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目的:优化腺苷钴胺片的处方组成。方法:以辅料中的羧甲基淀粉钠、微粉硅胶、硬脂酸镁用量为因素,以溶出度为指标,采用L9(34)正交设计试验优化腺苷钴胺片处方(每片含腺苷钴胺0.25 mg),对所制腺苷钴胺片进行验证试验(30 min溶出度、羟钴胺素在460 nm与352 nm处吸光度比值、崩解时限和含量),并考察制剂的加速稳定性。结果:辅料中影响腺苷钴胺片溶出度的主要因素是羧甲基淀粉钠;最优处方(10 000片)为羧甲基淀粉钠18 g,微粉硅胶1.8 g,硬脂酸镁3 g;所制片剂的30 min溶出度为97%~99%,羟钴胺素的吸光度比值均为0.93,崩解时间为9~10 min,含量为99.3%~99.7%,6个月的加速试验结果与0个月时比较无明显变化。结论:成功制得各项指标符合《中国药典》要求的腺苷钴胺片。
Objective: To optimize the formulation of adenosine cobalamin tablets. Methods: Taking the dosage of sodium carboxymethyl starch, silica fume and magnesium stearate in the excipients as factors, the dissolution rate was taken as the index to optimize the adenosine cobalamine prescription by L9 (34) orthogonal design Glycosaminoglycans 0.25 mg) were used to verify the preparation of adenosine cobalamin tablets (30 min dissolution, the ratio of hydroxocobalamin absorbance at 460 nm and 352 nm, disintegration time and content) stability. RESULTS: The main factor affecting the dissolution of adenosine cobalamin tablets was sodium carboxymethyl starch. The optimum prescription (10 000 tablets) was sodium carboxymethyl starch 18 g, silica gel 1.8 g, magnesium stearate 3 g ; The dissolution rate of the prepared tablets was 97% -99% in 30 min, the absorbance ratio of hydroxocobalamin was 0.93, the disintegration time was 9-10 min, the content was 99.3% -99.7%, and the acceleration of 6 months Test results compared with 0 months no significant change. Conclusion: The adenosine cobalamin tablets with the indexes of “Chinese Pharmacopoeia” were successfully obtained.