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OBJECTIVE To establish a method for the content determination of 11 components such as protodioscin in Guge fengtong tablets， and to evaluate the comprehensive quality of Guge fengtong tablets by combining with chemometric analysis and entropy weight-technique for order preference by similarity to ideal solution （EW-TOPSIS） method. METHODS HPLC method was adopted. The determination was performed on Agilent Eclipse Plus C18 column with a mobile phase consisted of acetonitrile- 0.2% phosphoric acid solution at the flow rate of 1.0 mL/min by gradient elution. The column temperature was set at 30 ℃ . The detection wavelengths were set at 203 nm （0-28 min， protodioscin， methyl protodioscin， pseudoprotodioscin， dioscin） and 280 nm （28-60 min， catechin， epicatechin， liquiritigenin， medicarpin， 6-gingerol， 8-gingerol， 10-gingerol）； the sample size was 10 μL. Using epicatechin as the internal reference， quantitative analysis of multi-components by single marker （QAMS） method was used to determine the contents of protodioscin， methyl protodioscin， pseudoprotodioscin， dioscin， catechin， liquiritigenin， medicarpin， 6-gingerol， 8-gingerol and 10-gingerol， which were compared with the results of the external standard method. SPSS 26.0 software and SIMCA 14.1 software were used for principal component analysis and orthogonal partial least squares-discriminant analysis， with variable importance in projection （VIP） value greater than 1 as the standard， to screen for differential markers that affect the quality； the EW-TOPSIS method was adopted to evaluate the quality of 15 batches of samples comprehensively.RESULTS The contents of protodioscin， methyl protodioscin， pseudoprotodioscin， dioscin， catechin， liquiritigenin， medi-carpin， 6-gingerol， 8-gingerol and 10-gingerol determined by HPLC combined with QAMS were 6.330-10.863， 1.150-2.274， 0.431- 0.740， 2.818-4.823， 0.826-1.510， 0.043-0.094， 0.079-0.231， 0.479-1.020， 0.146-0.288， 0.118-0.318 mg/g， respectively； there were no statistical significances， compared with the external standard method （P＞0.05）. A total of 15 batches of samples were clustered into 3 groups， with S1-S6， S7-S10， and S11-S15 clustered into one group， respectively. The VIP values of protodioscin， epicatechin， dioscin and 6-gingerol were greater than 1. Euclidean closeness values of the optimal solution （C）i for 15 batches of samples were 0.163 5 to 0.703 7， and Ci values of S11-S15 were all higher than 0.6. CONCLUSIONS The established QAMS method is accurate and simple， and can be used for comprehensive quality evaluation of Guge fengtong tablets， by combining with chemometric analysis and EW-TOPSIS method. Protodioscin， epicatechin， dioscin and 6-gingerol are the differential markers that affect the quality of Guge fengtong tablets. Samples S11-S15 have better quality.
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ObjectiveTo evaluate the efficacy and safety of Lianhua Qingke tablets in the treatment of acute bronchitis in children with the syndrome of phlegm-heat obstructing lung. MethodA randomized， open， parallel controlled， and multi-center clinical study was conduted. Children with acute bronchitis （syndrome of phlegm-heat obstructing lung） were randomly assigned to an observation group and a control group. The control group received routine basic treatment， and the observation group was treated with Lianhua Qingke Tablets on the basis of routine basic treatment. After 7 days of treatment， the clinical efficacy， TCM efficacy， time to symptom disappearance， time to cough disappearance， and clinical safety were compared between the two groups. ResultA total of 248 children were included （124 in the observation group and 124 in the control group）. After 7 days of treatment， the total response rate in terms of clinical efficacy in the observation group was 96.8% （120/124）， which was higher than that （90.3%， 112/124） in the control group （Z=-5.034， P<0.01）. The total response rate in terms of TCM syndrome in the observation group was 97.6% （121/124）， which was higher than that （93.5%， 116/124） in the control group （χ2=-5.326， P<0.01）. The scores of physical signs and TCM symptoms in the observation group were lower than those in the control group at the time of taking medicine for 3 days and 7 days （P<0.01）. The time to symptom disappearance and the time to cough disappearance in the observation group were shorter than those in the control group （P<0.01）. Drug-related adverse reactions occurred in neither group. ConclusionLianhua Qingke tablets demonstrate a definite effect on acute bronchitis in children with the syndrome of phlegm-heat blocking lung. The tablets can significantly shorten the course of disease and relieve cough and TCM symptoms， with high safety， which is worthy of clinical application and promotion.
