钙口服液中维生素D2稳定性研究

Stability of vitamin D2 in calcium oral liquid

中文关键词:  维生素D2  钙口服液  增溶剂  包合物  稳定性

英文关键词:vitamin D2  calcium oral liquid  solubilizer  inclusion compound  stability

中文摘要:

      目的 研究维生素D2在钙口服液中的稳定性。方法 通过在原处方中加入增溶剂泊洛沙姆188、吐温80、聚氧乙烯40氢化蓖麻油以及对原料中维生素D2进行包合的方法制备钙口服液; 在加速实验(40±1) ℃和留样观察实验(25±1) ℃条件下分别放置6个月, 于第0、1、2、3、4、5和6月取样检测维生素D2含量并观察口服液的澄明度。结果 以聚氧乙烯40氢化蓖麻油为增溶剂时, 维生素D2稳定性最高, 在加速实验及留样观察实验条件下存放6个月后, 钙口服液中维生素D2含量分别为0.96 μg/mL和1.54 μg/mL, 是原处方的8倍和2.3倍; 口服液的澄明度较好。结论 在钙口服液处方中加入聚氧乙烯40氢化蓖麻油为增溶剂能显著提高维生素D2的稳定性; 对口服液的外观质量影响较小。

英文摘要:

      To investigate the stability of vitamin D2 in calcium oral liquid. Methods The calcium oral liquid was prepared by adding solubilizers, including poloxamer 188, twee 80, polyoxyethylene 40 hydrogenated castor oil into the original prescription, and saturation of vitamin D2 in the raw material. Then, they were placed statically under the condition of the accelerating test at the temperature of (40±1) ℃ and the served sample observation experiment at the temperature of(25±1)℃ for six months, respectively. Then the vitamin D2 content were detected and the transparency of samples were observed in 0, 1, 2, 3, 4, 5 and 6 month. Result When the polyoxyl 40 hydrogenated castor oil was taken as the solubilizer, vitamin D2 had the highest stability. The content of vitamin D2 in calcium oral liquid in accelerating test and sample observation experiment were respectively 0.96 μg/mL and 1.54 μg/mL after being kept for 6 months, which were respectively 8 times and 2.3 times of the original prescription. The clarities of oral liquid under the conditions were good. Conclusion The stability of vitamin D2 can be significantly improved by adding the solubilizer of polyoxyl 40 hydrogenated castor oil in the calcium oral liquid, and it has little effect on the appearance quality of oral liquid.