1.Quality Evaluation and Analysis of Key Problems in Rukuaixiao Preparations
Rong CHEN ; Chao ZHANG ; Shuisheng ZHONG ; Wei CHEN ; Enyun TU ; Yaqiong WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):146-155
ObjectiveBased on multi-index and multi-method detection, the quality of Rukuaixiao preparations was systematically evaluated from the perspective of characteristic components, and the existing problems were analyzed. MethodsLiquid chromatography-mass spectrometry(LC-MS) for the determination of 16 characteristic components was established to evaluate the quality of 129 batches of Rukuaixiao preparations. High performance liquid chromatography(HPLC) was established to determine the contents of salvianolic acids and tanshinones, investigate the rationality of quality control index of Salviae Miltiorrhizae Radix et Rhizoma in the standard for Rukuaixiao preparations in the 2020 edition of Pharmacopoeia of the People's Republic of China(hereinafter referred to as Chinese Pharmacopoeia) (volume Ⅰ), and trace the causes of significant difference among different batches. The processing and different extraction methods of Vaccariae Semen were tested, analyzing the impact of formulation changes across different editions of Chinese Pharmacopoeia. The LC-MS was established for determining the changes in the ratio of toosendanin and isotoosendanin after water extraction of Toosendan Fructus. The contents of active components in different parts of Gleditsiae Spina were determined to identify the reason of the low contents of characteristic components in some enterprises. ResultsBased on the comprehensive analysis of the samples from different dosage forms, the contents of characteristic components of Vaccariae Semen and Gleditsiae Spina in tablets from manufacturer B and granules from manufacturer D were significantly higher than those in tablets from manufacturer A, and tablets and capsules from manufacturer C. The contents of tanshinones in some batches of products from manufacturer A were abnormally high, potentially linked to the use of 70% ethanol reflux during extraction of Salviae Miltiorrhizae Radix et Rhizoma. All samples from manufacturer C exhibited abnormally high proportions of salvianic acid A and 3,4-dihydroxybenzaldehyde(salvianolic acid degradation products) to the total seven phenolic acids, indicating a risk of blindly pursuing tanshinol content and neglecting more effective components. The extraction rate of the characteristic components from Vaccariae Semen by decocting with water was obviously higher than that by reflux extraction with 70% ethanol. However, using the stir-fried Vaccariae Semen could reduce the loss of ingredients. The content ratio of toosendanin and isotoosendanin decreased from the crude herb to the prepared medicine when Toosendan Fructus was prepared by water decoction. The reason for the low component content of Gleditsiae Spina may be attributed to manufacturers using excessive non-medicinal parts in their formulations. ConclusionIt is suggested that enterprises should ensure the quality of raw material inputs, especially those without quality-control items in the standard, reduce the use of non-medicinal parts, and prohibit arbitrary alterations to manufacturing methods or processes. It is also recommended that Vaccariae Semen in Rukuaixiao capsules and granules should be changed to the stir-fried processed products. Isotoosendanin should be taken into consideration in the drug supervision when Toosendan Fructus is prepared into medicine by water decoction. Salvianolic acid B should be set as a quality control index for Salviae Miltiorrhizae Radix et Rhizoma when revising the pharmacopoeia standard of Rukuaixiao preparations.
