1.Re-examination of Atractylodis Rhizoma and Dosage of Whole Formula in Yuejiuwan
Yanping HAN ; Yiyi ZHANG ; Huimin GAO ; Raorao LI ; Li YAO ; Zhaoxiang SUN ; Zhuo MA ; Huamin ZHANG ; Wei ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):223-233
Yuejuwan is a classic formula widely used by doctors to relieve liver and depression, with precise clinical efficacy in traditional Chinese medicine (TCM). The authors used bibliometric methods to collect and collate 495 ancient data related to Yuejuwan, and 105 valid data were screened out, involving 68 ancient Chinese medical books. After systematic verification of the origin of the formula of Yuejuwan, the main treatment symptoms, the principle of the formula, the composition of the drug, the dosage, the preparation method, the decoction method, and other information, the results showed that Yuejuwan originated from the Danxi Xinfa (《丹溪心法》) of the Yuan Dynasty by ZHU Zhenheng, and it is composed of five medicines, namely Atractylodis Rhizoma, Cyperi Rhizom, Chuanxiong Rhizoma, Massa Medicata Fermentata, and Gardeniae Fructus. In terms of drug base, Atractylodis Rhizoma, Cyperi Rhizom, Chuanxiong Rhizoma, and Gardeniae Fructus are in line with the records in the 2020 edition of Chinese Pharmacopoeia, and Massa Medicata Fermentata is used. The preparation method is as follows: Massa Medicata Fermentata and Gardeniae Fructus are fried, and Cyperi Rhizoma is roasted in vinegar. Chuanxiong Rhizoma is used in the raw form, and Atractylodis Rhizoma is prepared with rice swill. The formula can regulate Qi and relieve depression and broaden the middle and remove fullness. It is clinically used for the treatment of six types of depression syndromes, chest and diaphragm plumpness, abdominal distension and leg acid, acid swallowing and vomiting, eating and drinking disharmony, toothache, mouth and tongue sores, and other diseases. The most used dosage of the formula in the ancient records through the ages is converted into the modern dosage, namely 3.05 g Atractylodis Rhizoma, 3.05 g Cyperi Rhizoma, 3.05 g Chuanxiong Rhizoma, 3.05 g Massa Medicata Fermentata, and 3.05 g Gardeniae Fructus, and the daily dosage is 15.25 g. The converted dosage is similar to that recorded in the 2020 edition of the Chinese Pharmacopoeia. The formula is in pill form, and medicine should be taken with lukewarm boiled water after the meal. Through the excavation of the ancient literature related to Yuejuwan, the key information of the formula is identified, with a view to providing a more accurate reference for the clinical application of Yuejuwan and subsequent in-depth investigation.
2.Re-examination of Atractylodis Rhizoma and Dosage of Whole Formula in Yuejiuwan
Yanping HAN ; Yiyi ZHANG ; Huimin GAO ; Raorao LI ; Li YAO ; Zhaoxiang SUN ; Zhuo MA ; Huamin ZHANG ; Wei ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):223-233
Yuejuwan is a classic formula widely used by doctors to relieve liver and depression, with precise clinical efficacy in traditional Chinese medicine (TCM). The authors used bibliometric methods to collect and collate 495 ancient data related to Yuejuwan, and 105 valid data were screened out, involving 68 ancient Chinese medical books. After systematic verification of the origin of the formula of Yuejuwan, the main treatment symptoms, the principle of the formula, the composition of the drug, the dosage, the preparation method, the decoction method, and other information, the results showed that Yuejuwan originated from the Danxi Xinfa (《丹溪心法》) of the Yuan Dynasty by ZHU Zhenheng, and it is composed of five medicines, namely Atractylodis Rhizoma, Cyperi Rhizom, Chuanxiong Rhizoma, Massa Medicata Fermentata, and Gardeniae Fructus. In terms of drug base, Atractylodis Rhizoma, Cyperi Rhizom, Chuanxiong Rhizoma, and Gardeniae Fructus are in line with the records in the 2020 edition of Chinese Pharmacopoeia, and Massa Medicata Fermentata is used. The preparation method is as follows: Massa Medicata Fermentata and Gardeniae Fructus are fried, and Cyperi Rhizoma is roasted in vinegar. Chuanxiong Rhizoma is used in the raw form, and Atractylodis Rhizoma is prepared with rice swill. The formula can regulate Qi and relieve depression and broaden the middle and remove fullness. It is clinically used for the treatment of six types of depression syndromes, chest and diaphragm plumpness, abdominal distension and leg acid, acid swallowing and vomiting, eating and drinking disharmony, toothache, mouth and tongue sores, and other diseases. The most used dosage of the formula in the ancient records through the ages is converted into the modern dosage, namely 3.05 g Atractylodis Rhizoma, 3.05 g Cyperi Rhizoma, 3.05 g Chuanxiong Rhizoma, 3.05 g Massa Medicata Fermentata, and 3.05 g Gardeniae Fructus, and the daily dosage is 15.25 g. The converted dosage is similar to that recorded in the 2020 edition of the Chinese Pharmacopoeia. The formula is in pill form, and medicine should be taken with lukewarm boiled water after the meal. Through the excavation of the ancient literature related to Yuejuwan, the key information of the formula is identified, with a view to providing a more accurate reference for the clinical application of Yuejuwan and subsequent in-depth investigation.
