic Stroke , Humans , Consensus , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Coronary Disease/drug therapy , Ischemic Stroke/drug therapy , CapsulesABSTRACT
INTRODUCTION: The use of oral nonsteroidal anti-inflammatory drugs (NSAIDs) for acute musculoskeletal pain should be at the lowest effective dosage and for the shortest duration to minimize potential adverse effects. This study evaluated treatment satisfaction, effectiveness, and tolerability of a low-dose diclofenac epolamine 12.5-mg soft capsule formulation (DHEP 12.5-mg capsules) using patient-reported outcome measures in a real-life setting over a short period (3 days) in subjects with mild-to-moderate acute musculoskeletal pain. METHODS: A prospective, open-label, phase IV clinical study in adult outpatients at hospital clinic departments/general practitioner's clinics at eight sites in Italy. The primary efficacy variable was the degree of satisfaction with treatment at 72 ± 7 h after initiation of treatment, assessed using the Overall Satisfaction Question of the Pain Treatment Satisfaction Scale (PTSS) and described by classic descriptive statistics. Secondary objectives were to evaluate the analgesic effect after the first administration and over time; the time to and satisfaction with the onset of pain relief, amount of and duration of pain relief; pain intensity differences over time; and safety and tolerability. The investigator's satisfaction with the treatment was also assessed. Subjects initially took 1-2 capsules of the study treatment and then one or two soft capsules every 4-6 h according to their needs. Not more than six soft capsules were to be taken in any 24-h period. RESULTS: A total of 182 subjects (mean age, 56.2 years; 54.4% female) took ≥ 1 dose of DHEP capsule and were included in the full analysis set. The most common musculoskeletal conditions were arthralgia (39.0%) and low back pain (23.1%). All subjects completed the study, and 165/182 (90.7%, 95% CI 0.86, 0.95) were satisfied or very satisfied with the treatment at 72 ± 7 h after the first dose (primary efficacy variable). Similar percentages were recorded for treatment satisfaction concerning other efficacy parameters. The onset of the analgesic effect was rapid, with complete pain relief reached after a mean of 49.45 min. Investigators rated their overall treatment satisfaction as 92.9%. Treatment was well tolerated. CONCLUSIONS: The low-dose (12.5 or 25 mg) oral diclofenac epolamine soft capsules formulation exerted rapid, effective, and safe analgesic activity in patients with mild-to-moderate musculoskeletal pain, with subjects' overall satisfaction with treatment more than 90%. TRIAL REGISTRATION: EudraCT Number: 2018-004886-15 (Study 18I-Fsg08). Registered 04/09/2018.
ABSTRACT
Background: Pancreatic cancer is one of the most deadly malignancies in the world. It is characterized by rapid progression and a very poor prognosis. The five-year survival rate of pancreatic cancer in China is only 7.2%, which is the lowest among all cancers and the use of combined paclitaxel albumin, capecitabine, and digital has been the clinical standard treatment for advanced pancreatic cancer since 1997. Also, the application of multidrug combinations is often limited by the toxicity of chemotherapy. Therefore, there is an urgent need for a more appropriate and less toxic treatment modality for pancreatic cancer. Case presentation: The patient was a 79-year-old woman, admitted to the hospital with a diagnosis of unresectable locally advanced pancreatic cancer (T3N0M0, stage IIA), with its imaging showing overgrowth of SMV involvement and unresectable reconstruction of the posterior vein after evaluation. As the patient refused chemotherapy, lenvatinib (8 mg/time, qd) and icaritin soft capsules (three tablets/time, bid) were recommended according to our past experience and a few clinical research cases. The tumor lesion was greatly reduced by 57.5% after the treatment, and the extent of vascular involvement also decreased. The aforementioned medication resulted in a significant downstaging of the patient's tumor. Conclusion: Better results were achieved in the treatment with icaritin soft capsules and lenvatinib in this case. Because of its less toxic effect on the liver and kidney and bone marrow suppression, it was suitable to combine icaritin soft capsules with targeted drugs for treating intermediate and advanced malignancies, which brings hope to patients who cannot or refuse to take chemotherapy.