2.Quality Evaluation and Analysis of Key Problems in Rukuaixiao Preparations
Rong CHEN ; Chao ZHANG ; Shuisheng ZHONG ; Wei CHEN ; Enyun TU ; Yaqiong WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):146-155
ObjectiveBased on multi-index and multi-method detection, the quality of Rukuaixiao preparations was systematically evaluated from the perspective of characteristic components, and the existing problems were analyzed. MethodsLiquid chromatography-mass spectrometry(LC-MS) for the determination of 16 characteristic components was established to evaluate the quality of 129 batches of Rukuaixiao preparations. High performance liquid chromatography(HPLC) was established to determine the contents of salvianolic acids and tanshinones, investigate the rationality of quality control index of Salviae Miltiorrhizae Radix et Rhizoma in the standard for Rukuaixiao preparations in the 2020 edition of Pharmacopoeia of the People's Republic of China(hereinafter referred to as Chinese Pharmacopoeia) (volume Ⅰ), and trace the causes of significant difference among different batches. The processing and different extraction methods of Vaccariae Semen were tested, analyzing the impact of formulation changes across different editions of Chinese Pharmacopoeia. The LC-MS was established for determining the changes in the ratio of toosendanin and isotoosendanin after water extraction of Toosendan Fructus. The contents of active components in different parts of Gleditsiae Spina were determined to identify the reason of the low contents of characteristic components in some enterprises. ResultsBased on the comprehensive analysis of the samples from different dosage forms, the contents of characteristic components of Vaccariae Semen and Gleditsiae Spina in tablets from manufacturer B and granules from manufacturer D were significantly higher than those in tablets from manufacturer A, and tablets and capsules from manufacturer C. The contents of tanshinones in some batches of products from manufacturer A were abnormally high, potentially linked to the use of 70% ethanol reflux during extraction of Salviae Miltiorrhizae Radix et Rhizoma. All samples from manufacturer C exhibited abnormally high proportions of salvianic acid A and 3,4-dihydroxybenzaldehyde(salvianolic acid degradation products) to the total seven phenolic acids, indicating a risk of blindly pursuing tanshinol content and neglecting more effective components. The extraction rate of the characteristic components from Vaccariae Semen by decocting with water was obviously higher than that by reflux extraction with 70% ethanol. However, using the stir-fried Vaccariae Semen could reduce the loss of ingredients. The content ratio of toosendanin and isotoosendanin decreased from the crude herb to the prepared medicine when Toosendan Fructus was prepared by water decoction. The reason for the low component content of Gleditsiae Spina may be attributed to manufacturers using excessive non-medicinal parts in their formulations. ConclusionIt is suggested that enterprises should ensure the quality of raw material inputs, especially those without quality-control items in the standard, reduce the use of non-medicinal parts, and prohibit arbitrary alterations to manufacturing methods or processes. It is also recommended that Vaccariae Semen in Rukuaixiao capsules and granules should be changed to the stir-fried processed products. Isotoosendanin should be taken into consideration in the drug supervision when Toosendan Fructus is prepared into medicine by water decoction. Salvianolic acid B should be set as a quality control index for Salviae Miltiorrhizae Radix et Rhizoma when revising the pharmacopoeia standard of Rukuaixiao preparations.
3.Development status among infants at ages of 0 to 36 months in Xiaoshan District
LI Qing ; ZHONG Bihua ; SUN Jiarui ; DAI Fengpo ; DING Yina ; MIAO Xiangqing ; FU Yaxian ; TU Yuyan ; TAN Wenjuan ; YU Yinfei
Journal of Preventive Medicine 2024;36(3):255-259
Objective:
To learn the status and influencing factors of development among infants at ages of 0 to 36 months in Xiaoshan District, Hangzhou City, so as to provide the reference for promoting healthy development of infants.
Methods:
Infants at ages of 0-36 months who underwent physical examination in Child Health Clinic of Xiaoshan District Community Health Service Center were selected in 2022. General data of infants and their mothers were collected through questionnaires, and the development status of infants was screened by Age and Stages Questionnaire (third edition). Factors affecting the development status were identified using a multivariable logistic regression model.
Results:
A total of 2 519 infants were investigated, including 1 339 males (53.16%) and 1 180 females (46.84%). There were 608 infants with abnormal development of at least one functional area of communication (CM), gross motor (GM), fine motor (FM), problems solving (CG) and personal-social (PS). The abnormal rate was 24.14%, and the abnormal rates of the above functional areas were 9.77%, 6.59%, 7.98%, 6.39% and 9.33%, respectively. Multivariable logistic regression analysis showed that gender (male, OR=1.563, 95%CI: 1.191-2.052), mother's childbearing age (≥35 years, OR=1.411, 95%CI: 1.001-1.988), mother's educational level (lower than junior college, OR=1.460, 95%CI: 1.116-1.912) were factors affecting abnormal development of CM; preterm birth (OR=2.323, 95%CI: 1.315-4.103) was factors affecting abnormal development of GM; gender (male, OR=1.654, 95%CI: 1.225-2.232) was factors affecting abnormal development of FM; gender (male, OR=1.511, 95%CI: 1.086-2.102) and mode of delivery (cesarean section, OR=1.460, 95%CI: 1.060-2.010) were factors affecting abnormal development of CG; gender (male, OR=1.340, 95%CI: 1.019-1.763) and birth weight (low birth weight, OR=1.985, 95%CI: 1.149-3.432) were factors affecting abnormal development of PS.
