植物軟膠囊的處方優(yōu)化及加速穩(wěn)定性考察
發(fā)布時(shí)間:2018-01-25 04:55
本文關(guān)鍵詞: 植物軟膠囊 穩(wěn)定性 黏度 膠皮強(qiáng)度 膠皮彈性 崩解時(shí)間 出處:《中國(guó)醫(yī)藥工業(yè)雜志》2017年02期 論文類(lèi)型:期刊論文
【摘要】:以明膠、變性淀粉、κ-卡拉膠、ι-卡拉膠、低;Y(jié)冷膠為研究對(duì)象,分別考察濃度、溫度和p H值對(duì)膠液黏度、膠皮強(qiáng)度和彈性的影響,篩選替代明膠的植物膠。選用變性淀粉,再配合甘油、山梨醇和水制備軟膠囊膠皮,通過(guò)正交試驗(yàn)優(yōu)選膠皮處方,并壓制含液體石蠟的軟膠囊,進(jìn)行加速穩(wěn)定性試驗(yàn)。結(jié)果表明,具有黏度低、耐高溫、耐酸特性的變性淀粉在4種植物膠中最具優(yōu)勢(shì)。優(yōu)選得到的優(yōu)化軟膠囊膠皮處方為:變性淀粉∶增塑劑為2∶1,變性淀粉∶水為1∶1,甘油∶山梨醇為1∶1。3批優(yōu)化制品的膠液黏度、膠皮強(qiáng)度、膠皮彈性和崩解時(shí)間分別為(38.89±0.63)Pa·s、(242.51±4.91)g、(7.03±0.10)mm和(47.03±0.42)min。在40℃加速試驗(yàn)3個(gè)月,該優(yōu)化軟膠囊的外觀及崩解時(shí)間均未發(fā)生顯著改變。
[Abstract]:The effects of concentration, temperature and pH value on viscosity, strength and elasticity of gelatin, modified starch, 魏 -carrageenan, 1-carrageenan and low-acyl cold gel were investigated. The soft capsule rubber was prepared with modified starch, glycerol, sorbitol and water. The formulation of soft capsule was selected by orthogonal test, and the soft capsule containing liquid paraffin was pressed. The accelerated stability test was carried out. The results showed that it had low viscosity and high temperature resistance. The modified starch with acid-resistant properties had the most advantages among the four kinds of plant gum. The optimized formulation of soft capsule rubber was as follows: modified starch: plasticizer 2: 1, modified starch: water 1: 1. Glycerol: the viscosity, strength, elasticity and disintegration time of the products were 38.89 鹵0.63 Pa 路s, respectively. It was 7.03 鹵0.10mm and 47.03 鹵0.42mm. accelerated test at 40 鈩,
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