Study Of Preparation Process And Quality Standard Of Chuankeping Granules

Chuankeping granules is a modern prescription based on the experiences of TCM and pharmacodynamic studies, and composed of Ephedra, Scutellaria, Salvia, Artemisia and many other herbs. It was found to be used in the treatment of asthma due to heat-phlegm obstructing lungs by clinical observation, with the efficacies of removal of heat-phlegm and relieving cough and asthma. The effect was obvious while the side effects were little. According to the properties and pharmacology studies of pharmacodynamic materials, the decoction was changed into granules under the guidance of the TCM theory combination with the production practices. And the quality standards of the granules was also studied for solving the question of inconvenience clinical use and uncontrollable quality, and for developing a new drug with high and marked curative effects but fewer toxic reactions, which is convenient and easy to promotion for the clinical.Contents of ephedrine, tanshinone II A, baicalin, total flavonoids and extract yield were used as indices of appraisal in the orthogonal designs of this experiment combined with grading methods, in order to get the corresponding optimal processes of alcohol extraction, water extraction, and purification. The optimal ratio of drug and excipients was determined by single factor method used percentage moisture absorption, solubility and oral acceptance as indicators. The best molding process was screened by multiple guidelines grading method, using molding rate, percentage moisture absorption and fluidity of granules as indices. The techniques of TLC and HPLC was adopted in the studies of quantitative identification and content determination for the granules, and the conditions of prescription drugs by TLC and content determination methods of effective ingredients of monarch drug were determined. Then it was examined under the relevant contents of granule in the "China Pharmacopoeia" 2005 Edition, and the preliminary quality standards were established for Chuankeping granules.Studies show that the alcohol extraction, water extraction, purification and form-ing processes of Chuankeping granules are simple, reasonable and practicable. TLC and determination method are simple, specific. The quality standards of the prepara-tion are stable and controllable.