Study On The Extraction And Purification Crafts And The Quality Analysis Of JinXuan ZhiKe XunXiSan's Non-volatile Effective Parts

Jinxuan Zhike Xunxi San is a kind of Chinese medicine produced by Mayinglong Pharmaceutical Group Co., LTD. This preparation·is composed of Natrii Sulfas Exsiccatus,Herba Portulacae,Flos Lonicerae Japonicae,Calcine Alumen,Herba Schizonepetae. The preparation can expel pathogenic wind,remove dampness, reduce swelling,ease pain, and it could be used in clinical treatment of Inflammatory external hemorrhoids and Some symptoms such as rectal inflammation, swelling, and pain caused by the hemorrhoids surgery, and this drug has some good feature including rapid onset,Good effect and Easy to use et. Therefore, this traditional Chinese medicines received a warm welcome from the majority of patients, which have good market prospects. However, the varieties of traditional Chinese medicine is Produced through traditional craft, and has many shortcomings, for example, the quality control standard is imperfect,Material basis for efficacy is not clear, drug efficacy is Instability, dose of clinical use is comparatively large, hygienic conditions need to be improved and so on. this paper conducted a study of extraction and purification crafts of non-volatile anti-inflammatory effective parts from JinXuanZhiKeXunXiSan Prescription's three Botanicals by Solvent extraction and macroporous resin purification, and have developed a more comprehensive quality control standards, establish the Fingerprint of anti-inflammatory effective parts, laying a certain foundation for the traditional Chinese medicine preparation developped secondarily to Innovation TCM.This thesis considers the JinXuan ZhiKe XunXiSan prescription's three botanicals as a whole, using orthogonal design test and single factor combined's research methods, first, Using ethanol as extraction solvent, non-volatile parts of JinXuan ZhiKe XunXiSan's three botanicals are extracted by percolation to get the exacts, then, the extracts were purified by macroporous resin to get effective parts,and gets a reliable technical parameters, carried out the Medium-sized test validation, can the transition to industrialization. This study content is to apply a patent.The modern analysis methods were carried out to study on the quality standard of JinXuan ZhiKe XunXiSan's non-volatile effective substance, including Traits,TLC,Check, Determination. Establishing a relatively perfect quality standards of JinXuan ZhiKe XunXiSan's anti-inflammatory effective substance, Providing the basis for its quality control. Using HPLC method, according to the state Food and Drug Administration issued a "traditional Chinese medicine injections fingerprinting requirements (Interim) ", A HPLC fingerprint analysis method is established for quality control of JinXuanZhiKeXunXiSan' s non-volatile effective parts, Twenty-one peaks are selected as the common fingerprint peaks, the determination method is reliable, peaks is clearly visible and similarity is good. The method is reliable, accurate. and can Combine HPLC fingerprint and Quality Standards of JinXuan ZhiKe XunXiSan's non-volatile effective parts,which establishs the quality evaluation system of JinXuanZhiKeXunXiSan's non-volatile effective parts, and can effectively control the quality of the parts of active substances.