Study On Preparation And Pharmacology Of Yangchun Shenshu Capsules

1OBJECTIVEDeficiency of kidney-yang, due to be congenitally deficient kidney hormone deficiency, or frail, decline of vital gate fire, or room service is excessive, or prolonged illness, while the injured kidney yang deficiency, so that Yuanyang, warmth weakness, cold endogenous, or gasification to cold, filled; common in impotence, infertility, virtual fatigue, edema, diarrhea, asthma, asthma and other diseases, metrorrhagia. Traditional Chinese medicine treatment to deficiency of kidney-yang has a long history.Our hospital summary and form a series of clinical experience prescriptions with exact curative effect, safety and reliability,good social benefits and economic benefits,which have solved the many clinical problems. The prescription of Yangchun Shenshu Capsules is from clinical experience,which is composed of pilose antler, ginseng, Radix Astragali, epimedium, angelica, royal jelly freeze-dried powder with a function of Wen Yangyi kidney, treating deficiency of kidney-yang. The prescription has a significant clinical effect, and application disease is clear.So "Study on Preparation and pharmacology of Yangchun Shenshu Capsules"is selected as research subject for making full use of traditional Chinese medicine in the treatment of deficiency of kidney-yang, improving the clinical treatment effect and providing technical support for clinical applications and also laying the foundation for declaration of new drugs.2METHODSNearly10years of domestic related literature have been systematically consulted and the literature review and analysis were done.The prescription, preparation process, quality standard, pharmacological effects and clinical efficacy of the Yangchun Shenshu Capsules were studied systematically.The preparation of the Yangchun Shenshu Capsules was studied and orthogonal design was applied to optimize the extraction,concentration and drying conditions to achieve preparation process of Yangchun Shenshu Capsules.The quality control,quality standards and main components used in the prescription have been studied systematically.High-performance liquid chromatography was uesd for the determination of the content of icariin and astragalus on the treatment of kidney yang deficiency, and related pharmacodynamics experiment, acute toxicity test and long-term toxicity test of Yangchun Shenshu Capsules have been studied.The clinical efficacy observation verified the effectiveness of Yangchun Shenshu Capsules to deficiency of kidney-yang.3RESULTSAccording to the prescription characteristics of Yangchun Shenshu Capsules, preparation process, quality evaluation and quality control standards of the Yangchun Shenshu Capsules have been developed. Studies show that the method of quality control is reliable with good stability. According to the prescription of Yangchun Shenshu Capsules based on clinical application experience,main pharmacodynamics experiment, acute toxicity and long term toxicity study have been studied.The main pharmacodynamics results show that Yangchun Shenshu Capsules can obviously improve external stimulation excitability of penile tissue of castrated rats,shorten the penis erection latency, increase weight coefficient of accessory sexual organ in castrated male rats, markedly elevate the content of T and F in serum, and can promote the weight coefficient of pituitary and adrenal, and also regulate weight of thymus and spleen. The symptoms of the mice of Yang deficiency have been alleviated or even disappear and the results showed that the Yangchun Shenshu Capsules has the effect of warming kidney and strengthening yang; results of acute toxicity study show there is no acute toxicity; results of long-term toxicity study show, rats’ general status in each dose group of Yangchun Shenshu Capsules (appearance, activities, stool shape), growth (weight), hematopoiesis (blood tests), liver function, kidney function (blood biochemical examination) and vital organ weight coefficient, were not found to have significant long-term toxic effects, and the pathology inspection certificates, the high dose group of rat organs and tissues showed no obvious toxic injury change,which is suggested that toxicity of larger doses or a longer course of oral Yangchun Shenshu Capsules is very low with a safety; results of clinical efficacy study show, the clinical cure rate was51%,28.4%in the treatment group of Yangchun Shenshu Capsules while41.2%,24%in the control group of Yishenshu Xingyang Capsules, so the treatment group was better than control group.4CONCLUSIONThe project design is reasonable, feasible technical route, the means of study is reliable; retrieval shows, no studies have been reported in the domestic literature about the Yangchun Shenshu Capsules in the treatment of kidney yang deficiency syndrome system; the study of outcomes has provided the theory basis and the technical support for clinical application.The curative effect of Yangchun Shenshu Capsules is accurate, safe and reliable,and also have a good social reputation, high patient satisfaction by the trust of patients. The products of this project spread in use of the clinical application,which will achieve good economic and social benefits.