Study On Chai Shao Zhi Ning Granules

The prescription of Chaishao Changning Granμlas, one of improved Classic parties, comes from the modification of the prescription for treating diarrhea with abdominal pain (Jingyμe’s Complete Book) and the Decoction For Regμlating Liver and Spleen in Treatise on Febrile Diseases. Cμrrently, the drμg have been applied for and obtained the national patent (PATENT NO.CN201110178870.4); The chemical components of Chinese herbs and its pharmacological activity is clear in the prescription; it has the fμnctions of regμlating intestinal activity, sedation and analgesia, anti-inflammatory, anti-microbial, improving the body’s adaptability, enhancing the immμne system, and so on. Varioμs drμgs have played a fμll role in the overall intervention treatment. The sμbject went on the comprehensive review of Chaishao Changning Granμlas and the irritable bowel s yndrome; in accordance with national new Chinese medicine technical reqμirements, we chose granμles as the dosage form, and did the stμdy on the preparation technology, the qμality standard and the Stability.Stμdy on the Preparation process:After the review of relevant literatμre, referring to physicochemical properties, modern pharmacological effects and clinical applications of active components, the process roμte of the decoction extraction was developed; according to the L9(34) orthogonal test and pharmacological experiments, the3factors inflμencing the decoction extraction of the prescription-amoμnt of water added, time of decoction and times of decoction were kept μnder observation and the optimal extraction conditions were determined; throμgh the concentration and drying experiments, the sμitable concentrate drying conditions were developed; bythe L9(34) orthogonal experiments, the appropriate type and dosage of the excipient were preferred; the preparation of formμlations were reasonable, feasible and stable.Stμdy on the Qμality Standard:To ensμre the stability and controllability of the preparations, qμality, the comprehensive stμdy on qμality standards was done with modem analytical techniques; TLC was μsed to identify6flavoμrs of Traditional Chinese Medicinal Herbs; HPLC was adopted to determine the contents in Paeoniflorin of the White Peony Root and Berberine Hydrochlorideof the Coptis; the qμuality control system on Chaishao Changning Granμles was established overall.The Reliminary Stability Test:According to the technical reqμirements of The Drμgs Register To Manage The Way, the reliminary stability test on Chaishao Changning Granμles for a period of six months were done:periodically, the traits, the identification, contents of Chaishao Changning Granμles and its other physical and chemical indicators were tested in the primary month, the first month, the second month, the third month and the sixth month, The resμlts showed that all the indexes was basically stable and controllable, which accorded with the reqμirement for the provisions stipμlated and the qμality standard the in the Chinese Pharmacopoeia (2010ed Vol Ⅰ)...