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.

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.

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.

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.

End-stage hemolytic rate of leukocyte-reduced RBCs in additive solution: a 5-year retrospective study / 中国输血杂志

【Objective】 To evaluate the suitability of current quality standard for end-stage hemolytic rate required by Quality Requirements for Whole Blood and Blood Components in Taiyuan through a 5- year retrospective analysis of leukocyte-reduced RBCs in additive solution in Taiyuan Blood Center. 【Methods】 A total of 240 packs of leukocyte-reduced RBCs in additive solution were collected from January 2007 to December 2021. Hb concentration, hematocrit(Hct) and free Hb in supernatant at end-stage were detected to measure the hemolytic rate. And the hemolytic rate was then compared with the current standard(0.8%) to analyze whether statistical differences existed. 【Results】 The hemolytic rate of leukocyte-reduced RBCs in additive solution were 0.109±0.123 in 2017, 0.113±0.085 in 2018, 0.121±0.076 in 2019, 0.101±0.057 in 2020, and 0.128±0.089 in 2021, with no significant difference among each other (P>0.05). And 97.5% of the products showed an end-stage hemolytic rate below 0.4%, 0.83% among 0.6%~0.7%, and none over the standard of 0.8%. 【Conclusion】 The current national standard for end-stage hemolytic rate of leukocyte-reduced RBCs in additive solution might not be suitable for blood quality control in Taiyuan, and a much stricter criteria should be considered.

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 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 .

Study on quality standard of Jingtian Zhitong cream / 药学实践杂志

Objective To revise the determination method in the quality standard of Jingtian Zhitong cream. Methods The total saponins of angelica sinensis, Ligusticum wallichii, Rhizoma corydalis, and Panax notoginseng saponins were qualitatively identified by thin-layer chromatography (TLC). The contents of notoginsenoside R1, ginsenoside Rg1, and ginsenoside Rb1 in the preparation were determined by high performance liquid chromatography (HPLC). Results TLC showed strong specificity and good resolution. The concentration of notoginsenoside R1 showed a good linear relationship in the range of 0.1604 and 2.0050μg (r=0. 999). The concentration of ginsenoside Rg1 showed a good linear relationship in the range of 0.8003 and 10.0035μg (r=1.000). The concentration of ginsenoside Rb1 showed good linearity in the range of 0.6182 and 7.7275μg (r=1.000). The sample recovery rates were 101.43%, 98.75% and 100.95%, respectively. The relative standard deviation (RSD) were 2.56%, 2.71% and 2.75%, respectively. Conclusion The developed method is accurate and reliable with high sensitivity, which can be used for the quality control of Jingtian Zhitong cream.

Study on the improvement of quality standard for Niushanggui capsules / 中国药房

OBJECT IVE To provide reference for the improvement of the quality standard for Niushanggui capsules. METHODS Based on the previous quality standard ，thin-layer chromatography （TLC）identification methods were established for Angelicae dahurica and Anemarrhenae asphodeloides . High performance liquid chromatography （HPLC）method was established to determine the contents of 5 components simultaneously ，such as mangiferin ，prim-O-glucosylcimifugin，naringin，neohesperidin and 5-O-methylvisammioside. The limits were confirmed. RESULTS TLC chromatogram of Niushanggui capsules showed the same color spots in the same position as the corresponding （mixed）substance control or reference medicinal material of A. dahuricae and A. asphodeloides ，while the negative samples had no interference. The linear range of mangiferin ，prim-O-glucosylcimifugin， naringin，neohesperidin and 5-O-methylvisammioside were 7.98-127.63，6.74-107.84，53.06-848.96，39.31-628.90，13.54-216.62 μg/mL，respectively（all r＝0.999 9）. RSDs of precision ，stability（24 h）and repeatability tests were all no more than 1.20％（n＝ 6）. The average recoveries were 95.00％，105.16％，97.16％，101.00％ and 104.97％（RSD≤1.50％，n＝6）. In 4 batches of samples，the average contents of the above 5 components were 0.842，0.696，6.951，5.755 and 1.106 mg/g respectively ；the limits of A. asphodeloides ，Saposhnikovia divaricata and Citrus aurantium were based on the contents of mangiferin ，the total content of prim-O-glucosylcimmifugin and 5-O-methylvisammioside，naringin and neohesperidin ，which would not be less than 0.42，0.90 and 6.36 mg/grain，respectively. CONCLUSIONS TLC identification methods of A. dahurica and A. asphodeloides and the content determination methods of 5 components as mangiferin in Niushanggui capsules are established in this study ，and the limits of A. asphodeloides ，S. divaricata and C. aurantium are confirmed.

