Study on quality standard for Miao medicine Clinopodium gracile / 中国药房

OBJECTIVE To establish the quality standard of Clinopodium gracile. METHODS Ten batches of C. gracile were collected to perform appearance and property identification， microscopic identification and thin layer chromatography （TLC） identification. Moisture， total ash， acid-insoluble ash and dilute ethanol extract were detected， and the content of rosmarinic acid was determined by HPLC. RESULTS The stem of C. gracile was slender， square columnar， covered by white fluff， the surface was grayish green or greenish brown； epidermal cells， non-glandular hairs， cortical cells and so on were seen in the cross section of the stem. Non-glandular hairs， ducts， wood fibers， mesophyll cells and so on could be seen in the powder. Results of TLC identification showed that there were spots of the same color in the chromatographic position corresponding to the chromatographic position of buddlejasaponin Ⅳb control. The contents of water， total ash， acid-insoluble ash， dilute ethanol extract and rosmarinic acid in 10 batches of samples were 8.69%-12.33%， 5.96%-13.33%， 0.14%-3.29%， 18.57%-32.61%， 0.35%-0.82%， respectively. The average values were 10.10%， 9.73%， 1.06%， 23.54% and 0.56%， respectively. CONCLUSIONS The established method can be used for quality control of C. gracile. It is preliminarily proposed that the ash content in the herb should not exceed 12.0%， the total ash content should not exceed 12.0%， the acid-insoluble ash content should not exceed 1.5%， the dilute ethanol extract should not be less than 18.0%， and the rosmarinic acid content should not be less than 0.45%.

Study on quality standard of Yi medicine Gynura japonica and quality evaluation of medicinal materials from different producing areas / 中国药房

OBJECTIVE To improve the quality standard of Yi medicine Gynura japonica， and to evaluate its quality. METHODS Using 15 batches of G. japonica from different producing areas as samples， the contents of water， total ash， acid- insoluble ash and water-soluble extract were determined according to the method stated in part Ⅳ of Chinese Pharmacopoeia （2020 edition）. The contents of total alkaloid （calculated by senecionine） was determined by UV spectrophotometry. The contents of senecionine and seneciphylline were determined by HPLC. Using above 7 indexes as evaluation indexes， cluster heat map analysis， principal component analysis （PCA） and entropy weight approximation ideal ranking （TOPSIS） were used to evaluate the quality of medicinal material comprehensively. RESULTS Among 15 batches of G. japonica， the moisture contents were 8.88%-12.60%， the total ash contents were 4.43%-11.02%， the acid-insoluble ash contents were 0.56%-3.45%， the water-soluble extract contents were 21.71%-53.91%， the total alkaloid contents （calculated by senecionine） were 0.15%-0.39%， and the contents of senecionine and seneciphylline were 0.01% -0.05% and 0.01%-0.06% respectively. According to the results of various indicators， it was preliminarily proposed that the water content in the sample of G. japonica should not exceed 13.00%， the total ash content should not exceed 11.50%， the acid-insoluble ash content should not exceed 3.70%， the water-soluble extract should not be less than 20.70%， the total alkaloid content should not be less than 0.15%， the contents of senecionine and seneciphylline should not be less than 0.01% both. The results of cluster heat map analysis showed that the 15 batches of samples could be divided into four categories； the results of PCA and TOPSIS showed that the samples with high-quality ranking were jsq-2， jsq-5， jsq-6 and jsq-10， and the samples with low-quality ranking were jsq-4， jsq-13 and jsq-14. CONCLUSIONS In this study， the quantitative analysis method of total alkaloids （calculated by senecionine）， senecionine and seneciphylline in G. japonica is established， and the limits of each index are preliminarily determined. Among 15 batches of samples， the qualities of medicinal material collected from Linza Village of Ganluo County of Liangshan Yi Autonomous Prefecture， Machangping Village of Luojishan Town of Puge County of Liangshan Yi Autonomous Prefecture and other places are better.

