两种不同时期生产的中/长链脂肪乳注射液(卡路)的质量比较

Quality comparison of fat emulsion injection(kalu) produced in two different periods

目的对原国内主要的脂肪乳生产厂家生产合资并进行生产工艺改进前后所生产的20%的中/长链脂肪乳注射液各三批进行质量比较研究。方法参考国家标准、美国药典和《脂肪乳注射液(C14-C24)质量标准》(征求意见稿)要求,从pH值、乳粒大小和分布、酸值、过氧化值、甲氧基苯胺值、溶血磷脂、脂肪、中链三酰甘油、磷、甘油含量等方面进行比较。结果pH值为8.1～8.3;平均粒径为0.226～0.256μm,大于1μm的乳粒为0.4%～1.3%,无大于5μm的乳粒;酸值为0.2,过氧化值为0;甲氧基苯胺值为0.7～1.6;溶血磷脂为0.050～0.089g/L;脂肪、甘油和中链三酰甘油等含量均达到标示量的98%以上;磷含量为0.45～0.48g/L。合资前后生产的中/长链脂肪乳注射液所有指标均符合国家标准的规定,但合κ改进生产工艺后的产品在乳粒大小和分布、甲氧基苯胺值等项目的批间差异较小。结论该厂家合κ后优化了生产工艺,加强了中/长链脂肪乳注射液生产过程中的质量监控,产品质量的稳定性达到国内外先进水平,临床⒚药的安全性更高。

Objective To carry out the quality comparative study of lipid emulsion injection （kalu） produced before and after the establishment of joint venture and production process improvement. Methods Referring to the requirement of National Standard, USP and 〈fat emulsion injection quality standards （C14-C24）〉（the exposure draft）, the intensive attribute： pH value, particle size and distribution, acid value, peroxide value, anisidine value, Iysophosphatidylcholine（LPC）, the assay of fat, medium-chain tfiglycerides, phosphorus and glycerin were investigated and contrasted. Results The pH values were between 8.1 to 8.3; the particles whose size were larger than 1 μm were from 0.4% to 1.3% and those larger than 5 μm were no found; the mean diameters were from 0.226 to 0.256 μm; the acid values were all 0.2; the peroxide value was 0 and methoxy-aniline values were from 0.7 to 1.6; the LPC were from 0.50 to 0.89 mg/L. The assay of lipid, glycerin and medium-chain tfiglycerides were more than 98 % of the labeled amounts; the assay of phosphor were from 0.45 to 0.48 g/L. Conclusions The manufacture process has been upgraded after the joint venture buih and production process improvement, and the quality control of medium and long chain lipid emulsion injection are enhanced to improve the lipid emulsion more stable, it is more confidence to guarantee the safety and efficacy of clinical medication.