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.Proximal femoral nail antirotation for femoral intertrochanteric fractures with lateral wall integrity and lateral wall risk
Zhonghan WU ; Jingkun WANG ; Tao LI ; Xinzhong XU ; Shuisheng YU ; Li CHENG ; Dasheng TIAN ; Jian TANG ; Juehua JING
Chinese Journal of Tissue Engineering Research 2024;28(6):911-916
BACKGROUND:For elderly patients with traumatic hip fractures,the related factors of prognosis are very complex,and the integrity of the lateral wall is one of the influencing factors.It is of important clinical value to understand the effect of lateral wall injury on the prognosis of femoral intertrochanteric fracture. OBJECTIVE:To evaluate the relationship between the integrity of the lateral wall and hip functional recovery and other outcomes in patients with femoral intertrochanteric fractures. METHODS:Totally 82 patients with femoral intertrochanteric fractures were screened and all patients received proximal femoral nail antirotation fixation.According to the thickness of the lateral wall,the patients were divided into the lateral wall intact group(n=31)and lateral wall risk group(n=51).The perioperative indexes,weight-bearing time,fracture healing time,hip joint function and range of motion,postoperative pain and complications were compared between the two groups. RESULTS AND CONCLUSION:(1)The time of hospitalization and the number of fluoroscopies during operation in the lateral wall intact group were significantly lower than those in the lateral wall risk group(P<0.05),but there was no significant difference in other perioperative indexes.(2)Both groups were able to get down to the ground early after surgery and finally complete weight-bearing,but in the lateral wall risk group,the time of fracture healing was longer;the time of complete weight-bearing was significantly delayed;the Harris score of the last follow-up was lower;the range of motion of hip extension and flexion and neck trunk angle on the affected side were smaller(P<0.05).(3)There was no significant difference in the incidence of postoperative complications between the two groups,but the overall incidence of complications in the lateral wall intact group was significantly lower(P<0.05).(4)In summary,after internal fixation of proximal femoral nail antirotation,patients with the intact lateral wall had a relatively better prognosis than those with risk lateral wall.
4.Antitumor effect and mechanism of total alkaloids of Gelsemium elegans and sempervirine in vitro
Huixian CHEN ; Wenyi WANG ; Xinghui TAN ; Gaopan LI ; Xiaoqiong ZHANG ; Desen LI ; Shuisheng WU
China Pharmacy 2023;34(12):1437-1442
OBJECTIVE To explore the antitumor effect and mechanism of total alkaloids of Gelsemium elegans (TA) and sempervirine (SPV) in vitro. METHODS The effects of low, medium and high concentrations of TA (50, 100, 200 μg/mL) and SPV (10, 30, 50 μmol/L) on the morphology of human hepatoma cells (HepG2, Bel-7402), human lung cancer cells (A549) and human colon cancer cells (HCT-8) were observed, and the toxicity of TA and SPV to four tumor cells was monitored. The effects of TA and SPV on the contents of caspase-3 and caspase-9 in the supernatant of HCT-8 cells, the protein expressions of phosphorylated protein kinase B (p-Akt) (Thr308, Ser473), B-cell lymphoma 2 (Bcl-2), Bcl-2-related X protein (Bax), survivin, C/EBP-homologous protein (CHOP), immunoglobulin binding protein (Bip) and microtubule-associated protein 1 light chain 3Ⅱ (LC3Ⅱ) in HCT-8 cells were detected. RESULTS After the intervention of TA and SPV, the volume reduction and nuclear shrinkage were founded in four tumor cells; the cell activity decreased to varying degrees, among which TA and SPV had the best inhibitory effect on HCT-8 cells. After the intervention of TA and SPV, the contents of caspase-3 and caspase-9 in the supernatant of HCT-8 cells, the protein expressions of Bax, CHOP, Bip and LC3Ⅱ all increased to different degrees, while the protein expressions of p-Akt (Thr308, Ser473), Bcl-2 and survivin in HCT-8 cells all decreased to different degrees. CONCLUSIONS TA and SPV have inhibitory effects on the above four tumor cells, and the inhibitory effect on HCT-8 cells is the best. The mechanism of their action on HCT-8 cells may be related to promoting apoptosis, activating endoplasmic reticulum stress and autophagy.