Varieties systematization and standards status analysis of fermented Chinese medicine / 中国中药杂志

Fermented Chinese medicine has long been used. Amid the advance for preservation of experience, the connotation of fermented Chinese medicine has been enriched and improved. However, fermented Chinese medicine prescriptions generally contain a lot of medicinals. The fermentation process is complicated and the conventional fermentation conditions fail to be strictly controlled. In addition, the judgment of the fermentation end point is highly subjective. As a result, quality of fermented Chinese medicine is of great difference among regions and unstable. At the moment, the quality standards of fermented Chinese medicine are generally outdated and different among regions, with simple quality control methods and lacking objective safe fermentation-specific evaluation indictors. It is difficult to comprehensively evaluate and control the quality of fermented medicine. These problems have aroused concern in the industry and also affected the clinical application of fermented Chinese medicine. This article summarized and analyzed the application, quality standards, and the modernization of fermentation technology and quality control methods of fermented Chinese medicine and proposed suggestions for improving the quality standards of the medicine, with a view to improving the overall quality of it.

Problem Analysis and Standard Establishment of Grade Evaluation Method of Traditional Chinese Medicine Decoction Pieces / 中国实验方剂学杂志

High quality is the premise for the implementation of high quality and good price for decoction pieces， and grade is the most direct manifestation of high quality of decoction pieces. However， there is still a lack of scientific and reasonable methods for evaluating the grade of decoction pieces， and it is urgent to establish a widely recognized and unified standard for the grade of decoction pieces to ensure the quality of the decoction pieces and guarantee the safety and efficacy of clinical use. Based on this， this paper focused on analyzing the problems of the current grade evaluation methods， such as unclear distinction between quality standards and grade standards， unreasonable selection of grade evaluation indicators， and inaccurate application of mathematical statistical methods. Based on the analysis of the grade evaluation of decoction pieces， this paper proposed four criteria for establishing the grade evaluation method of decoction pieces， namely universality， comprehensiveness， reliability and convenience， in order to establish a more reasonable and unified grade standard for decoction pieces and promote the quality improvement of decoction pieces and the development of the industry.

Establishment of national reference panel for coxsackievirus A16 nucleic acid detection kit / 中国生物制品学杂志

@#ObjectiveTo establish the national reference panel for coxsackievirus A16(CA16)nucleic acid detection kit and related quality standard.MethodsThe CA16 positive and negative samples were collected and screened,and then were filled and lyophilized to establish the national reference panel for CA16 nucleic acid detection kit. According to the cooperative calibration results of various reagent manufacturers,the quality standard of reference panel was determined.Meanwhile,the homogeneity and stability of the national reference panel were well studied.ResultsThe national reference panel of CA16 nucleic acid detection kit consisted of 9 positive samples,8 negative samples,1 limit-detecting sample and1 precision sample. The quality standard was as follows:the coincidence rate of positive samples was no less than 8/9;The coincidence rate of negative samples was 8/8;The minimum detection limit required that the dilution of limit-detecting sample was no less than 1∶103;The precision required that the coefficient of variation(CV)of Ct value of 10 precision samples diluted 100 times was no higher than 5% and the results were all positive. The homogeneity of the reference panel met the requirement,and the stability was not affected by the storage at room temperature(25 ℃)for 24 hours and repeated freezing and thawing three times.ConclusionThe first national reference panel of CA16 nucleic acid detection kit and the related quality standard have been established,which provided a reference for the quality control and evaluation of the related reagents.

Factors influencing hemolysis rate of leukocyte-reduced red blood cells at the end of preservation period in blood donors / 中国输血杂志

