扶正解毒口服液质量控制方法研究(1)
摘要：目的 建立扶正解毒口服液的质量控制方法。方法 采用TLC法对扶正解毒口服液中的板蓝根、黄芪和淫羊藿进行鉴别;采用HPLC法测定(R，S)-告依春的含量。结果 在薄层色谱鉴别中均能检出板蓝根、黄芪和淫羊藿的特征性斑点;以(R，S)-告依春对照品浓度为横坐标，峰面积为纵坐标，以峰面积(Y，μv)对浓度(X，μg/ml)进行线性回归，绘制标准曲线，其回归方程为：Y=45784.94X-17640.25，相关系数r=0.99997，试验结果表明：(R，S)-告依春浓度在4.63～123.38 μg/ml，呈良好的线性关系。标准中建立的(R，S)-告依春的含量测定方法耐受性良好、灵敏度高、重现性好、专属性强，可以有效控制产品的质量。结论本方法能准确、可靠的对扶正解毒口服液中(R，S)-告依春含量进行测定，可作为该制剂的质量控制方法。
关键词：扶正解毒口服液;薄层鉴别;含量测定
中图分类号：R286.0 文献标识码：A DOI：10.3969/j.issn.1006-1959.2019.07.029
, 百拇医药
文章编号：1006-1959(2019)07-0100-04
Abstract：Objective To establish a quality control method for Fuzheng Jiedu Oral Liquid. Methods TLC method was used to identify Radix Isatidis， Astragalus and Epimedium in Fuzheng Jiedu Oral Liquid. The content of (R， S)-Gu Yichun was determined by HPLC. Results The characteristic spots of Radix Isatidis， Astragalus and Epimedium were detected in the identification of TLC; the concentration of (R， S)-Guyuechun reference was taken as the abscissa， the peak area was the ordinate， and the peak area was(Y， μv) linear regression of concentration (X， μg / ml)， draw a standard curve， the regression equation is： Y=45784.94X-17640.25， correlation coefficient r=0.99997， the test results show：(R， S) - The concentration of spring was in the range of 4.63～123.38 μg/ml， showing a good linear relationship. The method for determining the content of (R， S)-Yueyichun established in the standard is well tolerated， sensitive， reproducible and specific， which can effectively control the quality of the product.Conclusion The TLC method can accurately and reliably determine the content of (R，S)-Gu Yichun in Fuzheng Jiedu Oral Liquid， which can be used as the quality control method of the preparation.
, 百拇医药
Key words：Fuzheng Jiedu oral liquid;Thin layer identification;Content determination
扶正解毒口服液由板藍根、淫羊藿和黄芪组成，功能扶正祛邪，清热解毒[1]。用于治疗鸡传染性法氏囊病[2]。传统中药散剂在禽病防治中常采用常规方式粉碎混匀给药，由于鸡的肠道较短，药物在消化道的通过时间与家畜相比非常短，对纤维素的消化能力低，消化液中的消化酶只能将药物中的很少一部分有效成分浸出，药物的吸收利用率低，单位体重用量大，见效慢，同时仍大部分的药材随粪便而排出造成很大浪费。目前，提高中药材的生物利用度已成为竞相研究的热点，而超微粉、提取粉、口服液的生物利用度理论上均高于散剂，经过对比几种剂型的优劣势，选择将扶正解毒散经研究改变剂型为口服液，既提高药物的生物利用度，又节约了成本。本文将扶正解毒散经研究改变剂型，开发为新兽药扶正解毒口服液，原剂型产品质量标准较简单只有显微鉴别，没有薄层和含量测定项。为了控制产品质量，笔者建立了扶正解毒口服液的质量控制方法。定性方面建立了黄芪、板蓝根、淫羊藿的薄层色谱鉴别;含量方面建立了板蓝根中的(R，S)-告依春含量测定，可作为该制剂的质量控制方法。, 百拇医药(刘升 王延珍 冯文丽)
关键词：扶正解毒口服液;薄层鉴别;含量测定
中图分类号：R286.0 文献标识码：A DOI：10.3969/j.issn.1006-1959.2019.07.029
, 百拇医药
文章编号：1006-1959(2019)07-0100-04
Abstract：Objective To establish a quality control method for Fuzheng Jiedu Oral Liquid. Methods TLC method was used to identify Radix Isatidis， Astragalus and Epimedium in Fuzheng Jiedu Oral Liquid. The content of (R， S)-Gu Yichun was determined by HPLC. Results The characteristic spots of Radix Isatidis， Astragalus and Epimedium were detected in the identification of TLC; the concentration of (R， S)-Guyuechun reference was taken as the abscissa， the peak area was the ordinate， and the peak area was(Y， μv) linear regression of concentration (X， μg / ml)， draw a standard curve， the regression equation is： Y=45784.94X-17640.25， correlation coefficient r=0.99997， the test results show：(R， S) - The concentration of spring was in the range of 4.63～123.38 μg/ml， showing a good linear relationship. The method for determining the content of (R， S)-Yueyichun established in the standard is well tolerated， sensitive， reproducible and specific， which can effectively control the quality of the product.Conclusion The TLC method can accurately and reliably determine the content of (R，S)-Gu Yichun in Fuzheng Jiedu Oral Liquid， which can be used as the quality control method of the preparation.
, 百拇医药
Key words：Fuzheng Jiedu oral liquid;Thin layer identification;Content determination
扶正解毒口服液由板藍根、淫羊藿和黄芪组成，功能扶正祛邪，清热解毒[1]。用于治疗鸡传染性法氏囊病[2]。传统中药散剂在禽病防治中常采用常规方式粉碎混匀给药，由于鸡的肠道较短，药物在消化道的通过时间与家畜相比非常短，对纤维素的消化能力低，消化液中的消化酶只能将药物中的很少一部分有效成分浸出，药物的吸收利用率低，单位体重用量大，见效慢，同时仍大部分的药材随粪便而排出造成很大浪费。目前，提高中药材的生物利用度已成为竞相研究的热点，而超微粉、提取粉、口服液的生物利用度理论上均高于散剂，经过对比几种剂型的优劣势，选择将扶正解毒散经研究改变剂型为口服液，既提高药物的生物利用度，又节约了成本。本文将扶正解毒散经研究改变剂型，开发为新兽药扶正解毒口服液，原剂型产品质量标准较简单只有显微鉴别，没有薄层和含量测定项。为了控制产品质量，笔者建立了扶正解毒口服液的质量控制方法。定性方面建立了黄芪、板蓝根、淫羊藿的薄层色谱鉴别;含量方面建立了板蓝根中的(R，S)-告依春含量测定，可作为该制剂的质量控制方法。, 百拇医药(刘升 王延珍 冯文丽)