5.Effect of noninvasive positive pressure ventilation and high-flow nasal cannula oxygen therapy on the clinical efficacy of coronavirus disease 2019 patients with acute respiratory distress syndrome
Zhiling ZHAO ; Hong CAO ; Qin CHENG ; Nan LI ; Shuisheng ZHANG ; Qinggang GE ; Ning SHEN ; Lincheng YANG ; Weili SHI ; Jie BAI ; Qingyang MENG ; Chao WU ; Ben WANG ; Qiuyu LI ; Gaiqi YAO
Chinese Critical Care Medicine 2021;33(6):708-713
Objective:To observe the effect of noninvasive positive pressure ventilation (NIPPV) and high-flow nasal cannula oxygen therapy (HFNC) on the prognosis of patients with coronavirus disease 2019 (COVID-19) accompanied with acute respiratory distress syndrome (ARDS).Methods:A retrospective study was conducted in Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology when authors worked as medical team members for treating COVID-19. COVID-19 patients with pulse oxygen saturation/fraction of inspiration oxygen (SpO 2/FiO 2, S/F) ratio < 235, managed by medical teams [using S/F ratio instead of oxygenation index (PaO 2/FiO 2) to diagnose ARDS] from February to April 2020 were included. The patients were divided into NIPPV group and HFNC group according to their oxygen therapy modes. Clinical data of patients were collected, including general characteristics, respiratory rate (RR), fraction of FiO 2, SpO 2, heart rate (HR), mean arterial pressure (MAP), S/F ratio in the first 72 hours, lymphocyte count (LYM), percentage of lymphocyte (LYM%) and white blood cell count (WBC) at admission and discharge or death, the duration of dyspnea before NIPPV and HFNC, and the length from onset to admission. The differences of intubation rate, all-cause mortality, S/F ratio and RR were analyzed, and single factor analysis and generalized estimation equation (GEE) were used to analyze the risk factors affecting S/F ratio. Results:Among the 41 patients, the proportion of males was high (68.3%, 28 cases), the median age was 68 (58-74) years old, 28 cases had complications (68.3%), and 34 cases had multiple organ dysfunction syndrome (MODS, 82.9%). Compared with HFNC group, the proportion of complications in NIPPV group was higher [87.5% (21/24) vs. 41.2% (7/17), P < 0.05], and the value of LYM% was lower [5.3% (3.4%-7.8%) vs. 10.0% (3.9%-19.7%), P < 0.05], the need of blood purification was also significantly lower [0% (0/24) vs. 29.4% (5/17), P < 0.05]. The S/F ratio of NIPPV group gradually increased after 2 hours treatment and RR gradually decreased with over time, S/F ratio decreased and RR increased in HFNC group compared with baseline, but there was no significant difference in S/F ratio between the two groups at each time point. RR in NIPPV group was significantly higher than that in HFNC group after 2 hours treatment [time/min: 30 (27-33) vs. 24 (21-27), P < 0.05]. There was no significant difference in rate need intubation and hospital mortality between NIPPV group and HFNC group [66.7% (16/24) vs. 70.6% (12/17), 58.3% (14/24) vs. 52.9% (9/17), both P > 0.05]. Analysis of the factors affecting the S/Fratio in the course of oxygen therapy showed that the oxygen therapy mode and the course of illness at admission were the factors affecting the S/F ratio of patients [ β values were -15.827, 1.202, 95% confidence interval (95% CI) were -29.102 to -2.552 and 0.247-2.156, P values were 0.019 and 0.014, respectively]. Conclusion:Compared with HFNC, NIPPV doesn't significantly reduce the intubation rate and mortality of patients with COVID-19 accompanied with ARDS, but it significantly increases the S/F ratio of those patients.
6.Study on Inhibitory Effects of Total Alkaloids of Gelsemium elegans on the Proliferation and Angiogenesis of Human Colon Cancer Cells
Wenyi WANG ; Xinghui TAN ; Pingping ZHANG ; Yuke YANG ; Zihong HUANG ; Desen LI ; Shuisheng WU
China Pharmacy 2020;31(8):957-962
OBJECTIVE:To investigate the inhibitory effects of total alkaloids of Gelsemium elegans (TAG) on the proliferation and angiogenesis of human colon cancer cells. METHODS :Human colon cancer cell line HT- 29 and HUVEC were cultured in vitro . After the intervention of low- ,medium-,high-dose TAG (40,80,120 μg/mL),the morphology of the two cells was observed by fluorescence inversion microscope. The survival rate of HT- 29 cells and HUVEC was detected by CCK- 8 assay. Flow cytometry was used to detect HT- 29 cell cycle. The migration rate ,invasion rate and tube number of HUVEC were observed by scratching test ,Transwell invasion experiment and tube formation experiment. RESULTS :Compared with blank group ,HT-29 cells and HUVEC were decreased to different extents in TAG groups ;dead cells were observed ,and the survival rate of both decreased significantly (P<0.05 or P<0.01). The proportion of HT- 29 cells at G 2/M phase in TAG groups as well as those at G 0/G1 phase in medium-dose group were increased significantly ;the proportion of HT- 29 cells at S phase in TAG groups as well as those at G 0/G1 phase in high-dose group were decreased significantly (P<0.05 or P<0.01). Survival rate ,migration rate and invasion rate of HUVEC were decreased significantly in TAG groups ,and tube number was also decreased significantly at each time point during 4-24 h(P<0.01). CONCLUSIONS :TAG have inhibitory effect on the proliferation of human colon cancer HT- 29 cells and HUVEC,can change HT- 29 cell cycle ,inhibit the migration ,invasion and tube formation of HUVEC.
