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1.
China Pharmacy ; (12): 1526-1530, 2021.
Article in Chinese | WPRIM | ID: wpr-881293

ABSTRACT

OBJECTIVE:To investigate the effects of pharmaceutical management intervention on the use of TCM injection in primary medical institutions. METHODS :Twenty grass-roots health centers in Yichun city ,Jiangxi province were randomly selected. Relying on Department of Pharmacy and Health Services of the Municipal Health Committee and the Quality Control Center for Pharmacy Affairs of the City ,Yichun People ’s Hospital took the lead in establishing the prescription evaluation criteria for TCM injection ,training pharmaceutical service skills ,conducting special reviews on prescriptions/medical orders ,improving control measures ,obtaining relevant data of drug use in primary health centers by issuing questionnaires on the use of TCM injection and randomly selecting prescriptions/medical orders for comments. The relevant data without drug administration (before intervention)from Jan. to Jun. 2018 were taken as the non-intervention group ,and the relevant data with drug administration (after intervention)from Jan. to Jun. 2019 were taken as the intervention group. The use of TCM medicine injection ,DDDs,DDC and sequencing ratio were compared before and after intervention. At the same time ,the prescriptions/medical orders of TCM injections before(1 222 copies)and after (1005 copies)intervention were randomly selected for comment and the reasonable situations of the prescriptions/medical orders were compared before and after the intervention. RESULTS :After intervention ,total amount , consumption sum and DDDs of top 10 TCM injections in the list of amount were significantly decreased. The reasonable rate of prescriptions and medical orders was 48.04% before intervention , but increased to 70.65% after intervention. Besides , unreasonable situations before and after intervention all manifested as inappropriate indications. After the intervention ,the unreasonable rates of Xuesaitong powder for injection (lyophilized),Xueshuantong injection ,Xingnaojing injection (two specifications),Shengmai injection ,Xueshuantong for injection (lyophilized)and Qingkailing injection were significantly lower than before intevention (P<0.05). CONCLUSIONS :Pharmaceutical administration intervention can reduce the total amount and the consumption sun of TCM injection in primary medical institutions ,and promote rational drug use in the clinic.

2.
China Journal of Chinese Materia Medica ; (24): 1752-1762, 2021.
Article in Chinese | WPRIM | ID: wpr-879089

ABSTRACT

Traditional Chinese medicine(TCM) injections boast a definite efficacy and have been widely used in clinic. However, the problems in medication safety have been attracted increasing attention. Pharmacokinetics is of significance to guiding TCM injection administration regimen design and improving safety and effectiveness in clinical use. In recent years, with the improvement of ideas, technology and methods of TCM studies, the pharmacokinetic studies of TCM injections have been broadly performed, with a notable progress. This paper reviewed the advance in pharmacokinetics studies of TCM injections in recent ten years, which mainly focused on pre-clinical concentration-time course, distribution, metabolism and excretion in vivo based on analysis techniques, pharmacokinetic interactions of constitutes, impact of pathological state, pharmacokinetic interactions between TCM injection and chemical drugs, and clinical pharmacokinetics studies of TCM injections, in the expectation of providing reference for studies on quality control, product development and rational clinical use of TCM injections.


Subject(s)
Drugs, Chinese Herbal , Injections , Medicine, Chinese Traditional , Quality Control
3.
China Journal of Chinese Materia Medica ; (24): 4347-4351, 2018.
Article in Chinese | WPRIM | ID: wpr-775337

ABSTRACT

As a modern dosage form drug with rapid effect, traditional Chinese medicine (TCM) injection has been more and more used in clinical practice. Meanwhile the safety of TCM injection has attracted more and more attention. The retrospective analysis on 74 cases of adverse reaction of TCM injections collected from 2007 to 2016 in the Third Affiliated Hospital of Beijing University of Chinese Medicine showed that the proportion of men and women with adverse reactions was 0.54:1; the average age was 62.5 years old; 21 kinds of TCM injections were involved. Among them, the most reported were blood-regulating agents. The top four kinds of TCM injections with highest adverse drug reactions (ADRs) were Tanreqing injection, Danhong Injection, Shuxuening Injection and Xuesaitong for injection. The top three clinical manifestations of adverse reactions were lesions of skin and its appendages, damage of circulatory system and damage of nervous system. The potential causes of the adverse reactions of TCM injections were analyzed, and it was believed that individual difference, medicine, pharmaceutical excipients, solvent and TCM syndrome differentiation may be the main five causes for the adverse reactions of TCM injections. In order to reduce the adverse reactions of TCM injections, it is suggested that the clinical pharmacists should participate in the application management of TCM injections in the hospital; the production enterprises shall strengthen the whole life cycle management of the drugs; and at the same time, the drug control and administration authorities should improve the drug management methods constantly and encourage the development of TCM injections to the high quality level.


