Study On Preparation Technology And Quality Standards Of Xiaozhonghuoxue Granules

Objective:Xiaozhonghuoxue recipe, composed of Radix Angelicae Sinensis, radix paeoniae rubra, Cortex Phellodendri, Pericarpium Citri Reticulatae, Japan Bogorchid, Atractylodes lancea and other ten kinds of herbs,is an empirical prescription of orthopedics disease department in Zhangzhou traditional Chinese medical hospital,have activated blood circulation to dissipate blood stasis, detumescence and can relieve pain.The original prescription was mistura.It had been applied clinically for many years and got a significant effect.In order to serve the patients better during application, to get a well-controlled quality and to promote the paitiedts compliance.We changed the mistura into granule and did a systematic research on aspects of extraction process,preartion process, quality specification and preparation preliminary stability.Methods:1.Preparation Process:Take the content of peoniflorin and extracting ratio as index, the content of Xiaozhonghuoxue Granules were determined by the orthogonal design, and the water amount, boiling time and duration were selected as the factors in the design. Modeling technique of granules was made by comparing with degree of hardness and sof, determined proportion of adjuvant by qualification rate of granules.2.Quality Standards:Under mon-section preparation general information of the Chinese Pharmacopoeia(2010), we checked the traits, identification, microbial limits and content of Xiaozhonghuoxue granules through all item regulations of granule. The Paeonia,cortex phellodendri,the pericarpium citri reticulatae and chlorogenic acid were identified respectively by TLC. The contents of peoniflorin, berberine hydrochloride and aurantiamarin were determined by HPLC. We determined the contents’margin limit of peoniflorin, berberine hydrochloride and aurantiamarin3.Preliminary study on the stability:Under di-section Appendix XI X C of the Chinese Pharmacopoeia (2010), the stability were preliminary studyed by raw material medicine and guidance principle of pharmaceutics stability testResults: 1.The routes for preparing of Xiaozhonghuoxue granules were:soaking60minutes, boiling1.5hours with10times amount of water, boiling3times. The water decoctum was incorporated,centrifuged and filtered, while it was hot. Filtrate reduced pressure until dense mastic. The suit proportion of adjuvant were4amidulin,3dextrin and3sugar. Making soft wood and hygro-granules, drying under60centi-degree, mending granule, minuting charge. As a result, the missed data were all made sure,processing technology of preparing Granules was established.2.Establishment of quality standard of Xiaozhonghuoxue granules. Peoniflorin and berberine hydrochloride were identified respectively by TLC. The spots of sample on TLC can be well separated and reproducibility. Negative was non-interference and the method had strong specificity. It can be used for qualitation appreciation of Xiaozhonghuoxue granules. Linearity, precision, reproducibility, application of sample recovery were well. The method of quality control was simple, accurate, and reproducible by HPLC.3.Under the preliminary stability study process, we inspected respectively granules’trait, moisture, microbial limit, qualitation appreciation, and assay by common temperature and accelerated test experiment. The results were not marked change and every index consistented with specify. It was stability on the pot life.Conclusions:1.we optimized the extraction process, determined preparation technology, and established quality standard of Xiaozhonghuoxue granules. It was settled pharmacy experiment fundament to semi-works production of Xiaozhonghuoxue granules.2.Quality standard of Xiaozhonghuoxue granules was initial established. The method was stabilization and reliability. It can be exactly qualitation, quantitative assay, and can be used for quality standard of Xiaozhonghuoxue granules.3.Xiaozhonghuoxue granules initial stability test showed that the preparation quality was stable at room temperature. Term of validity could be tentatively scheduled for two years.