7.Changes of serum cortisol level in ischemic stroke patients with obstructive sleep apnea syndrome
Shuisheng ZHONG ; Qiongli HU ; Zhigang LI ; Shuoxi LIAO ; Yunxin HU ; Hui YANG ; Xiaomei TANG ; Zeyan BAO ; Mengqiu PAN ; Yuzhou WANG
Chinese Journal of Neuromedicine 2018;17(8):796-801
Objective To observe the serum cortisol level in ischemic stroke patients with obstructive sleep apnea syndrome (OSAS),and discuss the influence factors and its correlation with severity of cerebral infarction.Methods Two hundred ischemic stroke patients with onset of 6 h to 3 weeks,admitted to our hospital from July 2015 to April 2017,were recruited;all patients were monitored with polysomnography.According to apnea hypopnea index (AHI),all patients were divided into ischemic stroke without OSAS group (AHI<5/h,n=89) and ischemic stroke with OSAS group (AHI≥ 5/h,n=111).Moreover,according to AHI,patients from ischemic stroke with OSAS group were divided into three subgroups,namely,mild subgroup (5/h ≤AHI<15/h),moderate subgroup (15/h ≤AHI<30/h) and severe subgroup (AHI ≥30/h).According to National Institutes of Health Stroke Scale (NIHSS) scores,all subjects were divided into a group of NIHSS scores no more than 10 and a group of NIHSS scores>10.The general clinical data,biochemical indices,early morning blood pressure,serum cortisol level and sleeping parameters were detected and compared among the groups,and the main factors affecting serum cortisol levels were identified by multivariate linear regression analysis.Results (1) The serum cortisol level in ischemic stroke with OSAS patients ([195.41±75.31] μg/L) was significantly higher than that of ischemic stroke without OSAS patients ([158.65±77.28] μg/L,P<0.05);the serum cortisol level in ischemic stroke with mild OSAS subgroup ([227.32±75.12] μg/L) was significantly increased as compared with that in the ischemic stroke with moderate OSAS subgroup and ischemic stroke with severe OSAS subgroup ([191.27±71.50] μg/L and [175.21±75.13] μg/L,P<0.05).(2) The serum cortisol level of group of NIHSS scores>10 was significantly higher than that of group of NIHSS scores ≤ 10 (P<0.05).(3)AHI,NIHSS scores,longest duration of apnea,and lowest blood oxygen saturation at night had significant effects on serum cortisol levels.Serum cortisol levels increased with AHI (β=89.984,95%CI:71.325-108.644,P=0.000) and NIHSS scores (β=0.923,95%CI:0.377-1.468,P=0.001),increased with the longest sleep apnea (β=0.804,95%CI:0.262-1.325,P=0.000),and decreased with the lowest blood oxygen saturation at night (β=-0.709,95%CI:-0.290--0.041,P=0.000).Conclusion The serum cortisol level in cerebral infarction patients with OSAS was increased,and the higher the severity of cerebral infarction and OSAS is,the higher the serum cortisol level is.
8.Thinking and Suggestion on Positioning of Clinical TCM Pharmacists and the Cultivation of Post Service Ability
Desen LI ; Yinghao WANG ; Shuisheng WU
China Pharmacy 2017;28(36):5170-5173
OBJECTIVE:To promote the work of clinical TCM pharmacists.METHODS:The problems faced by clinical TCM pharmacists were analyzed in respects of status quo of training in colleges and universities,status quo of hospital post training and status quo of continuing education.From the ability of post service,the ways to determine the duty orientation and improve the training quality of clinical TCM pharmacists were discussed theoretically.RESULTS & CONCLUSIONS:According to the nature of different types of medical institutions as TCM hospital,western medicine hospital,township community hospital and clinics,the responsibilities of clinical TCM pharmacists should be differentiated.TCM curriculum system of colleges and universities should be improved by adding social pharmaceutical education and TCM practical teaching.Based on the ability of post service,great importance should be attached to professional training of clinical TCM tablets after their employment.The theory,practice and research ability of clinical TCM talents should be improved by strengthening continuing education.The medical and pharmaceutical clinical TCM inter-disciplinary talent can be cultivated by improving rational drug use standard system.
