复方维生素B_6缓释微丸胶囊的制备及质量控制

Preparation of Compound Vitamin B6 Sustained-release Capsules and their Quality Control

目的:制备复方维生素B6缓释微丸胶囊,并建立其含量测定方法以控制质量。方法:采用单因素实验法,对复方维生素B6缓释微丸的制备工艺进行优选,并采用高效液相色谱法同时测定最佳工艺条件下制备的胶囊中维生素B6和叶酸的含量。结果:复方维生素B6缓释微丸胶囊由微丸A、B、C灌装而成,其中微丸A、B采用粉末上药法制备,最佳工艺为:主机转速200～350 r.min-1、喷浆泵速20～40 r.min-1、供粉速度40～60 r.min-1、喷雾压力0.1～0.3 MPa;微丸C采用溶液上药法制备,最佳工艺为:流化温度40～60℃、雾化压力0.1～0.3 MPa、蠕动泵速10～20 mL.min-1、沸腾负压0.2～0.5 MPa。测得所制备胶囊中维生素B6和叶酸分别在74.20～593.6 mg.L-1(r=0.999 9)和1.022～8.162 mg.L-1(r=0.999 8)范围内呈线性关系,平均回收率分别为99.53%(RSD=0.44%)和98.38%(RSD=0.87%)(n=3)。3批样品中维生素B6的平均质量分数分别为99.68%、98.53%和98.98%,叶酸的平均质量分数分别为98.54%、98.63%和99.04%。结论:优选工艺稳定,定量方法简便准确、可靠且专属性强,可用于复方维生素B6缓释微丸胶囊的质量控制。

Objective：To prepare compound vitamin B6 sustained-release capsules and to establish a method for their quality control.Methods：The preparing technique of compound vitamin B6 sustained-release capsules were optimized by the monofactorial design,and the quantitative analysis of vitamin B6 and folic acid was conducted by HPLC.Results：The compound B6 sustained-release capsules were filled with pellets A,B and C which contained vitamin B6,calcium carbonate,folic acid and vitamin B12,respectively.The pellets A and pellets B were prepared by the same drug loading method,and the optimal conditions were as follows：speeds for engine,gunite pump and powder feeding were 200-350,20-40 and 40-60 r ·min-1,respectively,and the spray pressure was 0.1-0.3 MPa.The pellets C were prepared by the drug loading method different from that of pellets A and pellets B under the following conditions：fluidization temperature was 40-60 ℃,atomization pressure was 0.1-0.3 MPa,peristaltic pump speed was 10-20 mL ·min-1,and the negative pressure for boiling was 0.2-0.5 MPa.The linear range of vitamin B6 and folic acid in the compound vitamin B6 sustained-release capsules was 74.20-593.6 mg ·L-1（r=0.9999） and 1.022-8.162 mg ·L-1（r=0.9998）,respectively.And the average recovery rates of them were 99.53%（RSD= 0.44%）and 98.38%（RSD= 0.87%）（n=3）,respectively.The contents of vitamin B6 in three batches of the test capsules were 99.68%,98.53% and 98.98%,and the average contents of folic acid were 98.54%,98.63% and 99.04%,respectively.Conclusion：The optimal technique for the preparation of compound vitamin B6 sustained-release capsules was stable.And the quantitative method showed a strong specificity and was accurate for quality control of the test capsules.