Comprehensive Clinical Evaluation of Duliang Soft Capsules in Treatment of Migraine with Wind-cold Blood Stasis Syndrome / 中国实验方剂学杂志

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.

Network meta-analysis of five Chinese patent medicines in the treatment of coronary microvascular disease / 国际中医中药杂志

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.

Expert consensus on clinical application of Lixuwang~® Xuesaitong Soft Capsules / 中国中药杂志

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.

Simultaneous determination of 10 constituents in Huoxiang zhengqi soft capsules by UPLC-MS/MS / 中国药房

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.

Network pharmacology study of Yinqiao Jiedu Soft Capsules in treatment of COVID-19 / 中草药

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.

Effects of butylphthalide soft capsules on cognitive function and daily living ability in patients with Parkinson's disease dementia / 中国基层医药

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.

Clinical effects of Shendan-Huoxue capsule combined with etoposide soft capsules in the treatment of advanced ovarian carcinoma in elderly patients / 国际中医中药杂志

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.

Study on Dissolution in vitro of Cyclosporine Soft Capsules from 3 Domestic Manufacturers / 中国药房

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.

Observation on curative effect of Maren Soft Capsules in treatment of senile constipation / 中草药

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.

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 / 中国药房

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.

Quantitative research on multiple active components in Dandeng Tongnao Soft Capsules by UPLC-MS/MS-pattern recognition / 中草药

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.

Observation on curative effect of ozone combined with nifuratel nystatin vaginal soft capsules on the treatment of vaginitis / 中国生化药物杂志

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.

Clinical efficacy of butylphthalide soft capsules for treatment of acute cerebral infarction and its effect on the inflammatory reaction of patients / 新乡医学院学报

Objective To observe the clinical efficacy of butylphthalide soft capsules for treatment of acute cerebral infarction and its effect on the neurological function and inflammatory reaction of patients.Methods A total of 100 patients with acute cerebral infarction in the First Hospital of Zhangjiakou City and the Third Hospital Affiliated to Hebei North University from January 2016 to October 2016 were selected and divided into control group (n =50) and treatment group (n =50) according to the treatment protocols.The patients in the control group were given anti-platelet aggregation,statins,and other routine treatment;based on this,the patients in treatment group were orally administrated with butylphthalide soft capsules.The elbow venous blood of patients in the two groups was collected and the C reactive protein(CRP),interleukin-6 (IL-6) levels,the platelet aggregation rate were detected.The change of National Institute of Health stroke scale(NIHSS) score of patients after four weeks treatment was compared between the two groups.The recovery of neurological function of patients in the two groups was evaluated by modified Rankin grading after three months treatment.Results There was no statistic difference in the CRP,IL-6 levels and platelet aggregation rate before treatment between the two groups (P ＞ 0.05).The CRP,IL-6 levels and platelet aggregation rate of patients in the two groups after one week treatment were significantly lower than those before treatment (P ＜ 0.05);and the CRP,IL-6 levels and platelet aggregation rate of patients in the treatment group were significantly lower than those in the control group after one week treatment (P ＜ 0.05).The NIHSS score of patients in the treatment group was significantly lower than that in the control group after four weeks treatment (P ＜ 0.05);the Rankin score of patients in the treatment group was significantly lower than that in the control group after three months treatment (P ＜ 0.05).The total effective rate of patients in the treatment group was significantly higher than that in the control group (x2 =13.22,P ＜ 0.05).Conclusion Butylphthalide soft capsules can significantly reduce the inflammatory reaction in patients with acute cerebral infarction,improve and recover the neurologic impairment;and its curative effect is remarkable.

Effect of calcitriol soft capsules combined with telmisartan tablets in treatment of early diabetic nephropathy / 中国生化药物杂志

Objective To investigate the effect of calcitriol soft capsules and telmisartan tablets for the treatment of early diabetic nephropathy.Methods 80 cases of early diabetic nephropathy in 254 hospital of Chinese people's liberation army were selected.According to the treatment methods,they were divided into the conventional medication group(40 cases,Telmisartan Tablets were used)and the combined medication group(40 cases,telmisartan tablets combined with calcitriol soft capsules were used).The therapeutic effects in the two groups were compared.Results In the combined group,renal function improved significantly better than that in the control group(P<0.05).The total effective rate in the combined medication group is higher than that in the conventional group(P< 0.05).Conclusion the treatment of and It was effective which calcitriol soft capsules combined with telmisartan tablets on the treatment in the early stage of diabetic nephropathy,it can improve renal function and delay the disease progression.

