1.Reflections on supervision strategies of new Tibetan drug registration.
Dan LIANG ; Tsring PEMBA ; Jiang-Yong YU ; Jian-Yuan TANG ; Yue-Hua ZHOU ; Hua HUA ; Wei-Wu CHEN ; Yan-Ling AI ; Gang ZHOU ; Lei ZHANG ; Ting WANG ; Yong-Wen ZHANG ; Chong ZOU ; Wei-Xiong LIANG ; Jie-Lai XIA ; Nai-Qing ZHAO ; Xiao-Bo SUN ; Wei WEI ; Bao-He WANG ; Hong DING ; Guo-Chen WANG ; Tsring PUQIONG ; Phuntsok KELSNG ; Guo-Qiang WANG
China Journal of Chinese Materia Medica 2022;47(19):5383-5388
Tibetan medicine is an essential part of Chinese medicine and has unique theoretical experience and therapeutic advantages. According to the development principle of inheriting the essence, sticking to the truth, and keeping innovative, the supervision department should give clear and reasonable guidance considering the characteristics of Tibetan medicine, establish a standard system for quality control, clinical verification and evaluation, and accelerate the research and commercialization of new drugs. In view of the needs of drug supply-side reform and the current situation of Tibetan medicine and new pharmaceutical research, we ponder and provide suggestions on the confusion faced by the current supervision of Tibetan drug registration, hoping to contribute to the supervision strategy of Tibetan drug registration and the high-quality development of Tibetan medicine industry.
Tibet
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Medicine, Tibetan Traditional
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Quality Control
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Pharmaceutical Research
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Drug Industry
2.Intervention effects of hot spring bathing on blood pressure, resting heart rate, cardiovascular function indicators and physical signs in population with high-normal blood pressure
Da-peng WANG ; Ai-hua ZHANG ; Jun LI ; Qi-bing ZENG ; Lu MA ; Xiong CHEN ; Zhong-lan ZOU ; Qi WANG ; Qing-ling WANG
Shanghai Journal of Preventive Medicine 2021;33(S1):21-
Objective To investigate the effects of hot spring baths on blood pressure, resting heart rate, cardiovascular function related indicators and physical signs in population with high-normal blood pressure. Methods Residents of typical hot spring areas in Guizhou Province were included as the subjects. According to the epidemiological survey of the research group and the physical examination results before the intervention, combined with the inclusion and exclusion criteria, a total of 217 people with high normal blood pressure were selected as the observation subjects. The intervention of hot spring baths was carried out for four weeks, once time per day, 5 times per week, for 40-50 minutes each time. After the intervention, the blood pressure, resting heart rate and serum levels of creatine kinase(CK), lactate dehydrogenase(LDH), and
3.Consistency of peripheral whole blood and venous serum procalcitonin in children: a multicenter parallel controlled study
Quan LU ; Hong ZHANG ; Xiaoyan DONG ; Hanmin LIU ; Yongmei JIANG ; Yingxue ZOU ; Yongming SHEN ; Deyu ZHAO ; Hongbing CHEN ; Tao AI ; Chenggui LIU ; Zhaobo SHEN ; Junmei YANG ; Yuejie ZHENG ; Yunsheng CHEN ; Weigang CHEN ; Yefei ZHU ; Chonglin ZHANG ; Lijun TIAN ; Guorong WU ; Ling LI ; Aibin ZHENG ; Meng GU ; Yongyue WEI ; Liangmin WEI
Chinese Journal of Pediatrics 2021;59(6):471-477
