坤灵丸联合地屈孕酮治疗多囊卵巢综合征所致月经不调的疗效观察

目的建立匹伐他汀钙片溶出度测定方法，评价国内仿制药与原研药溶出曲线的相似性。方法建立高效液相色谱（HPLC）法测定匹伐他汀钙片含量，并进行专属性、回收率、精密度、重复性、稳定性等方法学考察。以原研药为参比制剂，采用桨法，转速50 r/min，测定仿制药与原研药在4种不同pH溶出介质（pH 1.2盐酸溶液、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液、水）中的溶出度，绘制溶出曲线，采用相似因子（f₂）法分析溶出曲线相似性。结果色谱条件为：色谱柱Diamonsil C₁₈（250 mm×4.6 mm，5 μm），醋酸盐缓冲液（冰醋酸500 μL、醋酸铵140.6 mg，加水至1 000 mL）-乙腈（15：85）为流动相，波长244 nm。方法学验证结果均符合检测要求。其中3家仿制药与原研药溶出行为基本一致，另外1家仿制药在水和pH 4.5醋酸盐缓冲液中均与原研药溶出曲线不相似。结论大部分厂家仿制药体外溶出与原研药一致。所建HPLC法适用于匹伐他汀钙片的浓度测定，可为今后匹伐他汀钙片溶出度一致性评价提供参考。

Clinical observation of Kunling Pills combined with dydrogesterone in treatment of irregular menstruation caused by polycystic ovary syndrome

Objective To investigate the clinical effect of Kunling Pills combined with dydrogesterone in treatment of irregular menstruation caused by polycystic ovary syndrome. Methods Patients (104 cases) with irregular menstruation caused by polycystic ovary syndrome in Luoyang Hospital of TCM from September 2018 to September 2019 were divided into control and treatment groups based on different treatments, and each group had 52 cases. Patients in the control group were po administered with Dydrogesterone Tablets from the 11th day of the menstrual cycle to the 25th day, 10 mg/time, twice daily. Patients in the treatment group were po administered with Kunling Pills on the basis of the control group, 15 pills/time, twice daily. Patients in two groups were treated for 3 menstrual cycle. After treatment, the clinical efficacy was evaluated, and the scores of GAGS, PBAC, F-G and HPS, the improvement time of clinical symptoms, and the sex hormone levels in two groups before and after treatment were compared. Results After treatment, the clinical effective rate of the treatment group was significantly better than that of the control group (98.08% vs 82.69% P<0.05). After treatment, the scores of GAGS, PBAC, F-G and HPS in the treatment group were significantly better than those in the control group (P<0.05). After treatment, the treatment group was significantly superior to the control group in menstrual recovery time, menstrual volume recovery time, menstrual color recovery time, fatigue disappearance time and obesity improvement time (P<0.05). After treatment, the serum LH, FSH and T levels in both groups were significantly decreased (P<0.05), and the decrease was more significant in the treatment group (P<0.05). Conclusion Kunling Pills combined with Dydrogesterone Tablets in the treatment of irregular menstruation caused by polycystic ovary syndrome can not only improve the clinical effective rate and improve clinical symptoms, but also improve the level of sex hormones, which has a certain clinical application value.