【摘要】：目的制備丁酸氯維地平脂微球注射液,并對(duì)所制備的脂微球注射液進(jìn)行質(zhì)量評(píng)價(jià),確保制劑安全、穩(wěn)定。方法采用高壓均質(zhì)法制備丁酸氯維地平脂微球注射液,通過(guò)單因素考察得到最佳處方和制備工藝,并對(duì)制劑進(jìn)行了理化性質(zhì)的表征及穩(wěn)定性考察。結(jié)果確定最優(yōu)處方為丁酸氯維地平0.5 g·L-1、油相大豆油200 g·L-1、乳化劑蛋黃卵磷脂12 g·L-1、穩(wěn)定劑油酸0.3 g·L-1、等滲調(diào)節(jié)劑甘油22.5 g·L-1、p H調(diào)節(jié)劑Na OH以及注射用水適量。油水兩相在70℃混合,高速分散機(jī)20 000 r·min-1,剪切10次,每次1 min,轉(zhuǎn)移至微射流中103 425 k Pa均質(zhì)12次,115℃滅菌30 min,即得。結(jié)論所設(shè)計(jì)的工藝可用于制備脂微球注射液。
[Abstract]:Objective to prepare chlorvedipine butyrate lipid microsphere injection and evaluate the quality of the prepared lipid microsphere injection to ensure the safety and stability of the preparation. Methods Clouvedipine butyrate microsphere injection was prepared by high pressure homogenization method. The best formulation and preparation process were obtained by single factor investigation. The physicochemical properties and stability of the preparation were also investigated. The results showed that the optimal formulation was chlorvedipine butyrate 0.5 g L -1, oil soybean oil 200 g L -1, emulsifier egg yolk lecithin 12 g L -1, stabilizer oleic acid 0.3 g L -1, isoosmotic regulator glycerol 22.5 g L -1 and injection water appropriate amount. The oil-water two-phase was mixed at 70 鈩，

本文編號(hào)：2217964