4.Analysis of phenotype formation mechanism of a new variety of Lonicera japonica Flos "Huajin 6" at long bud stage
Run-zhu LI ; Cong-lian LIANG ; Zhen-hua LIU ; Jia LI ; Yong-qing ZHANG ; Hai-yan LIU ; Gao-bin PU
Acta Pharmaceutica Sinica 2024;59(2):476-481
Based on the long bud stage phenotype of a new
5.Prediction of Bioequivalence of Lenvatinib Mesilate Capsules Based on Parallel Artificial Membrane Permeability Analysis
Hua ZHENG ; Guizhou HAO ; Pingping SHANG ; Jipeng HOU ; Qingxiao LIU ; Xingkai GENG ; Guimin ZHANG
Chinese Journal of Modern Applied Pharmacy 2024;41(13):1775-1780
OBJECTIVE
To predict the in vivo bioequivalence of lenvatinib mesilate capsules and reference preparation by using the parallel artificial membrane permeability analysis.
METHODS
Based on the biopharmaceutics classification system classification of lenvatinib mesilate and the parallel artificial membrane permeation model, the in vitro dissolution permeation rate test model of lenvatinib mesilate capsules was established, through real-time monitoring of the dissolution and penetration of lenvartinib mesylate capsules and reference preparations in fasting gastric juice, intestinal fluid and postprandial intestinal fluid, the flux and total penetration of drugs through the membrane were calculated.
RESULTS
In fasting state and fed state, the 90% confidence interval of geometric mean ratio of two key quality parameters (permeation flux and permeation amount) of the preparation A all were in the range of 80.00%−125.00%, the preparation B did not fall into this interval.
CONCLUSION
This research method can predict the bioequivalence of renvartinib mesylate capsule and reference preparation, and has a certain correlation in vivo and in vitro.
6.Application of quality monitoring indicators of blood testing in blood banks of Shandong province
Xuemei LI ; Weiwei ZHAI ; Zhongsi YANG ; Shuhong ZHAO ; Yuqing WU ; Qun LIU ; Zhe SONG ; Zhiquan RONG ; Shuli SUN ; Xiaojuan FAN ; Wei ZHANG ; Jinyu HAN ; Lin ZHU ; Xianwu AN ; Hui ZHANG ; Junxia REN ; Xuejing LI ; Chenxi YANG ; Bo ZHOU ; Haiyan HUANG ; Guangcai LIU ; Ping CHEN ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):258-266
【Objective】 To objectively evaluate the quality control level of blood testing process in blood banks through quantitative monitoring and trend analysis, and to promote the homogenization level and standardized management of blood testing laboratories in blood banks. 【Methods】 A quality monitoring indicator system covering the whole process of blood collection and supply, including blood donation service, blood component preparation, blood testing, blood supply and quality control was established. The questionnaire Quality Monitoring Indicators for Blood Collection and Supply Process with clear definition of indicators and calculation formulas was distributed to 17 blood banks in Shandong province. Quality monitoring indicators of each blood bank from January to December 2022 were collected, and 31 indicators in terms of blood testing were analyzed using SPSS25.0 software. 【Results】 The proportion of unqualified serological tests in 17 blood bank laboratories was 55.84% for ALT, 13.63% for HBsAg, 5.08% for anti HCV, 5.62% for anti HIV, 18.18% for anti TP, and 1.65% for other factors (mainly sample quality). The detection unqualified rate and median were (1.23±0.57)% and 1.11%, respectively. The ALT unqualified rate and median were (0.74±0.53)% and 0.60%, respectively. The detection unqualified rate was positively correlated with ALT unqualified rate (r=0.974, P<0.05). The unqualified rate of HBsAg, anti HCV, anti HIV and anti TP was (0.15±0.09)%, (0.05±0.04)%, (0.06±0.03)% and (0.20±0.05)% respectively. The average unqualified rate, average hemolysis rate, average insufficient volume rate and the abnormal hematocrit rate of samples in 17 blood bank laboratories was 0.21‰, 0.08‰, 0.01‰ and 0.02‰ respectively. There were differences in the retest concordance rates of four HBsAg, anti HCV and anti HIV reagents, and three anti TP reagents among 17 blood bank laboratories (P<0.05). The usage rate of ELISA reagents was (114.56±3.30)%, the outage rate of ELISA was (10.23±7.05) ‰, and the out of range rate of ELISA was (0.90±1.17) ‰. There was no correlation between the out of range rate, outrage rate and usage