Subject(s)
Female , Humans , Male , Middle Aged , Drugs, Chinese Herbal , Injections , Medicine, Chinese Traditional , Retrospective Studies
4.
China Pharmacy ; (12): 847-851, 2018.
Article in Chinese | WPRIM | ID: wpr-704690

ABSTRACT

OBJECTIVE:To provide reference for rational use of TCM injection. METHODS:Each 660 medical records were selected from 9 hospitals of Luzhou city before(Jan.-Mar. in 2015)and after(Jan.-Mar. in 2017)administrative intervention and pharmaceutical intervention(called"intervention"for short)according to random number tablet. The consumption sum,DDDs and B/A,utilization,per capita,cost of drug and TCM injection,rational and irrational use were compared before and after intervention. RESULTS:After intervention,total consumption sum and DDDs of 10 TCM injections were decreased in 7 hospitals compared to before intervention,but those of 2 hospitals were increased slightly. Before and after intervention,consumption sum of Xueshuangtong for injection took up the first place among 10 kinds of TCM injection. Top 5 injections in the list of DDDs were the same generally,i.e. Xuesaitong for injection,Xueshuangtong for injection,Shenmai injection,Salviae miltiorrhizae and ligustrazine hydrochloride injection and Safflower yellow for injection.10 kinds of TCM injections with B/A>1 included Xuesaitong for injection, Salviae miltiorrhizae and ligustrazine hydrochloride injection,Safflower yellow for injection and Gastrodin injection. After intervention,utilization rate of 10 TCM injections(24.70%)was significantly lower than before intervention(32.42%),rational rate of TCM injection(61.35%)was significantly higher than before intervention(41.59%),with statistical significance(P<0.01). After intervention,the per capita cost of TCM injection,the incidence of function inconsistency,excessive dose,irrational solvent selection,insufficient solvent amount and non-individual injection were significantly lower than before intervention,with statistical significance(P<0.05). There was no statistical significance in per capita cost of drug,the irrational utilization rate of repeated medication or excessive long treatment course before and after intervention(P>0.05). CONCLUSIONS:The administrative intervention combined with pharmaceutical intervention promote more safe,rational and economical use of TCM injection.

5.
Chinese Journal of Epidemiology ; (12): 248-252, 2017.
Article in Chinese | WPRIM | ID: wpr-737628

ABSTRACT

Objective To evaluate the safety of Tanreqing injection among children in thereal world.Methods A multicenter,large sample,ambispective cohort study,with registration-type clinical safety monitoring.A total of 6 188 inpatients and patients from the emergency units,aged ≤14 years who all had been using Tanreqing injection in 59 secondary and tertiary hospitals in China,were recruited between January,2014 and May,2015.The main outcomes would include incidence and severity of adverse drug reaction (ADR)/adverse drug event (ADE) of Tanreqing injection.Univariate analysis was used to explain the risk factors of ADR.Results The overall incidence of ADE was 4.20% (26 cases),including 4 serious ones.The incidence of ADR was 3.07% (19 cases),including 17 cases of general ADR and 2 cases of new ADR.All the ADR cases were mild or moderate,mostly showing damages in skin and appendages.The onset of disease happened in 24 hours after the Tanreqing injection but all the ADR cases got improved or cured.Having histories of allergies to drugs or foods would increase the incidence of ADR.Conclusion Tanreqing injection caused low incidence of ADR in children.Progams as stratifying high-risk patients and improving administrative management could further increase the safety level of Tanreqing injection.

