谢星辉, 顾晓晨, 刘芳宇. 半合成甘油脂肪酸酯栓剂基质的多晶型变化研究J. 药学学报, 1988, 23(5): 388-393.
引用本文: 谢星辉, 顾晓晨, 刘芳宇. 半合成甘油脂肪酸酯栓剂基质的多晶型变化研究J. 药学学报, 1988, 23(5): 388-393.
XH Xie, XC Gu , FY Liu, . STUDY ON THE POLYMORPHIC TRANSITION OF SEMISYNTHETIC TRIGLYCERIDES OF FATTY ACIDS SUPPOSITORY BASESJ. Acta Pharmaceutica Sinica, 1988, 23(5): 388-393.
Citation: XH Xie, XC Gu , FY Liu, . STUDY ON THE POLYMORPHIC TRANSITION OF SEMISYNTHETIC TRIGLYCERIDES OF FATTY ACIDS SUPPOSITORY BASESJ. Acta Pharmaceutica Sinica, 1988, 23(5): 388-393.

半合成甘油脂肪酸酯栓剂基质的多晶型变化研究

STUDY ON THE POLYMORPHIC TRANSITION OF SEMISYNTHETIC TRIGLYCERIDES OF FATTY ACIDS SUPPOSITORY BASES

  • 摘要: 本文对半合成甘油脂肪酸酯栓剂基质进行了多晶型变化研究,加速试验发现基质在贮藏期中熔点逐步上升,软化时间也逐步延长,X线衍射测定表明有多晶型变化,从非稳定的A型转变成稳定的B型,由此带来一系列物理性变化。晶型转化的速度与温度有关,30℃时4~6d即达到稳定,而在室温下则需要更长的时间。为了保证质量,建议新制基质的熔点应控制在34~35℃之间。

     

    Abstract: It is well known that some pharmaceutical properties of oleagenous suppositories change during storage. To clarify these phenomena, accelerated storage experiments were performed by use of five local semisynthetic fatty bases and one foreign base. The melting points increased gradually to an extent of 2~3℃ when the bases were stored at 30±1℃ after 4~6 days. The softening time and the disintegration time were also prolonged. X-ray diffraction was measured, and it was confirmed that there were two different crystal forms in the semisynthetic bases. One of them was an unstable form (A-form) found in freshly prepared samples. The other was a stable form (B-form) found in stored samples. The change of pharmaceutical properties of suppositories well corresponded to the A to B transition. It was also recognized that the transition rate intensely depended on storage temperature. In order to ensure the quality of suppositories, it is suggested that the melting point of freshly prepared bases are controlled within 34~35℃.

     

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