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ObjectiveTo explore the clinical efficacy and safety of Fuzheng Huaji Longbi decoction in treating benign prostatic hyperplasia （BPH） in the patients with the syndrome of healthy Qi deficiency and blood stasis. MethodA total of 94 BPH patients were randomized into control and observation groups， with 47 patients in each group. The control group was treated with doxazosin mesylate sustained-release tablets， and the observation group with Fuzheng Huaji Longbi decoction on the basis of the therapy in the control group. After eight weeks， the international prostate symptom score （IPSS）， quality of life （QOL） score， residual urine volume （RUV）， maximum urinary flow rate （Qmax）， TCM syndrome score， TCM symptom score， electrocardiogram， and liver and kidney function were determined to evaluate the clinical efficacy and safety of the two groups. ResultAfter 8 weeks of treatment， the total response rate in the control group was 63.64% （28/44）， which was lower than that （84.44%， 38/45） in the observation group （χ2=5.026， P<0.05）. The clinical efficacy in the observation group was higher than that in the control group （Z=-2.17， P=0.030）. The treatment in both groups decreased the IPSS， QOL score， RUV， and TCM syndrome scores and increased the Qmax （P<0.05）. Moreover， the observation group had lower IPSS， QOL score， RUV， and TCM syndrome score （P<0.05） and higher Qmax than the control group after treatment （P<0.05）. The treatment in the observation group decreased all the TCM symptom scores （P<0.05）， while that in the control group only decreased the frequency of urination at night and the scores of dysuria， weak urine stream， and post-urinary drainage （P<0.05）. After treatment， the observation group had lower frequency of urination at night and lower scores of mental fatigue， cold limbs， lower abdominal discomfort， and loose stool than the control group （P<0.05）. No adverse events associated with the administration of Fuzheng Huaji Longbi decoction were observed during the treatment period. ConclusionFuzheng Huaji Longbi decoction is effective in treating BPH in the patients with the syndrome of healthy qi deficiency and blood stasis. It can relieve the clinical symptoms and improve the quality of life， being a safe and reliable choice for clinical application.
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ObjectiveTo observe the clinical efficacy and safety of Tengfu Jiangya tablets combined with valsartan/amlodipine in the treatment of grade 2 hypertension with liver Yang hyperactivity syndrome. MethodAccording to a randomized，double-blind，and placebo parallel control method，288 patients with grade 2 hypertension with liver Yang hyperactivity from 7 subcenters were included. They were randomly divided into an observation group （144 cases） and a control group （144 cases），and then treated with Tengfu Jiangya tablets combined with valsartan/amlodipine and placebo combined with valsartan/amlodipine，respectively. The efficacy was evaluated after four weeks of intervention. During the experiment，the safety indicators and adverse reaction events of the subjects were recorded for safety evaluation，and the efficacy indicators and TCM syndrome scores were recorded for effectiveness evaluation. Sensitivity analysis was also conducted on the statistical results of the main efficacy indicators such as blood pressure （BP） compliance rate to ensure the accuracy of the analysis results. 88 groups of blood samples from each of the treatment and control groups were included as test subjects. Fasting blood samples were collected from the patients in the clinical trial on the day before and after medication，and enzyme linked immunosorbent assay （ELISA） was performed on the treated serum. The levels of arachidonic acid （AA），thromboxane B2 （TXB2），and prostaglandin E2 （PGE2） in the serum of the patients before and after treatment were measured to explore the regulation of inflammatory factors in the body by Tengfu Jiangya tablets. ResultA total of 271 patients （133 in the observation group and 138 in the control group） completed the trial. There was no statistically significant difference before and after treatment in such safety indicators as the blood routine （white blood cells，red blood cells，and platelets），urine routine （urinary protein and urinary red blood cells），alanine aminotransferase，aspartate aminotransferase，creatinine，urea，and abnormal electrocardiogram，and no serious adverse reactions were observed. After four weeks，the systolic blood pressure （SBP） difference and diastolic blood pressure （DBP） difference of patients in the observation group were greater than those in the control group（P<0.01）. According to the criteria for determining the antihypertensive effect，the overall response rate in the observation group［89.47%（119/133）］ was higher than that in the control group［57.97%（80/138）］ （Z=2.593，P<0.01）. The SBP