Determination of Aflatoxin B1 in Pharmaceutical Excipient Oil in Soft Capsules by LC-MS/MS / 中国药师

Objective:To assay aflatoxin B1 in the oil as a pharmaceutical excipient in soft capsules by LC-MS/MS. Methods:Aflatoxin B1 was extracted from the peanut oil in soft capsules by the solvent composed of methanol and 0. 1% formic acid solution, and then centrifuged and the supernatant was purified by neutral alumina cartridges and tested after the concentration with the mobile phase consisting of methanol and 0. 1% formic acid solution with gradient elution at the flow rate of 0. 3 ml·min-1 . 25μl of the tested solu-tion was injected for the analysis at the column temperature of 30℃. Electrospray ionization ( ESI) source was applied and operated in the position ion mode. Multiple reactions monitoring ( MRM) mode was used to quantify the samples. Results:Aflatoxin B1 was in good linearity within the range of 0. 098-1. 960 μg·L-1(r=0. 999 5). The limit of detection was 0. 05 μg·L-1. The average sampling recovery was 97. 73% (n=6) with RSD of 4. 625%. Conclusion:The method is proved to be sensitive, accurate, specified and re-producible, which is referential for the assay of aflatoxin B1 in oily preparations.

Effects of Perioperative Application of ELP Enteric Soft Capsules on Therapeutic Efficacy and Prognosis in Children after Grommet Insertion of Chronic Secretory Otitis Media / 中国药房

OBJECTIVE:To investigate the effects of perioperative application of Eucalyptol,limonene and pinene(ELP)en-teric soft capsules on therapeutic efficacy and prognosis in children after grommet insertion of chronic secretory otitis media. METH-ODS:92 cases(145 ears)of chronic secretory otitis media were divided into 2 groups by random number table method,including 46 cases in observation group(68 ears)and 46 cases in control group(77 ears). Both groups received grommet insertion under gen-eral anesthesia by otomicroscope. Control group was not given any drugs;observation group was given ELP enteric soft capsules 1.2 g,bid,from 3 d before operation to 5 d after operation. Subjective therapeutic efficacy and pure tone audiometry of 2 groups were observed 3 days,5 days,2 weeks,1 month and 3 months after surgery as well as acoustic impedance monitoring in children with tube withdrawal from ear 1 month and 3 months after surgery. RESULTS:The total effective rates of observation group 3 days,5 days,2 weeks,1 month and 3 months after surgery were 72.06%,82.35%,85.29%,89.70%and 95.59%;those of con-trol group were 59.74%,66.23%,80.52%,87.01% and 92.21%,with statistical significance(P<0.05). The pure tone audiome-try score of observation group 3 days,5 days,2 weeks,1 month and 3 months after surgery were significantly lower than those of control group,with statistical significance(P<0.05). Therapeutic effective rates of acoustic impedance monitoring in children with tube withdrawal from ear 1 month and 3 months after surgery were 77.78% and 90.48% in observation group,which were signifi-cantly higher than 61.54% and 81.48% in control group,with statistical significance(P<0.05). CONCLUSIONS:The periopera-tive application of ELP enteric soft capsules can significantly improve function recovery and hearing level in children after grommet insertion of chronic secretory otitis media.

Inhibitory Effects of Typhonium Giganteum Soft Capsules on Transplantation Tumor and Expression of p53 Gene in Human Liver Cancer Hep-2 Tumor-bearing Nude Mice / 中国中医药信息杂志