ABSTRACT
Objective:To evaluate the clinical efficacy rate, vascular endothelial relaxation factor NO and safety of five different Chinese patent medicines combined with western medicine in the treatment of coronary microvascular disease (CMVD).Methods:Randomized controlled trials (RCTs) of Shexiang Baoxin Pills, Tongxinluo Capsules, Compound Danshen Dripping Pills, Yindan Xinnaotong Soft Capsules, and Xinkeshu Tablets combined with conventional western medicine therapy in the treatment of CMVD were retrieved from China National Knowledge Infrastructure (CNKI), China Academic Journal Database (Wanfang Data), Chinese Science and Technology Journal Database (Chongqing VIP), China Biomedical Literature Service System (SinoMed), PubMed, Cochrance Library and Embase databases from the establishment of the database to June 2022. The literature was imported and screened by EndNote software, and the risk quality of literature bias was evaluated by Revman 5.4 software. StataSE16 (64-bit) software was used for reticular meta analysis to compare the differences in clinical efficacy and drug safety of five proprietary Chinese medicines combined with western medicine.Results:A total of 24 RCT studies were included, 24 of which were double-arm studies, and five kinds of proprietary Chinese medicine combined with western medicine were compared. The results of reticular meta analysis: in terms of improving the clinical effective rate, the order of the five proprietary Chinese medicine combination groups was as follows: Yindan Xinnaotong Soft Capsules group > Shexiang Baoxin Pills group > Tongxinluo Capsules group > Xinkeshu Tablets group > Compound Danshen Dripping Pills group. In terms of regulating vasodilation factor NO, the order of the four proprietary Chinese medicine combination groups is as follows: Yindan Xinnaotong Soft Capsules group > Compound Danshen Dripping Pills group > Tongxinluo Capsules group > Shexiang Baoxin Pills group. In terms of safety, there were 3 reports of adverse reactions in the research literature of the five proprietary Chinese medicines.Conclusions:The clinical efficacy rate of five kinds of proprietary Chinese medicine combined with western medicine routine regimen is better than that of western medicine routine regimen alone, and the combination group of four kinds of proprietary Chinese medicine is superior to western medicine in regulating vasodilation factor NO, and Yindan Xinnaotong Soft Capsules group is superior in clinical efficacy rate and regulation of vasodilation factor NO. However, the quality and samples of this study are different, and the comparison of the curative effect of the combined group of proprietary Chinese medicine still needs a large sample and high-quality RCT study to demonstrate.
ABSTRACT
Lixuwang~® Xuesaitong Soft Capsules(referred to as "Xuesaitong Soft Capsules") have the effects of promoting blood circulation, resolving blood stasis, and dredging meridians and collaterals. They are widely used in the prevention and treatment of cardiovascular and cerebrovascular diseases in clinical practice. Through years of clinical observation, they have shown significant efficacy in ischemic stroke, coronary heart disease, and other diseases, and have been recommended by multiple guidelines, consensus statements, and monographs. Based on the summary of clinical application experience by doctors and existing evidence-based research, following the Technical Specifications for Consensus Development of Chinese Patent Medicine by Clinical Experts issued by Standardization Office of the Chinese Association of Traditional Chinese Medicine, a nominal group method was used to reach 19 recommended opinions/consensus suggestions. This document proposes the timing of medication, syndrome differentiation for medication, therapeutic effects, dosage and administration, treatment duration, economic considerations, and safety considerations in the use of Xuesaitong Soft Capsules for the treatment of ischemic stroke and angina pectoris in coronary heart disease. It is intended for doctors in internal medicine, encephalopathy(neurology), cardiovascular medicine, geriatrics, emergency medicine, general practice, and traditional Chinese medicine departments of various medical institutions, as well as pharmacists in hospitals and pharmacies, as a medication reference when using Xuesaitong Soft Capsules. It is hoped that the widespread application of this consensus can improve the clinical efficacy of Xuesaitong Soft Capsules in the treatment of ischemic stroke and coronary heart disease, promote rational drug use, and reduce medication risks. This consensus has been reviewed and published by the China Association of Traditional Chinese Medicine, with the identification number GS/CACM 323-2023.