compliance rate was 61.65%（82/133） and 37.68%（52/138） in the observation group and control group， respectively. The DBP compliance rate in the observation group was 78.20%（104/133），while in the control group it was 55.07%（76/138）. The overall BP compliance rate in the observation group was 48.12%（64/133），while in the control group it was 23.19%（32/138）. The BP compliance rates in the observation group were all significantly higher than those in the control group（χ2=15.571，16.236，18.404，P<0.01）. According to the criteria for evaluating the therapeutic effect of TCM syndrome integration，the overall response rate of the observation group［57.89%（77/133）］ was higher than that of the control group［38.41%（53/133）］ （Z=-3.172，P<0.01）.Compared with those before treatment， the levels of serum AA and TXB2 in the two groups were significantly decreased after treatment （P<0.01）， and the level of PGE2 in the observation group was significantly increased （P<0.01）. Compared with those of the control group after treatment， the levels of AA and TXB2 in the observation group were significantly decreased， while the level of PGE2 was significantly increased （P<0.01）. The results suggest that Tengfu Jiangya tablets can effectively reduce inflammatory factors，reduce the production of inflammatory mediators，and thus prevent the occurrence of inflammatory reactions in the treatment of patients with grade 2 hypertension. ConclusionTengfu Jiangya tablets can more effectively reduce patients' SBP and DBP，improve their BP compliance rates，and improve their TCM syndromes in the treatment of grade 2 hypertension with liver Yang hyperactivity. Its clinical application is safe. Tengfu Jiangya tablets has outstanding clinical efficacy and can be used as an effective intervention method for the treatment of grade 2 hypertension with liver Yang hyperactivity syndrome.
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Background: The fact that about 90 % of newly discovered API’s or new molecular entity(NME) have little or no aqueous solubility, causes a significant protest to the initialization of development and their scale up of dosage form in the Pharma Industry. Aqueous solubility of API’s has critical role in drug dissolution or availability of drug at the site of action or bioavailability, when a dosage form is administered orally.Objective: The object of this study is to formulate a modified release tablet dosage form of a poorly aqueous soluble drug, which not only have higher aqueous solubility or bioavailability but also have sustained release characteristics with high mechanical strength &their commercial viability. Numerous techniques are available for the solubility enhancement but all individual techniques have its own limitations for commercialization.Method: Aqueous solubility of drugs is improved by the known Solubility enhancement techniques like Micronization &Solid dispersions. After successful solubility enhancement, sustained release or modified release tablets of poorly aqueous soluble drug can be easily formulated into a suitable shape or size by using a known Polymer Matrix Sintering Technology with commercial feasibility. Micronization of poorly water-soluble drugs can be performed by Air Jet Mill or Ball Mill. Whereas Solid dispersion technique involves, molecular dispersion of poorly soluble drug in a suitable inert carrier, to form an amorphous and highly soluble compounds. Sintering Technology is defined as the bonding of adjacent particle surfaces in a mass of powder, or in compact, by the application of heat. Conventional sintering technique involves the heating of compact at a temperature below the melting point of the solid constituents in a controlled environment under atmospheric pressure.Results: Enhanced solubility of poorly soluble API’s by these proposed techniques is due to either conversion of crystalline compound in to amorphous form or reduction of particle size to its molecular level by the application of Micronization or solid dispersion techniques. The developed modified release tablets will show a sustained release characteristic due to Sintering aspect and provides enhanced solubility of BCS class II or IV drugs.Conclusion: Novel modified release tablets have been designed through consolidation of Solubility enhancement and Polymer Matrix Sintering technologies. Simultaneous exploitation of well-known and established approaches- Micronization (optimum particle size reduction) or solid dispersion, optional surfactant and Polymer Matrix Sintering Technique in the recent concept, produces significant enhancement of solubility of poorly water soluble API’s without compromising the content uniformity of dosage form and also provide a modified or sustained release characteristics with high mechanical strength. The release profile of drug can be easily tailored by using combination of both techniques where challenges of low solubility are prominent.