Conclusions
The rate of abnormal development among infants at ages of 0 to 36 months in Xiaoshan District is 24.14%. Gender, preterm birth, mode of delivery, birth weight, mother's childbearing age and mother's educational level could affect the development status of infants.
4.Machine-learning-based models assist the prediction of pulmonary embolism in autoimmune diseases: A retrospective, multicenter study
Ziwei HU ; Yangyang HU ; Shuoqi ZHANG ; Li DONG ; Xiaoqi CHEN ; Huiqin YANG ; Linchong SU ; Xiaoqiang HOU ; Xia HUANG ; Xiaolan SHEN ; Cong YE ; Wei TU ; Yu CHEN ; Yuxue CHEN ; Shaozhe CAI ; Jixin ZHONG ; Lingli DONG
Chinese Medical Journal 2024;137(15):1811-1822
Background::Pulmonary embolism (PE) is a severe and acute cardiovascular syndrome with high mortality among patients with autoimmune inflammatory rheumatic diseases (AIIRDs). Accurate prediction and timely intervention play a pivotal role in enhancing survival rates. However, there is a notable scarcity of practical early prediction and risk assessment systems of PE in patients with AIIRD.Methods::In the training cohort, 60 AIIRD with PE cases and 180 age-, gender-, and disease-matched AIIRD non-PE cases were identified from 7254 AIIRD cases in Tongji Hospital from 2014 to 2022. Univariable logistic regression (LR) and least absolute shrinkage and selection operator (LASSO) were used to select the clinical features for further training with machine learning (ML) methods, including random forest (RF), support vector machines (SVM), neural network (NN), logistic regression (LR), gradient boosted decision tree (GBDT), classification and regression trees (CART), and C5.0 models. The performances of these models were subsequently validated using a multicenter validation cohort.Results::In the training cohort, 24 and 13 clinical features were selected by univariable LR and LASSO strategies, respectively. The five ML models (RF, SVM, NN, LR, and GBDT) showed promising performances, with an area under the receiver operating characteristic (ROC) curve (AUC) of 0.962-1.000 in the training cohort and 0.969-0.999 in the validation cohort. CART and C5.0 models achieved AUCs of 0.850 and 0.932, respectively, in the training cohort. Using D-dimer as a pre-screening index, the refined C5.0 model achieved an AUC exceeding 0.948 in the training cohort and an AUC above 0.925 in the validation cohort. These results markedly outperformed the use of D-dimer levels alone.Conclusion::ML-based models are proven to be precise for predicting the onset of PE in patients with AIIRD exhibiting clinical suspicion of PE.Trial Registration::Chictr.org.cn: ChiCTR2200059599.
