万氏牛黄清心微丸的制备及质量标准研究
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摘要
本文根据临床需要,并结合药厂GMP车间的生产条件将万氏牛黄清心蜜丸,增加规格为万氏牛黄清心微丸。对微丸成型工艺和包衣工艺进行研究制备了万氏牛黄清心微丸,并在此基础上研究了万氏牛黄清心微丸的体外溶出度,建立了检测内在质量的定性定量方法。
采用挤出-滚圆造粒法,在单因素考察的基础上,优化条件,筛选出对素丸粉体学性质影响较大的因素作为主要因素,应用正交设计试验优化了微丸的制备工艺,以微晶纤维素(MCC)为稀释剂,羟甲基纤维素钠(HPMC K4M)为粘合剂,80%乙醇为润湿剂,可制得表面较为光滑,圆整度较高的万氏牛黄清心微丸。
采用包衣锅,以欧巴代(胃溶型)为包衣材料,经过工艺筛选,溶出度检测,在优化条件下,确定万氏牛黄清心微丸包衣处方。建立了万氏牛黄清心微丸体外溶出度的检测方法,溶出度试验表明,本研究制备的万氏牛黄清心微丸的主要成分的释药行为,与万氏牛黄清心蜜丸一致。并对微丸溶出机制进行了初步探讨。
采用TLC方法,对万氏牛黄清心微丸中有效成分盐酸小檗碱、黄芩苷、栀子苷进行了定性鉴别:采用HPLC方法对样品中黄芩苷进行了含量测定;建立了万氏牛黄清心微丸体外溶出度的检测方法。各方法专属性好、灵敏、准确、重现性好。
According to clinical needs , with the production conditionsand of GMP pharmacertical plant, We transformated the Wanshi Niuhuang Qingxin sweetpills to Wanshi Niuhuang Qingxin pills. So we studied the preparation of the prescription. Based on these results, the dissolution of the pills was studied. The qualitative and quantitative analysis methods were developed to control the inherent quality of formulation.
Pellets were prepared by the method of extrusion-spheronization. Based on the studies of the influence factors, we optimized the condition, choosed the major factor which influenced the powder property of the pellets. Orthogonal test was used to optimize the experiment conditions. Wanshi Niuhuang Qingxin pills was prepared with MCC as dilute agent , HPMC(K4M) as adhesive agent and 80%Et0H as Wetting agent. The sruface of the pellets is glossy and the entire round degree is higher.
Coating pan was used to wrap up the pellets by OPADRY(gastric type solution). Thought selecting the making method, detecting the dissolution of compound, We identified Wanshi Niuhuang Qingxin pellets coated prescription In optimum conditions. Establish the pellets dissolution of the detection method, dissolution of experiments show that the dissolution of the major components in pellets was similar with the sweetpills. The description of dissolution model had been discussed.
TLC methods were used to identify Berberine Hydrochloride, Baicalin, Geniposide in WSNHQX; the method of HPLC for Baicalin was developed to determine its contents in preparation. the dissolution of the detection method with WSNHQX pellets was established.
采用挤出-滚圆造粒法,在单因素考察的基础上,优化条件,筛选出对素丸粉体学性质影响较大的因素作为主要因素,应用正交设计试验优化了微丸的制备工艺,以微晶纤维素(MCC)为稀释剂,羟甲基纤维素钠(HPMC K4M)为粘合剂,80%乙醇为润湿剂,可制得表面较为光滑,圆整度较高的万氏牛黄清心微丸。
采用包衣锅,以欧巴代(胃溶型)为包衣材料,经过工艺筛选,溶出度检测,在优化条件下,确定万氏牛黄清心微丸包衣处方。建立了万氏牛黄清心微丸体外溶出度的检测方法,溶出度试验表明,本研究制备的万氏牛黄清心微丸的主要成分的释药行为,与万氏牛黄清心蜜丸一致。并对微丸溶出机制进行了初步探讨。
采用TLC方法,对万氏牛黄清心微丸中有效成分盐酸小檗碱、黄芩苷、栀子苷进行了定性鉴别:采用HPLC方法对样品中黄芩苷进行了含量测定;建立了万氏牛黄清心微丸体外溶出度的检测方法。各方法专属性好、灵敏、准确、重现性好。
According to clinical needs , with the production conditionsand of GMP pharmacertical plant, We transformated the Wanshi Niuhuang Qingxin sweetpills to Wanshi Niuhuang Qingxin pills. So we studied the preparation of the prescription. Based on these results, the dissolution of the pills was studied. The qualitative and quantitative analysis methods were developed to control the inherent quality of formulation.
Pellets were prepared by the method of extrusion-spheronization. Based on the studies of the influence factors, we optimized the condition, choosed the major factor which influenced the powder property of the pellets. Orthogonal test was used to optimize the experiment conditions. Wanshi Niuhuang Qingxin pills was prepared with MCC as dilute agent , HPMC(K4M) as adhesive agent and 80%Et0H as Wetting agent. The sruface of the pellets is glossy and the entire round degree is higher.
Coating pan was used to wrap up the pellets by OPADRY(gastric type solution). Thought selecting the making method, detecting the dissolution of compound, We identified Wanshi Niuhuang Qingxin pellets coated prescription In optimum conditions. Establish the pellets dissolution of the detection method, dissolution of experiments show that the dissolution of the major components in pellets was similar with the sweetpills. The description of dissolution model had been discussed.
TLC methods were used to identify Berberine Hydrochloride, Baicalin, Geniposide in WSNHQX; the method of HPLC for Baicalin was developed to determine its contents in preparation. the dissolution of the detection method with WSNHQX pellets was established.
引文
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