rate (all P>0.05), while the outrage rate was positively correlated with the usage rate (r=0.592, P<0.05). A total of 443 HBV DNA positive samples were detected in all blood banks, with an unqualified rate of 3.78/10 000; 15 HCV RNA positive samples were detected, with an unqualified rate of 0.13/10 000; 5 HIV RNA positive samples were detected, with an unqualified rate of 0.04/10 000. The unqualified rate of NAT was (0.72±0.04)‰, the single NAT reaction rate [(0.39±0.02)‰] was positively correlated with the single HBV DNA reaction rate [ (0.36±0.02) ‰] (r=0.886, P<0.05). There was a difference in the discriminated reactive rate by individual NAT among three blood bank laboratories (C, F, H) (P<0.05). The median resolution rate of 17 blood station laboratories by minipool test was 36.36%, the median rate of invalid batch of NAT was 0.67%, and the median rate of invalid result of NAT was 0.07‰. The consistency rate of ELISA dual reagent detection results was (99.63±0.24)%, and the median length of equipment failure was 14 days. The error rate of blood type testing in blood collection department was 0.14‰. 【Conclusion】 The quality monitoring indicator system for blood testing process in Shandong can monitor potential risks before, during and after the experiment, and has good applicability, feasibility, and effectiveness, and can facilitate the continuous improvement of laboratory quality control level. The application of blood testing quality monitoring indicators will promote the homogenization and standardization of blood quality management in Shandong, and lay the foundation for future comprehensive evaluations of blood banks.
7.Application of quality control indicator system in blood banks of Shandong
Qun LIU ; Yuqing WU ; Xuemei LI ; Zhongsi YANG ; Zhe SONG ; Zhiquan RONG ; Shuhong ZHAO ; Lin ZHU ; Xiaojuan FAN ; Shuli SUN ; Wei ZHANG ; Jinyu HAN ; Xuejing LI ; Bo ZHOU ; Chenxi YANG ; Haiyan HUANG ; Guangcai LIU ; Kai CHEN ; Xianwu AN ; Hui ZHANG ; Junxia REN ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):267-274
【Objective】 To establish an effective quality monitoring indicator system for blood quality control in blood banks, in order to analyze the quality control indicators for blood collection and supply, and evaluate blood quality control process, thus promoting continuous improvement and standardizing management of blood quality control in blood banks. 【Methods】 A quality monitoring indicator system covering the whole process of blood collection and supply, including blood donation services, component preparation, blood testing, blood supply and quality control was established. The Questionnaire of Quality Monitoring Indicators for Blood Collection and Supply Process was distributed to 17 blood banks in Shandong, which clarified the definition and calculation formula of indicators. The quality monitoring indicator data from January to December 2022 in each blood bank were collected, and 20 quality control indicators data were analyzed by SPSS25.0 software. 【Results】 The average pass rate of key equipment monitoring, environment monitoring, key material monitoring, and blood testing item monitoring of 17 blood banks were 99.47%, 99.51%, 99.95% and 98.99%, respectively. Significant difference was noticed in the pass rate of environment monitoring among blood banks of varied scales(P<0.05), and the Pearson correlation coefficient (r) between the total number of blood quality testing items and the total amount of blood component preparation was 0.645 (P<0.05). The average discarding rates of blood testing or non-blood testing were 1.14% and 3.36% respectively, showing significant difference among blood banks of varied scales (P<0.05). The average discarding rate of lipemic blood was 3.07%, which had a positive correlation with the discarding rate of non testing (r=0.981 3, P<0.05). There was a statistically significant difference in the discarding rate of lipemic blood between blood banks with lipemic blood control measures and those without (P<0.05). The average discarding rate of abnormal color, non-standard volume, blood bag damage, hemolysis, blood protein precipitation and blood clotting were 0.20%, 0.14%, 0.06%, 0.06%, 0.02% and 0.02% respectively, showing statistically significant differences among large, medium and small blood banks(P<0.05).The average discarding rates of expired blood, other factors, confidential unit exclusion and unqualified samples were 0.02%, 0.05%, 0.003% and 0.004%, respectively. The discarding rate of blood with air bubbles was 0.015%, while that of blood with foreign body and unqualified label were 0. 