5.Application of nasal endoscopic Draf Ⅱ-Ⅲ frontal sinus surgery in recurrent frontal sinus infection and sinus formation after craniocerebral trauma
Cao LYU ; Xiaobin HUANG ; Jie CHEN ; Zhong LAN ; Yi TU ; Xiaohong YANG ; Zhong BAI
Chinese Archives of Otolaryngology-Head and Neck Surgery 2024;31(4):248-250
OBJECTIVE To investigate the application of endoscopic Draf Ⅱ-Ⅲ frontal sinus surgery in the treatment of recurrent frontal sinus infection and fistula formation after craniocerebral trauma.METHODS There were 8 cases of recurrent frontal sinus infection after craniocerebral trauma,the main manifestations were headache,recurrent frontal infection,discharge of pus,fistula formation.The average onset time was 43.25 months.The patients underwent DRAF Ⅱ-Ⅲ frontal sinus surgery under nasal endoscopy,including Draf Ⅱa 2,Draf Ⅱb 5,and Draf Ⅲ1,respectively.During the operation,the frontal sinus ostium was expanded.It was found that bone wax blocked the frontal sinus ostium in the frontal sinus.The bone wax was removed,and the frontal sinus drainage was smooth.No facial incision was made in all patients.RESULTS There were 8 patients with frontal infection who were cured after surgery.No cerebrospinal fluid rhinorrhea or intracranial infection occurred during or after operation.After discharge,the outpatient follow-up review was conducted in 1,3,6,and 12 months.It was found that the frontal sinus remained unobstructed.The frontal sinus did not become infected again,and the fistula gradually healed.CONCLUSION Draf Ⅱ-Ⅲ frontal sinus surgery under nasal endoscopy is an effective way to treat recurrent frontal sinus infection and fistula formation after craniocerebral trauma.
6.A multicenter study of neonatal stroke in Shenzhen,China
Li-Xiu SHI ; Jin-Xing FENG ; Yan-Fang WEI ; Xin-Ru LU ; Yu-Xi ZHANG ; Lin-Ying YANG ; Sheng-Nan HE ; Pei-Juan CHEN ; Jing HAN ; Cheng CHEN ; Hui-Ying TU ; Zhang-Bin YU ; Jin-Jie HUANG ; Shu-Juan ZENG ; Wan-Ling CHEN ; Ying LIU ; Yan-Ping GUO ; Jiao-Yu MAO ; Xiao-Dong LI ; Qian-Shen ZHANG ; Zhi-Li XIE ; Mei-Ying HUANG ; Kun-Shan YAN ; Er-Ya YING ; Jun CHEN ; Yan-Rong WANG ; Ya-Ping LIU ; Bo SONG ; Hua-Yan LIU ; Xiao-Dong XIAO ; Hong TANG ; Yu-Na WANG ; Yin-Sha CAI ; Qi LONG ; Han-Qiang XU ; Hui-Zhan WANG ; Qian SUN ; Fang HAN ; Rui-Biao ZHANG ; Chuan-Zhong YANG ; Lei DOU ; Hui-Ju SHI ; Rui WANG ; Ping JIANG ; Shenzhen Neonatal Data Network
Chinese Journal of Contemporary Pediatrics 2024;26(5):450-455
Objective To investigate the incidence rate,clinical characteristics,and prognosis of neonatal stroke in Shenzhen,China.Methods Led by Shenzhen Children's Hospital,the Shenzhen Neonatal Data Collaboration Network organized 21 institutions to collect 36 cases of neonatal stroke from January 2020 to December 2022.The incidence,clinical characteristics,treatment,and prognosis of neonatal stroke in Shenzhen were analyzed.Results The incidence rate of neonatal stroke in 21 hospitals from 2020 to 2022 was 1/15 137,1/6 060,and 1/7 704,respectively.Ischemic stroke accounted for 75%(27/36);boys accounted for 64%(23/36).Among the 36 neonates,31(86%)had disease onset within 3 days after birth,and 19(53%)had convulsion as the initial presentation.Cerebral MRI showed that 22 neonates(61%)had left cerebral infarction and 13(36%)had basal ganglia infarction.Magnetic resonance angiography was performed for 12 neonates,among whom 9(75%)had involvement of the middle cerebral artery.Electroencephalography was performed for 29 neonates,with sharp waves in 21 neonates(72%)and seizures in 10 neonates(34%).Symptomatic/supportive treatment varied across different hospitals.Neonatal Behavioral Neurological Assessment was performed for 12 neonates(33%,12/36),with a mean score of(32±4)points.The prognosis of 27 neonates was followed up to around 12 months of age,with 44%(12/27)of the neonates having a good prognosis.Conclusions Ischemic stroke is the main type of neonatal stroke,often with convulsions as the initial presentation,involvement of the middle cerebral artery,sharp waves on electroencephalography,and a relatively low neurodevelopment score.Symptomatic/supportive treatment is the main treatment method,and some neonates tend to have a poor prognosis.