Subject(s)
Humans , Consensus , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Coronary Disease/drug therapy , Ischemic Stroke/drug therapy , CapsulesABSTRACT
OBJECTIVE To establish the ultra-high performance liquid chromatography-mass spectrometry/mass spectrometry method for simultaneous determination of liquiritin ， naringin， hesperidin， neohesperidin， nobiletin， atractylenolide Ⅲ ， imperatorin，honokiol，isoimperatorin and magnolol in Huoxiang zhengqi soft capsules. METHODS Twelve batches of Huoxiang zhengqi soft capsules were extracted by ultrasonic extraction with ethanol. The determination was performed on Ultimate XB-C 18 column with mobile phase consisted of acetonitrile - 0.1％ formic acid solution for gradient elution at the flow rate of 0.4 mL/min. The column temperature was 30 ℃. The electrospray ionization source was applied to carry out the positive and negative ion scanning with multiple react ion monitoring mode. RESULTS The linear range of liquiritin ，naringin，hesperidin，neohesperidin， nobiletin，atractylenolide Ⅲ ，imperatorin，honokiol，isoimperatorin and magnolol were 1.64-52.40，1.73-55.20，1.54-49.20， 1.71-54.80，1.74-55.60，4.19-134.00，1.51-48.40，1.61-51.60，1.80-57.60，1.74-55.60 ng/mL（r≥0.999 5），respectively. The limits of quantitation were 0.41，0.43，0.19，0.43，0.11，1.05，0.19，0.40，0.45，0.11 ng/mL，respectively. RSDs of precision ，stability （24 h）and repeatability tests were all lower than 6％. Average recoveries were 102.42％，98.65％，98.34％，101.48％，96.74％， 100.40％，104.92％，98.53％，99.50％，105.40％（RSD＝1.34％-5.44％，n＝9）. The contents of the above 10 constituents in 12 batches of Huoxiang zhengqi soft capsules were 201.21-287.89，5.03-20.37，1 465.56-1 988.35，5.35-9.01，217.09-306.44，1.91- 16.17，1 081.59-1 377.12，2 388.34-2 915.13，341.26-397.45 and 7 633.47-8 976.99 μg/g，respectively. CONCLUSIONS The established method for content determination is convenient ，sensitive and accurate ，which can be used for the quality control and evaluation of Huoxiang zhengqi related preparations.
ABSTRACT
Calcitriol is an active product of vitamin D produced by the liver and kidney hydroxylase metabolism with strong physiological activity. It is the preferred form of medicine for patients with insufficient bone mineralization due to chronic kidney disease. Calcitriol soft capsule is one of the common preparation forms, the main drug content of which is very low (1.55 µg g-1), and the pharmaceutical excipients interfere greatly, especially the oily matrix medium-chain triglycerides. Therefore, removing the interference of oily matrix is ââthe main challenge in the content determination. At present, the commonly used sample purification method for the determination of calcitriol in soft capsules is liquid-liquid extraction, but it usually consumes a lot of toxic organic solvents and it is costly. The adoption of SPE purification method, on the one hand, requires specific experimental equipment, and on the other hand, the organic solvent used in the experiment may cause the dissolution of SPE column tube materials, which will interfere with the subsequent detection. Herein, in order to achieve a cost-effective and reliable determination of calcitriol soft capsule content, we developed a dispersive solid-phase (DSPE) extraction method that directly uses irregular silica as sorbent, which is followed by high-performance liquid chromatography equipped with a UV detector(HPLC-UV)analysis. Selective retention of calcitriol is achieved by the polar interaction between calcitriol and silica, what's more, sufficient contact between washing solvent and sorbent can be guaranteed. Therefore, after pretreatment with DSPE, the interference of oily matrix on detection can be mostly removed and then improve the accuracy of the method compared to the SPE method. Under the optimal conditions of DSPE, calcitriol showed a good linear relationship in the range of 0.15-2.99 µg g-1, the R2 was 0.997. Satisfactory recoveries ranging from 101.1%-102.0% for calcitriol were achieved in the oily matrix at the levels of 0.75, 1.50 and 2.24 µg g-1. And the intra-day and inter-day RSD were less than 2.5 % and 3.2 %. Meanwhile, the LOD and LOQ of calcitriol was 0.01 µg g-1 and 0.02 µg g-1, which is in full compliance with the regulatory level fixed by the EU, China or other countries. This method was further verified to determine the content of calcitriol in commercial calcitriol soft capsules and the recoveries of three batches of products was 86.2 %-94.4 %. Based on these characteristics, the proposed method makes it possible to determine the low content of weakly polar drugs in the oily matrix in a simple, low-cost and reliable way.