【Objective】 To compare the current standards and explore the influencing factors for hemolysis rate of leukocyte-reduced red blood cells at the end of the preservation period, in order to formulate reasonable internal control indicators. 【Methods】 A retrospective analysis was performed on hemolysis rate of 427 samples of leukocyte-reduced red blood cells at the end of the preservation period in Nanning Blood Center from 2015 to 2022. Compared with the current standard for hemolysis rate at the end of the preservation period (GB 18469-2012 Quality Requirements for Whole Blood and Component Blood), the differences were analyzed, and the factors influncing the hemolysis rate were analyzed in terms of different blood donor groups. 【Results】 1) Among the 427 samples, the hemolysis rate of 418 (97.89%) did not exceed 0.4%, all lower than 0.8%; 2)the hemolysis rate of the male group was higher than that of the female group; 3) the hemolysis rate of the 18-29 years old group was lower than that of the 30-39 year old group and the 40-60 year old group, with statistically significant difference; 4) in terms of occupation, the hemolysis rate of students was the lowest, and the differences between groups were statistically significant; 5) no statistical significance was found in ethnicity and blood type. 【Conclusion】 Statistics indicated that gender, age, blood donation volume and occupation of blood donors were the influencing factors of hemolysis rate. The current standard is obviously higher in the qualified range of blood quality control in Nanning. It is advisable to formulate a reasonable quality control strategy with internal control index of hemolysis rate set <0.4%, which is conducive to making accurate evaluation of internal quality control and ensuring blood safety.

Establishment of HPLC fingerprint and content determination of 8 components in Jianpi huayu decoction / 中国药房

OBJECTIVE To establish the HPLC fingerprint of Jianpi huayu decoction， and to determine the contents of 8 components. METHODS Thermo Hypersil Gold C18 column was used with mobile phase consisted of methanol-0.05% phosphoric acid aqueous solution （gradient elution） at the flow rate of 1.0 mL/min. The column temperature was 30 ℃， the injection volume was 5 μL. The detection wavelength of matrine was 211 nm， and the other components’ detection wavelength was 283 nm. The similarity evaluation of HPLC fingerprints for 10 batches of Jianpi huayu decoction was performed by using the Similarity Evaluation System of Chromatographic Fingerprint of Traditional Chinese Medicine （2012 edition）. The contents of chlorogenic acid， vanillic acid， p-coumaric acid， ferulic acid， hesperidin， quercetin， bergapten and matrine in the samples were determined by HPLC. RESULTS HPLC fingerprint of Jianpi huayu decoction was established. A total of 27 common peaks were identified， and 8 components were identified. The similarity between 10 batches of samples and the control map ranged from 0.942-0.999. RSDs of precision， repeatability and stability tests were less than 3% （n＝6）. The average recoveries of chlorogenic acid， vanillic acid， p-coumaric acid， ferulic acid， hesperidin， quercetin， bergapten and matrine were 99.48%， 101.32%， 101.18%， 100.79%， 101.12%， 99.19%， 99.81% and 102.46%， respectively； RSDs were 1.34%， 0.93%， 1.90%， 1.84%， 0.54%， 1.53%， 1.33% and 1.01%， respectively （n＝6）. The contents were 0.021-0.061， 0.025-0.034， 0.116-0.295， 0.006- 0.062， 0.014-0.053， 0.017-0.026， 0.014-0.027 and 14.05-24.11 mg/g， respectively. CONCLUSIONS The established fingerprint and content determination method can provide a reference for the quality control and subsequent preparation development for Jianpi huayu decoction.

Considerations on investigation on quality standard of Chinese patent medicine / 药学学报

Chinese patent medicine (CPM) is an important part of traditional and Chinese medicine (TCM). Its quality has direct impact on the safety and effectiveness of clinical use. The quality standard is the pivotal approach to guarantee the quality of CPM. Due to the complex material basis, multitudinous quality influencing factors and unveiled active ingredients, dose-effect relationship and action mechanism, the investigation on quality standard faces many difficulties. This paper surveys the current quality status of CPM and the general situation of CPM standards. At present, the dosing problem has the crucial impact on the quality of CPM. The current quality standard system of CPM is confirmed and the limitations are indicated. Based on the above analysis, the principles and considerations on investigation of quality standard are proposed as follows: ① Adhere to safety as the bottom line, strengthen the risk-control ability of the standard of CPM; ② Adhere to theory of TCM and comprehensive quality, improve the integrative control level of the CPM standard; ③ Emphasize technological development and innovation, promote the quality control competence of CPM standard; ④ Facilitate planning and coordination, optimize the management of the CPM standard system; ⑤ Reinforce investigation on evaluation method, develop grade evaluation standard, accelerate high-quality development of CPM. Finally, the future perspective on investigation of CPM quality standard is prospected.