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Purpose: Sildenafil citrate is widely used drug for the treatment of Erectile Dysfunction (ED) and Ginseng is a natural aphrodisiac reported to benefit this condition. The objective of the present study was to develop orodispersible tablets (ODTs) containing combination of Sildenafil citrate and Ginseng extract to improve the bioavailability, reduce the dosing frequency and thereby maintaining the therapeutic efficacy of the drug. Methods: The ODTs were prepared using superdisintegrants such as Croscarmellose sodium (CCS), povidone, and sodium starch glycolate (SSG) at varying concentrations (2%, 4% and 6%) by direct compression. The bitter taste of Sildenafil citrate was masked by Doshion resin. The optimized formulation based on least disintegration time (DT) was chosen to reformulate using sublimating agents such as camphor, menthol or thymol at varying concentrations (1%, 2%, 3%) to further reduce the DT. The compatibility of drug with excipients was investigated and the prepared formulations were evaluated for pre and post-compression parameters. Results: The post-compression parameters such as weight variation, hardness, friability, DT and in-vitro drug release was found within specified limit. The formulation with camphor (2%) had DT of 12 sec and drug release >90% within 5 min hence was considered as optimized formulation. The accelerated stability study and kinetics modelling was performed for optimized formulation. Conclusion: The formulated Sildenafil citrate and Ginseng ODT’s were found to be promising formulation with quicker DT and drug release which will eventually have higher bioavailability and better efficacy along with averting the issues of swallowing and improving patient compliance.
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Buccal tablets
Diclofenac sodium
Drug release
Mucoadhesion
Mucoadhesive tablets
Release kinetics
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Abstract The aim of this study was to compare the dissolution properties of ibuprofen solid oral dosage forms commercially available in Bosnia and Herzegovina and to estimate the influence of dissolution medium composition on the drug release. Eight products (A-H) were subjected to in vitro dissolution test using experimental conditions described in USP42-NF37. Dissolution properties of one selected product were examined in the presence of alcohol (22.2% v/v) and fruit juice (22.2% v/v). Products marked B-H complied with the pharmacopeial criteria. Dissolution profile of product B was similar with dissolution profiles of products D, E, F and G and similarity was also found between products A-D, C-G, D-G and E-F. Drug release from most of the examined preparations fitted best to the Weibull kinetic model. In the presence of alcohol in the medium, higher amount of ibuprofen was dissolved. Contrary, ibuprofen dissolved in the presence of fruit juice was significantly lower. Differences in the dissolution profiles of investigated preparations suggest that their interchangeability should be additionally considered and demonstrated with in vivo bioequivalence studies. Presence of different substances in the medium can affect dissolution properties of ibuprofen, emphasizing the importance of the patient's compliance.
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Ibuprofen/analysis , Interchange of Drugs , Dissolution , Tablets , In Vitro Techniques/methods , Pharmaceutical Preparations/analysis , Drug Liberation/drug effectsABSTRACT
Purpose: To evaluate the usefulness of asenapine sublingual tablets for the treatment of delirium in patients with advanced cancer. Methods: We conducted a retrospective study using electronic medical records of patients with advanced cancer who were admitted to our hospital between October 1, 2019 and September 30, 2022 and who received asenapine sublingual tablets as treatment for delirium. The Agitation Distress Scale (ADS) was used to evaluate the degree of improvement of agitation symptoms caused by delirium. Results: Twenty patients were included in the analysis. The mean ADS(range) before treatment was 12 (4–17), and the mean ADS(range) after treatment was 7.9 (0–18), with the p-value <0.001. Conclusion: Asenapine sublingual tablets may be useful as an option for pharmacological treatment of delirium.
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Objective:To systematically evaluate the clinical efficacy of compound α-ketoacid tablets in the treatment of diabetic kidney disease (DKD).Methods:CNKI, Wanfang database, EMBASE, PubMed and Cochrane Library database were searched for eligible records published from the establishment of individual database to November 13 th, 2022. The quality of the included studies were assessed, data were extracted, and meta-analysis was conducted using RevMan5.3. Results:A total of 26 randomized controlled trials were included, with a total of 2 790 DKD patients (1 465 in the experimental group and 1 325 in the control group). Multiple parameters were significantly improved in the experimental group compared with the control group, including 24-hour urinary protein, blood creatinine, urea nitrogen, nutritional index, oxidative stress level, fasting blood glucose, glycated hemoglobin, homocysteine, HGF, VEGF, TGF-β1, and systolic blood pressure.Conclusions:Limited low-quality evidence showed that compound α-ketoacid tablets combined with low-protein diet may be related to the improved 24-hour urinary protein, renal function, and glucose metabolism in patients with DKD. Due to the lack of randomized controlled trials designed for respective stages of DKD, the inclusion criteria of our study were relatively general, possibly leading to the lack of pertinence of the results. Some indicators showed apparent heterogeneity among different groups, and more high-quality multi-center studies with large sample sizes are still needed to verify our findings.