Improvement of the quality standard of Gerbera piloselloides / 中国药房

OBJECTIVE To improve th e quality standard for Gerbera piloselloides. METHODS The properties of G. piloselloides were observed and microscopic identification was conducted for powder. The moisture ，total ash ，acid-insoluble ash and ethanol-soluble extract were detected according to the method stated in 2020 edition of Chinese Pharmacopoeia （part Ⅳ）. The contents of nodakenin，luteolin-7-O-β-D-lutinoside，luteoloside，apigenin-7-O-β-D-lutinoside，apigenin-7-O-β-D-glucopyranoside and marmesin were determined by high performance liquid chromatography method. RESULTS G. piloselloides were shrunken ，densely covered with thick white cotton wool ，with many fibrous roots ；the surface was taupe or gray-brown ；its texture was brittle and easy to break ；the cross section was yellow-white ，and there was an obvious small wooden heart in the center. Its powder was tan ， and non-glandular hairs ，stone cells ，calcium oxalate cubes ，ducts，fibers could be seen unde r microscope. The measured values of moisture，total ash ，acid-insoluble ash and alcohol-soluble extract ， for 15 batches of samples were 8.63％-11.34％，10.39％-14.93％， 3.29％-6.37％ and 9.03％-15.02％，respectively；average values were 10.01％，12.26％，4.61％，12.36％. The linear ranges of nodakenin，luteolin-7-O-β-D-rutinoside，luteoloside，apigenin- 7-O-β-D-lutinoside，apigenin-7-O-β-D-glucopyranoside and marmesin we re 3.87-154.88，1.64-65.41，1.60-64.00，1.92-76.96， 1.27-50.93，0.40-15.89 μg/mL，respectively（r≥0.999 1）. RSDs of precision ，stability（24 h）and repeatability tests were all less than 3％. The average recoveries were 101.88％，100.89％，102.64％，95.75％，96.71％ and 103.48％，respectively；RSDs were 0.55％，0.43％，0.34％，0.49％，0.47％ and 0.37％，respectively（n＝6）；the contents of above 6 components were 0.152 7-0.852 2， 0.084 5-0.669 7，0.136 7-0.961 0，0.126 0-1.193 2，0.128 8-1.102 2，0.046 9-0.678 0 mg/g. CONCLUSIONS The established method can be used for the quality control of G. piloselloides . It is preliminarily proposed that the moisture in G. piloselloides is not more than 12.0％；the total ash is not more than 15.0％，the acid-insoluble ash is not more than 6.0％，the alcohol-soluble extract is not less than 9.0％；the contents of luteoloside and apigenin- 7-O-β-D-glucopyranoside are not less than 0.016％.

Quality standard of Lobeliae Chinensis Herba / 中国中药杂志

In light of related methods in Chinese Pharmacopoeia(2020 edition), this study established the quality standard for Lobeliae Chinensis Herba. The TLC identification method was established with silica gel GF_(254) thin layer plate, diosmin standard, linarin standard, and the reference material of Lobeliae Chinensis Herba. The loss on drying, total ash, acid-insoluble ash, and ethanol-soluble extracts of 18 batches of Lobeliae Chinensis Herba samples were determined according to the general principles in Chinese Pharmacopoeia. Then, HPLC was adopted in the establishment of characteristic chromatogram and content determination. The results showed that the established method can achieve good separation for diosmin, linarin, and lobetyolin. Based on the results of detection for 18 batches of Lobeliae Chinensis Herba samples, the draft quality standard was established, which was expected to provide reference for the revision of this medicinal herb in Chinese Pharmacopoeia.

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.