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OBJECTIVE To evaluate the rationality of epinephrine in the treatment of drug-induced anaphylactic shock， and to provide a reference for further standardizing the treatment measures of anaphylactic shock. METHODS According to the relevant data of the reports of severe adverse drug reaction （ADR） of drug-induced anaphylactic shock provided by Chongqing ADR Monitoring Center from 2015 to 2022， the selection of treatment drugs， and the application of epinephrine in anaphylactic shock were analyzed retrospectively； the clinical outcomes of anaphylactic shock with different epinephrine administration methods were investigated. RESULTS A total of 1 415 cases of severe ADR related to drug-induced anaphylactic shock were reported， with a male-to-female ratio of 1.04∶1； the drugs that caused allergic shock mainly included anti-infective drugs （47.92%）， TCM injections （9.12%）； the patients who suffered from drug-induced anaphylactic shock within 10 min after medication accounted for 43.96%； 97.24% of patients were cured or improved， and 2.76% of patients died or did not been improved. Among 1 415 patients， 63.39% of patients were treated with epinephrine， and the patients who preferred epinephrine treatment accounted for 53.14%； the intramuscular injection， subcutaneous injection， intravenous injection and intravenous drip accounted for 33.78%， 30.32%， 25.75% and 1.23%， respectively. The initial dose range of epinephrine was 0.01-10 mg， and the most frequent single dose was 1 mg （44.70%）. Excessive single doses of intramuscular injection， subcutaneous injection and intravenous injection accounted for 51.03% （148 cases）， 53.13% （136 cases） and 91.47% （193 cases） respectively， and the risk of overdose in intravenous injection was higher （P＜0.05）. The patients receiving initial treatment with epinephrine had a higher improvement rate/cure rate than those who did not use epinephrine （98.14% vs. 96.23%， P＝0.029）； the patients who preferred epinephrine had a higher improvement rate/cure rate than those who did not preferred epinephrine （98.14% vs. 95.17%， P＝0.031）； the improvement rate/cure rate of patients receiving intramuscular injection of epinephrine was higher than those without intramuscular injection （99.01% vs. 96.69%， P＝0.038）. CONCLUSIONS There are some unreasonable phenomena in the treatment of drug-induced anaphylactic shock， such as inappropriate selection of drugs， insufficient use of epinephrine， delay of administration， inappropriate route of administration and excessive single dose.
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OBJECTIVE To evalu ate the effects of perimenopausal one-day outpatient multidisciplinary model on the cognition of women to menopause hormone therapy （MHT）. METHODS The perimenopausal one-day outpatient service opened by the Third Affiliated Hospital of Chongqing Medical University in 2017 was introduced ，which was participated by doctors ，pharmacists， nutritionists，music psychotherapists ，nurses and other multidisciplinary members to provide systematic ，all-round，humanistic and face-to-face group science popularization and education ，practical experience and Q&A for women in perimenopause or about to enter perimenopause （called“students”）. The students who participated in one-day outpatient service in 2020 were selected as the survey object ， and the questionnaire was CMEI2020KPYJ（ZAMM）00206] designed to analyze the understanding of perimenopausal syndrome，awareness rate of MHT ，willingness to use and concerns. RESULTS A total of 295 students completed the questionnaire. Compared with before participation ， after participated in one-day outpatient service ，the cognition level of the students were all improved significantly ，including perimenopausal age （96.61％ vs. 99.32％，P＝0.037），the importance of perimenopausal health care knowledge （91.19％ vs. 96.95％，P＜0.001），whether the perimenopausal syndrome needs treatment （88.47％ vs. 99.32％，P＜0.001），willingness to use MHT （70.59％ vs. 94.48％ ，P＜0.001），MHT treatment timing （60.50％ vs. 95.17％ ，P＜0.001），reducing the risk of cardiovascular disease （51.68％ vs. 96.55％ ，P＜0.001），delaying aging （69.75％ vs. 97.59％ ，P＜0.001），preventing osteoporosis（65.13％ vs. 97.59％），P＜0.001）；the medical staff were higher than the non-medical staff （P＜0.05）. Totally 90％ of the students said they had gained knowledge about the prevention and treatment of common diseases ，nutrition and guidance， psychological regulation guidance hormone therapy related knowledges and exercise methods ；the proportion of the students who were willing to use MHT for 1 to 5 years（31.09％ vs. 47.93％）increased significantly. The proportion of the students who concerned about the risk of thrombosis （60.24％ vs. 36.81％），weight gain （59.64％ vs. 14.84％）and life-long dependence （52.41％ vs. 18.13％）was significantly reduced ，but that of the students who concerned about cancer risk was not diminished. From 2017 to 2020，the utilization rate of MHT was increased from 2.22％ to 62.16％ in non-medical staff among the students. CONCLUSIONS The multidisciplinary model of perimenopausal one-day outpatient service can improve the awareness of MHT among perimenopausal women ，eliminate misunderstandings ，and increase the utilization rate of MHT.
