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[复方丹参泡腾渗透泵片的制备及释药机制研究]

[Study on preparation and release mechanism of effervescent osmotic pump tablet of compound Danshen].

作者信息

Xue Li'an, Li Yuanbo, Guo Dandan, Yin Jianhua, Liu Yanchun, Hou Shixiang

机构信息

Hairong Yangtze River Pharmaceutical Group of Sichuan Pharmaceutical Co. Ltd., Dujiangyan 611830, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2009 Apr;34(7):848-51.

Abstract

OBJECTIVE

To prepare effervescent osmotic pump tablet (EOPTs) according to the rhythm of coronary heart disease based on efficacy material and the mechanism of compound Danshen and to study the mechanism of drug released of that tablets.

METHOD

Since compound Danshen consist of compounds with polyphenolic groups or carboxyl groups, such as phenolic acids, flavonoids, and triterpenoids that they were acidic. EOPTs were prepared from tablet cores which containing NaHCO3 as effervescent, NaCL and manitol as osmotic agents, HPMC as retarding agents coating with CA membrane. And study the mechanism of drug released according to the change of tablet osmotic pressure.

RESULT

The results of in vitro experiments showed that no difference was observed among the profiles of Danshensu, protocatechuic aldehyde, ginsenoside Rg1, Rb1, notoginsenoside R1 release EOPTs. The drug was completely released from the device with a zero-order release rate over 12 h.

CONCLUSION

EOPTs are Successfully obtained EOPT which the drug is released from the device over 12 h and the release mechanism of EOPTs is explained.

摘要

目的

基于冠心病发病节律,以有效物质为基础,结合复方丹参作用机制制备泡腾渗透泵片(EOPTs),并研究该片剂的释药机制。

方法

由于复方丹参由具有多酚基团或羧基的化合物组成,如酚酸、黄酮类化合物和三萜类化合物,它们呈酸性。EOPTs由含有NaHCO₃作为泡腾剂、NaCl和甘露醇作为渗透剂、HPMC作为阻滞剂并包被CA膜的片芯制备而成。并根据片剂渗透压的变化研究释药机制。

结果

体外实验结果表明,丹参素、原儿茶醛、人参皂苷Rg1、Rb1、三七皂苷R1在EOPTs中的释放曲线无差异。药物在12小时内以零级释放速率从装置中完全释放。

结论

成功获得了药物在12小时内从装置中释放的EOPT,并对EOPTs的释放机制进行了解释。

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