Subject(s)
Calcitriol , Silicon Dioxide , Capsules , China , Chromatography, High Pressure Liquid , Humans , Solid Phase ExtractionABSTRACT
This experiment was aimed to investigate the effect of Dengzhan Shengmai capsule combined with butylphthalide soft capsule on oxidative stress indexes and serum homocysteine (Hcy) and C-reactive protein (CRP) levels in patients with vascular dementia (VD). From July 2017 to July 2019, 123 patients with VD in our hospital were selected as the research object, and each patient was assigned a random number according to the order of treatment. Among them, No. 1 to 41 were the control group A, No. 42 to 82 were the control group B, and No. 83 to 123 were the research group. Control group A was given butylphthalide soft capsules, control group B was Dengzhanshengmai capsules, and the research group was given Dengzhanshengmai capsules combined with butylphthalide softgels. Comparison of clinical efficacy, the incidence of adverse reactions, and improvement of symptoms [Montreal Cognitive Assessment Scale (MocA) score, Vascular Dementia TCM Syndrome Differentiation Scale (SDSVD) score], vascular endothelial function [NO, endothelin 1 (ET-1)], oxidative stress [lipid peroxide (LPO), superoxide dismutase (SOD), C Dialdehyde (MDA)], endoplasmic reticulum stress response (Hcy, CRP) related indicators before and after treatment in three groups. Results showed that the total effective rate of treatment in the study group was higher than that in the control groups A and B, the difference was statistically significant (p<0.05). In symptom improvement, the MoCA score of the study group was higher than that of the control groups A and B after the treatment course, and the SDSVD score was lower than that of the control groups A and B (p<0.05); In the vascular endothelial function section, after the course of treatment, the serum NO level in the study group was higher than that in the control groups A and B, and the ET-1 level was lower than that in the control groups A and B (p<0.05). In oxidative stress experiment, after the course of treatment in the study group, the serum LPO and MDA levels were lower than those in the control groups A and B, and the SOD levels were higher than those in the control groups A and B (p<0.05). Endoplasmic reticulum stress response results showed that after the course of treatment in the study group, the serum Hcy and CRP levels were lower than those in the control groups A and B (p<0.05). In adverse reactions section, there was no significant difference in the incidence of adverse reactions among the three groups (p>0.05). Dengzhan Shengmai Capsule combined with butylphthalide soft capsule is the first treatment for VD, with definite curative effect, which can effectively reduce the damage of vascular endothelial function and inhibit oxidative stress response, antagonize the endoplasmic reticulum stress response, thereby further alleviating dementia symptoms and improving cognitive function.
Subject(s)
Benzofurans/therapeutic use , C-Reactive Protein/metabolism , Drugs, Chinese Herbal/therapeutic use , Homocysteine/blood , Oxidative Stress/drug effects , Aged , Dementia, Vascular/drug therapy , Dementia, Vascular/metabolism , Female , Humans , Male , Malondialdehyde/metabolism , Middle Aged , Oxidation-Reduction/drug effects , Reactive Oxygen Species/metabolism , Superoxide Dismutase/metabolismABSTRACT
Contrasting to the traditional centimeter-sized soft capsules that are difficult to swallow or micro/nanometer-sized soft capsules that suffer from limited loading capacity for fish oil/nutrients and lowered stability, the millimeter-sized soft capsules with good enough stability could be a potential solution in solving these problems. Herein, we report millimeter-sized soft core-shell capsules of 0.42-1.85 mm with an inner diameter of 0.36-1.75 mm, for fish oil/nutrients, obtained through an electrospray approach upon optimization of different fabrication parameters such as applied voltage, sodium alginate concentration, shell/core feeding rate ratio, times of feeding rate, and types of coaxial needles. Further in vitro and in vivo studies reveal that the resulting soft capsules were apparently weakened and became mechanically destructive in the simulated small intestine solution and were totally destroyed in the simulated small intestine solution if they were first treated in the simulated stomach solution but not in the simulated stomach solution, which makes the millimeter-sized capsules useful as containers for specific delivery of fish oils and lipophilic nutrients to the stomach and intestines with excellent in vivo bioavailability (>90%). The whole fabrication approach is very facile with no complicated polymer modification and formulations involved, which endows the resulting soft capsules with broad application prospect in food and drug industries.