6.
Chinese Journal of Epidemiology ; (12): 248-252, 2017.
Article in Chinese | WPRIM | ID: wpr-736160

ABSTRACT

Objective To evaluate the safety of Tanreqing injection among children in thereal world.Methods A multicenter,large sample,ambispective cohort study,with registration-type clinical safety monitoring.A total of 6 188 inpatients and patients from the emergency units,aged ≤14 years who all had been using Tanreqing injection in 59 secondary and tertiary hospitals in China,were recruited between January,2014 and May,2015.The main outcomes would include incidence and severity of adverse drug reaction (ADR)/adverse drug event (ADE) of Tanreqing injection.Univariate analysis was used to explain the risk factors of ADR.Results The overall incidence of ADE was 4.20% (26 cases),including 4 serious ones.The incidence of ADR was 3.07% (19 cases),including 17 cases of general ADR and 2 cases of new ADR.All the ADR cases were mild or moderate,mostly showing damages in skin and appendages.The onset of disease happened in 24 hours after the Tanreqing injection but all the ADR cases got improved or cured.Having histories of allergies to drugs or foods would increase the incidence of ADR.Conclusion Tanreqing injection caused low incidence of ADR in children.Progams as stratifying high-risk patients and improving administrative management could further increase the safety level of Tanreqing injection.

7.
China Pharmacy ; (12): 4686-4690, 2017.
Article in Chinese | WPRIM | ID: wpr-668660

ABSTRACT

OBJECTIVE:To evaluate therapeutic efficacy of Aidi injection,Compound kushen injection,Kanglaite injection, Elemene injection and Brucea javanica oil emulsion injection in the treatment of malignant pleural effusion(MPE),and to provide evidence-based reference in clinic. METHODS:Retrieved from PubMed,EMBase,Cochrane library,CJFD,Wanfang database and CJFD,RCTs about Aidi injection,Compound kushen injection,Kanglaite injection,Elemene injection and B. javanica oil emulsion injection in the treatment of MPE were collected. Meta-analysis was conducted by using ADDIS 1.16.6 statistical software after data extraction and quality evaluation by modified Jadad scale. RESULTS:A total of 54 RCTs were included,involving 3404 patients. All RCTs were two legs with a total number of 108. Results of network Meta-analysis showed that compared with cisplat-in,Compound kushen injection [OR=2.19,95%CI(1.30,3.76),P<0.05],Elemene injection [OR=3.55,95%CI(2.43,5.32),P<0.05] and B. javanica oil emulsion injection [OR=1.92,95%CI(1.34,2.76),P<0.05] could significantly improve response rate of MPE patients,with statistical significance. Pairwise comparison showed response rate of Elemene injection was significantly higher than that of Aidi injection [OR=0.32,95%CI(0.17,0.56),P<0.05],Kanglaite injection [OR=0.30,95%CI(0.13,0.68),P<0.05] and B. javanica oil emulsion injection [OR=1.85,95%CI(1.10,3.17),P<0.05] in improving response rate. The probability ranking was Elemene injection>Compound kushen injection>B. javanica oil emulsion injection>Aidi injection=Kanglaite injection=cispl-atin. Compared with cisplatin,Aidi injection [OR=0.29,95%CI(0.16,0.54),P<0.05],Compound kushen injection [OR=0.44, 95%CI(0.18,0.96),P<0.05],Elemene injection [OR=0.21,95%CI(0.10,0.44),P<0.05] and B. javanica oil emulsion injection [OR=0.41,95%CI(0.23,0.70),P<0.05] could significantly improve the rate of quality of life improvement in MPE patients,with statistical significance. Pairwise comparison showed the rate of quality of life improvement of Elemene injection in MPE patients was significantly higher than that of Kanglaite injection [OR=4.84,95%CI(1.03,25.01),P<0.05]. The probability ranking was El-emene injection>Aidi injection>Compound kushen injection>B. javanica oil emulsion injection>Kanglaite injection>cisplatin.CONCLUSIONS:All 5 kinds of TCM injection can effective-ly treat MPE and improve the quality of life,among which El-emene injection is mostlikely to be the most effective interven-tion.