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OBJE CTIVE To investigate the clinical characteristics of a dverse drug reactions of asparaginase-associated pancreatitis（AAP），so as to provide reference for clinical safe medication. METHODS Analysis and identification were performed on a severe adverse reaction case of acute pancreatitis complicated with diabetic ketoacidosis and liver injury in a patient with acute lymphoblastic leukemia in our hospital after using pegaspargase. Retrieved from Wanfang database ，CNKI，PubMed and Embase database，case reports of AAP were collected and summarized in terms of patient demographics ，drug use ，incubation period and adverse reaction outcome. Combined with this case ，the disease characteristics and potential risk factors of AAP were analyzed and discussed. RESULTS After analysis and identification ，it was determined that AAP occurred in this patient. A total of 47 case reports were retrieved from the database ，and a total of 52 patients（including this patient ）were included in the analysis ，including 29 males and 23 females，mainly minors （65.4％）. L-asparaginase was the main asparaginase preparation that causes AAP （80.8％）. Gastrointestinal symptoms were the main prodromal symptoms （92.3％），which could be accompanied by other asparaginase related adverse reactions. AAP could occur after 1-33 times of administration ，and the median latency was 14 days after administration；compared with children ，median latency of AAP in adult patients was shortened significantly （11 d vs. 16 d，P＝ 0.049）；the median latency of AAP had longer tendency in patients treated with pegaspargase than that of L-asparaginase （17 d vs. 12.5 d，P＝0.490）. Of the cases included in the analysis ，8 patients died due to AAP ，1 of which was related to re-exposure to asparaginase preparations. CONCLUSIONS Acute pancreatitis is a serious and potentially fatal adverse drug reaction of ； asparaginase preparations. Clinical medical staff should pay attention to the characteristics of AAP ，consider the possibility ： of AAP when the patients have gastrointestinal symptoms and do a good job in patient education and pharmaceutical care to minimize the damage caused by AAP to patients.
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OBJECTIVE:To study the formulation of Xiqingguo buccal tablet,optimize the proportion and quantity of main materials. METHODS:Using appearance,hardness,dissolution and taste as investigation indexes,orthogonal design was adopted to optimize the proportion and quantity of main thinner(lactose,mannitol),wetting agent(ethanol),lubricant(magnesium stea-rate),flavoring agent(aspartame),and critical relative humidity was detected. RESULTS:By wet granulation,the optimal formu-lation were as follows as the ratio of lactose and mannitol was 1:3,ethanol volume fraction was 60%,the dosage of menthol, magnesium stearate,aspartame and orange essence was 0.4%,0.9%,2.0%,0.4%;it was proven that the total score of 3 batches of samples were 2.67,2.67,2.70 (RSD=0.65%,n=3),respectively. The critical relative humidity of granule was 60%. CON-CLUSIONS:The Xiqingguo buccal tablet prepared by optimal prescription meets the requirements.
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OBJECTIVE:To study the absorption features of Silymarin enteric coated-polyllactic-co-glycolic acid (PLGA) nanoparticles in rat in situ intestine perfusion model and colonic adenoma Caco-2 cell model. METHODS:HPLC method was used to determine the content of silymarin. The absorption rate constant(Ka)and apparent absorption coefficient(Kapp)of Silymarin sus-pension,Silymarin PLGA nanoparticles and Silymarin enteric coated-PLGA nanoparticles were investigated in duodenum,jejunum, ileum and colon of rat in situ intestine perfusion model;the apparent permeability coefficient (Papp) of those drugs containing low-concentration,medium-concentration and high-concentration(20,40,60 μg/mL)of silymarin in Caco-2 cell model were also investigated. RESULTS:Compared with Silymarin suspension,Ka and Kapp of Silymarin PLGA nanoparticles and Silymarin enteric coated-PLGA nanoparticles were all increased in duodenum,jejunum,ileum and colon(P0.05). CONCLUSIONS:Silymarin enteric coated-PLGA nanoparticles can effectively increase the intestinal ab-sorption,cellular uptake and transmembrane transport rate of silymarin.