Subject(s)
Fish Oils , Gastric Mucosa/metabolism , Intestine, Small/metabolism , Alginates/chemistry , Animals , Capsules , Electrochemical Techniques , Fish Oils/chemistry , Fish Oils/metabolism , Fish Oils/pharmacokinetics , Particle Size , RabbitsABSTRACT
Objective: To explore the mechanism of Yinqiao Jiedu Soft Capsules in the treatment of coronavirus disease 2019 (COVID-19). Methods: The interactions between 1 418 compounds of Yinqiao Jiedu Soft Capsules and 48 inflammatory target proteins related to COVID-19 were analyzed by molecule docking. The drug-target network was established to clarify the active compounds and potential targets. Results: The network analysis suggested 50 active compounds of Yinqiao Jiedu Soft Capsules, which were mainly flavonoids and triterpenoids, and 37 potential targets, mainly including MTOR, JAK3, ACE, ACE2, PIK3CA, TNF, AKT2, and MAP2K1. The results of molecular docking exhibited that forsythiaside and vitexin 2″-O-rhamnoside had good affinity with SARS-CoV-2 3CL hydrolase, and glycyrrhizic acid had good affinity with ACE2. Conclusion: The molecular mechanism of Yinqiao Jiedu Soft Capsules for COVID-19 may be involved in interfering SARS-CoV-2 replication and regulating the expression of inflammatory signaling pathway and the secretion of inflammatory cytokines.
ABSTRACT
As a new dosage form, coenzyme Q10 (Co-Q10) soft capsules are easily absorbed and utilized by the human body. Co-Q10 soft capsules can effectively improve the bioavailability and reduce medical costs for patients. A main concern about Co-Q10 as an active pharmaceutical ingredient (API) is how to control the total quantity of related substances. In this article, according to the degradation pattern of the API, the most easily degradable impurity (impurity X) in the sample was prepared and its chemical structure was determined. Furthermore, a simple and accurate method was developed for the determination of related substances and to avert the interference of excipient ingredients in Co-Q10 soft capsules. The approach was validated adequately and the primary impurity X was confirmed accurately. The limit of total quantity of related substances (less than 1%) could be revised to the level of specific impurity X being no more than 0.5%, in this effective quality control method of Co-Q10 soft capsules. The revised level is suggested to be included in the corresponding standard of the supplement taken from the Pharmacopoeia of the People's Republic of China (2015 edition). This can provide a feasible method for the relevant enterprises and regulatory authorities to control the related substances of coenzyme Q10 soft capsules.