TLC identification and quantitative determination of Shipi Xiaoshui gel plaster / 药学实践杂志

Objective To establish the method of thin layer chromatography (TLC) for identification and quantitative determination of Shipi Xiaoshui gel plaster. Methods TLC was adopted to qualitatively identify astragalus radix, plantaginis semen, curcumae rhizome, cinnamomi ramulus, polyporus umbellatus and akebia quinata. UPLC-MS was used to determine the content of astragaloside Ⅳ. Results TLC spots were clear and well-separated; RSDs of precision, reproducibility and stability tests were all lower than 3%, the linear range of astragaloside Ⅳ was 2.75-33 μg/ml (r=0.999 9, n=6), and the average recovery was 100.49% (RSD=1.98%, n=6). Conclusion The established method in this study is accurate, reliable and specific, which could be used for the quality control of Shipi Xiaoshui gel plaster.

Discussion on several statistical problems in establishing quality standards of standard decoctions / 中草药·英文版

Since 2016, a number of studies have been published on standard decoctions used in Chinese medicine. However, there is little research on statistical issues related to establishing the quality standards for standard decoctions. In view of the currently established quality standard methods for standard decoctions, an improvement scheme is proposed from a statistical perspective. This review explores the requirements for dry matter yield rate data and index component transfer data for the application of two methods specified in “Technical Requirements for Quality Control and Standard Establishment of Chinese Medicine Formula Granules,” which include the average value plus or minus three times the standard deviation (X-±3SD) or 70% to 130% of the average value (X-±30%X-). The square-root arcsine transformation method is used as an approach to solve the problem of unreasonable standard ranges of standard decoctions. This review also proposes the use of merged data to establish a standard. A method to judge whether multiple sets of standard decoction data can be merged is also provided. When multiple sets of data have a similar central tendency and a similar discrete tendency, they can be merged to establish a more reliable quality standard. Assuming that the dry matter yield rate and transfer rate conform to a binomial distribution, the number of batches of prepared slices that are needed to establish the standard decoction quality standard is estimated. It is recommended that no less than 30 batches of prepared slices should be used for the establishment of standard decoction quality standards.

Establishment of Quality Standard for Benchmark Samples of Liangditang / 中国实验方剂学杂志

ObjectiveTo establish the quality standard of Liangditang benchmark samples. MethodUltra performance liquid chromatography-quadrupole time-of-flight mass spectrometry （UPLC-QTOF-MS） was used to qualitatively analyze the chemical composition of Liangditang on the basis of molecular and fragment ion peak information with cracking law. The mobile phase was methanol （A）-0.05% phosphate aqueous solution （B） for gradient elution （0-10 min， 5%-23.5%A； 10-20 min， 23.5%A； 20-58 min， 23.5%-63%A； 58-60 min， 63%-90%A）， the flow rate was 0.8 mL·min-1， and the detection wavelength was 254 nm. Electrospray ionization was employed under positive ion mode， the detection range was m/z 100-1 700. Key quality attributes and sources were determined by comparing with single medicine and reference substances. Through mass transfer analysis of multiple batches from decoction pieces to benchmark samples， high performance liquid chromatography （HPLC） for determining the contents of index components and HPLC detection of characteristic maps were established. Through the determination of 15 batches of benchmark samples， the content range of the index components and the common peaks of the characteristic map were determined. Thin layer chromatography （TLC） was applied to the identification of 5 medicines in the formula. Moisture and dry extract yield of the benchmark samples were determined by drying method. ResultA total of 27 compounds were inferred from the benchmark samples of Liangditang， among which 9 compounds were confirmed by comparison with the control， including catalpol， harpagide， gallic acid， albiflorin， paeoniflorin， verbascoside， angoroside C， cinnamic acid and harpagoside. A method for determining the characteristic maps of the benchmark samples were established and 13 peaks were assigned， and the characteristic peaks were mainly derived from wine-processed products of Rehmanniae Radix， Scrophulariae Radix and wine-processed products of Paeoniae Radix Alba. The similarity between the characteristic map of 15 batches of benchmark samples and the control characteristic map was >0.9. Methods for the determination of paeoniflorin， harpagoside， L-hydroxyproline and glycine were established， and the contents of these four components in 15 batches of benchmark samples were within ±30% of the corresponding mean value， and the transfer rate of decoction pieces to the benchmark samples was stable and controllable. TLC was established to identify 5 prescription drugs （except Ejiao） with two kinds of test solutions， and the results showed that the method had good specificity. The average dry extract yield was 48.06%， and the average moisture was 5.58%， which were within the range of ±10% and ±30% of their mean values， respectively. ConclusionThe quality standard of Liangditang benchmark samples was as follows：the similarity between the benchmark samples and the control characteristic map is >0.9， the contents of paeoniflorin， harpagoside， L-hydroxyproline and glycine are 217-403， 24-46， 634-1 178， 1 253-2 328 mg per dose， the dry extract yield is 43.0%-53.0%， the moisture is 4.0%-7.0%， under the set detection conditions， the benchmark samples have corresponding characteristic spots by comparing with the control herbs of 5 medicines. This quality standard is stable and reliable， which fills the gap in the quality control of Liangditang， and can provide a reference for the establishment of the quality standard of Liangditang granules.

