1.Similarity Evaluation of the Dissolution Curves between Generic and Original Metoprolol Tartrate Tablets
Bin KONG ; Xinxia LI ; Guizhen PEI ; Xinwen QI ; Wenjun LI
China Pharmacy 2017;28(9):1262-1264
OBJECTIVE:To establish the method for dissolution determination of Metoprolol tartrate tablets,and to evaluate the similarity of dissolution curves of generics and original drugs. METHODS:The paddle method was adopted with rotational the speed of 50 r/min,using pH 1.2 hydrochloric acid solution,pH 4.5 acetate buffer solution and pH 6.8 phosphate buffer solution as dissolution media. Fiber-optical drug dissolution real-time measurement instrument was used to determine the dissolution curves of generic and original Metoprolol tartrate tablets with optical distance of 10 mm. Similarity factor (f2) method was used to evaluate its similarity. RESULTS:In 3 dissolution mediums,the f2 of generic and original Metoprolon tartrate tablets were 80.5,66.8, 69.4,respectively,which indicated that the dissolution curves showed similarity. CONCLUSIONS:Established real-time dissolution process analysis method is suitabe for the dissolution determination of Metoprolol tartrate tablets. Generic and eriginal show the sim-ilarity in dissolation behavier,so they have good consistency in quality.
2.Effect of Acupuncture plus Small Dosage of Herba Epimedii on Improving the Life Quality of Climacteric Postmenopausal Women
Guizhen CHEN ; Yunxiang XU ; Pei LI ; Yuanchun XIAO
Journal of Acupuncture and Tuina Science 2006;4(3):176-179
Objective: To investigate the effects of acupuncture and combined acupuncture and medicine on the quality of life and the genital endocrine level in postmenopausal women. Methods:Forty-seven patients were randomly assigned to acupuncture and acupuncture plus medicine groups,23 cases in the acupuncture group and 24 cases in the acupuncture plus medicine group. The observed course of treatment was 3 months. A Chinese concise SF-36 questionnaire was used to evaluate the quality of life in the different groups of patients before and after treatment.Meanwhile, radioimmunoassay was used to observe the differences in serum genital hormones:follicle stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2) contents between pretreatment and posttreatment in both groups. Results: After treatment, there was a significant difference in quality of life between the two groups and it was better in the acupuncture plus medicine group than in the acupuncture group(P< 0.01). E2 content increased more markedly in the acupuncture plus medicine group than in the acupuncture group(P< 0.05). There were no significant differences in FSH and LH contents between the two groups (P > 0. 05). Conclusion: Both acupuncture and acupuncture plus medicine can improve the quality of life and increase obviously low E2 content in postmenopausal women. Acupuncture plus medicine raises the patients' quality of life and E2 content more markedly than acupuncture. It is suggested that both acupuncture and acupuncture plus medicine can improve the symptoms, signs, and physical and mental health, raise the quality of life and ameliorate genital-endocrine environment in postmenopausal women, but a combination of acupuncture and medicine has a better effect.