Screening Of Effective Parts Of Fuke Qianjin Capsule Against Uterine Fibroids And Its Drugability Stud

Objective:To establish and compare the fingerprints of Fuke Qianjin Capsule/Tablet,then to study the effect of Fuke qianjin capsule on uterine fibroids,the optimal site was selected and its components were analyzed,finally research the preparation process.To provide a basis for the research and development of new drugs for the clinical treatment of uterine leiomyoma.Method:1.The fingerprints of 40 batches of Fuke Qianjin Capsules and 40 batches of Fuke Qianjin Tablets were carried out on a Waters Epic C18（250×4.6 mm 5μm）at30℃,with a gradient mobile phase composed of acetonitrile and 0.1%formic acid at a flow rate of 1 m L/min.The detection wavelength was 254 nm.The cluster analysis,pattern recognition analysis and similarity evaluation were carried out by the SIMCA13.0 software,SPSS22.0 software and"similarity evaluation of chromatographic fingerprints of traditional Chinese medicine"software,so as to compare their quality.2.Estradiol and progesterone were injected intramuscularly to establish a rat uterine myoma model.The levels of estrogen and progesterone in serum of rats were measured by Elisa kit.The expressions of estrogen receptor and progesterone receptor in uterine smooth muscle of rats were determined by immunohistochemistry.The morphological changes of uterine cells were observed after HE staining.The serum metabolite profiles of rats were analyzed by GC-MS combined with Simca-P13.0software.3.The polysaccharides and flavonoids were extracted by water extraction and alcohol precipitation,and the volatile oil was extracted by supercritical CO₂fluid extraction.The best part of Anti-uterine leiomyoma was selected by HE staining,immunohistochemistry and Elisa test kit.4.The volatile oil was treated by methyl esterification and characterized by GC-MS.The exact compounds were obtained by matching analysis with database.5.The preparation conditions of volatile oil dropping pills,such as dropping speed,dropping distance,upper temperature of condensate,matrix ratio,matrix to oil ratio and liquid temperature,were investigated by single factor.The quality of dropping pills was judged by appearance evaluation,weight difference comparison and dissolution time.Result:1.The fingerprints of 40 batches of Fuke Qianjin Capsules and 40 batches of Fuke Qianjin Tablets were established.The fingerprints of capsules and tablets were similar,and the similarity was over 89%.A total of 23 common peaks were matched,but the peak areas of each peak were quite different.2.The Fuke Qianjin Capsule can improve the pathological morphology of uterine cells,reduce the content of estrogen and progesterone,improve the expression of estrogen and progesterone receptors and regulate the metabolism of the body in rats with uterine leiomyoma.3.Volatile oil of Fuke Qianjin Capsule significantly reduce the weight of uterus,uterine coefficient,improve the pathological state of uterus,reduce the level of estrogen and progesterone in serum.In addition,it can also improve the expression of estrogen and progesterone receptors.4.The volatile oil was analyzed by GC-MS,and 46 components were matched,accounting for 88.29%of the total volatile oil.The main components were oleic acid（12.05%）,palmitic acid（12.32%）,linoleic acid（10.79%）,waxy acid（7.76%）,undecanoic acid（7.1%）and stearic acid（5.26%）.5.The dropping pill appearance was round,weight difference was qualified,dissolution time was the shortest under the conditions as follows,the upper layer of condensate temperature was 5℃,matrix:oil was 4:1,matrix（PEG4000:PEG6000）was 1:1,dropping distance was 6 cm,dropping speed was 50 d·min^-1,liquid temperature was 80℃.Conclusion:The fingerprints of Fuke Qianjin Capsules and Tablets were established to provide reliable basis for the quality analysis and control of the two.Animal experiments showed that Fuke Qianjin Capsule had strong anti-myoma activity.All extracts had certain anti-hysteromyoma activity,among which volatile oil was the most effective.This experiment provides theoretical support for the quality standardization of Fuke Qianjin Capsule and provides experimental basis for the clinical research and application of Fuke Qianjin Capsule.