7.Establishment of UPLC-DAD fingerprint of raw and vinegar Bupleurum bupleurum and study on spectral effect relationship of anti-hepatic fibrosis
Ni-Ping CHEN ; Yan WANG ; Yan DONG ; Yang-Xin XIAO ; Ji-Yuan TU ; Yan-Ju LIU ; Zhong-Shi ZHOU
Chinese Pharmacological Bulletin 2024;40(6):1145-1152
Aim To establish the fingerprint of raw bupleurum and vinegar bupleurum,investigate the difference in their anti-liver fibrosis effects,and ex-plore the relationship between the chemical composition of raw bupleurum and vinegar bupleurum and their an-ti-liver fibrosis efficacy.Methods The fingerprints of 10 batches of raw bupleuri and 10 batches of bupleuri were established by UPLC method.The liver fibrosis cell model in vitro was established by TGF-β induced LX-2 hepatic stellate cells.The liver fibrosis cell mod-el was analyzed with collagen type Ⅰ(col1a1)and α-smoothmuscleactin.The expression of α-SMA protein was used as the pharmacodynamic index.MetaboAna-lyst5.0 was used to screen the difference markers af-fecting the quality of raw bupledges and vinegar bu-pledges with VIP value>1 as the criterion.Orthogo-nal partial least squares discriminant analysis(OPLS-DA)was used to screen the main components of raw bupleurum and vinegar bupleurum against liver fibro-sis.Results There were 18 peaks in the UPLC fin-gerprints of raw bupleurum and vinegar bupleurum,and the analysis results showed that there were nine main differences between raw bupleurum and vinegar bupleurum,among which peaks 9,7 and 6 could be considered as bupleurin d,bupleurin a and bupleurin f.The results of spectral effect relationship showed that the main components of bupleurum anti-liver fibrosis were peaks 11,12,14,15 and 18.Conclusions The established fingerprint method of raw bupleurum and vinegar bupleurum is simple and feasible,and the important components of anti-liver fibrosis activity are screened through the spectrum effect relationship,which provides a basis for clarifying the material basis of anti-liver fibrosis effect of raw bupleurum and vine-gar bupleurum.
8.Clinical application of four-hook needle combined with holographic image in robot-assisted partial nephrectomy for completely intrarenal tumors
Qiubo XIE ; Yu ZHOU ; Lei GAO ; Zhong TU ; Jian SONG ; Renhao WANG ; Xiang LI ; Guan ZHANG ; Le ZHANG ; Tiejun PAN
Chinese Journal of Urology 2024;45(5):343-347
Objective:To investigate the safety and efficacy of four-hook needle combined with holographic image in robot-assisted partial nephrectomy for completely intrarenal tumors.Methods:The clinical data of 8 patients with completely intrarenal tumors treated by robot-assisted partial nephrectomy with four-hook needle combined with holographic image admitted to General Hospital of Central Theater Command from October 2023 to December 2023 were retrospectively analyzed. There were 6 males and 2 females, with average age of (44.5±12.0) years old. Tumors of 6 cases were in the left side and 2 cases in the right side. The maximum diameter of the tumor was (23.2±8.1) mm. The R. E.N.A.L. score was (9.0±1.4). The preoperative serum creatinine (Scr) was (73.1±14.7) μmol/L. CT-guided four-hook needle was used to locate the edge of completely intrarenal tumor before surgery. During the operation, the tumor was precisely resected under the guidance of hologram and four-hook needle. Perioperative data of patients were collected and analyzed.Results:All the tumor were successfully resected under the guidance of four-hook needle and hologram without conversion to radical nephrectomy or open surgery. The mean operative time was (117.0±14.5) min, the mean hot ischemia time was (20.2±5.1) min, the mean intraoperative blood loss was (75.0±17.3) ml, and the average hospitalization time was (9.5±1.3) days.The one week postoperative Scr was (73.2±14.8) μmol/L, which had no significant difference with that of before operation ( P=0.952). None of them received blood transfusion. The pathology results of 8 patients were clear cell renal cell carcinoma, and the surgical margins were negative. Conclusions:For completely intrarenal tumors, the four-hook needle combined with the hologram can guide the surgeon to quickly locate the tumor, accurately resect the tumor, reduce perioperative complications, and is safe and effective.
