| Platycodon grandiflorum widely distributed in China's Anhui,Henan,Shanxi,Hebei,Sichuan,Hunan,Yunnan,Chongqing,Jilin,Gansu and other provinces and municipalities directly under the Central Government.China National Academy of Chinese Medical Sciences has completed resource surveys for the Platycodon grandiflora and collected and accumulated a large number of samples of Platycodon grandiflorum from different origins,which is representative of the origin and resource distribution of the Platycodon grandiflorum in China.In the 2015 edition of the Chinese Pharmacopoeia,the content of single component of the Platycodin D was used as a quality evaluation standard,and the results showed that the content and traits varied greatly with origin.So far,studies on the study of Platycodon grandiflorum have been carried out in the literature on safety indicators such as metals and harmful elements,mycotoxins,efficacy indicators such as fingerprints,and multi-index determinations of Platycodon grandiflorum from different origins.There is no comprehensive data and evaluation results for the safety and effectiveness of the Platycodon grandiflorum origin.For this purpose,the basic data of the following batches of the 58 samples of Platycodon grandiflorum collected from the 10 provinces and cities collected in the national resource survey were conducted.(1)The statutory standard specifies the basic data of the projectWith reference to the 2015 edition of the Chinese Pharmacopoeia,58 batches of Platycodon grandiflorum were tested for statutory standard test items.RESU1TS:The total failure rate of 58 batches of Platycodon grandiflorum was 67.24%,of which 20 batches of traits did not meet the requirements,and the rate of failure was:34.48%;The total disqualification rate of the identification project was 0%,but there were 4 abnormalities(Chongqing,Anhui,and Henan(2 batches))in the microscopic identification of the cross section;moisture content of 8.0 to 15.3%,the average value of 10.0%,1 batch does not meet the requirements,failure rate:1.72%;total ash content of 1.8 to 11.3%,the average value of 4.1%,10 batches do not In line with regulations,the rate of failure was 17.24%;the content of leachables was 12.9 to 39.5%with an average of 20.4%,17 batches did not meet the requirements,and the failure rate was 29.31%;the content of Platycodin D was 0.07 to 0.35%.The average value is 0.17%.There are 6 batches that do not meet the requirements,and the failure rate is 10.34%.SPSS software was used to analyze the frequency distribution of moisture content,total ash content,leachate content,and content determination data,and the overall correlation degree was analyzed by using the grey correlation coefficient method.The quality of the Platycodon grandiflorum samples from different producing areas was ranked.The result was:Anhui The quality of Platycodon grandiflorum was superior in the region,and the quality of Platycodon grandiflorum in Hunan was poor.(2)Development of basic data for project researchElemental spectrum detection.Refer to the 4 editions of the Chinese Pharmacopoeia(0412,2321)of the 2015 edition for the determination of Pb,Cr,Cd,Hg,As,Cu,Fe,Zn,Ni,and Sb in the Platycodon grandiflorum samples by inductively coupled plasma mass spectrometry(ICP-MS).20 kinds of metal elements such as T1,Ag,Be,Mn,Ba,Al,Sn,Dy,Se,Mo,etc.were measured.Among the 58 batches of samples,among 6 kinds of heavy metals and harmful elements,Cu>Cr>Pb>Cd>As>Hg,The contents of Cu and Pb in Platycodon grandiflorum were the highest in Changsha City,Hunan Province.They were Cu:17.500 mg.kg-1 and Pb:14.670 mg.kg-1;The contents of Al,Fe,Zn,and Ba in Platycodon grandiflorum were higher among the 14 trace elements,Al>Fe>Zn>Ba>Mn>Ni>Ag>Mo>Se>Be>Dy>Sb>Tl>Sn.The A1 content of the Platycodon grandiflorum in Qujiang District of Chongqing City was the highest,which was 4262.611 mg.kg-1.The contents of Fe and Zn in the Platycodon grandiflorum in Xingtai County of Hebei Province were the highest,which were Fe:3537.123 mg.kg-1 and Zn:229.366 mg.kg-1.SPSS software was used to analyze the geographical distribution of 58 batches of samples from 10 provinces and cities.The results were as follows:six kinds of heavy metal elements(Cu,As,Cd,Pb,Hg,Cr)and Al,Fe,Zn,and Ba.Although the differences among batches are relatively large,there is no