| Rehmanniae Radix earliest recorded in Shen-nung Pen-tsao Ching,is classified as top level,is commonly used clinical drugs.Rehmannia is from Scrophulariaceae plant's fresh or dried tuber roots.Rehmanniae Radix used as medicine there are four kinds of fresh Rehmannia,Rehmanniae Radix,Rehmanniae Radix Praeparata and Rehmannia glutinosa libosch charcoal.Although it is derived from one thing,the effect is different due to the different collection system.Fresh rehmannia are mostly graded per kilogram in the market,Rehmannia glutinosa libosch charcoal often temporarily concocted,Rehmanniae Radix and Rehmanniae Radix Praeparata are sold in the form of herbal decoction pieces.Currently,the Rehmanniae Radix and Rehmanniae Radix Praeparata have different specifications,and they are not graded.Most of them are distributed in the form of unified goods,and there is no scientific basis.This study combines traditional grading methods with modern detection techniques It is proposed to establish a set of graded standards for Rehmanniae Radix pieces and Rehmanniae Radix Praeparata with scientific basis.Objective:With the advancement of contemporary technology and changes in market demand,in the year of 1984 promulgated the "seventy-six kinds of medicinal products specifications",most standards can no longer meet the problem of grading.This study is based on the traditional Rehmannia grading method,based on fully respecting and inheriting the classification method of traditional decoction pieces,study on grading standard of Rehmanniae Radix pieces and Rehmanniae Radix Praeparata in combination with modern scientific methods.Formulates grade standards for Rehmanniae Radix and Rehmanniae Radix Praeparata to provide methodological basis for the development of quality Chinese herbal decoction medicine.Method:A total of 35 batches of Rehmanniae Radix pieces and Rehmanniae Radix Praeparata.Collecting 12 batches of Rehmanniae Radix pieces and Rehmanniae Radix Praeparata each in the typical producing area,8 batches of Rehmanniae Radix pieces and Rehmanniae Radix Praeparata each in the master producing area,15 batches of Rehmanniae Radix pieces and Rehmanniae Radix Praeparata each in the other producing area.First,initial grading by conventional grading methods,for example,in accordance with the width,diameter,proportion of large slices,and the cut surface color of the decoction pieces will be divided Rehmanniae Radix into three grades.Rehmanniae Radix Praeparata is divided into two grades.Then,combining modern scientific evaluation indicators,included moisture,ash,extracts,thin layer identification,active ingredient content determination and HPLC fingerprinting,determination of different grades standards of Rehmanniae Radix pieces and Rehmanniae Radix Praeparata.Finally,applicated with the statistical methods of cluster analysis,established the evaluation grade of Rehmanniae Radix pieces and Rehmanniae Radix Praeparata.Results:The water content of raw Rehmannia in each grade does not exceed the limit of 15%prescribed in the "2015 edition of the Chinese Pharmacopoeia",and there is no significant association with the grade of Rehmanniae Radix pieces.All the content ash and acid-insoluble ash content in the each grade Rehmanniae Radix pieces did not exceed 8%and 3%of the "2015 edition of the Chinese Pharmacopoeia",and there was no significant association with the Rehmanniae Radix pieces grade.The content of catalpols in each grade of Rehmanniae Radix pieces content was between 0.77%and 1.71%,which was in accordance with the minimum limit of 0.2%required by the "2015 edition of the Chinese Pharmacopoeia",and had no correlation with the herbal decoction pieces grade.The content of the Rehmannioside A,Rehmannioside D and leonuride in each grade of raw Rehmannia herbal decoction pieces were similar,can not be used as a grading indicator.However,the content of water-soluble extracts was between 67.33%and 84.42%,which was not lower than 65%of the "2015 edition of the Chinese Pharmacopoeia" and was positively related to the grades of Rehmanniae Radix pieces.And the content of 0.02%to 0.268%of acteoside,were in line with the "2015 edition of the Chinese Pharmacopoeia" of the minimum limit of 0.02%,with all grades of