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OBJECTIVE: To prepare Buserelin acetate nanoparticles(BA-NP) and to investigate its release property in vitro.METHODS: The BA-NP was prepared using double emulsion method.The content determination of BA-NP was performed using HPLC,and encapsulation efficiency and drug-loading rate of BA-NP were calculated.In vitro drug release property of nanoparticles was investigated by bag filter method.RESULTS: Prepared nanoparticles were even and regular in appearance.The linear range of buserelin acetate was 0.1～8.0 ?g?mL-1(r=0.999 9) with an average recovery of 105.38%.The RSD of intra-day and inter-day were lower than 1.78% and 0.93% respectively.The encapsulation efficiency of nanoparticles was(63.37?0.29)% and drug-loading rate of(1.03?0.09)%.The accumulative release rate of nanoparticles in phosphate buffer(pH=7.4) at 72 h was 62.35%.CONCLUSION: The preparation process of BA-NP is simple and particle with ideal release effect.
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OBJECTIVE:To evaluate the curative efficacy of Chinese medicine vs. western medicine in the treatment of diabetes. METHODS:The randomized controlled trials(RCTs) comparing western medicine with traditional Chinese medicine alone or combination of Chinese medicine and western medicine in the treatment of diabetes were systematically evaluated. Meta-analysis of the cited trials was performed by evidence-based medicine method with Revman 4.2 software for statistical analysis. RESULTS:A total of 14 RCTs met our inclusion criteria. Meta-analysis showed that there was no significant difference between traditional Chinese medicine and western medicine in clinical efficacy in the treatment of diabetes; however,the diabetic patients treated with integrated Chinese medicine and western medicine showed much better efficacy than those treated with western medicine alone. CONCLUSION:Treatment of diabetes with traditional Chinese medicine plus western medicine has more advantages; however,this conclusion remains to be confirmed further by studies of high quality given the low quality in test methodology.
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OBJECTIVE:To study the safety of polylatic acid used as sustained-release drug carrier in brain.METHODS:The toxicity and apoptosis of in vitro primary cultured cortical neurons in rats were evaluated using CCK-8 and Hoechst33258 staining after treated with polylatic acid and compared with the normal control group.Self-made polylatic acid blank tablet was implanted into rat brain and after 30 days the neuronal function was assessed through behavior ability testing,HE staining and Nissl staining,compared with sham groups and normal control group.RESULTS:When neurons were cultured for 7,9 and 12 days in polylatic acid group,there was no significant difference in absorbance value of CCK-8 and apoptosis rate between normal control group and polylatic acid group.Light inflammatory was observed in rat brain tissue in polylatic acid blank tablet group after 30 days,as compared with sham group.But the morphology,number and function of neuron had no obvious change.CONCLUSION:Polylactic acid has no significant inhibitory and inducing apoptosis effect on in vitro cultured cortical neurons and also has no obvious toxicity on brain tissue.
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OBJECTIVE:To prepare hydroxycamptothecin sustained-release tablets and to optimize its preparation technology and formulation.METHODS:The preparation technology and formulation were optimized by orthogonal experiment taking the type of excipient polylactic acid (A),tabletting pressure (B),ratio of HCPT to PLA (C) as factors with the deviation degree of the accumulative release percentage as evaluation index.Then the optimized results were verified.RESULTS:The optimal technology and formulation were as follows:A was PLA (20 000),B was 250 N,C was 1∶5.The deviation degree of the formulation was verified to be 2.963.CONCLUSION:The hydroxycamptothecin sustained-release tablets prepared in optimized preparation technology and formulation are up to the standard on preparation.