regional distribution between the provinces.Correlation analysis results show that the total ash content of Platycodon grandiflorum has significant correlation with Cu,As,and Cr elements.Mycotoxin detection.With reference to the fourth edition of the Chinese Pharmacopoeia(407)of the 2015 edition,the T-2 toxin,aflatoxin B1,aflatoxin B2,aflatoxin G1,aflatoxin G2,and Ochratoxin A in 58 batches of samples were determined by high performance liquid chromatography-tandem mass spectrometry(HPLC-MS).RESULT:Among the 58 batches of samples,aflatoxin B1 was detected in 7batches.Aflatoxin B2 was detected in 3 out of 7 batches;ochratoxin A was detected in 6 batches;Aflatoxins G1,G2,and T-2 toxin were not detected in 58 batches of Platycodon grandiflorum.High performance liquid chromatographic(HPLC)fingerprinting studies.The sample was sonicated with 50%methanol and separated on a C18 column using high performance liquid chromatography-evaporation light scattering detector(HPLC-ELSD).A standard fingerprint of 58 batches of Platycodon grandiflorum was generated to identify 17 major common peaks in 58 batches of HPLC chromatographic fingerprints.The similarity was analyzed.The similarity was between 0.353 and 0.989,There were 5 batches with similarity below 0.600,followed by Wuyuan County,Shanxi Province:0.353,Wushan County,Chongqing:0.357,Ningguo City,Anhui Province:0.386,Wuyuan City,Hunan Province:0.475,and Qianjiang District,Chongqing(0.536);there were 3 similarity levels between 0.600 and 0.800.Batches(Anhui,Shanxi(2 batches))accounted for 5.17%of the total;16 batches with similarity between 0.800 and 0.900(Sichuan(2 batches),Shanxi(3 batches),Henan(2 batches),Hebei(3 batches)),Jilin(2 batches),Yunnan,Gansu,Anhui,and Hunan)accounted for 27.59%of the total;46 batches with similarity higher than 0.900 accounted for 79.31%of the total;According to the difference of fingerprints,58 batches of Platycodon grandiflorum HPLC fingerprints were divided into 8 categories.The similarity between the same category and different categories was used to evaluate the fingerprint similarity.There is a large difference in similarity between classes,ranging from 0.557 to 0.950.In addition,high performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS)was used to qualitatively analyze the chromatographic peaks of Platycodon grandiflorum fingerprints,using electrospray ionization,negative ion mode,mass spectrometry,and comparison with existing reference materials.Combined with literature data,four chromatographic peak identities were identified,namely,2(Platycoside E),3(Deapioplatycodin D3),4(platycodin D3),7(platycodin D);13 peaks are inferred,which are 1(Deapio platycoside E),5(Platycoside I;2”-O-acetyl-Platycodin D2,3"-O-acetyl-Platycodin D2 or its isomers),6(Platyconic acid A),8(Platycodins K or Platycodins L;2”-O-acetyl-Platycodin D2,3”-O-acetyl-Platycodin D2 or its isomers),9(Platycodin C),10(3”-O-acetyl-Polygalacin D2),11(3"-O-acetyl-Polygalacin D),12(Platyconic acid B or its isomers),13(2”-O-acetyl-Platycodin D2,3"-O-acetyl-Platycodin D2 or its isomers;Platycodins K or Platycodins L),14(Platycodin A),15(2"-O-acetyl-Polygalacin D2),16(2,"-O-acetyl-Polygalacin D),17(Platyconic acid B or its isomers).Determination of four kinds of platycodon saponin content.The sample was sonicated with 50%methanol and separated on a C18 column using HPLC-ELSD.RESULTS:In the 58 samples,the contents of Platycoside E,Deapioplatycodin D3,platycodin D3,and platycodin D were 0.018-0.433%,0.003-0.109%,0.018-0.278%,0.021-0.460%,with mean values of 0.18%,0.03%,0.09%and 0.12%,respectively.The content of Platycoside E in Henan Province was higher in Henan,followed by Sichuan Province;the content of Deapioplatycodin D3,platycodin D3,and platycodin D in Sichuan Province were all higher.The total amount of four kinds of saponins was 0.18%(0055 in Fengqiu County,Henan Province)to 0.92%(0104 in Hanyuan County,Sichuan Province);the total amount of 4 saponins was generally higher in Sichuan Province and lower in Gansu,Hunan and Yunnan Provinces.On the basis of the foregoing work,the quality of the Platycodon grandiflorum was evaluated,and the Pharmacopoeia quality control project was evaluated,and a series of suggestions for revision of the Pharmacopoeia was put forward. |
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