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Objective:To investigate the effects of Zhibitai capsule combined with pitavastatin calcium tablets on blood lipids, blood glucose, and glycated hemoglobin in patients with coronary heart disease complicated by diabetes mellitus. Methods:A total of 100 patients with coronary heart disease and diabetes mellitus who received treatment in The Third Affiliated Hospital of Jinzhou Medical University from January 2017 to June 2020 were included in this study. They were divided into a control group ( n = 50) and an observation group ( n = 50) according to different treatment methods. Both groups were given conventional treatment such as pitavastatin calcium tablets. The control group was given pitavastatin calcium tablets based on conventional treatment. The observation group was given Zhibitai capsule combined with pitavastatin calcium tablets based on conventional treatment. After 6 months of treatment, serum levels of triacylglycerol, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, fasting plasma glucose, and glycated hemoglobin were compared between the two groups. Results:After treatment, serum levels of triacylglycerol, total cholesterol, low-density lipoprotein cholesterol, fasting plasma glucose, glycated hemoglobin in the observation group were (4.26 ± 0.67) mmol/L, (1.85 ± 0.38) mmol/L, (3.16 ± 0.27) mmol/L, (8.29 ± 1.07) mmol/L, and (8.20 ± 0.77)%, respectively, and they were (4.50 ± 0.39) mmol/L, (1.99 ± 0.19) mmol/L, (3.28 ± 0.27) mmol/L, (8.80 ± 0.66) mmol/L, (8.54 ± 0.74)%, respectively in the control group. After treatment, these indices in each group were decreased compared with those before treatment (control group: t = 19.56, 14.60, 10.66, 8.60, 10.18; observation group: t = 15.04, 14.68, 11.36, 12.36, 12.89, all P < 0.05). After treatment, these indices in the observation group were significantly lower than those in the control group ( t = -2.12, -2.23, 2.26, -2.84, -2.44, all P < 0.05). After treatment, the level of high-density lipoprotein cholesterol in the observation and control groups was (1.16 ± 0.18) mmol/L and (1.09 ± 0.13) mmol/L, respectively. After treatment, the level of high-density lipoprotein cholesterol in each group was increased compared with that before treatment (control group: t = -11.10, observation group: t = -11.07, P < 0.05). After treatment, the level of high-density lipoprotein cholesterol in the observation group was significantly higher than that in the control group ( t = 2.11, P < 0.05). Conclusion:Zhibitai capsule combined with pitavastatin calcium tablets can greatly improve the level of blood lipids and blood glucose in patients with coronary heart disease complicated by diabetes mellitus.
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Objective:To explore the effects of Bifidobacterium triple viable capsules combined with Berberine tablets on blood lipid and intestinal flora in patients with hyperlipidemia.Methods:A total of 420 hyperlipidemia patients admitted to the Second Medical Center of PLA General Hospital & National Clinical Research Center for Geriatric Diseases from January 2019 to December 2020 were selected and divided into the observation group and the control group according to the random number table method, with 210 cases in each group. Both groups were routinely given lipid-lowering drugs, the control group was also given Bifidobacterium triple viable capsules orally, and the observation group was combined with Berberine tablets orally on the basis of the control group. The levels of serum inflammatory factor, blood lipid, apolipoprotein and the number of intestinal flora before and after treatment were compared between the two groups. The incidence of adverse reactions was compared between the two groups during the treatment.Results:After treatment, the levels of interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), high-sensitivity C-reactive protein (hs-CRP) in the observation group were significantly lower than those in the control group: (26.78 ± 5.63) ng/L vs. (30.06 ± 5.79) ng/L, (12.88 ± 4.76) ng/L vs. (15.45 ± 5.32) ng/L, (8.22 ± 2.80) mg/L vs. (10.26 ± 3.71) mg/L, there were statistical differences ( P<0.05). After treatment, the levels of blood lipid in the observation group were improve better than those in the control group, the levels of apolipoprotein AⅠ in the observation group was higher than that in the