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OBJECTIVE: To investigate the inhibitory effect of hydroxycamptothecin (HCPT) on C6 gliomas cells in rats. METHODS: The cytotoxicity of HCPT at different concentration(1～0.031 25 mg?mL-1) on C6 in vitro was measured by MTT with conventional therapy for C6 gliomas cells as control. Meanwhile,the antitumor effect of O-HCPT(open ring form) and that of C-HCPT(closed ring form) were compared. RESULTS: At a high concentration,HCPT showed an inhibition ratio of as high as(69.43?4.5)% on C6 gliomas cells in concentration-dependent manner,showing no significant differences as compared with control. The antitumor effect of O-HCPT was lower than that of C-HCPT,and their IC50 were 3.626 mg?mL-1 and 0.135 mg?mL-1,respectively. CONCLUSION: HCPT had remarkable inhibitory effect on C6,and the antitumor effect of C-HCPT is potent than that of O-HCPT.
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OBJECTIVE:To compare the relative bioavailability of 2 kinds of domestic oxaprozin enteric tablets.METHODS:20 healthy volunteers were administered with single oral dose of trial tablet 400g and reference tablet 400g by crossover design,whose plasma oxaprozin level was determined by HPLC.The pharmacokinetic parameters and bioavailability of oxaprozin enterosoluble tablets were calculated by 3p97 software.RESULTS:The pharmacokinetic parameters of tested enteric tablets vs.reference tablets were as follows,t 1/2?(73.468?24.354),(73.556?24.406)h,t max(13.275?8.012),(13.200?15.154)h,C max(44.283?7.535)、(45.429?15.107)?g/ml,AUC 0～Tn(4471.792?1387.724),(4234.328?1741.380)(?g?h)/ml,AUC 0～inf(5040.407?2092.744),(4858.292?2423.656)(?g?h)/ml;No significant differences were noted between 2 tablets.The relative bioavailability of tested tablet was(112.8?38.5)%.CONCLUSION:2 kinds of oxaprozin enterosoluble tablets were bioequivalent.
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0.05) . CONCLUSION: Ampicillin and probenecid capsules are of bioe-quiavailability.
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Objective To prepare gliclazide (GZ) hydroxypropyl ? cyclodextrin (HP ? CD) inclusion complexes in order to enhance its aqueous solubility. Methods Inclusion complexes, prepared using 3 different methods of spray drying, freeze drying, and grinding, were identified by phase solubility analysis, infrared spectrophotometry, thermal analysis, and determination of the limited ammonium concentration. Results The HP ? CD inclusion complexes could be prepared by using the 3 different methods. The ratio of host/guest molecules was 1∶1. Ammonium residues were detected in inclusion complexes prepared by the freeze dried method. Conclusion The inclusion complexes can be prepared by the spray drying and grinding methods. The solubility of gliclazide can be significantly increased in the inclusion complexes.
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Objective To explore the protective effect of ligustrazine on the apoptosis of PC12 cells induced by dopamine(DA) and its mechanisms. Methods Apoptosis of PC12 cell was induced by dopamine at the concentrations of 0, 0.30, 0.60 mM. Ligustrazine at the concentrations of 0, 30, 60, 90 ?g/ml was added to defect the effect of ligustrazine on apotosis. The subdiploid peaks showing cell apoptosis rate were detected by flow cytometry. The cell activity was determined by MTT. Concentration of nitric oxide(NO) was determined by the Griess reaction. Results Compared with those of the control, the apoptosis rate and the level of NO induced by 0.30 or 0.60 mmol/L DA were higher, but the activity of PC12 cells was lower. Compared with those of the groups without ligustrazine, the apoptosis rate and the level of NO increased, but the cell activity decreased in a dose dependent manner. Conclusion Ligustrazine can inhibit the apoptosis induced by DA, which might be correlated with the decrease of NO production.
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Objective To prepare a biodegradable sckeral implant containing triamcinolone-acetonide-acetate(TAA) and polylactic acid(PLA) and investigate its release in vitro.Methods The TAA-PLA implant was prepared by melt-extrude technique.The drug release of TAA in vitro was determined by high performance liquid chromatography(HPLC).Results The implant was white pillar with 8 mm in length,8 mg in weight,and 0.8 mm in diameter.The drug loading was 30%.The drug was released at a steady and slow rate.Its accumulation release rate is 75.84% on the 30th day.Drug release profile in vitro was in accordance with Higuchi equation Q=0.137(t-0.752)1/2.Conclusion A sleral implant containing TAA-PLA is prepared,which has the evident feature in delaying the release of TAA and is biological degradable.It might be a novel vehicle for the topical use of TAA.