Objective:To explore the consistency of peripheral whole blood and venous serum procalcitonin (PCT) levels, and the value of peripheral whole blood PCT in evaluating pediatric bacterial infection.Methods:This multicenter cross-sectional parallel control study was conducted in 11 children′s hospital. All the 1 898 patients older than 28 days admitted to these hospitals from March 2018 to February 2019 had their peripheral whole blood and venous serum PCT detected simultaneously with unified equipment, reagent and method. According to the venous serum PCT level, the patients were stratified to subgroups. Analysis of variance and chi-square test were used to compare the demographic characteristics among groups. And the correlation between the peripheral blood and venous serum PCT level was investigated by quantitative Pearson correlation analysis.The PCT resultes were also converted into ranked data to further test the consistency between the two sampling methods by Spearman′s rank correlation test. Furthermore, the ranked data were converted into binary data to evaluate the consistency and investigate the best cut-off of peripheral blood PCT level in predicting bacterial infection.Results:A total of 1 898 valid samples were included (1 098 males, 800 females),age 27.4(12.2,56.7) months. There was a good correlation between PCT values of peripheral whole blood and venous serum ( r=0.97 , P<0.01). The linear regression equation was PCT?venous serum=0.135+0.929×PCT peripheral whole blood. However, when stratified to 5 levels, PCT results showed diverse and unsatisfied consistency between the two sampling methods ( r=0.51-0.92, all P<0.01). But after PCT was converted to ordinal categorical variables, the stratified analysis showed that the coincidence rate of the measured values by the two sampling methods in each boundary area was 84.9%-97.1%. The dichotomous variables also showed a good consistency (coincidence rate 96.8%-99.3%, Youden index 0.82-0.89). According to the severity of disease, the serum PCT value was classified into 4 intervals(<0.5、0.5-<2.0、2.0-<10.0、≥10.0 μg/L), and the peripheral blood PCT value also showed a good predictive value (AUC value was 0.991 2-0.997 9). The optimal cut points of peripheral whole blood PCT value 0.5、1.0、2.0、10.0 μg/L corresponding to venous serum PCT values were 0.395, 0.595, 1.175 and 3.545 μg/L, respectively. Conclusions:There is a good correlation between peripheral whole blood PCT value and the venous serum PCT value, which means that the peripheral whole blood PCT could facilitate the identification of infection and clinical severity. Besides, the sampling of peripheral whole blood is simple and easy to repeat.
4.Environmental Monitoring of A Laboratory for New Coronavirus Nucleic Acid Testing.
Pei Yong NING ; Ai Ping YU ; Yuan WANG ; Li Ru GUO ; Dan SHAN ; Mei KONG ; Ling Qi YU ; Li Kun LYU ; Ming ZOU ; Xu SU ; Chun Nan FEI ; Yu Hui ZHOU ; Bai Qi WANG
Biomedical and Environmental Sciences 2020;33(10):771-774
5.Expression Profile of CircularRNA in Tongue Squamous Cell Carcinoma
Ai-Ling ZOU ; Jian-Jiang ZHAO ; Xiang SUN ; Bo JIA ; Jiu-Song HAN ; Xiao-Ling QIU ; Hong-Xing CHU
Journal of Sun Yat-sen University(Medical Sciences) 2018;39(2):186-191,219
[Objective]To analyze the expression profile variation of circle RNA(circRNA)in tongue squamous cell carcinoma(TSCC)tissue and para-carcinoma tissue.[Methods]CircRNA microarray technology was performed to in-spect the difference of circRNA expression in 4 cases of TSCC tissues and 4 cases of para-carcinoma tissues,and then make analysis after the quality control and homogenization of raw data,to identify which have more than 2 times variation and significant difference(P<0.05)by statistical analysis as circRNA with differential expression. To perform functional analysis on circRNA with differential expression.[Results]Compared with para-carcinoma tissue,there were 17171 circRNA differentially expressed in TSCC tissue,while 9982 increase more than 2 times and 7189 reduce more than 2 times.[Conclusion]circRNA expression profile in TSCC changes significantly comparing with the para-carcinoma tis-sue,some differentially expressed circRNA may regulate the occurrence and progression of TSCC through a competitive combination of miRNA.