control group: (2.00 ± 0.45) g/L vs. (1.72 ± 0.39) g/L; and the levels of apolipoprotein B and apolipoprotein E in the observation group were lower than those in the control group: (1.08 ± 0.18) g/L vs. (1.20 ± 0.22) g/L, (4.80 ± 0.68) g/L vs. (5.12 ± 0.62) g/L, there were statistical differences ( P<0.05). After treatment, the numbers of Bifidobacterium and Lactic acid bacteria in the observation group were higher than those in the control group: (8.80 ± 0.80) lg CFU/g vs. (8.30 ± 0.75) lg cfu/g, (8.85 ± 0.64) lg cfu/g vs. (8.45 ± 0.68) lg cfu/g; and the numbers of Colon bacillus and Enterococcus faecalis in the observation group were lower than those in the control group: (8.20 ± 0.55) lg cfu/g vs. (8.52 ± 0.50) lg cfu/g, (6.42 ± 0.60) lg cfu/g vs.(6.84 ± 0.65) lg cfu/g, there were statistical differences ( P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups ( P>0.05). Conclusions:Bifidobacterium triple viable capsules combined with Berberine tablets in treatment of patients with hyperlipidemia can effectively reduce the level of blood lipid and regulate intestinal flora, with good safety.
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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.
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Objective To explore the effect of metformin hydrochloride tablets on the clinical efficacy, number of dominant follicles and ovarian volume of polycystic ovary syndrome. Methods 150 patients diagnosed with polycystic ovary syndrome who were diagnosed and treated in our hospital from January 2019 to March 2021 were selected .The patients were divided into observation group and control group by random number table. The control group was treated with letrozole + gonadotropin, and the observation group was treated with letrozole + gonadotropin + hydrochloric acid + Metformin tablets. The clinical efficacy, endometrial thickness, number of high-quality follicles, sex hormone levels, blood lipid levels, and adverse reactions were compared between the two groups. Results ① The effective rate of treatment in the observation group was 90.67%, which was significantly higher than that in the control group, 78.67% (P<0.05). ② After treatment, the endometrial thickness of the observation group was lower than that of the control group, and the number of high-quality follicles was more than that of the control group(P<0.05). ③ After treatment, the levels of Luteinizing Hormone-LH, Follicle Stimulating Hormone-FSH and Testosterone (T) in the observation group were lower than those in the control group (P<0.05). ④ After treatment, the total cholesterol (TC) and triglyceride (TG) in the observation group were lower than those in the control group (P<0.05). ⑤ The incidence of adverse reactions in the observation group was 8.00%, which was significantly lower than 20.00% in the control group (P<0.05). Conclusion Letrozole + gonadotropin + metformin hydrochloride tablets could significantly improve the sex hormone and blood lipid levels in patients with polycystic ovary syndrome, relieve the symptoms of the patients, and improve their uterine condition, which had a good clinical effect.
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Objective To evaluate the release characteristics in vitro, pharmacokinetics in rabbits and in vivo-in vitro correlation of silymarin phospholipid complex microporous osmotic pump controlled release tablets（SM-PC MPOP）. Methods The release characteristics of SM-PC MPOP in vitro were detected by HPLC in the artificial gastric fluid. Six beagle dogs were subjected to double cycle cross control, which were given SM-PC MPOP and Legalon（30 mg/kg）. The concentration of silybin in plasma was determined by HPLC and the data were processed by software. Results The cumulative release rate of SM-PC MPOP in vitro was over 85% in 12 h. The pharmacokinetics in beagle dogs showed that SM-PC MPOP and legalon conformed to double compartment first-order absorption model and the pharmacokinetic parameters were obtained: tmax:（3.2±0.4）and（0.9±0.1）h, Cmax:（0.298 6±0.068 9）and（0.629 9±0.076 5）μg/ml, AUC0→24:（2.996 8±0.583 3）and（2.268 9±0.432 8）h·μg /ml. The relative bioavailability of SM-PC MPOP was（162.21 ± 30.82）%. Conclusion SM-PC MPOP could release slowly, which could increase the relative bioavailability significantly. The correlation between the absorption in vivo and release in vitro was fine（r = 0.839 0）.
