【作者】 唐樑；

【导师】 秦明珠；

【作者基本信息】 南京中医药大学 ， 生药学， 2008， 硕士

【摘要】 CS清咽膏由CS膏及传统中药桔梗、苦杏仁、川贝母等组成,具有清肺化痰、止咳平喘之功效,主要用于肺热痰多、咳嗽气喘,哮喘、慢性支气管炎等症。本课题通过对CS清咽膏的药学研究,为哮喘患者提供一种安全、有效、便捷的新型中药膏滋。本研究首先对处方中的各味中药进行了全面鉴定,以2005年版《中国药典》为标准,保证了各味中药的质量,为制剂研究提供了有力保障。药材的提取研究分为两部分:川贝母采用乙醇渗漉提取,以总生物碱含量为检测指标,通过均匀设计试验确定了最佳提取工艺条件,结果是20倍量70%乙醇,浸渍120小时后渗漉提取,渗漉速度1ml/s;桔梗、苦杏仁等4味药采用水煎提取,以总皂苷含量和苦杏仁苷含量为检测指标,通过均匀设计试验确定了最佳提取工艺条件,结果是加8倍量水,煎煮3次,每次150分钟。制剂工艺研究主要考察辅料的选择和用量,收膏工艺以及膏滋的成型,结果是采用相当于稠膏量1/4的炼蜜,加入0.1%薄荷脑和0.1%山梨酸钾,混匀收膏,按此条件制备的膏滋色泽均匀、流动性较好,口感也较好。制剂的质量标准建立了桔梗、枇杷叶和川贝母的薄层色谱鉴别方法;采用高效液相色谱法建立了苦杏仁苷的含量测定方法;采用紫外一可见分光光度法建立了总皂苷、总生物碱和总氨基酸的含量测定方法。结果薄层色谱鉴别方法简便可行;苦杏仁苷在25.00～400.00μg/ml浓度范围呈现良好的线性关系（r=0.99994）,平均回收率为98.54%,RSD为2.69%,含量限度为每瓶膏滋含苦杏仁苷不少于1.00g;总皂苷测定以人参皂苷Rg₁为对照品,平均回收率为97.01%,RSD为1.75%,含量限度为每瓶膏滋含总皂苷不少于550mg;总生物碱测定以贝母素乙为对照品,平均回收率为101.65%,RSD为2.62%,含量限度为每瓶膏滋含总生物碱不少于1.390mg;总氨基酸测定以甘氨酸为对照品,平均回收率为100.63%,RSD为1.92%,含量限度为每瓶膏滋含总氨基酸不少于16.50g。该质量控制方法简单、专属性强、重现性好,可有效控制产品质量。三批样品的初步稳定性实验表明,该制剂在自然储存条件下连续放置3个月,各项考察项目均符合规定,结果表明本品基本稳定。本研究以中医药理论为指导,采用现代技术为实验手段,为CS清咽膏这一新型中药制剂提供了质量评价方法,为企业的工业化生产提供了科学依据。更多还原

【Abstract】 CS Qingyan Gao is made of CS meat extract and several traditional Chinese herbs including Radix Platycodi, Semen Armeniacae Amarum and Bulbus Fritillariae Cirrhosae, etc., which is effective for phlegm, cough, asthma and chronic bronchitis. Based on the pharmaceutical study of CS Qingyan Gao, the topic provided the bronchitis patients with a safe, effective and convenient new Chinese medicine "Gaozi".Firstly, the topic made a comprehensive identification of every kind of herbs in the prescription according to Chinese Pharmacopoeia as a standard. The identification results ensured the quality of the herbs, and provided guarantee for the pharmaceutical preparation.Study on the extraction of herbs includes two parts. The alcohol percolation was used for the extraction of Bulbus Fritillariae Cirrhosae. With the total alkaloids content for detecting indicator by uniform design, we determined the optimum extraction conditions, the result was 20 times the volume of 70% ethanol, 120 minutes after impregnation, and the rate of 1ml/s. Radix Platycodi and Semen Armeniacae Amarum etc. were extracted by water. With the content of total saponins and amygdalin for detecting indicators by uniform design, we determined the optimum extraction conditions, the result was 8 times the volume of water, boiling 3 times and 150 minutes for each time.The preparation study was mainly on the selection and dosage of the additive, and the preparation process. The result was using 1/4 honey equivalent to the thick paste, by adding 0.1% xylenol and 0.1% Potassium sorbate. The Gaozi preparation of this condition was of uniform color, good liquidity and fine taste.In the study on quality standard, we used the TLC method to identify Radix Platycodi, Folium Eriobotryae and Bulbus Fritillariae Cirrhosae; used the HPLC method to determination the content of amygdalin; used the UV-vis method to determination the content of total saponins, total alkaloids and total amino acids. The results: the TLC method was simple and feasible; amygdalin in 25.00～400.00μg / ml concentration was of a good linear relationship （r = 0.99994）, the average recovery rate was 98.54%, RSD=2.69%; the total saponins determination to ginsenoside Rg₁ for reference substance, the average recovery rate was 97.01%, RSD=1.75%; the total alkaloids determination to peiminine for reference substance, the average recovery rate was 101.65%, RSD=2.62%; the total amino acids determination to glycine for reference substance, the average recovery rate was 100.63%, RSD=1.92%. The content limits of amygdalin, total saponins, total alkaloids and total amino acids for each bottle were not less than 1.00g, 550mg, 1.390mg and 16.50g. The quality control method is simple, specific and reproducible, and can effectively control the quality of products.The elementary stability studies demonstrated that each item of three batches of sample was accordance with the quality standard at room temperature. Therefore, the products were stable.In this study as a guide of Chinese medicine theory, the use of modern technology for the experimental means provides a quality evaluation method for the new health food CS Qingyan Gao, and also provides a scientific basis for the industrial production in further development of this new Chinese medicine.更多还原