薄芝片的质量控制标准研究

Quality control standard for Bozhi tablets

目的:建立薄芝片的质量控制方法。方法:采用 TLC 方法,使用4%磷酸氢二钠的羧甲基纤维素钠溶液为粘合剂的硅胶 GF_(254)(10～40 μm)薄层板,以甲苯-乙酸乙酯-甲醇-异丙醇-浓氨试液(12∶6∶3∶3∶1)为展开剂,对薄芝片中核苷类成分腺苷进行定性鉴别;采用 HPLC 法,使用 Alltima C_(18)色谱柱(250 mm×4.6 mm,5 μm),以乙腈-水(5∶95)为流动相,流速1.0mL·min^(-1),检测波长262 nm,柱温25 ℃,进样量20 μL,对薄芝片中的腺苷和尿苷同时进行含量测定。结果:腺苷的 TLC 鉴别专属性强;HPLC 测定,腺苷、尿苷的线性范围分别为0.12～0.62μg(r=0.9994,n=5)和0.18～0.88μg(r=0.9998,n=5),平均回收率(n=6)分别为99.22%(RSD=2.2%)和100.5%(RSD=2.0%)。结论:本方法简单、可靠、准确,可用于控制薄芝片的质量。

Objective：To establish the quality control standard for Bozhi tablets. Method：Adenosine in Bozhi tablets was identified by TLC. Silica gel GF254 （10 -40 μm） plate by carboxyme -thylcellulose sodium with 4% sodium hydrogen phosphate as adhesion agent was used. The developing agent was toluene - ethyl acetate - methyl alcohol- 2-propanol -concentrated ammonia test solution （12：6： 3：3：1 ）. The contents of adenosine and uridine in Bozhi tablets were determined simultaneously by HPLC. Alhima C lscolumn（250 mm ×4. 6 mm ,5μm） was used. The mobile phase was acetonitrile -water（5：95 ）at a flow rate of 1.0 mL · min^-1, the detection wavelength was 262 nm, and the column temperature was 25 ℃. The injection volume was 20 μL. Results：The method of identifying adenosine by TLC had strong specificity. The calibration curves were linear in the ranges of 0. 12 -0. 62 μg （r = 0. 9994, n = 5 ） for adenosine and 0. 18 - 0. 88 μg （ r = 0. 9998, n = 5 ） for uridine. The mean recoveries （ n = 6） of adenosine and uridine were 99. 22% （ RSD = 2.2% ） and 100.5% （ RSD = 2.0% ） respectively. Conclusion： The method is simple, reliable and accurate, and can be used to control the quality of Bozhi tablets.