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[艾纳香挥发油栓的制备工艺及溶出度研究]

[Preparation technology and dissolution research of Blumea volatile oil suppository].

作者信息

Wang Song, Zhao Yong-Heng, Zhou Yi-Sheng, Li Fang-Fang

出版信息

Zhongguo Zhong Yao Za Zhi. 2014 May;39(10):1805-10.

PMID:25282886
Abstract

OBJECTIVE

To research the preparation technology and dissolution of Blumea volatile oil suppository.

METHOD

In order to establish the content determination and methodology inspection method of Blumea volatile oil plug, the extraction process of Blumea volatile oil was optimized by using orthogonal test. Optimization on the investigation to the suppository matrix by melting time, appearance and dissolution was carried on. The best prescription craft was determined by determining the best molding temperature, dosage of the matrix and complementary makings. The determination method of dissolution was established by investigating different dissolution method and its impact on the preparation of dissolution.

RESULT

The best conditions of steam distillation extracted Blumea volatile oil was as followed, the ratio of gardenia to liquor 1:6, 2.5% drug amount of sodium, 8 hours of extracting time. The optimum temperature for mold was 60-65 degrees C. Preparation technique of Blumea volatile oil suppository was stable, which after 45 minutes and 3 h in pH 4.5 PBS released at least 70% and 90%.

CONCLUSION

Blumea volatile oil suppository with rational prescription, simple preparation and good stability.

摘要

目的

研究艾纳香挥发油栓的制备工艺及溶出度。

方法

为建立艾纳香挥发油栓的含量测定及方法学考察方法,采用正交试验对艾纳香挥发油的提取工艺进行优化。通过对栓剂基质的熔融时间、外观及溶出度进行考察优化。通过确定最佳成型温度、基质用量及辅料用量来确定最佳处方工艺。通过考察不同溶出方法及其对制剂溶出度的影响建立溶出度测定方法。

结果

水蒸气蒸馏提取艾纳香挥发油的最佳条件为:药材与水的比例为1:6,加药量2.5%的氯化钠,提取时间8小时。最佳成型温度为60 - 65℃。艾纳香挥发油栓制备工艺稳定,在pH 4.5的磷酸盐缓冲液中45分钟和3小时后分别释放至少70%和90%。

结论

艾纳香挥发油栓处方合理,制备工艺简单,稳定性良好。

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