6.Quality standard for Weigela japonica var.sinica
zhi Jun WANG ; ling Bao GOU ; qi Hong ZHANG ; li Hai YU ; ling Ai WANG ; fang Hui L(U) ; Kun ZOU
Chinese Traditional Patent Medicine 2017;39(12):2529-2533
AIM To establish the quality standard for Weigela japonica Thunb.var.sinica (Rehd.) Bailey (W.j.).METHODS TLC was adopted in this medicinal material's qualitative identification after morphological identification and microscopic identification.The contents of water,total ash,acid-insoluble ash and extracts were detected according to Chinese Pharmacopoeia methods.Then the contents of scopoletin and total coumarins were determined by HPLC and UV,respectively.RESULTS The morphologies and microscopic characters of W.j.could be distinguished from other same generic plants.The clear TLC spot displayed good resolution.The contents of water,total ash,acid-insoluble ash,water-soluble extract and acid-soluble extract were no more than 12.0%,no more than 2.0%,no more than 0.5%,no less than 5.0% and no less than 4.5%,respectively.Scopoletin and total coumarins showed good linear relationships within the ranges of 1.25-40.0 μg/mL(r =0.999 7)and 2.0-64.0 μg/mL (r =0.999 9),whose average recoveries were 98.19% (RSD =0.90%) and 99.21% (RSD =2.5%),respectively.CONCLUSION This accurate and reliable method can be used for the quality control of W.j..
7.Chinmedomics strategy to discover effective constituents and elucidate action mechanism of Nanshi capsule against kidney-yang deficiency syndrome.
Qi LIU ; Hong-Wei ZHAO ; Ai-Hua ZHANG ; Hui SUN ; Xiao-Hang ZHAO ; Yang NAN ; Ling KONG ; Yu GUAN ; Shi-Yu ZOU ; Zhong-Hua MA ; Xi-Jun WANG
China Journal of Chinese Materia Medica 2016;41(15):2901-2914
The chinmedomics method was used to explore the effect of Nanshi capsule on endogenous metabolites of rats with kidney-yang deficiency syndrome, investigate the metabolites and metabolic pathways closely related to kidney-yang deficiency syndrome (KYDS)and identify the therapeutic basis of Nanshi capsule(NPC)as well as its action mechanism for KYDS. The routine biochemical indexes of serum were detected and histomorphology was observed. Based on the chinmedomics technology platform, discriminatory analysis in multivariate modes was conducted for rat blood and urine, thus to investigate the biomarkers of KYDS and the therapeutic effect of NPC against KYDS. Meanwhile, the main constituents of NPC in rat serum were also detected to analyze its correlation between the constituents in vivo and the biomarkers of KYDS, and determine the potential effective compounds for therapeutic effect. Eleven biomarkers of KYDS were identified in the rat models, involving steroid hormone biosynthesis, tryptophan metabolism and tyrosine metabolism. It was found that NPC could regulate steroid hormone biosynthesis, tryptophan metabolism and tyrosine metabolism; PCMS analysis showed that caffeic acid, 2-hydroxy-1-methoxy-anthraquinone, 1-hydroxy-2-methoxyanthraquinone, ferulic acid glucuronide conjugation, deacetylasperulosidic acid, cynaroside, betaine and umbelliferone were the main effective compounds of NPC for KYDS. In this study, cynaroside, betaine, umbelliferone and other compounds in NPC could integrally regulate the disturbance of metabolic profile in KYDS by improving the hormone synthesis, hormone synthesis pathway, hormone synthesis and release pathway in tyrosine metabolism and linoleic acid synthesis pathway in linoleic acid metabolism. These results indicated that the NPC had the characteristics of multi-pathway, multi-target and overall regulation in the treatment of KYDS. Chinmedomics approach can provide methodology support to discover innovative drug from traditional Chinese medicine.
8.Determination content of Paeoniflorin in Fufang Jinsha Lidan Keli by HPLC
Ai-Ling YI ; Fu-Sheng ZOU ; Guang DU ; Cong-Hui ZHOU ; Ying-Ying WEI ; Wei CHEN
The Chinese Journal of Clinical Pharmacology 2016;32(5):452-454
Objective To establish the determination method for the content of paeoniflorin in Fufang Jinsha Lidan Keli and the standard for the quality control of Fufang Jinsha Lidan Keli.Methods The analysis was performed on a Welch Utimate XB-C18 (4.6 mm ×250 mm, 5μm) column .The mobile phase was acetonitrile and water (17∶83) at a flow rate of 1.0 mL· min -1 .The column temperature was room temperature and the detection wavelength was 230 nm.The injection volume was 20μL.Scutellaria baicalensis Georgi , Cynanchum otophyllum and Fructus aurantii were identified qualititatively by Thin—Layer Chromatography ( TLC).Paeoniflorin in Fufang Jinsha Lidan Keli were determined by HPLC.Results The TLC spots were highly clear without the interference of negative control.The calibration curve for Paeoniflorin was linear ( r=0.9995 ) in the range of 3.92~98.00 μg· mL-1.And the mean recovery was 98.11%.RSD was 1.10%(n=6).Conclusion This method is ac-curate,simple,sensitive and reliable and it can be used for the quality con-trol of Fufang Jinsha Lidan Keli.