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Objective To prepare the flurbiprofen orally disintegrating tablets and establish the procedures of controlling the quality.Methods Flurbiprofen orally disintegrating tablets was prepared by wet granulation and it content was determined by HPLC.Results The obtained tablets were fine in the shape and smooth in the surface.Their hardness was 2 kg,the disintegrating time was about 30 s.The linear correlation was in a range of 1.0-10.0 ?g/ml,r=0.999 9.The average recovery was 99.32%,RSD=1.09%(n=7).Conclusion Our methods of flurbiprofen orally disintegrating tablets are simple and feasible in preparation and quality control.
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Objective To investigate the dissolution rates of glibenclamide and metformin in compound metformin hydrochloride. Methods The concentrations of the glibenclamide and metformin were determined by HPLC method. The rotating basket method was used to measure and compare the dissolution rates of glibenclamide and metformin between the compound metformin hydrochloride and conventional tablets. Results The dissolution rates of glibenclamide and metformin with different preparation came up to the standard of CHP (2005), but the dissolution parameters were different. Conclusion The dissolution rate of glibenclamide indicated significant difference between the compound metformin hydrochloride and the conventional tablets, and no significant difference for metformin.
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Objective To establish an HPLC method for the determination of plasma metformin hydrochloride and an HPLC/ESI-MS method for the determination of plasma glibenclamide in human. Methods The metformin plasma samples were added with acetonitrile to denature proteins and the supernatant was injected into the system directly by using EC 250/4.6 NUCLEOSIL 100-5 analytical column (4.6 mm?250 mm, 5 ?m) with a mobile phase of 0.03 mol/L (NH 4) H 2PO 4∶acetonitrile (75∶25, pH 7.0) at the flow rate of 1.0 ml/min and the detection wavelength of 240 nm. Using glipizide as a internal standard, the glibenclamide plasma samples were extracted with ethyl acetate and determined by LC-MS using a chromatographic column ORBAX SB300C 18 (2.1 mm?150 mm, 5 ?m) with a mobile phase of acetonitrile-0.1% ammonium acetate (55∶45, V/V) at the flow of 0.2 ml/min. Results The glibenclamide concentration had a good linear correlation in the range of 2-200 ng/ml (r=0.999 8) while the metformin concentration in the range of 6.25-4 000 ng/ml (r= 0.999 9 ). Both the inter-day and intra-day RSD of metformin and glibenclamide were lower than 5%. Conclusion The assays have been proved to be sensitive, accurate and convenient and can be used in the study of human pharmacokinetics of glibenclamide and metformin hydrochloride.
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OBJECTIVE:To survey and objectively evaluate the present situation and trend of the usages of the antivirals METHODS:To make a survey of the usage for above-mentioned drugs in 136 hospitals of 6 cities in the Yangtse valley of China during the period 1998～2000 concerning the sum of money for drugs,main pharmaceutical enterprises etc and to analyse the situation of clinical use and trend forecast RESULTS:The sum of money for the antivirals was 17 330 331 yuans,24 068 239 yuans and 47 427 419 yuans in 1998,in 1999 and in 2000,respectively Total expenditure and consumption for the antivirals in China increased year by year CONCLUSION:The antivirals is a kind of drug which has developmental potential,the expenditure and consumption will increase rapidly
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OBJECTIVE:To survey and objectively evaluate the present situation and trend of the usages of interferon.METHODS:To make a survey of the interferon used in 136 hospitals of 6 cities in the Yangtse valley of China during the period 1998～2000 in respect to the sum of money for drugs,production enterprises etc.and to analyse the situation of clinical use.RESULTS:The sums of money for the interferon were 25 925 795 yuans and 28 512 161 yuans and 28 038 402 yuans in 1998,in 1999 and in 2000,respectively.The proportion of domestic interferon in total consumption of interferon increased year by year.CONCLUSION:With the interferon declining in price and interferon-? having been fixed as a drug in state Basic Drugs for Medical Insurance,its consumption will increase at a high speed.