血卟啉注射液的稳定性

目的:研究血卟啉注射液不同温度放置条件下的稳定性。方法:采用高压液相色谱法(HPLC),色谱柱PolarlsC18A柱(5μm,4.6mm×250mm),检测波长390nm,流动相:甲醇∶水∶乙腈∶四氢呋喃(160∶220∶105∶190),每1000mL流动相加入磷酸0.5mL调节pH值,流速:1.5mL·min-1。结果:血卟啉注射液随温度升高(30～70℃)含量呈直线下降,在温度30,40,50,60℃下降50%的时间分别为100,28,7,3d。在4℃4mo,30℃5d内未见明显变化。结论:由于血卟啉注射液对温度敏感,建议贮放条件应在30℃下不超过5d。

Stability of hematoporphrin injection

To research the stability of hematoporphyrin injections under diff erent temperature condition. METHODS: HPLC method was adopted, using Polarls C_(18) column(5 μm,4.6 m mm×250 mm)and UV detector at 390 nm wavelength. The mobile phase was consisted of methanol∶KG-*2]water∶KG-*2]acetonitrile∶KG-*2]tetrahydrofuran (160∶KG -*2]220∶KG-*2]105∶KG-*2]190), adding 0 .5 mL phosphoric acid to 1 000 mL the mobile phase adjusting the pH. The flow r ate was 1.5 mL·min~(-1). RESULTS: The content of hematoporphrin injection p resented linear clescending with the raising of temperature between 30 ℃-60 ℃. The time periods for descending 50 % coutent were 100,28,7,3 d under the temper a ture of 30,40,50,60 ℃, respectively. No obrious change was shown within 4 mo i n 4 ℃ refrigerator and 5 d under room temperature of (30 ℃.) CONCLUSION: Owing to the hematoporphyrin injection seusitive to temperature, sug gest it’s store coudition should under 30 ℃ no excess 5 d.