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Objective To provide direction for the improvement of quality control of hospital preparations and ensure the safety for clinical use by analyzing the hospital preparation deviations in recent three years. Methods A retrospective analysis on 59 minor hospital preparation deviations from 2017 to 2019 was conducted. Brainstorming, fishbone drawing and, Minitab software were used to analyze the root causes of deviations from five aspects: personnel, machine, materials, methods and environment. The preventive and corrective measures were implemented. The results were evaluated. Results 1 significant deviation (1.7%), 24 major deviation (40.7%), and 34 minor deviation (57.6%) were identified among the 59 casses of preparation deviation. With the implementation of preventive and corrective measures, the total number of deviations in 2018 was significantly reduced compared to that in 2017. The total number of deviations in 2019 was about the same as that in 2018. The human factors need to be focused. Conclusion The pharmaceutical preparation deviations in our hospital have been reduced. The further quality improvements for pharmaceutical preparations will be carried out by following the regulations of pharmaceutical production quality management standards and pharmaceutical production supervision and administration measures.
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Objective To analyze the quality of the hospital preparation magnesium sulfate oral solution by using capability sixpack. Methods By using the capability sixpack of Minitab, the content of magnesium sulfate in the magnesium sulfate oral solution was used as an indicator to determine whether the magnesium sulfate composition reached a controlled state during the production process and whether the production process of magnesium sulfate oral solution was stable. Results The content of magnesium sulfate and the production process of magnesium sulfate oral solution was under control, but there were potential disadvantages. Based on the concept of risk management philosophy, The failure model and effect analysis (FMEA) were applied to the prospective management of potential risks. Conclusion The application of the capability sixpack in the quality analysis of the hospital preparation of magnesium sulfate oral solution is helpful for us to discover the potential risks under the controlled state of the production process, which is beneficial to the improvement of the preparation production process and the assurance of the quality of the preparation.
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OBJECTIVE: To analyze the potential adulterations in a traditional Chinese medicine hospital preparation for the treatment of rheumatism. METHODS: The suspicious crystalline substances were isolated under a stereoscopic microscope, and analyzed with GC-MS and UHPLC-MS. GC-MS measurements were preformed on an Agilent HP-5MS column with ion electron impact ionization. UHPLC-MS measurements were preformed with Agilent Zorbax SB-C18 as stationary phase and the mixture of acetontrile-0.1% formic acid as mobile phase under electronic spray ionization mode. RESULTS: Five kinds of chemical drugs were identified from the hospital preparation, including piroxicam, prednisone acetate, indomethacin, ibuprofen and vitamin B2. CONCLUSION: More attention should be paid to the adulteration in some hospital preparations.
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Objective: To predict the optimal single-batch production and annual production batches for five oral solutions in order to support equipment upgrade and control reasonable cost as well as provide reference for optimizing production management of new preparation room. Methods: The clinical use of the five oral solutions in four consecutive validity periods was retrospectively analyzed. Decision analysis was used to predict the optimal single-batch production and annual production batches for the five oral solutions. The weight coefficient was adjusted according to the clinical characteristics of each preparation. Results: The optimal single-batch produc-tion for the five oral solutions was five to seven times larger than the current scale while the annual production batches were greatly re-duced. In particular, compound ammonium chloride and glycyrrhiza oral solution ( formerly known as brown mixture) were reduced from 95 batches to 13 batches per year. Conclusion: The optimal prediction can provide reference for the appropriate adjustment of production scale of hospital preparations to lower the cost of single packaging production. At the same time, it is also beneficial to the overall management of production equipment selection and future scale design for new preparation room.
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Objective To observe the influence of Kuailvning capsule(KLN)and its drug serum on the concentration of Ca2 + in rat ventricular muscle cells.Methods SD rats were randomly divided into five groups:the control group,serum control group,KLN high -dose group,KLN medium -dose group and KLN low -dose group,six mice in each group.The rat ventricular myocytes were separated by enzymatic hydrolysis.The influence of KLN and its drug serum on the concentration of Ca2 + in rat ventricular muscle cells were observed by Fluo -3 /AMprobe.Results The mean fluorescence intensity of cytosolic Ca2 + in the KLN high -dose group,KLN medium -dose group and KLN low -dose group after 50s,100s,150s,200s,250s were [(18.75 ±1.55),(16.69 ±0.93),(17.76 ±1.26)], [(25.47 ±1.118),(17.86 ±1.49),(17.81 ±1.13)],[(29.05 ±1.31),(20.14 ±1.73),(18.26 ±1.37)], [(35.21 ±1.33),(23.19 ±0.97),(18.18 ±1.46)],[(41.08 ±1.21),(26.34 ±1.69),(17.91 ±1.01)], which were higher than those in the control group(F =5.556,7.007,8.816,10.208,12.232,all P 0.05).Conclusion KLN drug serum can promote myocardial cell spon-taneous extracellular calcium influx,the mechanism of KLN antiarrhythmic effect may be related to the Ca2 + channel.
