Research Of New Traditional Chinese Medicine Huangbai Zhimi Uppository

Huangbai zhimi Uppository is a kind of 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 uppository is prepared by extracts from six kinds of TCM, Amur Corktree Bark,Taraxacum,Purpleflower Violet,Arnebia Root,Lightyellow sophora root and Dragon's Blood, all recorded in the Chinese Pharmacopoeia. The preparation is organized reasonable and creatively used to cure cervical erosion.The main aim of this dissertation is to study the preparation procedure and quality control standards of Huangbai zhimi Uppository. Selecting uppository 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 Amur Corktree Bark and Arnebia Root by testing the content of berberine hydrochloride. 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 Amur Corktree Bark and Arnebia Root after alcohol extraction by testing extract content and the content of ammothamnine. 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 ammothamnine. 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 and other aspects were studied in detail. The optimum preparation procedure was established.C. The quality standards researchThe qualitative TLC and quantitative HPLC research were well studied in the dissertation.Amur Corktree Bark,Purpleflower Violet and taraxacum were identified 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 Huangbai zhimi Uppository.The contend of Ammothamnine was 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 Ammothamnine is no less than 0.14mg 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 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 Huangbai zhimi Uppository is reasonable in technics, controllable in quality and good in stability. The thesis provided whole pharmaceutical document for the declaration of Huangbai zhimi Uppository.