摘要
目的制备用于治疗慢性病毒性肝炎的蕨麻总皂苷缓释微丸，并建立检测方法以控制其质量。方法对蕨麻总皂苷缓释微丸的制备工艺进行优选，用薄层色谱法进行定性鉴别，并采用高效液相色谱法同时测定了JMGⅠ和JMGⅡ的含量。结果通过单因素考察筛选出蕨麻总皂苷缓释微丸的最佳制备工艺，含量测定中JMGⅠ和JMGⅡ分别在0．400～4．00μg（r=0．9995）和0．640～6．40μg（r=0．9994）范围内呈良好线性关系，加样回收率分别为103．4％（RSD=2．8％）和102．1％（RSD=1．9％）（n=5）。结论优选工艺稳定，定性方法简便，专属性强，定量方法准确可靠，可有效控制该制剂的质量。
Aim To prepare JM sustained-release capsules and establish a method for quality control. Methods The preparing technique of JM sustained-release capsules were optimized by the monofactorial design. The TLC was used in qualitative analysis and the HPLC was used for the quantitative analysis of JMG Ⅰ and JMG Ⅱ. Results The spots in TLC were clear and distinguishable. The linear ranges of JMG Ⅰ and JMG Ⅱ were 0. 400 -4.00μ（ r = 0.999 5） and 0. 640 - 6.40μg（ r = 0. 999 4） ,with average recovery rates at 103.4% （ RSD = 2.8% ） and 102.1% （ RSD = 1.9% ） （ n = 5 ）, respectively. Conclusion The preparation of capsules was stable and the qualitative method was simple and quick. The qualitative result was accurate and reproducible.
出处
《解放军药学学报》
CAS
2008年第2期153-155,180,共4页
Pharmaceutical Journal of Chinese People's Liberation Army