8.
China Pharmacy ; (12): 1034-1037, 2017.
Article in Chinese | WPRIM | ID: wpr-514837

ABSTRACT

OBJECTIVE:To investigate the application of key monitoring varieties among adjuvant drugs in medical institu tions of Yunnan province,and to provide reference for the formulation of related policy and the promotion of clinical rational drug use.METHODS:The related data of key monitoring varieties in medical institutions of Yunnan province during Jan.1st-Mar.31st,2015 were investigated and analyzed statistically.RESULTS:The data with highest effective rate were reported by tertiary hospi tals,being 93.94%.Among top 10 drugs in the list of consumption sum,the number of key monitoring varieties was the highest in tertiary hospitals,being (5.50 ± 2.12) varieties averagely.The consumption sum of key monitoring varieties in tertiary hospitals took up the highest proportion in total consumption sum of hospitalization drug,being(31.94 ± 16.99)% averagely;being(26.13 ± 11.93)% and (22.14 ± 16.39)% in second level hospitals and first level hospitals.Among top 10 drugs in the list of consumption sum,the consumption sum of key monitoring varieties in second level hospitals took up the highest proportion in total consumption sum of hospitalization key monitoring varieties,being (50.34 ± 26.87) % in average,up to 98.53 %;being (39.13 ± 22.55) % and (27.38 ± 27.75)% in tertiary hospitals and first level hospital.Among top 5 key monitoring types in the list of hospitalization con sumption sum,safflower yellow pigment and omeprazole were involved in hospitals at various levels.CONCLUSIONS:Adjuvant drug use are widespread in medical institutions of Yunnan province.Key monitoring varieties are given priority to TCM injection and proton pump inhibitors.It is necessary to take effective measures,formulate and implement the corresponding supervision sys tem so as to promote rational clinical drug use.

9.
China Pharmacy ; (12): 458-461,462, 2017.
Article in Chinese | WPRIM | ID: wpr-606094

ABSTRACT

OBJECTIVE:To promote effective supervision of key monitoring drugs by provincial pharmaceutical quality control center,and to improve rational drug use. METHODS:The effects of No.2 district of Sichuan province pharmaceutical quality con-trol center on 3 categories of key monitoring drugs guidance and supervision,through urging medical institution in the area to estab-lish key monitoring drugs supervision system,formulating prescription review guideline for 3 categories of key monitoring drugs [TCM injection,adjunctive drug,proton pump inhibitors (PPIs)],developing baseline data survey,inspecting the application of key monitoring drug in medical instaurations on the spot and other measures,were introduced. Through collecting the reports of re-gional quality control center to the provincial quality control center,supervision system of medical institutions were analyzed statisti-cally. Key monitoring drugs of medical institutions in the area were analyzed statistically in respects of rational utilization ratio,uti-lization quantity,utilization amount,etc.,so as to evaluate supervision effects. RESULTS:Up to Apr. 2016,92.26%medical insti-tutions had been aware of the relevant requirements of the documents;84.25% had established the hospital supervision system. 3 categories of key monitoring drugs prescription(orders)comment guideline had been developed in Mar. 2016. 18 third-grade class-A general medical institutions were randomly selected;among 3 categories,irrational utilization ratio of TCM injection decreased by 12.35%(35.41% vs. 47.76%);that of adjunctive drugs decreased by 9.64%(20.95% vs. 30.59%);that of PPIs decreased by 7.44%(40.49% vs. 47.93%) in May 2016,compare to Jan. 2016. Average consumption sum of them decreased by 12.07%, 13.30%,9.49%,respectively in Apr. 2016,compared to Jan. 2016. 55.02% medical institutions had started to collect the baseline data. CONCLUSIONS:The provincial pharmaceutical quality control center has played an important role on establishing a supervi-sion system,it can promote the effective supervision by guiding and supervising the medical institutions evaluating the supervision of medical institutions and pointing out the problems.

