工艺优化前后乳癖消片的主要药效学研究

目的探讨乳癖消片（RPX）工艺优化前后，对大鼠乳腺增生的影响。方法长期外源性注射苯甲酸雌二醇、黄体酮建立乳腺增生模型。给药4周后，取乳腺组织做病理切片；测定子宫指数、卵巢指数；放射免疫方法测定血清中雌二醇（E2）、孕酮（P）、睾酮（T）、泌乳素（PRL）、促黄体生成素（LH）和促卵泡生成素（FSH）的含量。结果与模型组相比，全部治疗组大鼠乳头红肿、乳腺小叶、腺泡、导管增生均较轻；血清中E2、P、T、LH不同程度降低，PRL不同程度升高。两种工艺的样品对大鼠乳腺增生均有明显的治疗作用；所有指标组间比较均无显著性差异。结论RPX工艺优化后，对大鼠乳腺增生有治疗作用，与原工艺相比，主要药效指标无显著性差异。

Pharmacodynamics Study of Rupixiao Tablets Prepared by Optimized Process

Objective To compare the effect of Rupixiao Tablets prepared by or not by optimized process on hyperplasia of mammary glands in rats. Methods Rat models with hyperplasia of mammary glands were established by injection of estradiol benzoate and progesterone . After treatment with Rupixiao Tablets for four weeks, the mammary gland tissues were sliced for pathological examination, uterine index and ovarian index were measured, the serum contents of estradiol, progesterone, testosterone, prolactin, luteining hormone and follicle stimulating hormone were determined by radioimmunoassay method. Results Compared with the model group, the symptom of red and swollen nipples was relieved, hyperplasia of lobule of mammary gland and gland vacuole and duct were reduced, the levels of estradiol, progesterone, testosterone, luteining hormone were reduced and prolactin was increased in all treatment groups. Rupixiao Tablets prepared by two kinds of process both had evidently therapeutic effect, and the differences of the compared indexes were insignificant. Conclusion Rupixiao Tablets prepared by optimized process has therapeutic effect on hyperplasia of mammary glands in rats and has no significant differences in the main pharmacodynamics indexes when compared to those of the original preparation.