原料药粒径对盐酸决奈达隆片体外溶出行为的影响

Influence of Particlesize of the API on the Dissolution Behavior of Dronedarone HCl Tablets

目的:研究原料药粒径对盐酸决奈达隆片溶出行为的影响。方法:参照2015版中国药典第二法,以pH值4.5磷酸盐缓冲液为介质,转速为75 r/min,采用紫外-可见分光光度法,考察不同原料药粒径对盐酸决奈达隆片体外溶出的影响以及与参比制剂(RLD)溶出的相似性。结果:采用D90分别为3.463和100.538μm的原料药制备的样品体外溶出与参比制剂不相似;采用D90:14.918~55.828μm范围内的原料药制备的样品体外溶出与参比制剂相似。结论:原料药粒径对盐酸决奈达隆片在体外溶出影响较大,合理控制原料药粒径可确保与参比制剂溶出一致。

Objective: Influence of particlesize of the API on the dissolution behavior of Dronedarone HCl Tablets. Methods:According to the second method of the Ch P 2015,phosphate buffer solution of p H4. 5 was selected as dissolution medium with the stirring speed of 75 r/min and UV spectrophotometry to study influence of particlesize of the API on the dissolution behavior of Dronedarone HCl. Results: The dissolution of samples prepared with APIs D90: 3. 463 or100. 538 μm was not similar to that of RLD;the dissolution of samples prepared with APIs in the range of D90: 14. 918 ~ 55. 828 μm was similar to that of RLD.Conclusion: The particle size of the API has a great influence on the dissolution of Dronedarone HCl tablets in vitro. Micronizing the API can effectively improve the dissolution rate of Dronedarone HCl tablets. Reasonable control of the particle size of API ensure that the dissolution rate is similar with that of RLD.