摘要
探讨生产条件对乳酸环丙沙星注射液成品质量的影响。方法：对该注射液成品的含量下降进行了实验，并测定了成品pH值、颜色和有关物质的变化。此外，进一步测定了中间品pH值在3.5-4.5变化时对成品含量下降的影响。结果：中间品pH值和消毒时间对成品含量下降有极显著影响（P＜0.01）。中间品pH值和酸的种类对成品pH值的影响差异没有显著性意义（P＞0．05）。注射液成品颜色没有变化，但有关物质有所增加，q检验表明，中间品pH＞4．3时，对成品含量下降影响与其它pH值比较差异有极显著性（P＜0.01）。结论：生产过程中应严格控制消毒温度和时间，中间品的pH值应调节在3.8-4.1范围内为宜。
OBJECTIVE : To study the factor of preductive technological process that affects the quality of ciprofloxacin lactate in-jection. METHODS: Experiments were done on the content reduction, pH, color and related substances changes of the final pnductmeasured. The affects of pH change between 3. 5 -4. 5 on the content reduction of the final preduct were measured. RESULTS: Thecontent reduction of the final preduct was affected markedly by intermediate pH and sterilizing time(P＜0.01 ). The affects of inter-mediate pH and the different kinds of acid on the DH of the final preduct was almost the sam(P ＞0.05). The oolor of the final pred-uct does not occur change, but its relative mater increased. Using q test, when intermediate pH is 4. 3 or more, the content reductionof the final preduct was affected very markediy(P＜ 0. 01 ). CONCLUSIONS: The temperature and time of sterilizing should be con-trolled. Intermediate pH change between 3. 8-4. 1 might be selocted.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
1999年第10期601-603,共3页
Chinese Journal of Hospital Pharmacy
关键词
乳酸环丙沙星
注射液
质量
析因实验
ciprofloxacin lactate injection, final product quality, factorial experiment
