| Objective:Make research on the grade specifications and quality evaluation pieces Fritillaria thunbergii Miq.to provide a scientific basis for the development of the commodity specifications new industry standard by the investigation on the Materia Medica and circulation market,relying on traditional classification methods of Fritillaria thunbergii Miq.,combined with modern science and technology.Methods:Firstly,46 batches of Zhebeipian and 32 batches of Zhubei were divided into four classes according to the traditional grading standards.Secondly,46 batches of Zhebeipian and 32 batches of Zhubei were quantitatively studied according to "length/diameter,impurities,uniformity" traditional experience to identify indicators,and samples of each grade was divided into A,B,C,D four categories according to each indicator data.Thirdly,46 batches of Zhebeipian and 32 batches of Zhubei were detected for each project in accordance with the"Chinese Pharmacopoeia" in 2015 edition,in order to examine whether they met the requirements of the pharmacopoeia.For each grade Fritillaria thunbergii Miq.,the topic identificated HPLC fingerprinting,analyzed the content of the alkaloids of each of the sample,evaluated of each grade quality pieces.Fourthly,traditional appearance indicators(length/diameter,impurities,uniformity)and internal quality indicators(alcohol extract,peimisine,peimine,peiminine)for each samples were clustered analysis to 4 categories.Then we worked out quality standards for each grade.Results:(1)Moisture content of each grade Zhebeipian range from 7.84%to 19.76%,the content of S41 to S43 samples were more than 18%of the Pharmacopoeia,as samples failed,the rest reached Pharmacopoeia standards.Total ash content of each grade samples range from 1.66%to 10.75%,the content of S32 and S39 samples were more than 8.0%of the Pharmacopoeia,as samples failed,the rest reached Pharmacopoeia standards.Alcohol-soluble extract content of each grade samples range from 1.12%to 5.89%in line with the Pharmacopoeia.Alkaloid content of each grade samples range from 0.04%to 0.26%,the content of S8,S21,S27,and S32 to S37,samples were less than 0.8%of the Pharmacopoeia,as samples failed,the rest reached Pharmacopoeia standards.(2)Moisture content of each grade Zhubei range from 7.36%to 17.29%in line with the Pharmacopoeia.Total ash content of each grade samples range from 2.58%to 16.44%,the content of S57 to S60 and S65 to S66 samples were more than 8.0%of the Pharmacopoeia,as samples failed,the rest reached Pharmacopoeia standards.Alcohol-soluble extract content of each grade samples range from 1.82%to 4.04%in line with the Pharmacopoeia.Alkaloid content of each grade samples range from 0.03%to 0.19%,the content of S47,S53,S58 to S63,and S77 to S78,samples were less than 0.8%of the Pharmacopoeia,as samples failed,the rest reached Pharmacopoeia standards.(3)Zhebeipian were divided into class A,B,C,D using for traditional grading method.Traditional appearance indicators and internal quality indicators for each Zhebeipian were clustered analysis 3 categories.That was superior,first order,second order and parcel of mixed goods.The indicators were:①Superior grade:length of at least 30mm;first order:length of at least 25mm;second order:length of at least 20mm;parcel of mixed goods:length of at most 20mm.②Superior grade:impurity content at most as 0.50%;first order:impurity content at 0.50%to 0.80%;second order:impurity content at 0.80%to 1.00%;parcel of mixed goods:impurity content at least 1.00%.③Superior grade:uniformity at least as 90%;first order:uniformity at 75%to 90%;second order:uniformity at 60%to 75%;parcel of mixed goods:uniformity at most 60%.④Superior grade:moisture content at most as 10%;first order:moisture content at 10%to 13%;second order:moisture content at 13%to 16%;parcel of mixed goods:impurity content at least 16%.⑤Superior grade:total ash content at most as 2.0%;first order:total ash content at 2.0%to 3.5%;second order:total ash content at 3.5%to 5.0%;parcel of mixed goods:total ash content at least 5.0%.⑥Superior grade:alcohol-soluble extract content at most as 2%;first order:alcohol-soluble extract content at 2%to 4%;second order:alcohol-soluble extract content at 4%to 6%;parcel of mixed goods:alcohol-soluble extract content at least 6%.⑦Superior grade:total alkaloid content at least as 0.20%;first order:total alkaloid content at 0.15%to 0.20%;second order:total alkaloid content at 0.10%to 0.15%;parcel of mixed goods:total alkaloid content at most 0.10%.(4)Zhubei were divided into class A,B,C,D using for traditional grading method.Traditional appearance indicators and internal quality indicators for each Zhubei were clustered analysis 3 categories.That was superior,first order,second order and parcel of mixed goods.The indicators were:①Superior grade:diameter of at least 30mm;first order:diameter of at least 25mm;second order:diameter of at least 20mm;parcel of mixed goods:diameter of at most 20mm.②Superior grade:impurity content at most as 0.50%;first order:impurity content at 0.50%to 0.80%;second order:impurity content at 0.80%to 1.00%;parcel of mixed goods:impurity content at least 1.00%.③Superior grade:uniformity at least as 90%;first order:uniformity at 75%to 90%;second order:uniformity at 60%to 75%;parcel of mixed goods:uniformity at most 60%.④Superior grade:moisture content at most as 10%;first order:moisture content at 10%to 13%;second order:moisture content at 13%to 16%;parcel of mixed goods:impurity content at least 16%.⑤Superior grade:total ash content at most as 2.0%;first order:total ash content at 2.0%to 3.5%;second order:total ash content at 3.5%to 5.0%;parcel of mixed goods:total ash content at least 5.0%.⑥Superior grade:alcohol-soluble extract content at most as 2%;first order:alcohol-soluble extract content at 2%to 4%;second order:alcohol-soluble extract content at 4%to 6%;parcel of mixed goods:alcohol-soluble extract content at least 6%.⑦Superior grade:total alkaloid content at least as 0.20%;first order:total alkaloid content at 0.15%to 0.20%;second order:total alkaloid content at 0.10%to 0.15%;parcel of mixed goods:total alkaloid content at most 0.10%.Conclusion:Standards established for the specifications of commodity of Fritillaria thunbergii Miq.and its quality evaluation,provide the corresponding evaluation standard for the production enterprise,provide reference for the clinical use of drugs,provide a powerful means of production supervision and management for the management department,provide technical support for high quality and high price management of commodity of Fritillaria thunbergii Miq.,provide a scientific basis for the development of relevant management measures in traditional Chinese medicine goods industry. |
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