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纳米乳液的配方:相转化组成法与高压均质法的比较

Formulation of nanoemulsion: a comparison between phase inversion composition method and high-pressure homogenization method.

作者信息

Kotta Sabna, Khan Abdul Wadood, Ansari S H, Sharma R K, Ali Javed

机构信息

Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard , New Delhi , India and.

出版信息

Drug Deliv. 2015;22(4):455-66. doi: 10.3109/10717544.2013.866992. Epub 2013 Dec 13.

Abstract

There is lot of confusion in the literatures regarding the method of production of nanoemulsion. According to some authors, only the methods using high energy like high-pressure microfluidizer or high-frequency ultra-sonic devices can produce actual nanoemulsions. In contrast to this concept, one research group reported for the first time the preparation of nanoemulsion by a low-energy method. Later on many authors reported about the low-energy emulsification method. The purpose of this work is to formulate, evaluate and compare nanoemulsions prepared using high-energy as well as low-energy method. Nanoemulsions formulated were based on the phase inversion composition technique (low energy method) and were selected from the ternary phase diagram based on the criterion of their being a minimum concentration of S(mix) used in the formulation. For high-pressure homogenization method (high energy method) Design-Expert software was used, and the desirability function was probed to acquire an optimized formulation. No significant difference (p > 0.05) was observed in the globule size of formulations made by each method, but the value of poly-dispersibility index between the two methods was found to be extremely significant (p < 0.001). A very significant difference (p < 0.001) was observed in the drug release from formulations made by each method. More than 60% of the drug was released from all the formulations in the initial 2 h of the dissolution study.

摘要

关于纳米乳剂的制备方法,文献中存在很多混淆之处。一些作者认为,只有使用高能方法(如高压微射流均质器或高频超声设备)才能制备出真正的纳米乳剂。与此概念相反,一个研究小组首次报道了通过低能方法制备纳米乳剂。后来,许多作者也报道了低能乳化方法。本研究的目的是制备、评估和比较采用高能和低能方法制备的纳米乳剂。所制备的纳米乳剂基于相转变组成技术(低能方法),并根据配方中使用的S(混合)最低浓度标准从三元相图中选取。对于高压均质法(高能方法),使用了Design-Expert软件,并探究了合意函数以获得优化配方。两种方法制备的制剂的球粒大小未观察到显著差异(p>0.05),但两种方法之间的多分散指数值差异极为显著(p<0.001)。两种方法制备的制剂的药物释放情况存在非常显著的差异(p<0.001)。在溶出度研究的最初2小时内,所有制剂中超过60%的药物被释放出来。

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