目的 为有效评控消食类中药的质量，研究基于消化酶活力检测的消食类中药生物效价测定方法并结合传统论述以探索消食类中药的质量控制方法。方法 以山楂、六神曲、麦芽、谷芽为研究对象，筛选适宜消化酶种类；采用“质反应平行线法”建立基于酶活性的生物效价测定法，并进行方法学考察，测定10个批次各药物的生物效价；最后采用营养糊黏度测定法验证不同效价各药降低黏度的活性差异，评价酶活力效价与药物质量的相关性。结果 蛋白酶、脂肪酶与淀粉酶活力测定方法的吸光度与产物质量浓度有良好线性关系，r²均大于0.99；结合实验结果与传统论述，山楂善消肉积且蛋白酶活力效价系数为效价综合系数中的最大值，六神曲善消谷麦酒积但脂肪酶活力效价系数为效价综合系数中最大值，麦芽谷芽善消淀粉食积且淀粉酶活力效价系数为效价综合系数中的最大值，故山楂、六神曲、麦芽和谷芽分别选取蛋白酶、脂肪酶、淀粉酶做标准酶。实验所用供试品制备方法的量效曲线与阳性药胃蛋白酶片相似，重复性、精密度及中间精密度考察结果均符合要求；各药10批样品的效价差异较大，山楂蛋白酶活力效价为175.40～330.66 U/mg，六神曲脂肪酶活力效价为187.36～858.61 U/mg，麦芽淀粉酶活力效价为6.18～19.35 U/mg，谷芽淀粉酶活力效价为1.87～7.79 U/mg。验证实验结果显示，各药样品对应效价越高，营养糊黏度降低越明显，表明酶活力效价与药物质量有较高相关性。结论 结合药物传统论述所建立的基于消化酶活性的消食类中药生物效价测定方法可靠，可用于反映部分消化类中药的质量优劣，可为消食类中药的质量标准研究提供参考。

Objective In order to effectively evaluate and control the quality of digestible traditional Chinese medicine (TCM), the biological potency determination method of digestible TCM based on the detection of digestive enzyme activity was studied and combined with traditional discussions to explore the quality control method of digestible TCM.Methods Shanzha (Crataegi Fructus), Liushenqu (Massa Medicata Fermentata), Maiya (Hordei Fructus Germinatus) and Guya (Setariae Fructus Germinatus) were used as objects of study to screen the digestive enzyme types. The “parallel line method of qualitative reaction” was used to establish a method for determining the biological potency of Chinese herbal medicine based on enzyme activity, and the methodology was investigated to determine the biological potency of 10 batches of each drug; The viscosity determination of nutrient paste was used to verify the difference of viscosity reducing activities of each drug with different potencies, and to evaluate the correlation between the activity and potency of each enzyme and the drug quality.Results The results showed that the r² of the standard curves of each enzyme activity determination method was greater than 0.99, and there was a good linear relationship between the absorbance and the product concentration; Combined with the experimental results and traditional discussion, Crataegi Fructus was good at treating dyspepsia caused by meat and had the largest protease activity potency coefficient in the comprehensive potency coefficient; Massa Medicata Fermentata was good at treating dyspepsia caused by cereal wine but had the largest lipase activity potency coefficient in the comprehensive potency coefficient; Hordei Fructus Germinatus and Setariae Fructus Germinatus were good at treating dyspepsia caused by starch and had the largest amylase activity potency coefficient in the comprehensive potency coefficient, so the protease, lipase and amylase were selected as standard enzymes forCrataegi Fructus, Massa Medicata Fermentata, Hordei Fructus Germinatus and Setariae Fructus Germinatus respectively. The dose effect curve of the test article preparation method used in the experiment was similar to that of the positive drug pepsin tablets, and the repeatability, precision and intermediate precision inspection results met the requirements; The potency of 10 batches of samples of each drug varied greatly, with Crataegi Fructus protease activity ranging from 175.40 to 330.66 U/mg, Massa Medicata Fermentata lipase activity ranging from 187.36 to 858.61 U/mg, Hordei Fructus Germinatus amylase activity ranging from 6.18 to 19.35 U/mg, and Setariae Fructus Germinatus amylase activity ranging from 1.87 to 7.79 U/mg. The validation test results showed that the higher corresponding titer of each drug sample, the more obvious reduction of the viscosity of the nutrient paste, indicating that there was a high correlation between the enzyme activity titer and the drug quality.Conclusion The research results show that the method for determining the biological potency of TCM for digestion based on digestive enzyme activity established in this paper is reliable and can be used to reflect the quality of some digestive TCM, and can provide a reference for the quality standard research of TCM for digestion.

R283.6

四川省科技计划资助（2022YFS0429）；四川省中医药管理局科研专项（2021MS530）