【Conclusion】 The quality control indicator system of blood banks in Shandong can monitor weak points in process management, with good applicability, feasibility, and effectiveness. It is conducive to evaluate different blood banks, continuously improve the quality control level of blood collection and supply, promote the homogenization and standardization of blood quality management, and lay the foundation for comprehensive evaluation of blood banks in Shandong.
8.Quality monitoring indicator system in blood banks of Shandong: applied in blood donation services, component preparation and blood supply process
Yuqing WU ; Hong ZHOU ; Zhijie ZHANG ; Zhiquan RONG ; Xuemei LI ; Zhe SONG ; Shuhong ZHAO ; Zhongsi YANG ; Qun LIU ; Lin ZHU ; Xiaojuan FAN ; Shuli SUN ; Wei ZHANG ; Jinyu HAN ; Haiyan HUANG ; Guangcai LIU ; Ping CHEN ; Xianwu AN ; Hui ZHANG ; Junxia REN ; Xuejing LI ; Chenxi YANG ; Bo ZHOU ; Hui YE ; Mingming QIAO ; Hua SHEN ; Dunzhu GONGJUE ; Yunlong ZHUANG
Chinese Journal of Blood Transfusion 2024;37(3):275-282
【Objective】 To establish an effective quality indicator monitoring system, scientifically and objectively evaluate the quality management level of blood banks, and achieve continuous improvement of quality management in blood bank. 【Methods】 A quality monitoring indicator system that covers the whole process of blood collection and supply was established, the questionnaire of Quality Monitoring Indicators for Blood Collection and Supply Process with clear definition of indicators and calculation formulas was distributed to 17 blood banks in Shandong. Statistical analysis of 21 quality monitoring indicators in terms of blood donation service (10 indicators), blood component preparation (7 indicators ), and blood supply (4 indicators) from each blood bank from January to December 2022 were conducted using SPSS25.0 software The differences in quality monitoring indicators of blood banks of different scales were analyzed. 【Results】 The average values of quality monitoring indicators for blood donation service process of 17 blood banks were as follows: 44.66% (2 233/5 000) of regular donors proportion, 0.22% (11/50) of adverse reactions incidence, 0.46% (23/5 000) of non-standard whole blood collection rate, 0.052% (13/25 000) of missed HBsAg screening rate, 99.42% (4 971/5 000) of first, puncture successful rate, 86.49% (173/200) of double platelet collection rate, 66.50% (133/200) of 400 mL whole blood collection rate, 99.25% (397/400) of donor satisfaction rate, 82.68% (2 067/2 500) of use rate of whole blood collection bags with bypass system with sample tube, and 1 case of occupational exposure in blood collection.There was a strong positive correlation between the proportion of regular blood donors and the collection rate of 400 mL whole blood (P<0.05). The platelet collection rate, incidence of adverse reactions to blood donation, and non-standard whole blood collection rate in large blood banks were significantly lower than those in medium and small blood banks (P<0.05). The average quality monitoring indicators for blood component preparation process of 17 blood banks were as follows: the leakage rate of blood component preparation bags was 0.03% (3/10 000), the discarding rate of lipemic blood was 3.05% (61/2 000), the discarding rate of hemolysis blood was 0.13%(13/10 000). 0.06 case had labeling errors, 8 bags had blood catheter leaks, 2.76 bags had blood puncture/connection leaks, and 0.59 cases had non-conforming consumables. The discarding rate of hemolysis blood of large blood banks was significantly lower than that of medium and small blood banks (P<0.05), and the discarding rate of lipemic blood of large and medium blood banks was significantly lower than that of small blood banks (P<0.05). The average values of quality monitoring indicators for blood supply process of 17 blood banks were as follows: the discarding rate of expired blood was 0.023% (23/100 000), the leakage rate during storage and distribution was of 