【作者】 秦明明；

【导师】 金向群； 丁志英；

【作者基本信息】 吉林大学 ， 药物化学， 2008， 硕士

【摘要】 本文以六味药材共同起效为目的,研究制备了六类新药—黄柏治糜栓。在中药提取方面,采用正交实验法,分别以黄柏中盐酸小檗碱的量为指标,对黄柏、紫草乙醇提取的最佳工艺进行了考察;以苦参中氧化苦参碱的量为指标,对其余药材和醇提后的黄柏、紫草残渣水煎煮提取及水煎醇沉提取的最佳工艺进行了考察。在制剂成型工艺方面,筛选了适用的辅料,并对制剂成型工艺进行了研究。在质量标准方面,定性研究采用TLC法对制剂中的黄柏、蒲公英、紫花地丁三味药材进行了鉴别;定量研究采用HPLC法对制剂中氧化苦参碱进行了方法学考察和含量测定,并制定了本制剂的含量限度。在制剂稳定性方面,分别对制剂的定性鉴别、含量测定、检查等项进行了考察,常温试验考察了12个月,目前仍在继续考察;加速试验考察了3个月。通过本课题的研究,提供了黄柏治糜栓制备工艺、质量标准、含量测定、稳定性考察等方面药学部分的资料,为申报该新药品种药学部分奠定了基础。更多还原

【Abstract】 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.更多还原