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OBJECTIVE To investigate the efficacy and safety of domestic Paliperidone extended-release tablets as a substitute for original Paliperidone extended-release tablets in the treatment of stable schizophrenia. METHODS A total of 65 patients with schizophrenia， who were treated with single original Paliperidone extended-release release tablets for 2 months or more in the outpatient or inpatient department of Shandong Daizhuang Hospital from June 2021 to June 2022， were collected and randomly divided into the domestic group （33 cases） and the original group （32 cases）. The domestic group was treated with the same dose of domestic Paliperidone extended-release tablets instead for 2 months， and the original group continued to use the previous dose of the original drug for 2 months. Positive and negative syndrome scale （PANSS） and treatment emergent symptom scale （TESS） were used to evaluate the two groups at the time of enrollment and the end of 1 week， 1 month and 2 months after enrollment. The incidence of ADR was calculated at the end of 2 months after enrollment. The fasting blood glucose， blood lipid indicators （triglyceride， total cholesterol， low-density lipoprotein， high-density lipoprotein， very-low-density lipoprotein）， serum prolactin levels， and paliperidone blood concentration were determined after the intravenous blood sample was collected. The ratio of paliperidone blood concentration to dose （C/D value） was calculated， and an electrocardiogram was performed. RESULTS There were 31 and 30 patients in the domestic group and the original group who completed the trial， respectively. There were no statistical significances in PANSS score， TESS score or C/D value at the time of enrollment and the end of 1 week， 1 month and 2 months after enrollment； there were no statistical significances in the levels of fasting blood glucose， blood lipid or serum prolactin at the time of enrollment and at the end of 2 months after enrollment （P＞0.05）. PANSS scores of both groups significantly decreased at the end of 1 month and 2 months after enrollment （P＜0.01）. The incidences of ADR were 25.81% in the domestic group and 30.00% in the original group， without significant difference （P＞0.05）， and there were no significant abnormalities in the electrocardiograms of the two groups. CONCLUSIONS Domestic Paliperidone extended-release tablets can directly replace the original tablets in the treatment of stable schizophrenia， and their clinical efficacy and safety are comparable.
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Objective To improve the quality of prescriptions and promote the rational drug application of Dingqing Tablets by investigating the outpatient prescriptions in a tertiary A hospital. Methods A total of 4 796 prescriptions of outpatient pharmacy patients from August 1, 2020 to August 1, 2021 were extracted from the hospital information system by the hospital information software, focusing on the analysis of indications, usage and dosage, drug interaction, etc. Results 10 departments including hematology department and geriatrics department were used Dingqing Tablets, and the irrationality was mainly manifested in the superposition of drug flavors and drug interactions. Conclusion Dingqing tablets were widely used in clinic and had remarkable curative effect. However, there are certain risks in the use of Dingqing tablets. It is necessary to add medication education and supervision to promote the safe and rational use of drugs in clinic.
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AIM: To evaluate the clinical effect of Iron Dextran Dispersible Tablets on patients with chronic heart failure who reduced ejection fraction after 24 weeks. METHODS: From January 2020 to June 2022, forty-five patients with heart failure complicated with iron deficiency and reduced ejection fraction were selected as the research objects. According to the random number table, they were randomly divided into control group and observation group.The control group was given routine anti-heart failure treatment such as Sacubitril Calsartan sodium tablets, while the observation group was given iron dextran dispersible tablets 50 mg three times a day on the basis of the anti-heart failure treatment of the control group for 8 weeks. The 6-minute walking distance, Hemoglobin, Serum Ferritin, N-terminal B-type natriuretic peptide precursor, Left Ventricular Ejection Fraction, Left Ventricular end Diastolic Diameter and 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) overall summary score and clinical summary score were compared between the two groups. RESULTS: There was no significant difference in baseline data between the two groups (P > 0.05). After treatment, the 6-minute walking distance in the observation group was longer than that in the control group, while the serum ferritin level in the observation group was higher than that in the control group. The N-terminal pro-B-type natriuretic peptide level in the two groups was lower than that before treatment, and the left ventricular end diastolic diameter was shorter than that before treatment, and the left ventricular ejection fraction, clinical comprehensive score and symptom score were higher than that before treatment. The difference was statistically significant (P 0.05). CONCLUSION: Iron Dextran Dispersible Tablets can improve the exercise endurance and quality of life of patients with chronic heart failure who reduced ejection fraction after 24 weeks.
