Study On Preparation Technology And The Quality Control Of Chidan Capsule

ObjectiveChidan pill(CDP) is an agreement prescription of the affiliated Shenjing hospital of china medical university, which can not only clear away heat and relieve toxin, but also activate blood and transform stasis, is composed of the Radix Paeoniae Rubra, the Radix Salviae Miltiorrhiae, the Radix Scutellariae, the Poria and the Rhizoma Sparganii. It is used primarily to the treatment of chronic pevic inflammatory disease and appendagitis for women. This preparation has been proved having certain curative effect and no side reactions over 30 years in clinical. However, CDP has many defaults, such as the dosage is too large, the taste is bad, and the carrying is inconvenient. To overcome the shortages, improve the compliance and raise the bioavailability, Dose pattern renovation of CDP needs to be done, In the present study, the extraction process was optimized and the quality control methods of Chidan capsule was developed.MethodsAn uniform design was used to search for the best experimental condition. This research takes the content of tanshinone II A, peoniflorin, baicalin and baicalein as the determination index, ethanol concentration, the quantity of solvent and extraction time as influencing factors. The formula screening was accomplished based on the results of extraction study. The process and formula were proved to be reasonable by the verification experiment. The 5 herbs in Chidan capsule were identified by TLC with clear spots and good reproducibility. The contents of Peoniflorin and 6 components in Chidan preparation were determined by HPLC respectively. The qulitative and quantitive RP-HPLC method was established with fingerprinting technology for the control of the quality of three crude materials and the prescription. The HPLC fingerprinting was established from 10 batches, and the data showed there were 24 characteristic peaks. The TLC, determination and HPLC fingerprinting methods could be used for the quality control of Chidan capsule.ResultsThe results showed that the optional extraction process by uniform design was to Salvia miltiorrhiza and paeoniae rubra add 7 times 90% ethanol and reflux three times, 80 min each time. Then, the residue and three herbs in prescriptionn were 6 times water and reflux three times, 65 min each time. The above mentioned extracts are dealt with freeze drying, comminution, sieving, adding to proper stalch 1500, granulation, sealing with aluminum plastics, and then are made into final products. In a word, the method was accurate, reproducible and consistent. This study supplied basic and instructive data for further research and development of Chidan capsule formulation.ConclusionsThe manufacture procedure of Chidan capsule was reasonable, feasible, stable, controllable and be safe to skin.