Study on quality standard for vinegar-steamed Corydalis rhizoma / 药学实践杂志

Objective To set up the quality standards for vinegar-steamed Corydalis rhizome, which can be used for the quality control of production, supervision, circulation and application of the steam processed Corydalis rhizoma with vinegar. Methods The moisture content, total ash, ethanol extract content and active ingredients of the steam processed Corydalis rhizoma with vinegar were determined according to the related assay method in Part IV of Chinese Pharmacopeia 2015. Results According to the guidelines from the traditional Chinese medicine quality standards and related testing methods, the moisture content of steam processed Corydalis rhizoma with vinegar should be less than 15.0%, the total ash content less than 4.0%, the ethanol extract content more than 11.0%, and the representative component of tetrahydropalmatine more than 0.05%. Conclusion The established process with this study for the quality standard of vinegar-steamed Corydalis rhizoma was conformed to the state requirements for traditional Chinese medicine. It can be used as a reference for the quality standard of vinegar-steamed Corydalis rhizoma.

Study on the quality standard of Kuipingning gastric floating tablets / 中国药房

OBJECTIVE To establish the quality standard of Kuipingning gastric floating tablets. METHODS Kuipingning gastric floating tablets were prepared and investigated in terms of property ，weight difference and friability. Crydalis yanhusuo was identified qualitatively by thin layer chromatography （TLC）method. High performance liquid chromatography method was used to determine the content of total anthraquinones in Rheum palmatum ，and set the content limit of total anthraquinones. The floating performance and release degree of the preparation were investigated ，and the release kinetic process was fitted. RESULTS Kuipingning gastric floating tablets prepared in this study were gray white to gray tablets with slight smell and bitter taste ；the weight difference and friability were all in line with relevant regulations ；the established TLC method possessed strong specificity and could accurately identify C. yanhusuo . The average content of total anthraquinones in R. palmatum was 17.95 mg/tablet，and its content limit would not be less than 14.36 mg/tablet. The initial floating time of the preparation was no more than 10 s，and the holding time was more than 8 h. The release kinetics process accorded with the Retger-Peppas release model. CONCLUSIONS The method established in this study shows good reliability ，stability and feasibility ，and can effectively control the quality of Kuipingning gastric floating tablets.