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AIM: To assess the bioequivalence of oral dexamethasone acetate tablets between the test and reference formulations in healthy adult Chinese subjects on an empty stomach and after meals. METHODS: A randomized, open, single-dose, two-cycle double crossover bioequivalence study was followed. Twenty-four healthy subjects were included in the fasting group, and 32 healthy subjects were included in the postprandial group, taking 2 tablets (0.75 mg/tablet) of the test formulation (T) or 3 tablets (0.50 mg/tablet) of the reference formulation (R) per cycle for two cycles. The concentrations of dexamethasone acetate in human plasma were determined using liquid chromatography-mass spectrometry, and the pharmacokinetic parameters were calculated according to the non-atrial model using WinNonlin 8.0 software.The bioequivalence of both the test formulation and the reference formulation was evaluated. RESULTS: The pharmacokinetic parameters after oral administration of dexamethasone acetate tablets in a fasted state in subjects with the reference formulation are as follows: Tmax 1.13 (0.50, 4.00) and 1.00 (0.50, 5.00) h, AUC0-t (72.25±21.55) and (69.23±17.76) ng · mL
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OBJECTIVE@#To explore the mechanism of Radix Scrophulariae (RS) extracts in the treatment of hyperthyroidism rats by regulating proliferation, apoptosis, and autophagy of thyroid cell through the mammalian sterile 20-like kinase 1 (MST1)/Hippo pathway.@*METHODS@#Twenty-four rats were randomly divided into 4 groups according to a random number table: control, model group, RS, and RS+Hippo inhibitor (XMU-MP-1) groups (n=6 per group). Rats were gavaged with levothyroxine sodium tablet suspension (LST, 8 μ g/kg) for 21 days except for the control group. Afterwards, rats in the RS group were gavaged with RS extracts at the dose of 1,350 mg/kg, and rats in the RS+XMU-MP-1 group were gavaged with 1,350 mg/kg RS extracts and 1 mg/kg XMU-MP-1. After 15 days of administration, thyroid gland was taken for gross observation, and histopathological changes were observed by hematoxylin-eosin staining. The structure of Golgi secretory vesicles in thyroid tissues was observed by transmission electron microscopy. The expression of thyrotropin receptor (TSH-R) was observed by immunohistochemistry. Terminal-deoxynucleoitidyl transferase mediated nick end labeling assay was used to detect cell apoptosis in thyroid tissues. Real-time quantity primer chain reaction and Western blot were used to detect the expressions of MST1, p-large tumor suppressor gene 1 (LATS1), p-Yes1 associated transcriptional regulator (YAP), proliferating cell nuclear antigen (PCNA), G1/S-specific cyclin-D1 (Cyclin D1), B-cell lymphoma-2 (Bcl-2), Caspase-3, microtubule-associated proeins light chain 3 II/I (LC3-II/I), and recombinant human autophagy related 5 (ATG5). Thyroxine (T4) level was detected by enzyme-linked immunosorbent assay.@*RESULTS@#The thyroid volume of rats in the model group was significantly increased compared to the normal control group (P<0.01), and pathological changes such as uneven size of follicular epithelial cells, disorderly arrangement, and irregular morphology occurred. The secretion of small vesicles by Golgi apparatus was reduced, and the expressions of receptor protein TSH-R and T4 were significantly increased (P<0.01), while the expressions of MST1, p-LATS1, p-YAP, Caspase-3, LC3-II/I, and ATG5 were significantly decreased (P<0.01). The expressions of Bcl-2, PCNA, and cyclin D1 were significantly increased (P<0.01). Compared with the model group, RS extracts reduced the volume of thyroid gland, improved pathological condition of the thyroid gland, promoted secretion of the secretory vesicles with double-layer membrane structure in thyroid Golgi, significantly inhibited the expression of TSH-R and T4 levels (P<0.01), upregulated MST1, p-LATS1, p-YAP, Caspase-3, LC3-II/I, and ATG5 expressions (P<0.01), and downregulated Bcl-2, PCNA, and Cyclin D1 expressions (P<0.01). XMU-MP-1 inhibited the intervention effects of RS extracts (P<0.01).@*CONCLUSION@#RS extracts could inhibit proliferation and promote apoptosis and autophagy in thyroid tissues through MST1/Hippo pathway for treating hyperthyroidism.