10.
China Pharmacy ; (12): 3184-3187, 2016.
Article in Chinese | WPRIM | ID: wpr-504892

ABSTRACT

OBJECTIVE:To provide reference for ration use of TCM injection. METHODS:The utilization of TCM injections in 39 hospitals from Chongqing area during 2012-2014 was analyzed statistically in respects of consumption sum,DDDs,DDC and B/A. RESULTS:The total consumption sum of TCM injections increased slowly in 39 hospitals from Chongqing area during 2012-2014,increasing from 767 581 thousand yuan to 911 759 thousand yuan,with annual growth rate of 8.98%. Total sum of consumption sum of top 10 drugs was 1 326 019.7 thousand yuan,accounting for 51.11% of total. The consumption sum of Hong-hua injection and Shenxiong glucose injection always took up the first 2 places in those years. DDDs of Xuesaitong injection, Shenxiong glucose injection glucose,Honghua injection and Shuxuetong injection always took up the first 4 places in those years. DDC of Xuebijing injection and Kanglaite injection always took up the first and second places in those years. Among top 10 TCM injection in the list of consumption sum,most of B/A was lower than 1.00;B/A of Shuxuetong injection,Xingnaojing injection, Shenqiong glucose injection and Xueshuantong injection were close or equal to 1.00. Xuesaitong injection was the one that B/A>1.00 from beginning to end. CONCLUSIONS:Total use of TCM injection increased steadily and drug use relatively concentrated in 39 hospitals from Chongqing area during 2012-2014,and rationality of drug use by physicians had been improved gradually.

11.
China Pharmacy ; (12): 3181-3183,3184, 2016.
Article in Chinese | WPRIM | ID: wpr-605775

ABSTRACT

OBJECTIVE:To provide reference for rational use of TCM injection in the clinic. METHODS:The utilization of TCM injections in 34 hospitals from Nanjing area during 2012-2014 was analyzed statistically in respects of consumption sum, DDDs,DDC. The occurrence of ADR induced by TCM injections was also analyzed statistically in the First Affiliated Hospital of Nanjing Medical University. RESULTS:The consumption sum of TCM injections in 34 hospitals from Nanjing area during 2012-2014 increased year by year;top 10 kinds of TCM injections mainly were anti-tumor drugs and cardio-cerebrovascular drugs in 2014,and each of them involved 4 categories and their consumption sum accounted for 46.08% and 32.59%,respectively. Total consumption sum of anti-tumor TCM injections increased slowly,while those of cardio-cerebrovascular drugs,antibiosis and anti-phlogosis increased rapidly. Lentinan injection steadily took up the top in the list of consumption sum and DDDs of single type,its DDC was the lowest and B/A=1.00. In the First Affiliated Hospital of Nanjing Medical University,most of ADR was induced by Xiyanping injection (27 cases,45.00%). CONCLUSIONS:The type of TCM injections keep stable in 34 hospitals from Nanjing area during 2012-2014,mainly involving anti-tumor drugs and cardio-cerebrovascular drugs which were used widely. Clinic should strengthen dialectial therapy close monitoring and attch improtance to the rational use of TCM injections.

12.
China Pharmacy ; (12): 2425-2427,2428, 2016.
Article in Chinese | WPRIM | ID: wpr-605710

ABSTRACT

OBJECTIVE:To provide reference for the rational drug use of traditional TCM injection. METHODS:Medical re-cords of 792 patients receiving TCM injection were collected from Qingdao Municipal Hospital in the first quarter of 2014(before intervention)and 836 patients collected from the first quarter of 2015(after intervention),and then analyzed comparatively in re-spects of patient’s gender information,rationality of TCM injection,irrational drug use,ADR. RESULTS:After intervention,the use of TCM injection in the hospital became standard gradually,and rational rate increased from 42.42% to 69.98%. Irrational drug use as super-indication medication,overdose,inadequate solvent amount decreased;the ratio of TCM injection prescription cost per capita decreased from 16.64% to 12.59%;the incidence of ADR decreased from 6.94% to 2.51%,with statistical signifi-cance(P<0.05). Except that the amount of Andrographolide for injection,Xuesaitong for injection,Zhengqing fengtongning injec-tion,Reduning injection increased,those of other TCM injection decreased. CONCLUSIONS:Pharmaceutical intervention mea-sures of clinical pharmacists are effective and feasible,and promote rational and standard use of TCM injection.

