Research Of New Traditional Chinese Medicine Shenhua Fukang Capsule

Shenhua fukang Capsule is a kind of oral preparation composed of Traditional Chinese Medicine (TCM).It is experied from effective prescription of TCM after properly disposed according to pharmacological results and clinical practices. The prescription is prepared by extracts from seven kinds of TCM including Angelica sinensis (Oliv.) Diels,Salvia miltiorrhiza Bge,Paeonia lactiflora Pall,Ligusticum chuanxiong Hort,Cyperus rotundus L,Carthamus tinctorius L,Sophora flavescens Ait which are all recorded in the Chinese Pharmacopoeia. The pharmaceutical formulation of Shenhua fukang Capsule is compounded with rationality and novelty and it is creatively used in the treatment of stagnation of vital energy and blood stasis type of pelvic inflammation with dramatic curative effect.The purpose of this research is to investigate the preparation procedure and quality control standards of Shenhua fukang capsule. The dosage form in this study is capsule and the preparation thchnology, the quality control standards as well as the stability of Shenhua fukang capsule were lucubrated and the results are as follows:(1) The preparation thchnology of Shenhua fukang capsule1. The alcohol extraction technics of Salvia miltiorrhiza Bge was studied by testing the content of tanshinoneâ…¡A. The optimum alcohol concentration was tested firstly, then the extraction time, the extraction times and the alcohol amount were selected as the investigating factors.The optimum preparation procedure was studied by orthogonal text and then the reasonable and available process conditions were established.2. The optimum condition of extrating volatile oil from Angelica sinensis (Oliv.) Diels and Cyperus rotundus L were estabolished using the method of wet distillation by seclecting the extraction time as the consideration factor.3. The ethanol extraction technics of paeonia lactiflora pall and other drugs and the remainder of Radix Salviae Miltiorrhizae after alcohol extraction were studied by testing extract content and the content of Paeoniflorin. The water amount, the decoction time, the decoction times and error were chosen as the consideration factors and the optimum preparation thchnology was studied by orthogonal text so as to establish the reasonable and available process conditions. (2) The molding preparation procedure of Shenhua fukang capsuleThe kinds of accessories, the dosage of the accessories and other adjuvants of the Shenhua fukang capsule were studied in detail and then optimum preparation modeling technique was established.(3) The quality control standards of Shenhua fukang capsuleThe qualitative thin-layer chromatography (TLC) and quantitative high efficiency liquid chromatography (HPLC) research of Shenhua fukang capsule were also accomplished in this study.The Salvia miltiorrhiza Bge, Paeonia Lactiflora Pall, Ligusticum chuanxiong Hort and Sophora flavescens Ait in the preparation of Shenhua fukang capsule were identified by TLC. The experimental results indicated that the spots on the chromatograms are clear, characteristic, with good reproducibility and without interference by negative material. This illustrates that TLC is applicable in the qualitative identification of Shenhua fukang Capsule.The concentratios of Tanshinoneâ…¡A and Paeoniflorin in the preparation of Shenhua fukang capsule were quantitatively determined by HPLC. The experimental results suggested that their linearity, precision, reproducibility, recovery are all satisfactory. Their content limits were both regulated: the content of tanshinoneâ…¡A is no less than 0.08mg per pill and the content of Paeoniflorin is no less than 2mg per pill.(4) The stability research of Shenhua fukang capsuleIn order to investigate the stability of the preparation of Shenhua fukang capsule, the outward appearance character, the load difference, the disintegration time limit, the microorganism limit, the qualitative distinction as well as the the content determination of the preparation were researched by normal temperature test for 12 months and by acceleration test for 3 months separately and the results showed that the items mentioned above did not changed obviously. This illustrates that the preparation of Shenhua fukang capsule has good stability in the storage time.The results of this study showed that the preparation procedure of Shenhua fukang Capsule is reasonable in technics, controllable in quality and good in stability. This research provided integrated pharmaceutical document for the declaration of Shenhua fukang capsule.