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Objective:During establishing a big general hospital, to pay attention to the organization methods and implementation steps of medical equipment management can shorten the erection time and increase establishing efficiency.Methods: According to government investment for medical equipment and infrastructure project plan, to optimize medical equipment planning scheme; to carry on expert verification, declaration and purchasing by invitation to bid; and coordinate the equipment factories, infrastructure engineers and technicians to finish the installation site condition in order to make sure the equipment installation timely and acceptance check. Results: Based on the amount of government investment, to finish the 0.5 billion equipment plan, hundreds of medical equipment purchasement, arrival, installation and acceptance so as to ensure the hospital basic clinical requirement. To put forward solutions to difficult problems about medical equipment management can ensure every work smoothly.Conclusion: The construction of a new hospital is a system engineering included from planning design, capital construction, equipment inviting bid and installation, and decoration to application. There is affinity between each point and equipment in this system, and this system need higher professional ability and coordinated ability of equipment manager. At present, Shenzhen hospital of Southern Medical University is establishing, managers should communicate and coordinate the process and progress of various aspects; provide planning ideas and implement methods; improve quality; shorten project period and then obtain the whole advancement effect based on possible problem in different stage of equipment management.
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Objective To explore the development of hospital preparation under the domestic health care reform .Meth-ods Research the ideas to further develop hospital preparation by analyzing the opportunities and challenges .Results The de-velopment of hospital preparation can be achieved through new technologies ,new dosage forms ,improved preparation of tradi-tional Chinese medicines ,expanded contract manufacturing ,and broader application of pharmacy compounding .Conclusion In the new health care environment ,the sustainable development of hospital preparation can be realized .Hospital preparation will continue to grow if strategies are in place to recognize and grasp new opportunities .
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This paper discusses the current prevalence of hospital preparations backward quality standard test methods, quality standards for lack of a serious problem , and analyses the reasons from four aspects , proposed to strengthen the construction of a pharmaceutical ethics; examination and approval departments shall strictly agents registration review technical requirements;rectify and improve the quality of all preparation standards;Introduction and training of strengthen pharmacy personnel , and actively improve the quality standard revision work;hospital in-creasing hardware and software construction , support quality standards revision suggestions for the improvement of work, provide reference standard for quality improvement of hospital preparations .
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TCM hospital preparation, which is only used inside its own orgnations, is an important part of clinical medicine in TCM. In recent years, the lack of a corresponding constitution of legal safeguard seriously hampered the prosperities of TCM hospital preparations. It's a high time to settle a targeted legal safeguard constitution of TCM preparations developed by the hospital. The author takes hospital of TCM preparation as the research object, starting from the current situation and problems of development of hospital of TCM to dig out the reasons. It has great significance to ensure the status of TCM preparation developed by the hospital at first, to combine with other measures. and to put forward about the establishment of comprehensive legal safeguard mechanism for the development TCM hospital preparation.
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OBJECTIVE:To provide reference for the development of hospital preparation in our hospital. METHODS:The method of SWOT analysis was applied to analyze competitive strengths,weaknesses,opportunities and challenge about the develop-ment of pharmaceutical preparations in our hospital,and to explore the development strategies of hospital preparation. RESULTS &CONCLUSIONS:The strengths include the prominent specialty characteristics of clinical key subject,a long R&D history,diverse dosage forms and varieties,definite therapeutic efficacy,etc. The weaknesses contain production capacity shrinkage,deficient con-struction of professional team,external exchange and cooperation deficiency,etc. The opportunities contain national health con-sciousness enhancement,hospital preparation included into local medical insurance reimbursement,etc. The threats contain great difficulty to register new preparation and low preparation pricing,etc. It is suggested to rely on advantage resources to enhance clin-ical formulation development,strengthen human resource management and team building,strengthen cooperation and exchanges to enhance research and development,strengthen the meticulous management to improve operational capacity,in order to formulate scientific development strategy.
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OBJECTIVE: To provide references for the development of hospital preparation. METHODS: Current situations for hospital preparation were analyzed, and development advises were provided accordingly. RESULTS AND CONCLUSION: Hospital preparation was facing many difficulties, and the resolutions could involve enforcing policy support, establishing preparation center, optimizing preparation sort, developing traditional Chinese medicine preparation, widening cooperation channel and changing work function.