13.
China Pharmacy ; (12): 4063-4065, 2015.
Article in Chinese | WPRIM | ID: wpr-502722

ABSTRACT

OBJECTIVE:To provide reference for rational application of TCM injection. METHODS:The utilization of TCM injection in our hospital during 2011-2014 was analyzed in terms of species,consumption sum,DDDs and DDC,etc. RESULTS:The type and consumption sum of TCM injection kept stable in our hospital during 2011-2014. TCM injection for activating blood circulation to dissipate blood stasis as Shuxuetong(Heilougjiang),Danhong,Shuxuening took up the front of consumption sum in 4 years. Top 3 TCM injections in the list of DDDs were Shuxuetong,Shuxuening(Heilougjiang), Danhong/Xueshuangtong corre-sponded to consumption sum. DDC of TCM injection were kept around 100 yuan. DUI ratio of TCM injection were almost equal to 1 or close to 1. CONCLUSIONS:The amount and DDDs of TCM injection are synchronous in our hospital,and the utilization of TCM injection is stable and rational basically in our hospital. TCM injection with suitable price and definite efficacy take up a large share,and the amount of TCM injection for clearing away heat and toxic material with anti-inflammatory effect increase rapidly.

14.
China Pharmacy ; (12): 3902-3905, 2015.
Article in Chinese | WPRIM | ID: wpr-502683

ABSTRACT

OBJECTIVE:To explore the idea and method of post-marketing safety reevaluation of TCM injection in our hospi-tal. METHODS:In case-control study,salvianolate for injection was chosen for practice. 1 000 patients with stable angina receiv-ing Salvianolate for injection in our hospital during May 2012-Oct. 2013 were selected as subjects. The occurrence of ADR/ADE were observed and Logistic regression analysis was conducted by using SPSS 20.0 software. RESULTS:The incidence of ADR/ADE was 0.6%,and rare(0.1%-1%). The ADR/ADE were general and mainly manifested as erythra(66.67%). Skin and its ap-pendants were main organs involved in ADR(66.67%). Logistic regression analysis showed that gender,drug combination and age are risk factors of ADR/ADE. CONCLUSIONS:The post-marketing safety reevaluation of TCM injection not only make up for the deficiency of pre-marketing safety evaluation of TCM injection and find out potential delayed and severe ADR/ADE and drug inter-action,but also provide reference for rational drug use in the clinic and guarantee the safe and rational drug use.

15.
Chinese Journal of Information on Traditional Chinese Medicine ; (12): 120-121, 2015.
Article in Chinese | WPRIM | ID: wpr-481346

ABSTRACT

Objective To analyze the features of adverse reactions of compatibility of 70 cases of TCM injections in Wuzhou Chinese Medicine Hospital;To provide references for reasonable medication.Methods Reports about adverse reaction caused by 70 cases of TCM injection compatibility in our hospital were under retrospective analysis, in order to summarize the features of adverse reactions and study coping strategies.Results The compatibility between TCM injections and transfusion, chemicals, TCM injections and biological medicine may cause adverse reactions. Among the 70 cases, the types of adverse reactions were 28 cases of skin system (40.00%), 18 cases of the digestive system (25.71%), 12 cases of central nervous system (17.14%), 4 cases of cardiovascular system (5.71%), the other 8 cases (11.43%). TCM injection with compatibility of adverse reactions were mainly compound Danshen Injection,Shenmai Injection,Tanreqing Injection,Qingkailling Injection,Danhong Injection andXuesaitong Injection.Conclusion The compatibility of TCM injections may cause unpredictable adverse reactions. Therefore, TCM injections should be used according to relevant regulations, with a purpose to ensure the security and effectiveness of TCM injections in clinic.