Study on the improvement of quality standard for Tibetan medicine Qinjiaohua / 中国药房

OBJECTIVE To improve the quality standard of T ibetan medicine of Qinjiaohua ，and to provide scientific basis for comprehensive quality evaluation. METHODS The qualitative analysis of 16 batches of Qinjiaohua with different producing areas and different origins was carried out by microscopic and TLC identification. According to the method stated in 2020 edition of Chinese Pharmacopoeia ，water content ，total ash content ，acid-insoluble ash content and alcohol-soluble extract content were determined. HPLC method was used to determine the contents of 5 components （loganic acid ，swertiamarin，gentiopicrin， swertionolin，isoorientin） in Qinjiaohua. RESULTS The medicinal powder of Qinjiaohua was light brown-yellow ，and the microscopic features of the powder were clear ，and pollen grains ，ducts，non-glandular hairs ，corolla epidermal cells and calyx epidermal cells were all found. The results of TLC indentification showed that there were fluorescent spots of the same color in the chromatogram of the tested product and the corresponding position of substance control （isoorientin）. The content ranges of water content，total ash content ，acid-insoluble ash content and alcohol-soluble extract were 5.40％-8.87％，3.76％-6.40％，0.27％-0.58％， 26.81％-42.51％，respectively. The results of content determination methodology met the requirements of pharmacopoeia ；the content ranges of loganic acid ，swertiamarin，gentiopicrin，swertionolin and isoorientin in 16 batches of Qinjiaohua were 3.13-9.36，1.26-22.39，13.80-74.60，1.24-12.22，2.58-14.96 mg/g，respectively. CONCLUSIONS On the basis of the original quality standard of Qinjiaohua ，microscopic identification ，TLC identification ，content determination and examination items of water，total ash ，acid-insoluble ash and alcohol-soluble extract are added. It is preliminarily proposed that water content ，total ash content and acid-insoluble ash content should not exceed 9.0％，6.5％ and 0.6％，while the contents of ethanol-soluble extract and gentiopicrin should not be less than 26.0％ and 13.8 mg/g，respectively.

Study on quality standard for Xuanxi Rongjin powder / 药学实践杂志

Objective To revise the qualitative and quantitative determination methods of Xuanxi Rongjin powder. Methods TLC was used to qualitatively identify Chuanxiong and Chuanshanlong. The content of cinnamaldehyde in the preparation was determined by HPLC with KR100-5C18 column (250 mm×4.6 mm, 5μm). The mobile phase was acetonitrile-water (35:65) and the detection wavelength was 290 nm. Results TLC can qualitatively identify Chuanxiong and Chuanshanlong. Cinnamaldehyde has a good linear relationship in the range of 0.0489~0.3260 µg/ml (r=1.00), The average recovery was 95.71% (RSD=1.78%). Conclusion The method has high sensitivity, good specificity, simple operation and good reproducibility.

Study on quality standard for Hylocereus undatus / 中国药房

OBJEC TIVE To establish the qu ality standard of Hylocereus undatus ，and to provide reference for its quality control. METHODS The sample of H. undatus medicinal materials was collected for character observation ，powder microscopic identification and thin-layer chromatography （TLC）identification. Moisture content ，total ash ，acid-insoluble ash ，water-soluble extracts and alcohol-soluble extracts were determined according to the corresponding methods in the general provisions of the 2020 edition of Chinese Pharmacopoeia （part Ⅳ）. The contents of kaempferol and isorhamnetin in H. undatus were determined by high performance liquid chromatography. RESULTS The medicinal materials of H. undatus were in brown or yellowish brown irregular long bundles ；the calyx tubes were twisted in bundles ；the scales on the outside of the flower were shrunken ，and many stamens were inserted on the inside. The powder was brown-green or brown-yellow ，and pollen grains ，ducts and non-glandular hairs were found.In the TLC diagram of test sample ，fluorescent spots of the same color were displayed on the corresponding position of the chromatogram of substance control （kaempferol， isorhamnetin） and reference material. The moisture content ， total ash ， acid-insoluble ash ，water-soluble extract and alcohol-soluble extract of the 15 batches of samples ranged from 10.70％ to 12.23％， 7.48％ to 11.29％，0.25％ to 0.70％，30.34％ to 49.91％，and 25.27％ to 36.92％，respectively. The average values were 11.44％，9.51％，0.46％，40.13％，32.33％，respectively. The contents of kaempferol and isorhamnetin were 1.787-3.785 and 0.597-2.211 mg/g，respectively. CONCLUSIONS This study add microscopic identification ，TLC identification and inspection items such as moisture content ，ash and extract on the basis of the existing quality standards of H. undatus . It is preliminarily proposed that the moisture content in H. undatus shall not exceed 13.0％ and total ash content shall not exceed 12.0％，and the water-soluble extract and alcohol-soluble extract shall not be less than 30.0％ and 25.0％ respectively；the contents of kaempferol and isorhamnetin shall not be less than 1.780 and 0.590 mg/g，respectively. The established quality standard can be used for quality control of H. undatus .

