Objective To evaluate the anti-tussive effect of a total alkaloid agent extracted from Papaver Somniferum L. on simple chronic bronchitis of which the syndrome was counterflow ascent of lung qi according to traditional Chinese medicine (TCM). Methods Randomised, double blind method, placebo control and add on design were applied. Forty-five patients with counterflow ascent of lung qi of simple chronic bronchitis were randomly divided into two groups: treatment group (n=21) with alkaloid agent and control group (n=24) with placebo. Results The incidences of obvious coughing in treatment and control groups were 66.67% and 70.83% (P=0.763 3) respectively. The cough alleviation time of patients was 14.64±16.30 h and 15.12±15.28 h (P=0.795 6) respectively. The loss of cough rates on the third day was 28.57%, 16.67% (P=0.337 7) respectively. The average scores decreased were 4.29 and 2.88 (P=0.054 8) respectively. Conclusions The study indicates that total alkaloid agent extracted from Papaver somniferum L. has no significant anti-tussive effect on patients with counterflow ascent of lung qi of simple chronic bronchitis treated with cefaclor sustained release capsules simultaneously. The trial was interrupted by the advice from experts who disagreed with the selection of drug indication.
【摘要】 目的 考察用乌头碱水解物、新乌头碱水解物、次乌头碱水解物的含量作为附片水煎剂及附片质量控制指标的可行性。 方法 采用高效液相色谱分析法，色谱柱为Shimpack CLC-ODS，以甲醇-乙酸铵溶液（0.2 mol/L）（200︰210）为流动相，流速1.0 mL/min，检测波长为241 nm，对乌头碱新，乌头碱、次乌头碱水解物的含量测定进行研究。 结果 3种水解物检测方法测得水解物在进样范围有良好线性关系，重现性好，稳定性好，生药提取时间宜选定为40 min，不同批号的附片中3种水解物含量差别较大。 结论 此方法简便，使用新乌头碱、乌头碱、次乌头碱的水解物作为含附片制剂的质量控制指标是可行的。【Abstract】 Objective To examine the feasibility of regarding the hydrolyzate from aconitine, new aconitine, and hypaconitine to be the decoction of radix aconite and the quality control index. Methods High performance liquid chromatographic method (HPLC) method was adopted. Shimpack CLC-ODS column with UV detection at 241 nm was used. The mobile phase consisted of (200∶210), and the flow rate was 1.0 mL/min. Results The content of the hydrolysis objects in the water decoction and toxicity were correlated with each other, and the contents of hydrolysis were significantly different among different groups of radix aconiti. Conclusion This method is simple, accurate and effective for content research of hydrolyzate from aconitine-type alkaloids in Monkshoo decoction of Radix Aconiti, and it is feasible to take it as the quality control index.