Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards* ; Humans ; Consensus ; Drugs, Chinese Herbal/therapeutic use* ; Surveys and Questionnaires

A liquid chromatography-tandem mass spectrometry method was established and validated for determining the concentrations of costunolide(CO), piperine(PI), agarotetrol(AG), glycyrrhizic acid(GL), vanillic acid(VA), and glycyrrhetinic acid(GA) in rat plasma. This method was then applied to the toxicokinetic study of these six compounds in rats with chronic cerebral ischemia(CCI) following multiple oral doses of Zhachong Shisanwei Pills. Finally, the effects of continuous multiple-dose administration of Zhachong Shisanwei Pills on the liver of CCI rats were investigated. The results showed that after oral administration of different doses of Zhachong Shisanwei Pills, the in vivo exposure of AG, VA, and GA was relatively high, with AUC_(0-∞) values ranging from 604.0-2 494.2, 1 305.4-4 634.5, and 2 177.5-4 045.7 h·ng·mL~(-1), respectively, while the exposure of CO, PI, and GL was relatively low, with AUC_(0-∞) values ranging from 37.8-238.2, 2.4-17.0, and 146.9-408.5 h·ng·mL~(-1), respectively. The C_(max) and AUC_(0-∞) of the six compounds were positively correlated with the administered dose. The T_(max) of PI and AG ranged from 0.3 to 2.0 h, their T_(1/2) ranged from 0.8 to 2.9 h, and their mean residence time(MRT) ranged from 1.0 to 3.7 h. The T_(max) of GL and VA was shorter(0.4-1.9 h), while their T_(1/2)(2.6-5.9 h) and MRT(2.5-8.5 h) were longer. Both CO and GA exhibited a bimodal phenomenon, with T_(max) ranging from 1.6 to 6.6 h, T_(1/2) ranging from 2.8 to 7.7 h, and MRT ranging from 4.1 to 12.9 h. Liver histopathology after 28 days of continuous multiple-dose administration of Zhachong Shisanwei Pills showed that the liver tissue remained normal at a low dose(crude drug 0.8 g·kg~(-1), approximately 5 times the clinical equivalent dose). However, as the dose increased(crude drug 1.1-3.0 g·kg~(-1), 6.9-18.8 times the clinical equivalent dose), varying degrees of liver damage were observed. Blood biochemical tests revealed no significant changes in the serum levels of alanine aminotransferase(ALT), aspartate aminotransferase(AST), alkaline phosphatase(ALP), and total bile acid(TBA) in CCI rats from administration groups 1 to 3(crude drug 0.8, 1.1, 1.5 g·kg~(-1)). However, ALT, AST, ALP, and TBA levels in groups 4 and 5(crude drug 2.1, 3.0 g·kg~(-1)) showed significant increases. This study preliminarily elucidated the toxicokinetic characteristics of the six compounds in Zhachong Shisanwei Pills and their effects on liver tissue in CCI rats, providing data as a reference for clinical use.
Animals ; Tandem Mass Spectrometry/methods* ; Rats ; Drugs, Chinese Herbal/toxicity* ; Male ; Rats, Sprague-Dawley ; Brain Ischemia/blood* ; Chromatography, Liquid/methods* ; Polyunsaturated Alkamides/blood* ; Piperidines/toxicity* ; Benzodioxoles/toxicity* ; Alkaloids/blood* ; Liquid Chromatography-Mass Spectrometry