Improvement on Quality Standard of Belladonnae Herba / 中国实验方剂学杂志

ObjectiveTo improve the current standard of Belladonnae Herba in the 2020 edition of Chinese Pharmacopoeia. MethodTaking hyoscyamine sulfate， atropine sulfate and scopoletin as reference substances， and ethyl acetate-methanol-concentrated ammonia（17∶4∶2）as developing solvent， thin layer chromatography （TLC） was applied in the qualitative identification of Belladonnae Herba. The moisture， total ash and ethanol-soluble extract of Belladonnae Herba were determined based on the general principles in the 2020 edition of Chinese Pharmacopoeia （volume Ⅳ）. The contents of hyoscyamine sulfate and scopolamine hydrobromide were analyzed by high performance liquid chromatography （HPLC） with mobile phase of acetonitrile-54 mmol·L-1 phosphate buffer solution （14∶86）， flow rate of 1.0 mL·min-1 and detection wavelength at 210 nm. ResultThe spots in the TLC were clear with good separation and specificity. Hyoscyamine sulfate and scopolamine hydrobromide showed a good linearity with peak area in the range of 0.024 7-0.789 6 g·L-1 （r=0.999 9） and 0.003 9-0.124 0 g·L-1 （r=0.999 9）， the average recoveries of these two ingredients were 100.29% （RSD 1.6%） and 99.04% （RSD 1.4%）， respectively. The limits for moisture， total ash in Belladonnae Herba should be less than 13.0% and the limit for the ethanol-soluble extract should be more than 10.0%. Due to the low content and wide variation of scopolamine hydrobromide， the content of hyoscyamine sulfate should not be less than 0.098%. ConclusionThe established method is simple， specific and reproducible， which can be used to improve the quality control standard of Belladonnae Herba.

Thoughts on Current Quality Standard of Atractylodis Rhizoma Based on Genuine Advantages of Traditional Chinese Medicine / 中国实验方剂学杂志

Atractylodis Rhizoma is a kind of commonly used clinical Chinese medicine （TCM）， which was first recorded in Shennong Bencaojing （《神农本草经》）. At that time， it was called "Zhu"， which is the general name of Atractylodis Rhizoma and Atractylodis Macrocephalae Rhizoma. After Song dynasty， Atractylodis Rhizoma and Atractylodis Macrocephalae Rhizoma were separated. Atractylodis Rhizoma can be divided into Atractylodes lancea and A. chinensis. In history， A. lancea as authentic， that its quality is better than A. chinensis. However， the quality of Atractylodis Rhizoma was evaluated by the index component atractylodin in the 2020 edition of Chinese Pharmacopoeia. The general results showed that the content of atractylodin in A. lancea was low， even failed to meet the specified standard， and its content in A. chinensis was significantly higher than that in A. lancea. The results were inconsistent with the records of ancient books and documents， and the quality theory of "genuine medicine is the best". It could not reflect the quality advantage of genuine Atractylodis Rhizoma， and may even affect the clinical application and development momentum of genuine medicine. In short， the quality standard of TCM should not only conform to the historical experience， but also have the connotation of modern science and technology， which can stand the test of practice. Based on this， the author intends to sort out relevant laws and regulations， sort out the literature related to the authenticity， composition and efficacy of Atractylodis Rhizoma， and analyze the rationality of the current standard of Atractylodis Rhizoma by integrating the relevant records of historical classics and modern research results， so as to provide a basis for the improvement of the quality standard of Atractylodis Rhizoma.