9.Experimental study on pharmacodynamics and acute toxicity of compound Jinshalidan Granules
Ai-Ling YI ; Fu-Sheng ZOU ; Ying-Ying WEI ; Wei CHEN ; Guang DU
The Chinese Journal of Clinical Pharmacology 2015;(7):560-562,572
Objective To investigate the cholagogic and anti -infla-mmatory effects and acute toxicity of Jinshalidan Granules.Methods The cholagogic effect of Jinshalidan Granules was observed and deter-mined by common bile duct drainage in mouse .The acute inflammatory models was established by xylene -induced ear edema to research the inflammatory effects of Jinshalidan Granules.The acute toxicity and the maximum tolerated dose in mice were also studied.Results Compared with the normal control group , the bile secretion for the mouse and the degree of swelling of mice ear induced by xylene were significantly improvemed in all the 3 different dosages of Jinshalidan Granules.After 14 days, continuous observation ,no mouse was found dead and no signifi-cant toxicity occurred by naked eyes.The maximum tolerated dose of Compound Jinshalidan Granules is 244.8 g · kg -1 ( crude drug ).Conclusion Compound Jinshalidan Granules have obviously effects on the increased the bile secretion and anti -inflammatory ,it is has very low acute toxicity in mice and preliminary proven to be safe .
10.Evaluation and nursing of continuous blood purification therapy on acute respiratory distress syndrome in children
Huan ZOU ; Ai-Qiu LI ; Xiao-Ying GU ; Jia-Ling CHEN ; Yu-Cai ZHANG
Chinese Journal of Applied Clinical Pediatrics 2013;28(12):927-930
Objective To investigate the efficacy of continuous blood purification (CBP) in treatment of acute respiratory syndrome (ARDS) in children,and the methods as well as the key points in nursing care.Methods There were 97 cases of ARDS,and 18 cases were treated with CBP.The model for CBP was continuous veno-venous hemofiltration dialysis (CVVHDF) or high volume hemofiltration (HVHF).The observational index included arterial partial pressure of oxygen [pa(O2)],arterial partial pressure of carbon dioxide [Pa(CO2)],mechanical ventilation parameters,complications and side reaction during CBP.Results The pediatric critical illness score in CBP treatment group and non-CBP treatment group were (62.5 ± 25.2) and (78.1 ± 16.3) respectively,and the difference between the 2 groups was significant (P < 0.05) ; the median of pediatric risk of score mortality Ⅲ score in CBP treatment group and non-CBP treatment group were 16(10-20) and 12(7-14),and the difference was significant between the 2 groups (all P <0.05).The average duration of CBP in 18 cases was 58 hours(12-232 hours),death occurred in 5 cases,and 2 cases of them were due to giving up treatment,the mortality was 27.8% ;while in non-CBP treatment group,21 cases occurred death and the mortality was 26.6%.The difference of mortality between the 2 groups was not significant (P > 0.05).Pa (O2)/fraction of inspired oxygen (FiO2) and dynamic compliance (Cdyn) were improved after 2-6 hours CBP,and the pulmonary exudation alleviated after 2 hours treatment.Mechanical ventilation parameters including FiO2,peak inspiratory pressure and positive end expiratory pressure were reduced.The complications related with CBP treatment included aggravating anemia,thrombopenia,lower body temperature,hemorrhage,oliguria,thick sputum,pain and dysphoria.No serious lethal complication was observed.Conclusions CBP treatment is a safe and effective rescue method for ARDS in children,it can reduce pulmonary edema,improve pa (O2)/FiO2 and Cdyn,and improve mechanical ventilation parameters.During CBP therapy,the key points include monitoring vital sign and the changes of hemodynamic,keeping body position nursing care well,tranquilizing,as well as maintaining the pipe unobstructed.

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