AIM: To investigate the risk factors associated with neovascular glaucoma(NVG)after pars plana vitrectomy(PPV)for proliferative diabetic retinopathy(PDR).METHODS: The PDR patients who received 23G PPV treatment at Shenyang He Eye Specialist Hospital from October 2015 to September 2020 and were followed up for at least 12mo with complete data were retrospectively collected. The patients were divided into two groups according to the occurrence of NVG during follow-up. The preoperative and intraoperative variables between two groups were compared. The cumulative hazard ratio for NVG was evaluated. RESULTS: A total of 151 PDR patients(169 eyes)with a mean follow-up of 18.07±12.55(1～79)mo were included, of which 30(17.8%)eyes developed NVG, the mean time of occurrence was 6.27±4.01(1～17)mo, and 50%(15 eyes)of NVG occurred within 5mo after vitrectomy. The cumulative hazard ratios of NVG at postoperative 3, 6 and 12mo were 4.8%, 12.6% and 18.1%, respectively. Multivariate logistic regression analysis showed that preoperative best corrected visual acuity(OR=3.077, 95%CI: 1.203～7.869, P=0.019), preoperative iris rubeosis(OR=7.897, 95%CI: 1.313～47.498, P=0.024), and contralateral NVG(OR=22.108, 95%CI: 1.562～312.861, P=0.022)were risk factors with the occurrence of NVG, while the number of intraoperative retinal laser photocoagulation(OR=0.772, 95%CI: 0.666～0.893, P=0.001)was the protective factor with the occurrence of NVG.CONCLUSIONS: The incidence of NVG in PDR eyes after PPV was 17.8%, of which 50% occurred within 5mo after surgery. PDR eyes with poor baseline visual acuity, iris rubeosis, and contralateral NVG are prone to postoperative NVG, and sufficient intraoperative retinal laser photocoagulation has a certain protective effect. PDR eyes after PPV should be closely followed up for 1a.

Objective:Compare the effects of 3 administration methods (tracheal perfusion, tail vein injection and aerosol inhalation) with bleomycin (BLM) in inducing pulmonary fibrosis in rats, in order to find out the optimal administration methods. Method:Eighty sprague-dawley (SD) male rats with SPF were randomly divided into aerosol inhalation blank group, single tracheal perfusion group(10 mg·kg^-1), multiple tracheal perfusion group(5 mg·kg^-1), single intravenous injection group(150 mg·kg^-1), multiple intravenous injection group(50 mg·kg^-1), single aerosol inhalation group (30 min)and multiple aerosol inhalation group(30 min). The mortality and body weight of rats in each group were observed at 7 d, 14 d and 28 d after the administration. And 28 days later after the administration, the lung coefficients of rats in each group were observed, paraffin sections were prepared, hematoxylin-eosin staining (HE) and Masson staining were performed, and the contents of hydroxyproline (HYP) and plasminogen activator inhibitor-1 (PAI-1) in lung tissues were detected by enzyme-linked immunosorbent assay (ELISA), so as to evaluate the alveoli inflammation and pulmonary fibrosis of rats in each group. Result:Compared with the aerosol inhalation blank group, the rats in the trachea perfusion group had the highest mortality among the drug treatment groups. The pulmonary coefficients of rats in the multiple intravenous injection group and the multiple inhalation group were significantly higher than those in the blank group(P<0.05,P<0.01). The multiple inhalation group was higher than the other model group and the single atomization model group. The results of HE and Masson staining showed thickening of pulmonary septum and higher degree of pulmonary interstitial fibrosis in tracheal perfusion group, intravenous injection group and multiple inhalation group. The degree of pulmonary fibrosis in the multiple inhalation group was more obvious than that in other groups. The results of ELISA showed that the levels of HYP and PAI-1 in lung tissues of rats in aerosol inhalation group and tracheal perfusion group were significantly higher than those in control group(P<0.05). The multiple inhalation group and the single atomization inhalation group were significantly higher than other modules. Conclusion:Bleomycin was inhaled repeatedly to establish pulmonary fibrosis model. The pathological injury and physiological indexes of the model rats were relatively stable, which conforms with the evolution process of pulmonary fibrosis.

