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品牌甾体软膏和通用甾体软膏的流变学特性以及与类肝素乳膏混合兼容性的差异:其表面活性剂的作用。

Differences in the rheological properties and mixing compatibility with heparinoid cream of brand name and generic steroidal ointments: The effects of their surfactants.

作者信息

Kitagawa Shuji, Yutani Reiko, Kodani Rhu-Ichi, Teraoka Reiko

机构信息

Kobe Pharmaceutical University, Motoyamakita-machi 4-19-1, Higashinada-ku, Kobe 658-8558, Japan.

出版信息

Results Pharma Sci. 2016 Feb 13;6:7-14. doi: 10.1016/j.rinphs.2016.02.001. eCollection 2016.

Abstract

Most steroidal ointments contain propylene glycol (PG) and surfactants, which improve the solubility of corticosteroids in white petrolatum. Surfactants aid the uniform dispersal of PG within white petrolatum. Since the surfactants used in generic ointments are usually different from those used in brand name ointments, we investigated the effects of surfactants on the rheological properties of three brand name ointments and six equivalent generic ointments. We detected marked differences in hardness, adhesiveness, and spreadability among the ointments. Further examinations of model ointments consisting of white petrolatum, PG, and surfactants revealed that the abovementioned properties, especially hardness and adhesiveness, were markedly affected by the surfactants. Since steroidal ointments are often admixed with moisturizing creams prior to use, we investigated the mixing compatibility of the ointments with heparinoid cream and how this was affected by their surfactants. We found that the ointments containing glyceryl monostearate demonstrated good mixing compatibility, whereas those containing non-ionic surfactants with polyoxyethylene chains exhibited phase separation. These results were also consistent with the findings for the model ointments, which indicates that the mixing compatibility of steroidal ointments with heparinoid cream is determined by the emulsifying capacity of the surfactants in their oily bases.

摘要

大多数甾体软膏含有丙二醇(PG)和表面活性剂,它们可提高皮质类固醇在白凡士林中的溶解度。表面活性剂有助于PG在白凡士林中均匀分散。由于仿制药软膏中使用的表面活性剂通常与品牌药软膏中使用的不同,我们研究了表面活性剂对三种品牌药软膏和六种等效仿制药软膏流变学性质的影响。我们检测到这些软膏在硬度、粘性和铺展性方面存在显著差异。对白凡士林、PG和表面活性剂组成的模型软膏进行进一步研究发现,上述性质,尤其是硬度和粘性,受表面活性剂的影响显著。由于甾体软膏在使用前常与保湿霜混合,我们研究了这些软膏与类肝素霜的混合相容性以及表面活性剂对其的影响。我们发现,含有单硬脂酸甘油酯的软膏表现出良好的混合相容性,而含有聚氧乙烯链非离子表面活性剂的软膏则出现相分离。这些结果也与模型软膏的研究结果一致,这表明甾体软膏与类肝素霜的混合相容性取决于其油性基质中表面活性剂的乳化能力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f207/4773392/276d2e94095e/fx1.jpg

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