Subject(s)
Antioxidants/chemistry , Capsules/chemistry , Drug Compounding , Ubiquinone/analogs & derivatives , Antioxidants/therapeutic use , Biological Availability , Capsules/therapeutic use , China , Dietary Supplements , Humans , Ubiquinone/chemistry , Ubiquinone/therapeutic useABSTRACT
Objective To investigate the effects of butylphthalide soft capsules on cognitive function and daily living ability in patients with Parkinson's disease dementia(PDD). Methods From January 2016 to January 2017, 90 patients with PDD in the First People's Hospital of Wenling were divided into control group and study group by random number table method,with 45 cases in each group. The patients in the two groups were treated with conventional symptomatic treatment, and the control group was treated with donepezil, the study group was treated with butylphthalide soft capsules on this basis. The treatment time was 12 weeks. The clinical efficacies of the two groups were compared. Before treatment and 12 weeks after treatment,the cognitive functions of patients were assessed by Montreal cognitive assessment scale (MoCA) and mini - mental state examination (MMSE),and the daily living abilities of patients were assessed by Barthel index scale. Results The total effective rate of the study group was 93. 33％ ,which was higher than 75. 56％ of the control group (χ2 = 5. 414,P < 0. 05). 12 weeks after treatment,the scores of MoCA and MMSE scales in the two groups were (20. 54 ±2. 53)points,(18. 95 ± 2. 63)points,(23. 53 ± 2. 87)points,(22. 53 ± 2. 62)points,respectively,which were significantly higher than those before treatment[(16. 78 ±2. 34)points,(16. 03 ± 2. 24)points,(16. 23 ± 2. 78)points,(15. 23 ± 2. 34)points](t = 2. 863,2. 735,3. 062,3. 178,all P < 0. 05),and the scores of MoCA and MMSE scales in the study group were higher than those in the control group (t = 2. 798, 2. 753,all P < 0. 05). 12 weeks after treatment,the Barthel scores of the two groups were (64. 43 ± 5. 89) points, (76. 33 ± 5. 23 ) points, respectively, which were significantly higher than those before treatment [( 59. 34 ± 4. 83)points,(58. 26 ± 6. 65)points](t = 2. 916,3. 203,all P < 0. 05),and the Barthel score in the study group was higher than that in the control group (t = 2. 835,P < 0. 05). The incidence rate of adverse reaction in the control group was 6. 67％ ,which in the study group was 8. 89％ ,there was no statistically significant difference between the two groups (χ2 = 0. 155,P > 0. 05). Conclusion Butylphthalide soft capsules can significantly improve the cognitive function and daily living ability of patients with PDD,which is suitable for clinical application and promotion.
ABSTRACT
Objective To evaluate the clinical effects of Shendan-Huoxue capsule combined with etoposide soft capsule in the treatment of advanced ovarian cancer in the elderly patients. Methods A total of 94 elderly patients with ovarian cancer who met the inclusion criteria were divided into 2 groups using random number table method, 47 patients in each group. All patients were given conventional chemotherapy, the control group was given etoposide soft capsule on this basis, and the observation group was given Shendan-Huoxue capsule on the basis of the control group. Both groups were treated for 12 weeks and followed up for 2 years. Ovarian cancer specificity scale version 4 (FACT-OV4) was used to evaluate the life quality of the patients, flow cytometry was used to detect the level of CD3+, CD4+, CD8+, CD19+. Ovarian cancer was detected by CT, toxic and side effects during treatment were recorded, and clinical efficacy was evaluated. Results The total effective rate in the observation group was 87.2% (41/47), and that in the control group was 70.2% (33/47). The difference between the two groups was statistically significant (χ2=3.782, P=0.041). The 1-year survival rate was 87.2% (41/47) and 2-year survival rate was 61.7% (29/47) in the observation group, and 74.4% (35/47) and 53.2% (25/47) in the control group, respectively. The 1-year and 2-year survival rates of the two groups were statistically significant (χ2=4.109, 4.268 respectively, P=0.038, 0.036). The median total survival time in the observation group and the control group was 13.9 months (95% IC 12.4-16.2) and 10.3 months (95% IC 8.2-14.1), respectively. The median total survival time in the observation group was significantly longer than that in the control group (P<0.05). After treatment, scores of social/family status and functional status in the observation group were significantly higher than those in the control group (t values were 3.711 and 4.003, respectively, P<0.05), and scores of additional attention, physiological status and emotional status were significantly lower than those in the control group (t values were 4.335, 4.522 and 4.202, respectively, P<0.05). After treatment, the levels of CD3+, CD4+, CD8+, CD19+ in the observation group were all higher than those in the control group (t values were 7.217, 7.129, 7.434 and 6.521, respectively, P<0.01 or P<0.05). During the period of treatment , the incidence of skin rash, liver function injury, decreased white blood cell count, nausea and vomiting, peripheral neuropathy, diarrhea and abdominal pain in the observation group were significantly lower than those in the control group (χ2 values were 4.114, 4.782, 4.521, 3.911, 3.931, 3.821, P<0.05, respectively). Conclusions The Shendan-Huoxue capsule combined with etoposide soft capsule can improve the survival time of elderly patients with advanced ovarian cancer, improve the body immunity, reduce toxic and side effects, and the clinical effect is better than conventional chemotherapy.
