Research Of New Traditional Chinese Medicine Qufeng Jieyang Capsule

Qufeng Jieyang Capsule is a kind of oral preparation composed of Traditional Chinese Medicine (TCM). It developed from effective prescription of TCM after properly disposed according to pharmacological results and clinical practices. The capsule is prepared by extracts from eight kinds of TCM, viz. Radix Scutellariae Baicalensis, Radix Ledebouriella Divaricatae, Radix Paeoniae Rubrae, Herba Taraxaci Mongolici cum Radice, Cortex Dictamni Dasycarpi Radicis, Radix Sophorae Flavescentis, Radix Platycodi Grandiflori and Fructus Xanthii Sibirici, all recorded in the Chinese Pharmacopoeia. The preparation is organized reasonable and creatively used to cure skin disease mainly arised from wind-heat. Although there are many preparations to treat this kind of disease clinically at present, they are most external preparations, e.g. Huatuo Ointment, Pikangwang Ointment, Fuqingsong Ointment, and Piyanping Ointment, according to clinic investigations, the external preparations lack of curative effect, moreover, easily to recur after application, the oral preparations are few and most of them are soup medicines in hospital yet, the soup medicines are difficult to take and carry, the capsule is a widely used preparation form with its advantage on easy to take and carry. Thus, we carefully researched Qufeng Jieyang Capsule based on the differentiation of TCM.The main aim of this dissertation is to study the preparation procedure and quality control standards of Qufeng Jieyang Capsule. Selecting capsule as the preparation form, the dissertation included preparation procedure, quality control, stability research and others by preliminary examinations. The results are as follows. A. The preparation procedure1. Studying the alcohol extraction technics of Radix Scutellariae Baicalensis by testing the content of baicalin. The optimum alcohol concentration was studied firstly. Then selecting extraction time, extraction times and the alcohol amount as the investigating factors, the optimum preparation procedure was studied by orthogonal text. The reasonable and available process conditions were established.2. Studying the water extraction technics of other drugs and remainder of Radix Scutellariae Baicalensis after alcohol extraction by testing extract content and the content of peoniflorin. Selecting the water amount, decoction time, decoction times and error as the investigating factors, the optimum preparation procedure was studied by orthogonal text. The reasonable and available process conditions were established.3. Studying the water extraction-alcohol deposition technics of drugs by testing extract content and the content of peoniflorin. Selecting relative density of the liquor and alcohol concentration as the investigating factors, the optimum preparation procedure was studied by orthogonal text. The reasonable and available process conditions were established.B. The molding preparation procedureThe kinds and usage amount of dressing, the kinds and concentration of wetting agent, and other aspects were studied in detail. The optimum preparation procedure was established.C. The quality standards research The qualitative TLC and quantitative HPLC research were well studied in the dissertation.Radix Scutellariae Baicalensis, Radix Ledebouriella Divaricatae, Radix Paeoniae Rubrae, Herba Taraxaci Mongolici cum Radice, Cortex Dictamni Dasycarpi Radicis, Radix Sophorae Flavescentis and Fructus Xanthii Sibirici were differentiated by TLC. The experimental results suggested that the spots on the chromatograms are clear, characteristic, reproducibility, and without interference by negative material. The methods are applicable to controll the standards of Qufeng Jieyang Capsule.Baicalin and peoniflorin were quantitative 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 baicalin ( C₂₁H₁₈O₁₁ ) in Radix Scutellariae Baicalensis and peoniflorin(C₂₃H₂₈O₁₁)in Radix Paeoniae Rubrae are no less than 8.0mg, and 1.2mg per pill, respectively. D. The stability researchIn the preparation stable aspect, used the normal temperature test and the acceleration test to the preparation character outward appearance, the load difference, the disintegration time limit, the moisture content determination, the microorganism limit, the qualitative distinction, the content determination item has separately carried on the inspection. The normal temperature test inspected for 12 months, the acceleration test inspected for 3 months, the results not obviously changed, showed the preparation stable in the storage time, the stability was good.The results showed that the preparation procedure of Qufeng Jieyang Capsule is reasonable in technics, controllable in quality and good in stability. The thesis provided whole pharmaceutical document for the declaration of Qufeng Jieyang Capsule.