Objective To observe the inhibitory effects of Typhonium Giganteum soft capsules on tumor growth in Hep-2 tumor-bearing nude mice and its effects on the expression of tumor suppressor p53 gene; To discuss its mechanism of action.Methods Human liver cancer Hep-2 cell suspension back subcutaneous vaccination was conducted to prepare tumor models. BALB/c nude mice were randomly divided into model group, cisplatinum group, and TCM high-, medium-, and low-dose groups. Each group was given relevant medicine for gavage, once a day for 21 days. Growth changes of tumor volume were monitored; HE staining was used to observe pathological changes of tumor tissues; RT-PCR was used to detect the expression of p53 gene in tumor tissue of Hep-2 nude mice.Results Compared with the model group, all medication groups could inhibit the tumor growth, and the anti-tumor rates were 55.1%, 42.8%, 30.1%, and 79.5%, respectively; the expression of p53 gene increased; pathological observation results showed that the number and the volume of tumor cells increased, with cytoplasm rarefaction and nucleus anachromasis. All medication groups had karyopyknosis, slight staining, and decreasing blood capillary and focal necrosis in varying degrees.ConclusionTyphonium Giganteum soft capsules can inhibit the growth of human liver cancer, and its mechanism may be associated with the up-regulating expression of p53 gene leading to apoptosis.

Curative effect of Eucalyptol on the treatment of chronic rhinosinusitis / 中国耳鼻咽喉头颈外科

OBJECTIVE To explore the curative effect of Eucalyptol on the treatment of chronic rhinosinusitis (CRS). METHODS CRS patients were randomly divided into treatment group (conventional medications plus Eeucalyptol) and control group (conventional medications). The therapeutic effect of Eucalyptol were objectively and subjectively evaluated after treatment. RESULTS Evaluation at 3, 6 and 12 month after treatment, we found that the curative effect of the treatment group was better than that of the control group. There was a significant difference. CONCLUSION Eucalyptol as a kind of mucus dissolving medication, it has good treatment effect for CRS and is worth popularizing.

Clinical Observation of Piracetam Combined with Butylphthalide Soft Capsules in the Treatment of Patients with Lacunar Infarction Complicated with Vascular Cognitive Impairment / 中国药师

Objective:To observe the clinical efficacy and safety of piracetam tablets combined with butylphthalide soft capsules in the treatment of patients with lacunar infarction(LI) complicated with vascular cognitive impairment(VCI). Methods:Totally 87 cases of patients with LI and VCI were selected and randomly divided into the control group(44 cases)and the treatment group(43 cases). The control group was only treated with piracetam tablets(1. 2 g,tid),while the treatment group was treated with piracetam tablets(1. 2 g,tid)and butylphthalide soft capsules(0. 2 g,qid),and the treatment course was 30 days. The changes of MMSE score,serum of SOD level and adverse drug reactions were observed and compared in the two groups. Results:Compared with those before the treatment,the mini-mental state examination(MMSE)score and serum level of SOD of the two groups were increased(P < 0. 01)after the treatment,and the increase in the treatment group was more notable than that in the control group(P < 0. 01and P < 0. 05). The effective rate of the treatment group was 86. 05% ,which was higher than that of the control group(75. 00% ,P < 0. 05). Conclusion:Piracetam combined with butylphthalide soft capsules can effectively improve the cognitive impairment of the patients with LI and VCI,and the effect may be related with increasing the level of SOD.

Randomized Controlled Trials on Compound Shenqi Soft Capsules in Children with Functional Dyspepsia / 中国药师

Objective:To evaluate the clinical effects of compound Shenqi soft capsules in the children with functional dyspepsia(FD). Methods:A stratified random,parallel,control and non-blind design was used,and the children with FD were randomly divided into groups after stratified by age. The children in the trial group were given compound Shenqi soft capsules,one capsule for the children with age under three and two capsules for the children with age over three,tid. The control group was treated with compound Shenqi granules,half a bag for the children with age under three and 1 bag for the children with age over three,tid. The treatment course was one month. The two groups were compared by the symptoms of bellyache,abdominal distension,early satiety,belching and nausea. The electrogastrogram was analyzed in two groups. Results:Compound Shenqi soft capsules could improve the symptoms of ballyache,abdominal distension,early satiety,belching and nausea obviously,increase normal rhythm and reduce bradygastria obviously,and there were significant differences compared with those before the treatment(P < 0. 05). The trial group was better than the control group in the improvement of ballyache,abdominal ditension,early satiety and bradygastria,and the difference was significant(P < 0. 05). The total effective rate of the trial group was 91. 9% ,while that of the control group was 78. 3% ,and the difference was statistically significant(P < 0. 05). Conclusion:The clinical effect of compound Shenqi soft capsules is satisfied without any adverse reaction during the test,suggesting the capsules are suitable for clinical application.