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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.

DOI:10.3109/10717544.2013.866992
PMID:24329559
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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