Rehmanniae Radix pieces is positively related.In each of grade Rehmanniae Radix pieces fingerprinting,the number of first-grade Rehmanniae Radix pieces fingerprinting's common peak is 18,the number of second-grade Rehmanniae Radix pieces fingerprinting's common peak is 14,the number of third-grade Rehmanniae Radix pieces fingerprinting's common peak is 21,The degree of similarity is not less than 0.90 compared with the fingerprinting's common peak of the same grade.The water content of Rehmanniae Radix Praeparata in each grade does not exceed the limit of 15%prescribed in the "2015 edition of the Chinese Pharmacopoeia",and there is no significant association with the grade of Rehmanniae Radix Praeparata.All the content of ash and acid-insoluble ash in the each grade Rehmanniae Radix Praeparata did not exceed 8%and 3%of the "2015 edition of the Chinese Pharmacopoeia",and there was no significant association with the ripe Rehmanniae Radix Praeparata grade.The content of water-soluble extracts was between 80.69%and 89.10%,which was not lower than 65%of the "2015 edition of the Chinese Pharmacopoeia" and there was no significant association with Rehmanniae Radix Praeparata grade.The content of verbascoside was between 0.02%and 0.09%in the each grade Rehmanniae Radix Praeparata,were in line with the "2015 edition of the Chinese Pharmacopoeia" of the minimum limit of 0.02%,the content of catalpols was between 0.13%and 0.40%,the content of the Rehmannioside A was between 0.03%and 0.06%,the content of the Rehmannioside D was between 0.18%and 0.37%,the content of the aucubin was between 0.10%and 0.41%.Among them,the content of the verbascoside,catalpols and Rehmannioside A were with the ripe Rehmanniae herbal decoction pieces grades positively related,the number of high quality fingerprinting is 21,the number of common quality fingerprinting is 15.It is recommended to divide the Rehmanniae Radix pieces into three grades:the first-grade Rehmanniae Radix pieces average width 1.8cm or more,per kilogram large pieces(wide diameter ? 1.5cm)accounted for more than 60%,the water soluble leachables is not less than 75%,the content of catalpols is not less than 0.5%,the content of verbascoside is not less than 0.05%,the content of Rehmannioside D is not less than 0.2%.The second-grade Rehmanniae Radix pieces average width are between 1.7cm and 1.8cm,per kilogram large pieces(wide diameter ? 1.5cm)accounted for between 50%and 60%,the water soluble leachables is not less than 70%,the content of catalpols is not less than 0.3%,the content of verbascoside is not less than 0.03%,the content of Rehmannioside D is not less than 0.2%.The third-grade Rehmanniae Radix pieces average width are 1.7cm or less,per kilogram large pieces(wide diameter ? 1.5cm)accounted for 50%or less,the water soluble leachables is not less than 65%,the content of catalpols is not less than 0.2%,the content of verbascoside is not less than 0.02%,the content of Rehmannioside D is less than 0.2%.It is recommended to divide Rehmanniae Radix Praeparata into two grades,optimal level Rehmanniae Radix Praeparata average width are 1.7cm or more,per kilogram large pieces(wide diameter>1.5cm)accounted for 50%or more,the water soluble leachables is not less than 65%,the content of verbascoside is not less than 0.02%,the content of catalpols is not less than 0.2%,the content of Rehmannioside A is not less than 0.05%.General level Rehmanniae Radix pieces average width are 1.7cm or less,per kilogram large pieces(wide diameter>1.5cm)accounted for 50%or less,the water soluble leachables is less than 65%,the content of verbascoside is not less than 0.02%,the content of catalpols is not less than 0.1%,the content of Rehmannioside A is not less than 0.02%.Conclusions;According to the identification of traditional traits,the application of modrnm indicators,are able to establish quality grade standards for Rehmanniae Radix pieces and Rehmanniae Radix Praeparata,provide technical support for premium quality and clinically reasonable dispensing of decoction pieces.At the same time,can provide new ideas and methods for the study of the standard grades of traditional Chinese medicine herbal decoction pieces. |
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