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目的比较不同厂家生产的替米沙坦片或胶囊在不同溶出介质中的体外溶出度。方法按中国药典2010版采用紫外分光光度法,以1000 mL不同溶液为溶出介质,转速50 r.min·1,温度(37±0.5)℃,测定不同厂家的6个品种的替米沙坦片剂或胶囊的体外溶出度。结果在pH 7.5磷酸盐缓冲液中,30 min的累积溶出量均超过标示量的85%;而在0.1 mol.L·1盐酸中,只有R片剂(Micardis)30 min的累积溶出量>80%,其中C和D在60 min的累积溶出量<30%,D片30 min的溶出度<10%。结论各生产厂家应严格控制产品内在质量,保证临床用药安全有效。
Objective To compare the in vitro dissolution of telmisartan tablets or capsules produced by different manufacturers in different dissolution media. Methods According to the Chinese Pharmacopoeia 2010 edition, UV spectrophotometry, 1000 mL different solutions were used as dissolution medium, the speed was 50 r.min · 1 and the temperature was 37 ± 0.5 ℃. Six kinds of telmisartan tablets In vitro dissolution of the agent or capsule. Results In the pH 7.5 phosphate buffer solution, the cumulative leaching amount in 30 min exceeded 85% of the indicated amount. In the 0.1 mol·L · 1 hydrochloric acid, only the cumulative leaching amount of Micardis 30 min was> 80 %, Of which C and D at 60 min cumulative dissolution of <30%, D piece 30 min dissolution <10%. Conclusion All manufacturers should strictly control the intrinsic quality of products to ensure the safe and effective clinical use.