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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 establish the HPLC fingerprint of Zhibai dihuang pills(concentrated pills),and to evaluate its quality. METHODS:The determination was performed on Dikma Diamonsil C18column with mobile phase consisted of 0.1%acetic acid solution-methanol(gradient elution)at the flow rate of 1.0 mL/min. The detection wavelength was set at 260 nm,and column temperature was 30 ℃. The sample size was 10 μL. Using paeonol as reference,HPLC chromatograms of samples from A, B,C manufacturers within validity period and samples from manufacturer A within validity period and out of validity period were drawn. The similarity of HPLC chromatogram for samples from A,B and C manufacturers and samples from A manufacturer within validity period and out of validity period was evaluated by TCM Chromatogram Fingerprint Similarity Evaluation System (2004 A). Common peaks of HPLC chromatogram for 3 manufacturers sample within validity period were confirmed. RESULTS:There were 24,29 and 32 common peaks in HPLC chromatograms for each 10 batches of samples from manufacturer A,B and C within validity period,respectively. The similarity of corresponding HPLC chromatograms of samples from manufacturer A,B and C compared with control HPLC chromatography were all higher than 0.94 with good agreement. HPLC chromatograms of sample from A manufacturer within validity period had good agreement with that from A manufacturer out of validity period. CONCLUSIONS:Established HPLC fingerprint analysis method can represent the quality of Zhibai dihuang pills (concentrated pills),but cannot effectively identify the expired samples.
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AIM To evaluate the stability of Zuogui Concentrated Pills.METHODS HPLC was applied to determining the contents of acteoside,loganin and hyperoside,whose relative contents were detected by classical constant temperature accelerated test,after which the fitting of kinetic equation was conducted.The period of validity was predicted by classical constant temperature method and multivariate linear model,and the stability was investigated by high temperature,high humidity,strong light,accelerated and long-term tests.RESULTS The degradation of acteoside,loganin and hyperoside accorded with the first-order kinetic process.The periods of validity were found to be 25.6 months and 23.9 months by two methods,respectively.No obvious changes were observed on three constituents' contents,appearance and character,disintegration time limit,moisture content and weight variation under various tests.CONCLUSION A tentatively scheduled two-year validity period is suitable for Zuogui Concentrated Pills due to its good stability.
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Objective To study the validity period of glassware containing sterilized oral instruments after disinfection unsea‐ling .Methods Fifteen stomatology consulting rooms were selected on the normal working day by using the convenience sampling method .2 sterilized glass containers (filled with sterilized instruments) were selected in each room .The samples were collected at 4 ,8 ,24 ,48 ,72 ,96 ,120 ,144 ,168 h during the use process after unsealing the containers and the growth situation of bacteria was carefully observed .Results Thirty glasswares had no bacterial growth at 4 ,8 ,24 ,48 h during the use process after unsealing ,only 3 bacteria grew in the sampling culture at 72 h ,the differences had no statistical significance compared with at 4 ,8 ,24 ,48 h (P>0 .05);10 bacteria grew in the sampling culture at 96 h ,the differences had statistical significance compared with at 4 ,8 ,24 ,48 h (P<0 .05) .The validity period of glassware containing sterilized oral instruments after disinfection unsealing was 48 h .Conclusion The validity period of glassware containing sterilized oral instruments is 48 h after disinfection unsealing ,the extension of validity period can decrease the sterilization times ,reduce the equipment wastage and prolong the equipment service life .
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Currently, all medical advertisements in periodicals, leaflets, posters, street banners and online newspapers are subjected to prior review to verify whether they comply with relevant standards. Ironically, medical advertising on public transportation, on the Internet or on broadcast is not subjected to prior review even though such media are far more influential to medical consumers. With these facts in mind, Korean government needs to widen the scope of prior review for medical advertisements on the media. The expansion of the regulation should not be considered as an increased governmental interference with commercial activities. Appropriate advertisement standards are necessary to prevent excessive competition, and also to protect interests of the medical service providers, who themselves could become the victims of false and exaggerated advertisement. Since it is likely that the medical advertisement on broadcast to be allowed from the year 2010, relevant laws and regulations need to be revised in due time to enable proper review. Claims made on Internet websites by medical service providers should also be reviewed. In addition, approvals for medical advertisements should have a temporal regulation so that certificates of approval are only valid during a given period of time.