Study on the Consistency Evaluation of Nifedipine Extended-release Tablets(Ι)Based on Dissolution Evaluation Method in Vitro
The evaluation method of in vitro dissolution of nifedipine sustained-release tablets(Ι)was established,and the self-developed drugs before and after the consistency study of the company were evaluated with the original drugs as the reference(Hereinafter referred to as self-developed drugs 1,self-developed drugs 2),so as to provide the basis for quality consistency.0.3%Tween 80 solution with different pH values(pH value 1.0,pH value 4.0,pH value 6.8,water)was selected as the dissolution medium,the release rates of 0.25,0.5,1,2,3,10,12 hours were investigated by HPLC,and the dissolution curve method was established in vitro,and the methodology was verified,finally,the similarity factor method(f2)was used to compare the self-developed drugs with the reference.The results showed that the specificity,linearity,precision,accuracy,filtration membrane adsorption and solution stability of the established in vitro dissolution curve method met the requirements;self-developed drugs 1 is inconsistent with the reference dissolution behavior and f2 is less than 50,after adjusting the prescription technology,self-developed drugs 2 is consistent with the reference dissolution behavior in vitro,and f2 is greater than 50.The evaluation method of in vitro dissolution established by this product is accurate and reliable,and the self-developed drugs 1 is inconsistent with the reference in vitro dissolution;the self-developed drugs 2 was similar to the reference dissolution curve,and the in vitro dissolution was consistent.
nifedipine sustained-release tablets(Ι)dissolution in vitroconsistency evaluationsimilarity factor method
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