奥维加与临床常用输液的配伍稳定性研究

Study on the Compatible Stability of Lansoprazole for Injection and Clinical Commonly-Encountered Transfusion

目的探讨奥维加与临床常用输液的配伍稳定性。方法选择国产注射用兰索拉唑（奥维加）与进口注射用兰索拉唑（进口品），按照说明书中配制方法溶解2种药品，并分别加人到100mL生理盐水注射液中，观察不同供试品在室温条件下放置0、2、4、6、8h的含量、pH、颜色、澄清度及不溶性微粒的变化。结果配伍后，在观察时间内奥维加与进口品溶液的含量均有普遍下降的趋势，溶液pH值均随时间的变化而普遍呈线性下降趋势，奥维加和进口品两组间比较差异无统计学意义（P〉0．05）；配伍后，进口品溶液中10μm不溶性微粒数为755．60～9911．10粒，奥维加溶液中10μm不溶性微粒数为520.00～1988．90粒；进口品溶液中25μm不溶性微粒数为33．30～555．60粒，奥维加溶液中25μm不溶性微粒数为0～111．10粒，奥维加和进口品两组间比较差异有统计学意义（P〈o．05）；奥维加与进口品溶液中的兰索拉唑在配伍后一段时间内，颜色均未发生变化，均保持澄清。结论在室温条件下将兰索拉唑溶于100mI。生理盐水注射液中，在含量、pH值、溶液颜色、溶液澄清度等方面奥维加与进口品等同，在不溶性微粒（10μm和25μm）方面优于进口品。

Objective To explore the compatible stability of Lansoprazole for injection and clinical commonly- encountered transfusion. Methods Domestic and imported Lansoprazole for injections were selected. According to the prepared methods in specification,two kinds of drugs were dissolved and put into 100 mL normal saline injection to observe the changes of contents, pH value, color, clarity and insoluble particles in different lansoprazole test solutions at 0, 2,4,6 and 8 h under room temperature. Results The lansoprazole contents in Lansoprazole for injection and imported product generally had the tendency of decrease within the observation time,and pH value of solution was on a declining curve with time. There was no significant difference between Lansoprazole for injection and imported product （P〉0. 05）. After compatibility, the number of 10μm insoluble particles in the imported product was 755.60-9 911.10,while that in Lansoprazole for injection was 520.00-1 988. 90;the number of 25μm insoluble particles in the imported product was 33.30-555.60, while that in Lansoprazole for injection was 0-111.10, and statistical significance was presented between Lansoprazole for injection and imported product （P〈 0. 05）. Lansoprazole contents in Lansoprazole for injection and imported product still remained clear,with no color changing after compatibility for a while. Conclusion Lansoprazole for injection,equal to the imported product in the aspects of content,pH value, solution color and clarity, is superior to the imported product in terms of insoluble particles （10μm and 25 μm） when lansoprazole is dissolved into 100 mL normal saline injection under room temperature.