ABSTRACT
OBJECTIVE： To investigate the similarity of in vitro dissolution curve between the generic drugs and the reference preparation （original drugs） of the domestic Cyclosporine soft capsules in 6 dissolution mediums. METHODS： The dissolution test was performed with paddle method. 2％ SDS water solution， 2％ SDS pH 1.2 hydrochloric acid solution， 2％ SDS water solution， 2％ SDS pH 4.5 acetate buffer solution， 2％ SDS pH 5.5 acetate buffer solution， 2％ SDS pH 6.8 phosphate buffer solution and 2％ SDS simulated gastric fluid were used as the dissolution medium， and the rotation speed was 50 r /min. HPLC method was used. The determination was performed on Agilent Eclipse XDB-C18 column with mobile phase consisted of acetonitrile phosphate solution （73 ∶ 27 ∶ 0.25，V/V/V），the flow rate was 1.0 mL/min. The detection wavelength was set at 226 nm， the column temperature was 60 ℃， and sample size was 20 μL. The dissolution curves in 6 medium were drawn and the similarity factor （f2） was used to investigate the similarity between the samples from 3 domestic manufacturers （5 batches） and a batch of original drugs. RESULTS： The linear range of cyclosporine was 5-250 μg/mL （r＝0.999 6-0.999 9）； RSDs of precision， stability （12 h） and reproducibility tests were lower than 2.0％ （n＝6 or 7）； the recoveries were 98.4％-99.7％ （RSD＜2.0％， n＝9）. The cumulative dissolution of 6 batches of samples within 15 min reached 85％ in 2％ SDS pH 1.2 hydrochloric acid solution and 2％ SDS simulated gastric juice. f2 of the dissolution curve of 5 batches of generic and original drugs of Cyclosporine soft capsules were 75， 45， 57， 42， 83 in 2％ SDS water solution and 44， 76， 38， 32， 76 in 2％ SDS pH 4.5 acetate buffer solution 76， 47， 49， 40， 79 in 2％ SDS pH 5.5 acetate buffer solution and 52， 49， 55， 48， 80 in 2％ SDS pH 6.8 phosphate buffer solution， respectively. CONCLUSIONS： There have differences in the similarity of the dissolution curve between the domestic generic and the original drugs of 5 batches of Cyclosporin soft capsule from 3 domestic manufacturers.
ABSTRACT
Objective To observe the curative effect of Maren Soft Capsules in the treatment of senile constipation. Methods A total of 120 elderly patients with constipation were randomly divided into the observation group and the control group with 60 patients, in each group had. The observation group was treated with Maren Soft Capsules, and the control group was treated with Maren Pills. After one week's treatment, the efficacy and symptom improvement of the two groups were observed. Results The total effective rate of the observation group was 90.0%, which was significant higher than that of the control group (P < 0.05), and the dry stool, defecation, defecation incompletely, and abdominal distension symptoms were obviously improved. There was no obvious adverse reaction in two groups during the treatment. Conclusion Maren Soft Capsules are effective in the treatment of senile constipation.
ABSTRACT
OBJECTIVE:To observe the effects of Alprostadil dried emulsion for injection combined with Butylphthalide soft capsules on nerve function,inflammatory factor and coagulation function of patients with severe ischemic stroke. METHODS:A total of 66 patients with severe ischemic stroke selected from our hospital during Jun. 2015-Oct. 2017 were divided into control group and observation group according to random number table,with 33 cases in each group. On the basis of routine treatment, control group was additionally given Butyphthalide soft capsules 0.2 g/time,orally at fasting state,tid. On the basis of control group,observation group was additionally given Alprostadil dried emulsion for injection 10 μg added into 0.9% Sodium chloride injection 10 mL,via slow infusion or slow dripping with pipkin,qd. Both groups were treated for 14 days. NIHSS and Barthel index scores,the levels of serum inflammatory factors(CRP,PCT)and coagulation function indexes(D-D,TT,PT,APTT, FIB)were observed in 2 groups before and after treatment,and the occurrence of ADR was also recorded. RESULTS:Before treatment,there was no statistical significance in above indexes between 2 groups(P>0.05).After treatment,NIHSS scores,the levels of CRP,PCT,D-D and FIB in 2 groups were deceased significantly,while Barthel index scores were increased significantly,TT,PT,APTT were prolonged significantly;observation group was significantly better than control group,with statistical significance(P<0.05). No obvious ADR was found in 2 groups. CONCLUSIONS:Alprostadil dried emulsion for injection combined with Butylphthalide soft capsules can effectively improve nerve function and coagulation function of patients with severe ischemic stroke,and reduce the levels of inflammatory factor with good safety.
