[關(guān)鍵詞]
[摘要]
目的 考察前列地爾脂微球載體制劑與生理鹽水、5%葡萄糖注射液配伍的穩(wěn)定性。方法 在室溫25 ℃避光條件下,考察配伍液的pH值及外觀的變化,采用高效液相色譜法測(cè)定前列地爾配伍液在0~4 h含量及有關(guān)物質(zhì)的變化,并采用靜態(tài)激光散射計(jì)測(cè)定配伍液的平均粒徑、90%累積粒徑的變化。結(jié)果 前列地爾脂微球載體制劑分別與生理鹽水注射液、5%葡萄糖注射液配伍后4 h內(nèi)pH值、外觀、含量、有關(guān)物質(zhì)、平均粒徑及90%累積粒徑均未發(fā)生明顯變化。結(jié)論 前列地爾脂微球載體制劑在室溫避光條件下放置4 h內(nèi)穩(wěn)定性較好,各項(xiàng)指標(biāo)均符合國(guó)家標(biāo)準(zhǔn),臨床使用時(shí)可以依照病人情況選用靜脈滴注的方式給藥。
[Key word]
[Abstract]
Objective To study the compatibility stability of lipo prostagradin E1 in compatibility with normal saline (NS) and 5% glucose injection. Methods Content changes of prostagradin A1 in lipo prostagradin E1 during 0 — 4 h were determined by RP-HPLC, protected protected form light at the room temperature 25 ℃. The changes in appearance and pH value were observed. The particle diameters including mean diameter and 90% accumulative diameter were also measured by Static Laser Light Scattering Meter. Results The pH value, appearance, content, prostagradin A1, and particle diameter were not changed significantly within 4 h in lipo prostagradin E1 combined with NS and 5% glucose injection for injection. Conclusion Lipo prostagradin E1 is stable at room temperature for 4 h, and the indicators are conformed with national standards which may be used in clinical by iv administration according to the specific condition of the patients.
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