16.
Chinese Journal of Primary Medicine and Pharmacy ; (12): 2159-2161, 2014.
Article in Chinese | WPRIM | ID: wpr-451563

ABSTRACT

Objective To understand the rules and characteristics of adverse drug reaction ( ADR) in Xinhua Hospital of Xinhua Medical Group ( Huainan City Anhui Province )′s traditional Chinese medicine ( TCM) injection ca-ses,and to provide reference for rational and safety usage of TCM injection .Methods Reorganization was preformed on 663 cases of ADR report from January 2010 to November 2013 in this hospital .We selected 103 cases of TCM in-jection′s ADR reports,and made statistics and analysis according to patients′age,sex,drug source,report source,eval-uation,clinical features,system and organ ADR involved,etc.Results 103 cases of ADR reports involved in 26 kinds of drugs.All of them were vein medication .87.37%of the above cases were happened in 30 minutes with gender ratio of 60:43.54.36%were old patients over 60 with the highest incidence rate .33.98%were skin and appendages dis-orders.14.56%were Breviscapine ADR reports which was the most one .Conclusion It must insist on monitoring ADR of TCM injection and re-evaluation of market products ,to use TCM injection normative and rational ,and guaran-tee the medication security .

17.
World Science and Technology-Modernization of Traditional Chinese Medicine ; (12): 1433-1436, 2013.
Article in Chinese | WPRIM | ID: wpr-441629

ABSTRACT

It has been widely accepted in modern pharmaceutical industry that quality cannot be tested into products , instead quality should be built-in by design . However , the implementation of Quality by Design ( QbD ) in development , manufacture and supervision of traditional Chinese medicine ( TCM ) still remains to be a challenge . The program of safety re-evaluation of TCM injections provides an opportunity to practice QbD approach in TCM industry . This paper discussed some potential ways that improve the quality of TCM injec-tions base on QbD related tools , including identification of critical quality attributes , critical process parameters and critical material attributes, development of design space and control strategy.

18.
China Pharmacy ; (12)2007.
Article in Chinese | WPRIM | ID: wpr-534402

ABSTRACT

OBJECTIVE:To analyze the problems of TCM injection included in Primary Medical Institutions Parts of National Essential Drugs List(2009 edition).METHODS:Danshen injection was taken as an example.The chemical composition of it (including water-soluble ingredients,fat-soluble components,other types of compounds,inorganic elements,proteins,tannins,polysaccharides,volatile oil),adverse reactions and quality standards were analyzed to investigate the problems of TCM injection included in Primary Medical Institutions Parts of National Essential Drugs List(2009 edition).RESULTS & CONCLUSION:Complex chemical composition of TCM injection and poor controlled quality standards require the further study.Because the safety of TCM injection is difficult to be guaranteed,it is necessary that reevaluation,research,consolidation of TCM injection.

19.
China Pharmacy ; (12)2005.
Article in Chinese | WPRIM | ID: wpr-534180

ABSTRACT

OBJECTIVE: To probe into the safety and reasonability of TCM injection infusion prescription in outpatient and emergency department of hospitals in Tianjin.METHODS: Infusion prescriptions were randomly collected from outpatient and emergency department of secondary and three-tier hospitals in Tianjin.Reasonability of TCM injection intravenous infusion prescriptions were analyzed in respect of dosage and usage,compatibility and administration route.General information of patients and prescription were recorded.Primary data were classified,summarized and screened using EXCEL and the statistic data were calculated using SPSS11.0 software.RESULTS: 11 medical institutions were included and 2 309 TCM injection infusion prescriptions were collected within 4 days.Dosage and dosing interval of reasonable prescription accounted for 66.91% and 80.60% respectively.The safety compatibility proportion of prescriptions was only 58.64%.CONCLUSION: TCM injection infusion prescriptions in outpatient and emergency department of hospitals in Tianjin are reasonable while there is still some unreasonable compatibility of injection.

20.
China Pharmacy ; (12)2005.
Article in Chinese | WPRIM | ID: wpr-534179

ABSTRACT

OBJECTIVE: To probe into cognition of medical staff about TCM injection and iatrogenic factors of ADR caused by TCM injection in order to provide reference for rational use of TCM injection.METHODS: The cognition of 100 pharmacists and 100 nurses in 6 hospitals about TCM injection were surveyed using questionnaire.The results of survey were analyzed statistically.RESULTS: Most of the utilization of TCM injection was standardised.A small number of inappropriate utilization of TCM injection should be improved.CONCLUSION: Clinical pharmacists need to further improve their knowledge on TCM injection because of false cognition to avoid iatrogenic factors of ADR induced TCM injection and promote rational use of TCM injection.

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