Study On Grading Specifications And Quality Evaluation Of Phellodendron Chinense And Its Pieces

Phellodendron chinense is the dry bark of phellodendron chinense Schneid. belong to Rutaceae. It has a history of more than2,000years of medicinal,and is one of the commonly used Chinese medicine for the treatment of Heat-clearing and Detoxifying in clinical practice of TCM. The pieces of Phellodendron chinense as the bulk drugs of proprietary Chinese medicines and prescription medication, widely was used in the market, higher prices for better quality management using for development of clinical efficacy on it.So we study the grade specifications and quality evaluation pieces of Phellodendron chinense.Objective:Make research on the grade specifications and quality evaluation pieces of Phellodendron chinense to provide a scientific basis for the development of the commodity specifications new industry standard by the investigation on the production and circulation market of decoction pieces,relying on traditional classification methods of Phellodendron chinense, combined with modern science and technology. Firstly,11batches of medicinal materials collected in the genuine producing areas(in Sichuan Province) and2batches of non authentic producing areas(in Enshi, Hubei Province), are divided into two classes according to the traditional grading standards, and then were processed into13batches of decoction pieces.In addition, we purchased6batches of decoction pieces from market、14batches of decoction pieces from enterprise.Secondly,33batches of Pieces were quantitatively studied according to"thick skin, impurities, length, width" traditional experience to identify indicators,and samples of each grade is divided into A, B, C three categories according to each indicator data.Thirdly,33batches of samples were detected for each project in accordance with the "Chinese Pharmacopoeia" in2010edition, in order to examine whether they meet the requirements of the pharmacopoeia, that is, whether qualified, as the research object.For each grade Cork Pieces,the topic identificated HPLC fingerprinting, analyzed the similarity value between the control map and spectrum of each of the samples, evaluated of each grade quality pieces.Fourthly, as the grading line of road estate areas of Pieces, the other origin refer to this standard. Traditional appearance indicators (thickness, impurity content, uniformity, cork go No) and internal quality indicators (berberine, cork base, alcohol extract) for Class A,and Class B were clustered analysis to2categories, that is, superior grade、first order.Then,it can be drawn from the three levels for comprehensive analysis with Class C, thus, we worked out quality standards for each grade.Results:(1) Moisture content、total ash content of each grade samples range from 5.60%to9.46%、5.15%to7.05%,less than12.0%、8.0%in line with Pharmacopoeia. Alcohol-soluble extract content was from9.92%to24.0%, the content of the S19sample is less than14.0%of the Pharmacopoeia, as samples failed,the rest reached Pharmacopoeia standards. The content of Berberine hydrochloric acid and Hydrochloric acid Treats alkali in the range from3.48%to7.39%, from0.45%to0.95%met the requirements of the pharmacopoeia as3.0%and0.34%of the minimum limit.(2)Based on HPLC fingerprint Cork and its similarity, the results show that the similarity is greater than0.990, the overall appearance of each grade Cork fingerprint is basically the same, there is no significant difference.(3)33batches of Phellodendron Pieces were divided into Class A、B、C using for traditional grading method.Traditional appearance indicators and internal quality indicators for Class A,and Class B were clustered analysis to2categories.Then,it can be drawn from the three levels for comprehensive analysis with Class C, that is, superior grade, first order、 parcel of mixed goods. the indicators were:①. superior grade:to the net crude cork; first order and parcel of mixed goods:cork to the net or to rough②. superior grade:thickness of at least0.3cm; first order:thickness of at least0.2cm; parcel of mixed goods:thickness of at least0.1cm③. superior grade:impurity content at most as1.00%; first order impurity content at most as3.00%; parcel of mixed goods:impurity content at most as9.00%④. superior grade:uniformity at least as80.00%; first order:uniformity at least as70.00%;parcel of mixed goods:regardless of the length and width size⑤. superior grade:the content of berberine hydrochloride at least as7.00%; first order:the content of berberine hydrochloride at least as5.00%; parcel of mixed goods:the content of berberine hydrochloride at least as3.00%⑥. superior grade:the content of hydrochloric acid Cork alkali at least as0.70%; first order:the content of hydrochloric acid Cork alkali at least as0.55%; parcel of mixed goods:the content of hydrochloric acid Cork alkali at least as0.34%⑦. superior grade:alcohol-soluble extract content at least as20.00%; first order:alcohol-soluble extract content at least as16.00%; parcel of mixed goods:alcohol-soluble extract content at least as14.00%Conclusion:Standards established for the specifications of commodity decoction pieces of Phellodendron Chinense and its quality evaluation, provide reference for the clinical use of drugs, provide a scientific basis for the development of relevant management measures in decoction pieces of Chinese medicine industry, provide technical support more for management departments to develop、implement of decoction pieces registration standards、the formulation of management approach on barcode ID card and higher prices for better quality of decoction pieces.