不同厂家替米沙坦制剂的体外溶出度比较

Comparison of the Dissolution Rate of Telmisartan Formulation in Vitro

关键词:  替米沙坦  溶出度  浆法

Key words:  telmisartan  dissolution rate  paddle method

摘要:

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1 000 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。

Abstract:

OBJECTIVE To contrast the in vitro dissolution rate of telmisartan formations in different dissolution medium. METHODS The dissolution rate was revealed according to Ch.P (2010) by UV spectromphotometry, use 1 000 mL solution with different dissolution medium, at the speed of 50 r·min^-1, with (37±0.5)℃．RESULTS In the phosphate saline buffer solution, the dissolution rate of 30 min of all of the formations showed advantage than 85% of labelled amount. However in the 0.1 mol·L^-1 HCl dissolution solution, the dissolution rate of C and D in 60 min was lower than 30% of that. And the dissolution rate of D in 30 min was lower than 10% of that. CONCLUSION It is necessary to control the dissolution rate of telmisartan formulation．