To observe synergistic effects of 999 Ganmaoling (GML) and its Chinese/Western materia medica (CMM and WMM) on pharmacodynamic action and to study underlying mechanisms, their anti-inflammatory, antipyretic effects were compared by assaying the increased capillary permeability induced by glacial acetic acid in mice, ear swelling induced by Xylene in mice, non-specific pleurisy induced by carrageenan in rats, and yeast induced fever in rats. Crystal violet (CV) and microbial activity (XTT) assay were used to evaluate the inhibition of GML and its CMM and WMM on KPN biofilm formation, and scanning electron microscopy (SEM) was applied for observing KPN biofilm morphology changes. The results showed that compared with control group, GML could reduce exudation amount of Evans-Blue and the degree of Ear swelling significantly, and CMM and WMM have no significant effects. The concentration of TNF-α and IL-1β of rat pleural effusion in GML, CMM and WMM group decreased significantly. The concentration of TNF-α, IL-1β and IL-8 in GML group, TNF-α, IL-8 in WMM group and IL-8 in CMM in rats serum decreased significantly. The body temperature in rats decreased significantly in GML and WMM group after 4-8 h of administration. CMM group showed no significant difference in rat body temperature compare with control. Compared with control group, GML (55-13.75 g•L⁻¹) could inhibit KPN biofilm formation and reduce number of viable cells in the KPN biofilm. CMM (45-22.5 g•L⁻¹) and WMM (10 g•L⁻¹) could also inhibit KPN biofilm formation and reduce number of viable cells (P<0.01). Result of SEM also showed that GML (55 g•L⁻¹) and its CMM (45 g•L⁻¹) and WMM (10 g•L⁻¹) could interfere the bacterial arrangement of KPN biofilm and extracellular matrix. GML and its CMM & WMM could inhibit the formation of KPN biofilm, CMM & WMM in GML showed synergism and complementation in inhibit KPN biofilm. Results showed that GML had obvious anti-inflammatory and antipyretic effects and could destruct KPN mature biofilm. WMM and CMM showed obvious synergistic effect against inflammation and inhibition of KPN biofilm formation and reduction of number of viable cells but no same effects against fever.

OBJECTIVETo observe the protective effect of Yixinshu capsule on myocardial ischemia reperfusion injury (MIRI) in SD rats.

METHODSixty healthy SD rats were randomized into six groups: sham group, MIRI model group, Xinsuning capsule group, low, middle or high dose Yixinshu capsule. Acute MIRI rat models were created by reperfusion for 120 min after anterior interventricular branch of the left coronary artery for 30 min. The serum creatine kinase (CK), lactic dehydrogenase (LDH), aspartate aminotransferase (AST) and malondialdehyde(MDA), blood viscosity, and infarction area of myocardium were determined.

RESULTYixinshu capsule could reduce serum CK, LDH, AST and LDH activity, improve the blood viscosity, and reduced the myocardial infarct size.

CONCLUSIONYixinshu capsule can protect against MIRI in rats.

Animals ; Blood Viscosity ; drug effects ; Capsules ; Drugs, Chinese Herbal ; therapeutic use ; Lipid Peroxidation ; drug effects ; Male ; Myocardial Infarction ; drug therapy ; metabolism ; pathology ; Myocardial Reperfusion Injury ; prevention & control ; Rats ; Rats, Sprague-Dawley

OBJECTIVETo examine the in vitro dissolution of forsythin in Forsythia suspensa powder of different particle diameter, in order to give guidance to the grinding process.

METHODHPLC was used to determine the in vitro dissolution quantity and dissolution velocity of forsythin coarse powder, fine powder and ultramicroscopic powder.

RESULTThe dissolution curves of Forsythia suspensa coarse powder, fine powder and ultramicroscopic powder were basically inconformity to Weibull distribution. Specifically, T50 was 11.8, 10.5 and 6.8 min, respectively, and Q45 was 78.22%, 81.91% and 90.76%, respectively.

CONCLUSIONThe superfine milling process can significantly increase the dissolution quantity and dissolution velocity of forsythin.

Bridged Bicyclo Compounds, Heterocyclic ; chemistry ; Chromatography, High Pressure Liquid ; Forsythia ; chemistry ; Furans ; chemistry ; Particle Size ; Powders

OBJECTIVETo detect the stability of PEGylated puerarin (PEG-PUE), in order to provide experimental basis for storage conditions of PEGylated puerarin.

METHODFirst, a method for determining the content of PEG-PUE was established. Next, a system study was conducted for the stability of PEG-PUE affected by different factors such as temperature, humidity, light and light avoidance.

RESULTPEG-PUE was severely degraded under the conditions of high temperature, high humidity and light. It was also seriously degraded under high temperature.

CONCLUSIONPEG-PUE shall be stored under low temperature and in a dark and dry environment.