Quality standard improvement study of ginkgo semen decoction pieces / 药学实践杂志

Objective To establish and improve the quality standard of ginkgo semen decoction pieces. Methods The morphological character for 29 batches of ginkgo gemen and 12 batches of stir-fried ginkgo gemen were observed, and the moisture contents were assayed using the method in Chinese Pharmacopoeia 2015 edition, the first supplement. Results The character of ginkgo gemen and stir-fried ginkgo gemen were consistent in different batches. The moisture content of ginkgo gemen was 8.8% to 12.2%, with an average of 10.5%. The moisture content of stir-fried ginkgo gemen was from 5.4% to 12.3%, with an average of 8.9%. Considering that ginkgo semen decoction pieces are stored for a long time, they are prone to the attack of mildew and insects, and the moisture limit is set to be no more than 10.0% in ginkgo gemen and stir-fried ginkgo. Conclusion Compared with the Chinese Pharmacopoeia 2015 edition, the first supplement, the character identification for ginkgo semen decoction pieces was added and the quality standards were improved. The moisture content of ginkgo semen decoction pieces needs to be strictly controlled under 10.0% to prevent mildew and insects.

Study on quality standard for rice-fired Glehnia littoralis / 中国药房

OBJECTIVE To establish a quality standard for rice-fired Glehnia littoralis . METHODS Appearance observation ， powder microscopic identification and thin-layer chromatography （TLC）identification were performed for the samples of rice-fired G. littoralis decoction piece. According to the relevant methods stated in 2020 edition of Chinese Pharmacopoeia （part Ⅳ），the contents of moisture ，total ash ，acid-insoluble ash ，water-soluble extract and acid-soluble extract were determined. The contents of psoralen，zanthoxylin，bergapten，imperatorin and isoimperatorin were determined by high performance liquid chromatography （HPLC）. RESULTS The rice-fired G. littoralis decoction pieces were round-like small segments ，slightly rough ，yellow（peeled） or dark yellowish brown （with peel ），special gas and slightly sweet taste. The powder was yellowish white. Under the microscope ， secretions and secretory cells ，ducts，gelatinized starch granules ，ray cells ，parenchyma cells ，etc. could be seen. TLC showed the spots developed clearly. In the chromatogram of the test sample ，there was the same blue fluorescent spot at the corresponding position of the chromatogram of isoimperatorin control sample. The moisture ，total ash ，acid-insoluble ash ，water-soluble extract and ethanol-soluble extract from 9 batches of samples were 5.82％-6.27％，3.19％-3.59％，0.21％-0.27％，24.91％-30.30％ and 20.66％ -25.83％ ，respectively. The linear range of psoralen ，zanthotoxin，bergapten，imperatorin and isoimperatorin were 0.240-2.400，0.320-3.200，0.224-2.240，0.292-2.920，0.208-2.080 µg/mL（all r＞0.999 0）. Limits of quantitation were 0.032 0， 0.030 0，0325 0，0.032 0，0.045 0 µg，respectively. Limits of detection were 0.100 8，0.089 6，0.071 5，0.090 0，0.132 0 µg， respectively. RSDs of prescision ，stability（24 h）and reprodu- cibility tests were less than 3％. Average recoveries were 100.56％ （RSD＝1.36％ ，n＝6），100.73％（RSD＝2.25％ ，n＝6）， 100.36％（RSD＝0.98％，n＝6），98.24％（RSD＝0.40％，n＝6） E-mail：853063968@qq.com and 99.40％（RSD＝0.35％，n＝6），respectively. The contents of above five components were 5.85-13.31，8.63-33.38，6.23- E-mail：shixiaofeng2005@sina.com 15.25，6.12-12.98，5.52-10.77 µg/g，respectively. The total contents were 34.20-83.47 µg/g. CONCLUSIONS It is preliminarily proposed that the moisture ，total ash and acid-insoluble ash should not exceed 7.30％，4.10％，0.30％. The water-soluble extract and ethanol-soluble extract are no less than 21.00％ and 18.00％，respectively. The total content of coumarin should not be less than 52.03 µg/g（with peel ）and 26.34 μg/g（peeled）. Established quality standard can be used for the quality control of rice-fired G. littoralis .