银杏叶片处方筛选及稳定性研究

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以银杏叶片片剂外观、硬度、崩解时限、含量、片重差异等为指标,对试验处方进行筛选,并对筛选后的处方进行高温、高湿的加速实验,以考察产品的稳定性。通过小试研究出银杏叶片的成型处方和工艺,且在进一步中试中对成型处方和工艺进行重现及稳定性考察。研究表明,选用淀粉作填充剂、羟丙纤维素作黏合剂、羧甲基淀粉钠作为崩解剂、4‰硬脂酸镁作润滑剂所压片剂,成型性好,外观、崩解时限合格,且质量稳定性强,适宜用作银杏叶片的成型处方,可以应用于工业化生产。 Ginkgo leaf tablet appearance, hardness, disintegration time, content, weight and other differences as an indicator of the test prescription screening, and screening of the prescriptions for high temperature and high humidity accelerated experiments to study the stability of the product. Through a small test to study the formation of ginkgo leaf prescription and process, and in the pilot in the process of shaping the recipe and process to reproduce and stability inspection. Studies have shown that the selection of starch as a filler, hydroxypropyl cellulose as a binder, sodium carboxymethyl starch as a disintegrant, 4 ‰ magnesium stearate as a lubricant tablet, good moldability, appearance, disintegration time Qualified, and strong quality and stability, suitable for forming ginkgo leaf prescription, can be used in industrial production.
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