0.1%玻璃酸钠滴眼液原料分子量和灭菌条件的筛选

Screening of Sterilization Condition of 0.1 % Sodium Hyaluronate Eye Drops

目的筛选0.1%玻璃酸钠滴眼液原料的分子量和滴眼液灭菌条件。方法选用高、中、低分子量的玻璃酸钠原料,配制0.1%玻璃酸钠滴眼液,分别在116℃×40 min,116℃×30 min,121℃×15 min的条件下热压灭菌,测定终产品的运动黏度、分子量和分子量分布。结果在3个灭菌条件下,低分子量组的样品灭菌后运动黏度低于或接近标准下限,高分子量组的样品灭菌后运动黏度高于或接近标准上限,中分子量组的样品灭菌后运动黏度均在标准范围内;相同分子量的样品,运动黏度和分子量下降幅度116℃×40 min条件下最大,121℃×15 min次之,116℃×30 min与121℃×15 min相当。结论中分子量的玻璃酸钠原料,121℃×15 min灭菌条件适合0.1%玻璃酸钠滴眼液的生产。

Objective To screen molecular weight of sodium hyaluronate and stermzauon conoluon for 0.1% Sodium Hyaluronate Eye Drops. Methods 0.1% Sodium Hyaluronate Eye Drops were produced using sodium hyaluronate with different molecular weight, and were autoclaved under 116 ℃ × 40 min, 116℃ × 30 min, and 121℃ × 15 min, respectively. Dynamic viscosity, molecular weight and molecular weight distribution were tested. Results Under three conditions, the dynamic viscosity of preparations in low molecular weight group was below or close to lower limit; for high molecular weight group, the dynamic viscosity of the preparations was above or close to upper limit; for medium molecular weight group, the dynamic viscosity of the preparations was within the limit. For the preparations with the same molecular weight, the dynamic viscosity and molecular weight of the preparations autoclaved under 116 ℃ × 40 min decreased most apparently, secondly was the preparation autoclaved under 121℃× 15 min. The decrease of the dynamic viscosity and molecular weight were similar for preparations autoclaved under 116 ℃× 30 min and 121℃ × 15 min. Conclusion Medium molecular weight of sodium hyaluronate and sterization condition of 121℃ × 15 min were applicable for production of 0.1% Sodium Hyaluronate Eye Drops.