Preparation And Evaluation Of Shen'e Capsules

Subject:To study an ideal preparation of Traditional Chinese Medicine for treating Endometriosis. Shen'e Capsules is selected. Extracting processes,qulity standards,tentative stability, acute toxicity test and Pharmacodynamics will bestudied.Methods: Methods:Preparation process was optimized by content of active components and indexes of pharmacodynamics.The orthogonal test was adopted to optimize the ethanol extraction process of Radix Salviae Miltiorrhizae and Rhizoma Corydalis.The extraction and inclusion process of naphtha of Rhizoma Curcumae and Rhizoma Sparganii were also optimized by orthogonal test.We didn't only select out the best condition of spray drying,but also study the molding process of preparation.The quality of herbs in the prescription were identified with TLC, and HPLC method was used to determine the contents of tanshinoneⅡA and salvianolic acid B in Salvia miltiorrhiza which was monarch drug in the prescription and made reasonable content limit. Primary stability of this preparation was investigated, acute toxicity test and the chief study of pharmacodynamic were made superficially. Results:The basic technology route of this preparation was:Radix Salviae Miltiorrhizae was extracted by soaking operation with high concentration alcohol, its dregs and Rhizoma Corydalis were extracted together with proper concentration alcohol. The naphtha was extracted from Rhizoma Curcumae and Rhizoma Sparganii. The optimal extracting process of Radix Salviae Miltiorrhizae and Rhizoma Corydalis was:Radix Salviae Miltiorrhizae was soaked one hour by five times alcohol; the remainder of filtrate was added by suitable water, then filtered, the filtrate was dried under low temperature; the Rhizoma Corydalis and the remainder of Radix Salviae Miltiorrhizae were extracted by refluxing process with five times 65% alchol, one hour per time,the remainder of filter liquor was concentrated to the density of 1.15 under 60℃. The ideal naphtha-extracting process was:Rhizoma Curcumae and Rhizoma Sparganii was pulverized to coarse granule and then extracted 6hours for naphtha with 10times water; The gotten naphtha was grinding 30minutes with 4 times'β-CD and 12 times' water by colloid mill, and the wrapper was dried under the temperature of 40-50℃. The method of TLC and HPLC were reasonable and controllable, the content range of tanshinoneⅡA and salvianolic acid B were respectively no less than 0.5mg per pill and no less than 8.0 mg per pill. The stability experimentof this preparation showed that it was stable under normal stroing condition.The pharmacodynamics experiment indicated that the new preparation had significant effect on endometriosis, and the toxicological test showed that it was safe.Conclusion:Shen'e Capsules is an optimum preparation which is used to treat Endometriosis.It has suitable and controllable quality standards.