Study On The Quality Standard And Pharmacodynamics Of Ruxiaoping Pills

Objective: Ruxiaoping Pill is a self-made preparation of the First Hospital of PLA.It has been used clinically for more than two decades.According to the theory of traditional Chinese medicine,the main cause of breast hyperplasia is caused by internal injuries,which are mostly caused by qi stagnation.Ruxiaoping,composed of dandelion,angelica,licorice,melon and other herbs,has the effects of Endometriosis,Smoothing liver-qi stagnation,detoxification swelling treatment,carbuncle,which is used for breast hyperplasia breast hyperplasia and its treatment effect is prominent.The clinical effect of this product is remarkable.In order to better ensure the quality of medicine,the study was conducted.In this study,the main constituents of the prescription drugs,pharmacological effects and clinical applications,research on the preparation process and quality standards of Ruxiaoping Pills Preliminary evaluation of its efficacy for the treatment of breast hyperplasia Chinese medicine to lay a foundation.Methods: The TLC determination was used to identify the main medicinal materials of Chinese Herbal Medicine Angelica sinensis radix,dandelion,licorice,melon,Fritillaria,and corydalis rhizome.At the same time,the content of ferulic acid in Angelica sinensis radix,caffeic acid in dandelion,glycyrrhizin in glycyrrhiza and glycyrrhizinate in licorice was determined simultaneously by gradient elution with acetonitrile-0.1% phosphoric acid.And the 4main components in 3 batches of Ruxiaoping Pills were determined.The pharmacodynamic study mainly divided 60 SPF-grade SD rats into 6 groups: control group,model group,positive control group,and Ruxiaoping Pill low-medium high-dose group.Estradiol benzoate was used to divide the blank group.SD rats were injected intraperitoneally for injection.25 days later,the rats were intraperitoneally injected with progesterone for 5 days.During this time,the control group received intraperitoneal saline injection.After the completion of the modeling,the rats were established ligation method.The blank control group and the model group were injected separately.A considerable amount of distilled water,Ruxiaoping Pill low-medium high-dosegroup was poured into the aqueous solution of Ruxiaoping Pills,and the positive control group was poured into the aqueous solution of Rupixiao Pills.The milk papule diameter,mammary gland tissue,uterine coefficient,serum of Ruxiaoping Pill was examined.The levels of estradiol(E2),prolactin(PRL),and progesterone(PROG)in the samples varied.Results: Research result showed that the method of TLC identification of Angelica sinensis radix,dandelion,licorice,melon,Fritillaria,and corydalis rhizome was simple,rapid and reproducible.The retention time of caffeic acid,ferulic acid,licorice and licorice acid were10.95 min,19.37 min,22.46 min and 24.55 min respectively.3.05 ~ 61.00,4.75 ~ 95.00,9.20 ~46.00,17.60 ~ 88.00?g/m L with a good linear relationship(r = 0.9999),the average recoveries were 1.34%,1.52%,1.22% and 0.92%.Pharmacodynamics experiments showed that in the other five groups during the modeling period compared with the control group,the nipple was inflamed and the diameter of the nipple was increased.The number of breast ductal lobes and the number of alveoli in the breast tissue increased significantly;serum E2,PRL content was significantly increased and PROG content was significantly reduced.Compared with the model group,the diameter of the nipple of the high-dose and the low-dose group was significantly decreased;the number of catheters,the number of alveoli and the lobular tree in the mammary gland tissues were significantly reduced;the coefficient of uterus decreased significantly;the content of E2 and PRL in the serum was significantly decreased,PROG content was significantly increased;each compared with the blank control group no significant difference.Conclusion: In this study,Angelica sinensis radix,dandelion,licorice,melon,Fritillaria,and corydalis rhizome were identified by TLC,the contents of caffeic acid,ferulic acid,glycyrrhizin and glycyrrhizinate were controlled by gradient elution on the same mobile phase by high performance liquid chromatography(HPLC).Meanwhile,the differences of weight,loading capacity,moisture,dissolution time and microorganisms were examined Included in the draft quality standards.The draft quality standards can be used as Ruxiaoping pills quality control standards,in line with the state of the hospital preparations of the relevant provisions.The pharmacodynamic study of Ruxiaoping Pills showed that Ruxiaoping Pills had a good therapeutic effect on mammary gland hyperplasia.