0.009%(9/100 000), the discarding rate of returned blood was 0.106% (53/50 000), the service satisfaction of hospitals was 99.16% (2 479/2 500). The leakage rate of blood components during storage and distribution was statistically different with that of blood component preparation bags between different blood banks (P<0.05). There were statistically significant differences in the proportion of regular blood donors, incidence of adverse reactions, non-standard whole blood collection rate, 400 mL whole blood collection rate, double platelet collection rate, the blood bag leakage rate during preparation process, the blood components leakage rate during storage and distribution as well as the discarding rate of lipemic blood, hemolysis blood, expired blood and returned blood among large, medium and small blood banks (all P<0.05). 【Conclusion】 The establishment of a quality monitoring indicator system for blood donation services, blood component preparation and blood supply processes in Shandong has good applicability, feasibility and effectiveness. It can objectively evaluate the quality management level, facilitate the continuous improvement of the quality management system, promote the homogenization of blood management in the province and lay the foundation for future comprehensive evaluation of blood banks.
9.Comparison of clinical features and outcomes of proliferative, fibrotic, and mixed subtypes of IgG4-related disease: A retrospective cohort study
Linyi PENG ; Xinlu ZHANG ; Jiaxin ZHOU ; Jieqiong LI ; Zheng LIU ; Hui LU ; Yu PENG ; Yunyun FEI ; Yan ZHAO ; Xiaofeng ZENG ; Wen ZHANG
Chinese Medical Journal 2024;137(3):303-311
Background::Immunoglobulin G4-related disease (IgG4-RD) is a recently recognized immune-mediated disorder that can affect almost any organ in the human body. IgG4-RD can be categorized into proliferative and fibrotic subtypes based on patients’ clinicopathological characteristics. This study aimed to compare the clinical manifestations, laboratory findings, and treatment outcomes of IgG4-RD among different subtypes.Methods::We prospectively enrolled 622 patients with newly diagnosed IgG4-RD at Peking Union Medical College Hospital from March 2011 to August 2021. The patients were divided into three groups according to their clinicopathological characteristics: proliferative, fibrotic, and mixed subtypes. We compared demographic features, clinical manifestations, organ involvement, laboratory tests, and treatment agents across three subtypes. We then assessed the differences in treatment outcomes among 448 patients receiving glucocorticoids alone or in combination with immunosuppressants. Moreover, risk factors of relapse were revealed by applying the univariate and multivariate Cox regression analysis.Results::We classified the 622 patients into three groups consisting of 470 proliferative patients, 55 fibrotic patients, and 97 mixed patients, respectively. We found that gender distribution, age, disease duration, and frequency of allergy history were significantly different among subgroups. In terms of organ involvement, submandibular and lacrimal glands were frequently involved in the proliferative subtype, while retroperitoneum was the most commonly involved site in both fibrotic subtype and mixed subtype. The comparison of laboratory tests revealed that eosinophils ( P = 0.010), total IgE ( P = 0.006), high-sensitivity C-reactive protein ( P <0.001), erythrocyte sedimentation rate ( P <0.001), complement C4 ( P <0.001), IgG ( P = 0.001), IgG1 (P <0.001), IgG4 (P <0.001), and IgA ( P <0.001), at baseline were significantly different among three subtypes. Compared with proliferative and mixed subtypes, the fibrotic subtype showed the lowest rate of relapse (log-rank P = 0.014). Conclusions::Our study revealed the differences in demographic characteristics, clinical manifestations, organ involvement, laboratory tests, treatment agents, and outcomes across proliferative, fibrotic, and mixed subtypes in the retrospective cohort study. Given significant differences in relapse-free survival among the three subtypes, treatment regimens, and follow-up frequency should be considered separately according to different subtypes.Trial Registration::ClinicalTrials. gov, NCT01670695.


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