Study On The Preparation And Quality Standards Of Shi Mo Kang Granule

Shi Mo Kang granule is treated for central serous chorioretin- opathy with promoting blood circulation and removing blood stasis, Soothing Liver and strengthening spleen, dispelling wind and dampness. It is made from Atractylodes, Salvia, Red peony root, bupleurum, equisetum, etc. Studying on the technique, quality standard and the preliminary stability of compound preparation of Shi Mo Kang granule is offered for reference.The optimum conditions for the preparation were investigated by single factor exploration. The rate of oil utilization was used as a major criterion to evaluate steam distillation. The optimum extraction process is dipped in 10 times water for 2h and distilled 8h. Results showed that by stirring a mixture of 1:15β-cyclodextrin and water, 4:1β-cyclo- dextrin and oil at 50℃for one hour gave the best result with the ratio of linalool in the inclusion compound and yielding rate as indicator. The optimized extract process of Salvia Miltiorrhiza is refluxed 1h for 2 times by 90% ethanol. Mother-of-pearl decocted 0.5h firstly, then it with the medicines distilled the essential oil, Salvia Miltiorrhiza refluxed by 90% ethanol and the medicines dipped in water for 1h is refluxed 1.5h for 2 times by 8 times water.Combine the concentrated solution, dry and spray to extracting powder. Combineβ-CD inclusion with the excipient, mixed thoroughly, make granules, dry and pack.Establish the TLC identification of 13 kinds of medicines including Atractylodes lancea, Exocarpium Citri Grandis, etc.; Content determination of TanshinoneⅡA, Salvianolic acid B and Paeoniflorin in the preparation assayed by HPLC; Preparation check on appearance, moisture, the gross deviation, hygiene is up to the general rule of granule in 2005 Chp.Using the content of TanshinoneⅡA and Salvianolic acid B as indexes, studying on ultrasonic extraction, reflux extraction and Smashing extraction, determine the optimum exacting conditions of Salvia is refluxed with ethanol first, and then refluxed with water. Investigation on the preliminary stability of three batches sample in 0, 1st, 2nd, 3rd month postoperative month at room temperature show they were stable and accord with every prescripts.The technique of Shi Mo Kang granule is reasonable and feasible. The methodical control of quality is quick, specific, reproducible and controls the quality effectively.