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History and current situation of hospital preparation in our country and practical demands of pharmaceutical industry were analyzed. With the implementation of GMP in pharmaceutical industry and enhanced drug administration, lots of problems were exposed. The scale of hospital preparation was decreasing year by year, though it still stayed at a predominate position in hospital works currently.
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OBJECTIVE:To evaluate the role and function of hospital preparations.METHODS:A retrospective analysis was conducted on the utilization of hospital preparations in our hospital from July 1,2005 to June 30,2006.RESULTS:A total of 158 kinds of hospital preparations were used in our hospital,with their sales value totaling RMB 10.025 3 million,representing 1.13% of total drug sales.The top 10 selling hospital preparations accounted for 72.2% of all hospital preparations in sales value.A difference was seen in use of hospital preparations by outpatient and inpatient departments.CONCLUSIONS:Hospital preparations are indispensable for routine diagnosis and medication despite their small proportion in sales value of total drugs.
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The external preparation Metronidazole (MTZ) is reported to be useful in controlling the malodor associated with advanced and recurrent breast cancer patients. We prepared two different MTZ external preparations, a 1% MTZ Hydrophilic Ointment and a 0.8% MTZ Carbopol Gel. These preparations were then used to control malodor associated with breast cancer and the results were clinically evaluated. Malodor disappeared within 1 week of administration of either preparation and no adverse reactions were observed. These MTZ external preparations were thus found to be useful in the elimination of malodor as part of the treatment of those patients with advanced and recurrent breast cancer.
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OBJECTIVE: To establish a RP-HPLC method for the determination of preservative ethylparaben content in hospital preparation.METHODS: The determination was carried out on Spherisorb C18 column and the mobile phase consisted of acetonitrile-water(50∶50,V/V) at a flow rate of 1 mL?min-1.The column temperature was set at 35 ℃;the detection wavelength was set at 254 nm and the sample size was 20 ?L.RESULTS: The linear range of ethylparaben was 1.812 5～18.125 0 ?g?mL-1(r=0.999 9) with an average recovery rate of 99.92%.The intra-day RSD was less than 2.10% and inter-day RSD was less than 4.89%.CONCLUSION: The method is simple,rapid and accurate,and applicable for the determination of ethylparaben content in hospital preparation.
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OBJECTIVE: To provide reference for the research and development of current hospital pharmaceutical preparation.METHODS: The development strategy and research & development thinking were put forward on the basis of current state laws and regulations as well as the newest trend in pharmaceutical researching field.RESULTS: Firstly,the development strategy should be planned elaborately such as building moderate-scale manufacturing laboratory,introducing advanced instrument and equipment,cultivating high quality talented group,establishing highly efficient running mechanism,formulating valid incentive policy and implementing scientific standardized management.Furthermore,research and development thinking should be scientific and feasible to adopt new pharmaceutical technology to research new pharmaceutical dosage form and develop new compound preparation,distinctive preparation and Chinese traditional medicine preparation based on the clinic requirement.CONCLUSIONS: Hospital pharmaceutical preparation can go out of the predicament and realize sustainable development so long as formulating active correct development strategy and stick to scientific feasible research thinking.
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OBJECTIVE: To introduce validation to the equipments of self-made preparations in medical institutions.METHODS: The necessity and difficulties for the validation of the equipments of self-made preparations in medical institutions were analyzed from aspects of the specificity of self-made preparations,the status quo of the preparation equipment as well as the requirements on the equipments etc.RESULTS: The scope and the procedures of the validation on the equipments of preparations had been presented.CONCLUSIONS: Medical institutions should adopt suitable methods,approach and validation procedures to develop corresponding validation work for equipments of preparations based on their own condition.
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OBJECTIVE: To standardize the management on test of hospital preparations to ensure the quality of preparations. METHODS: The Access database and Word application of in Microsoft Office automatic groupware were integrated organically using VBA programming, and the data management system suitable for hospital preparation test was designed. RESULTS: The print files of various primary records and reports related to testing work exhibited beautiful page and uniformed format. Testing data of preparations were included into data base by computer recording, which facilitated data inquiry and data processing related to quality of hospital preparations. CONCLUSION: Due to this system, both the efficiency and quality of hospital preparation test work have been enhanced, which contributes to institutionalization and standardization of hospital preparation work.
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Hospital preparation is an important part of hospital pharmacy which plays an important role in the development of clinical practice.The current situation and importance of hospital preparation will be analyzed in this article.According to practice,corresponding recommendations will be expressed.
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Based on the requirements of Good Preparation Practice in Medical Institutions(GPP) and considering the actual conditions of the hospital,we decided upon a right way in the reconstruction of the hospital's preparation room and amelioration of the equipment and apparatus that constituted 30% of the investment.The results were reduced investment,higher efficiency,with perfect conformity to the GPP requirements.