9.Spatial correlation between the prevalence of dental fluorosis and the chemical elemental composition of drinking water sources in a typical coal-fired pollution fluorosis area.
Jian Ying WANG ; Jian Zhong CHENG ; Na YANG ; Jiang Hui ZHANG ; Cheng Long TU
Chinese Journal of Epidemiology 2023;44(6):891-898
Objective: To investigate the spatial distribution characteristics and correlation between the prevalence of dental fluorosis and the chemical elemental composition of drinking water sources in coal-fired fluorosis areas. Methods: Based on the survey data on the prevalence of dental fluorosis at CDC in Guizhou Province in 2022, 274 original surface drinking water sources were collected in typical coal-fired fluorosis areas, and fluoride (F), calcium (Ca), magnesium (Mg), aluminum (Al), titanium (Ti), chromium (Cr), manganese (Mn), iron (Fe), nickel (Ni), copper (Cu), zinc (Zn), arsenic (As), selenium (Se), molybdenum (Mo), cadmium (Cd), barium (Ba), lead (Pb) 17 elements; apply Moran's I index, Getis-Ord Gi* hotspot analysis of the global spatial autocorrelation of chemical elements in drinking water and the degree of aggregation of each element on the local area, and correlation analysis with the prevalence of dental fluorosis in the region. Results: Except for Cu, Zn, and Cd, global spatial autocorrelation Moran's I was negative, and all other elements were positive. F, Ca, Al, Ti, As, Mo, Cd, and Cu elements showed high values of aggregation in the southeastern low-altitude area; Mg, Ba, Pb, Cr, Mn, and Fe elements were mainly aggregated in the central altitude terrain transition area, Zn and Se elements in water sources are significantly positively correlated with the prevalence of dental fluorosis (P<0.05). In contrast, F, Mg, Al, Ti, As, Mo, Cd, Ba, and Pb elements negatively correlate (P<0.05). Elements in the central region were high-high aggregation, as a hot spot aggregation area with high disease incidence, while F, Al, Mn, Mo, Cd, and Ba elements in the western region were low-low aggregation, as a cold spot aggregation area with a low incidence of fluorosis. Conclusions: The risk of population fluoride exposure in surface drinking water sources is shallow. However, the chemical element content of drinking water sources in coal-fired polluted endemic fluorosis areas has prominent spatial geographical distribution characteristics. There is a significant spatial aggregation effect with the prevalence of dental fluorosis, which may play a synergistic or antagonistic effect on the occurrence and prevalence of dental fluorosis.
Humans
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Drinking Water
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Prevalence
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Coal
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Fluorides/adverse effects*
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Cadmium
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Fluorosis, Dental/epidemiology*
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Lead
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Selenium
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Arsenic
10.Technical status and development trends of electronic tongue
Shu-ye QI ; Yue-zhong MAO ; Li-hua GENG ; Dao-xuan YANG ; Hui-dan TU ; Shang-chen YAO ; Shi-yi TIAN ; Bao-ming NING
Acta Pharmaceutica Sinica 2023;58(11):3165-3172
Electronic tongue is one kind of bionic detection technologies, which can objectively reflect the taste of drugs based on electrochemical principle. In this paper, the development histories of electronic tongue both of potential type and voltammetry type were introduced, including their detection principles and key innovation technologies. In order to comprehensively improve the understanding of electronic tongue, its technological progresses, such as the study of dedicated sensors or biosensors for specific tastes, and the development of miniaturized or hybrid devices, were also discussed in detail. And the challenges and countermeasures in the application of electronic tongue were analyzed to provide some suggestions for its further technology promotion.


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