9.The study on the diagnostic value of serum pepsinogens to gastric precancerous lesions
Junwang ZHANG ; Junhong ZHEN ; Shuisheng SHI ; Shan YU ; Shoutao WANG ; Ying QI
Journal of International Oncology 2014;(7):541-545
Objective Toinvestigatethepossibilityandquantitativerangeofpepsinogen(PG)usedas the screening marker of gastric cancer by detecting serum pepsinogen level in different gastric mucous pathologic status.Method ThelevelofserumpepsinogenⅠ(PGⅠ)andpepsinogenⅡ(PGⅡ)bytimeresolvedfluoro-immunoassay(TRFIA)in 64 chronic atrophic gastritis patients,63 gastric mucous atypical hyperplasia patients, 67 gastric cancer patients and 20 healthy volunteers were defeeted ,and the ratio of PGR(PGⅠ/PGⅡ)was calculated.Then the three kinds of diseases were graded.The data was analyzed between groups and sub-groups.Result ①Compared with normal control group,the median PGⅠvalues were 1 24.01 ,91 .23 and 71 .23 respectively,which were all lower than that of healthy group (1 52.00).There were significant differ-ences(Z=-2.52,P=0.01 7 0;Z=-3.42,P=0.001 4;Z=-3.57,P=0.000 9).The median PGR values were 7.61 ,5.21 and 4.32 respectively,which were also lower than that of healthy group,the differences were significant(Z=-2.98,P=0.002 9;Z=-3.1 7,P=0.000 2;Z=-2.89,P=0.000 1 ).The PGⅡlevel of these diseases were not significantly different with control group.②The serum PGⅠlevel of gastric mucous atypical hyperplasia and gastric cancer were reduced significantly in contrast with atrophic gastritis (Z =-3.42,P =0.001 4;Z=-3.62,P=0.000 9);the levels of PGⅡand PGR were varied without significance (P>0.05 );③The levels of PGⅠamong atrophy gastritis and gastric cancer subgroup have no significant difference(χ2 =2.86,P=0.41 4 3;χ2 =1 .67,P=0.1 36 8).But the level of PGⅠwas significantly different in gastric atypical hyperplasia(χ2 =0.83,P=0.043 0).It decreased in light and medium grade dysplasia and went up in severe grade dysplasia.The levels of PGⅡ and PGR were varied without significance(P>0.05).④The areas under the ROC curves performed by the PGⅠ and PGR from normal control group and atypical hyperplasia group were 0.782 and 0.831 respectively;The sensitivity and specificity of PGⅠ≤72.1 2 μg/L and PGR≤4.32 for gastric dysplasia were 89.48%and 76.31%respectively.Conclusion ①The level of PGⅠand PGR were decreased along with the seriousness of gastric pathological changes and probably regarded as the screening markers of gastric mucous malignant transformation.②Serum pepsinogen level is closely correlated with gastric precancerous lesion,PGI≤72.1 2 μg/L and PGR≤4.32 has better specificity and sensitivity for gastric atypical hyperplasia in this area.
10.Application progress of Glutamine in the gastrointestinal cancer patients after operation
Shuisheng WANG ; Chunlin ZHAO ; Xinguang QIU
International Journal of Surgery 2014;41(11):770-773
Glutamine is not only a special nutritional substance but a conditional essential amino acid,which is the most abundant amino acids in plasma,representing about 60% of free amino acids in the body,and it's normal plasma concentration is from 0.6 to 0.9 mmol/L.In recent years,with the increasing deepening study of the field of clinical nutrition,the concept of glutamine study has been gradually changed gradually changed it's concept from a simple nutritional support to immune nutrition therapy.Glutamine can not only improve the body's protein levels of nutrition,protect the gastrointestinal mucosa,but also reduce the incidence of infection and the inflammation in the body,improve immune function,reduce side effects of chemotherapy,and at the same time enhance tumor sensitivity to chemotherapy and promote gastrointestinal cancer patients' postoperative recovery,reduce surgical complications.This paper aims to review the application and research of glutamine in the gastrointestinal cancer patients after the operation.

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