Study On The Quality Control Of Ziziphi Spinosae Semen, Corydalis Rhizome And Ginseng Radix Et Rhizome Ruhra In Xiangren Zhitonganshen Capsule

ObjectiveDysmenorrhea is the most common gynecologic complaint in the young adult female. Nonsteroidal anti-inflammatory drugs (NSAID) are the most common pharmacologic treatment for dysmenorrhea, which also lead to gastrointestinal side effects. Case studies suggest that traditional Chinese medicine may be effective and safety in treating primary dysmenorrhoea. Xiangren Zhitonganshen Capsules is a compound preparation of traditional Chinese medicine, which mainly used for the treatment of dysmenorrhea. This study is to establish reasonable quantitative analysis approach of the compound preparation, to develop a reasonable content limits and the validity period, to provide the necessary information to develop a reasonable and feasible quality standards of the test.MethodsIn the study of content determination, we used the "Chinese Pharmacopoeia"2010edition as the main execution standards. We treat the determination of ginsenoside Rg,, Re, Rb,, Jujuboside A and tetrahydropalmatine as indicators for the preparation of the test solution, chromatographic conditions by using high performance liquid chromatography (HPLC), finally, to establish determination methodology of these five ingredients and provide content limits.In the study of stability:according to the "Chinese Pharmacopoeia"2010edition,"traditional Chinese medicine, natural medicine, the stability of the guiding principles of research techniques" and technical requirements of new Chinese medicine standards, we studied the test of influencing factors with a pilot product, and accelerated testing, long-term trials with three pilot products, taking moisture, load difference formulation, disintegration, microbial limit, content determination as the evaluation indexes. Finally,we predict the preparation of validity with the data of accelerated testing, long-term trials, using statistical methods.ResultsIn the study of content determination, RP-HPLC methods were established to determine. The determination of ginsenosides Rg1, Re, Rb1, jujubosideA and tetrahydropalmatine could be accomplished by different mobile phase systems in C18columns. The linear ranges were730.0～29.20μg· ml-1(r=0.9999),503.0～20.12μg· ml-1(r=0.9999),824.0～32.96μg· ml-1(r=0.9999),810.0～32.40 μg· ml-(r=0.9999),50.50～5.050 μg· ml-1(r=0.9998) respectively. The recoveries were95.86%(RSD=1.21%),96.12%(RSD=2.20%),97.29%(RSD=1.69%)、96.81%(RSD=1.98%).96.11%(RSD=1.16%).respectively. Intermediate precision, repeatability, instrument precision, robustness proved the reliability of test method for minor changes in chromatographic condition.The content of total ginsenosides Rg1, Re, can not be less than0.0574mg each cap of the preparation, ginsenoside Rb1can not be less than0.0459mg each cap of the preparation, JujubosideA can not be less than0.0103mg each cap of the preparation, tetrahydropalmatine can not be less than0.0341mg each cap of the preparation.In the study of stability, we predict24months as the preparation of validity, taking moisture, load difference formulation, disintegration, microbial limit, content determination as the evaluation indexes.ConclusionsStudies showed the methods of content determination is reasonable, high sensitivity and repeatability. The quality standard of the preparation is stable and controllable.