ABSTRACT
Objective: To establish a rapid MS method for the determination of nine principal active components (danshensu, caffeic acid, rosmarinic acid, salvianolic acid B, salvianolic acid A, tanshinone I, cryptotanshinone, tanshinone IIA, and ursolic acid) in Dandeng Tongnao Soft Capsules (DTSC), in order to make a comprehensive evaluation of the quality of drugs by pattern recognition technology. Methods: The UPLC-MS/MS method was used and the chromatographic conditions were as follows: The column was Acquity UPLC® BEH C18 (50 mm × 2.1 mm, 1.8 μm); The mobile phase was consisted of acetonitrile-water (containing 0.1% formic acid) at a flow rate of 0.2 mL/min with gradient elution; Mass spectrometer conditions: a triple quadrupole mass spectrometer equipped with electrospray ionization source (ESI) was used in positive and negative ion mode, and multiple reaction monitoring (MRM) was performed except ursolic acid in selected ion recording (SIR) for quantitative analysis of these compounds; The results of determination were calculated by the pattern recognition function of multivariate data processing software SIMCA 14.0 to evaluate the quality of DTSC. Results: Under the optimized conditions, danshensu, caffeic acid, rosmarinic acid, salvianolic acid B, salvianolic acid A, tanshinone I, cryptotanshinone, tanshinone IIA, and ursolic acid all showed good liners in the ranges of 100.0-1 000.0, 1.0-10.0, 8.0-80.0, 120.0-1 200.0, 15.0-150.0, 40.0-400.0, 10.0-100.0, 10.0-100.0, and 1.2-12.0 μg/mL, respectively (r ≥ 0.999 6). The recoveries were ranged from 98% to 101%, and RSDs were below 3%. The average contents in 10 batches of DTSC were (4.854 ± 0.314), (0.063 ± 0.005), (0.764 ± 0.070), (12.937 ± 0.648), (1.954 ± 0.178), (3.623 ± 0.221), (0.720 ± 0.062), (1.437 ± 0.116), and (0.073 ± 0.007) mg/g, respectively. The data were analyzed by SIMCA 14.0 software, and the results showed that the quality deviation of 10 batches of DTSC was below 2 SD (standard deviation, SD) range. Conclusion: The result shows that the UPLC-MS/MS method is simple, sensitive, and accurate for the rapid determination of main active components in the DTSC; It also shows that the quality of DTSC is stable in the different batches and displays an overall comprehensive evaluation of the drug quality using the multivariate data pattern recognition method, and provides a scientific basis and data processing method for the quality control of this drug.
ABSTRACT
Objective To explore the clinical effect of ozone combined with nifuratel nystatin vaginal soft capsules on the treatment of vaginitis, and to provide the basis for clinical application. Methods 204 patients with vaginitis in our hospital from January 2013 to December 2016 were divided into the observation group (114 cases) and the control group (90 cases) according to the different treatment methods. The control group was treated with nifuratel nystatin vaginal soft capsules, and the observation group was treated with ozone combined with nifuratel nystatin vaginal soft capsules. The clinical efficacy, symptom relief time and adverse reaction were compared between the two groups. Results After treatment, the total effective rate in the observation was 97.37%, which was significantly higher than 85.56% in the control group(P<0.05). The rapid remission rate of the clinical symptoms in the observation group was significantly higher than that in the control group (P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups.Conclusion The effect is significant that ozone combined with nifuratel nystatin vaginal soft capsules is used on the treatment of vaginitis, which can quickly relieve symptoms, and will not significantly increase the adverse reactions, is worthy of application.
