生产工艺对复方草珊瑚注射液质量稳定性研究的论文.pdfVIP

生产工艺对复方草珊瑚注射液质量稳定性研究 郁建生 （铜仁职业技术学院 贵州 铜仁 554300） 摘要：黄酮类化合物是复方草珊瑚注射液中含量最多，最主要的有效成份。研究表明，复方草珊 瑚注射液中总黄酮含量在存放三年中平均每年降低 0.86%；在加热灭菌后降低 0.82%，变化甚微， 是非常稳定的。强光直射 30h可使注射液中总黄酮含量平均下降 9.91%，影响较大。注射液的 pH 值在 4-6时总黄酮含量最高。在温度、时间、pH值对注射液质量稳定性影响中，以 pH值变化影 响较大，三批注射液样品灭菌后 pH值平均降低 0.67，在存放三年中 pH值平均年降低 0.167。在 八种常用注射液的附加剂中以硫代硫酸钠，亚硫酸钠对总黄酮的稳定性影响较大，使总黄酮含量 降低 21.98%-12.07%。在与 26 种中草药注射液的配伍中，与博落回、苦参、黄柏、虎仗、朱砂 莲、地苦胆、十大功劳有配伍禁忌。 关键词：生产工艺，复方，草珊瑚，注射液，质量稳定性，研究 Studies on the qualitative stability of the Injection made from Sarcandrae glabra with productive technology YU Jian-sheng (Tongren Vocational Institute, Tongren 554300, china) Abstract: The flavonoids are important and main compositions in the injection made from Sarcandrae glabra . The research results expressed that the flavonoids were measured in the injection are stable after place three years and flavonoids average lower 0.86% annually and lower 0.82% after heating put out germ. The strong light shooting for 30 hours can make the flavonoids descend average 9.91%. The flavonoids in the injection are the most stable in pH 4~6. In the factors to influence stability of the injection, pH influenced bigger than other factors include temperature, time and pH value. pH value in the injection average lower 0.67 after heating put out germ and average lower 0.16% annually after place three years. In the Additives for the eight kinds common injections used, sodium thiosulphate and sodium sulfate made the flavonoids to descent 21.98%~12.07%. In mixture with 26 kinds different injections made from traditional chinese herbal medicine, it is not viable for mixture with the injections made from Sarcandrae glabra, Sophora flavescens, Phellodendron chinense,