Drug Stability ; Drug Storage ; Isoflavones ; chemistry ; Light ; Polyethylene Glycols ; chemistry ; Temperature

OBJECTIVETo establish a HPLC-MS-MS determination method of artemether (ARM) and active derivatives DHA, and compare the pharmacokinetic parameters of ARM after transdermal and oral administration.

METHODThe mice were divided two groups (transdermal and oral) by parallel design. ARM and active derivatives DHA in plasma of mice at different sampling time were determined. The pharmacokinetic parameters were calculated by DAS 2.0 and by statistic analysis.

RESULTcompare oral administration, the pharmacokinetic parameters of ARM after transdermal, Cmax Tmax , AUC(0-t) MRT, had significant difference (P < 0.05).

CONCLUSIONThe artemether patch has long-releasing property.

Administration, Cutaneous ; Administration, Oral ; Animals ; Artemisinins ; administration & dosage ; blood ; metabolism ; pharmacokinetics ; Calibration ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal ; administration & dosage ; metabolism ; pharmacokinetics ; Male ; Mice ; Mice, Inbred ICR ; Sensitivity and Specificity ; Tandem Mass Spectrometry

OBJECTIVETo observe the treatments on the patients with acute methamidophos dichlorvos (DDV) and omethoate poisoning and provide the reliable basis for the rational treatments on these three organophosphorus pesticides poisoning.

METHODS101 patients with AOPP in 7 hospitals were divided into three groups: Group A, 59 patients with acute methamidophos poisoning, Group B, 32 patients with acute DDV/dipterex (DEP) poisoning, Group C, 10 patients with acute omethoate/dimethoate poisoning. The levels of erythrocyte AChE and the therapeutic efficacies of pralidoxime chloride (PAM-Cl) were compared among the three groups.

RESULTSThe AChE activities of all the three groups were inhibited on level of (9.12 +/- 7.99) U/g Hb (group A), 7.32 +/- 4.62 U/g Hb (group B) and (12.01 +/- 9.53) U/g Hb (group C), among which no significant difference was found (P > 0.05). All the patients recovered from acute cholinergic excitation or crisis after the treatment of PAM-Cl. The erythrocyte AChE activities were obviously reactivated in group A three hours later after admission to hospital, each on level of (11.37 +/- 8.67) U/g Hb, (12.51 +/- 6.98) U/g Hb, (15.90 +/- 7.31) U/g Hb, (18.33 +/- 4.78) U/g Hb and (18.91 +/- 7.00) U/g Hb at the 12th, 24th, 48th, 72nd hour and discharge (P < 0.05), and the upgrade tendency was continuous. AChE activities in group B were also reactivated after treatment, each on level of (8.91 +/- 5.89) U/g Hb, (1.31 +/- 6.61) U/g Hb, (13.00 +/- 7.55) U/g Hb, (14.22 +/- 7.80) U/g Hb, (12.78 +/- 7.07) U/g Hb and (16.87 +/- 7.06) U/g Hb at the 3rd, 12th, 24th, 48th, 72nd hour and discharge, but the upgrade tendency turned slowly after 12 hours, the inhibited AChE activities were not reactivated in group C from the beginning to the end.

CONCLUSIONAfter the treatment of PAM-Cl, the AChE activities of the patients with acute methamidophos poisoning could be continuously reactivated, the AChE activities of the patients with acute DDV/DEP poisoning could also be reactivated in 12 hours, and then keep stable, but the AChE activities of the patients with acute omethoate/dimethoate poisoning could not be reactivated. However, PAM-Cl has therapeutic efficacy against acute toxicity of all the three organophosphorus pesticides. Oximes should be vigorously used in the treatment of AOPP, including acute omethoate/dimethoate poisoning.

Acetylcholinesterase ; metabolism ; Acute Disease ; Adult ; Cholinesterase Reactivators ; therapeutic use ; Dichlorvos ; poisoning ; Dimethoate ; analogs & derivatives ; poisoning ; Female ; Humans ; Male ; Middle Aged ; Organophosphate Poisoning ; Organothiophosphorus Compounds ; poisoning ; Pralidoxime Compounds ; therapeutic use ; Retrospective Studies