Digestive activity, dissolution and stability of enzyme ingredients were compared among 4 commercial products (SV, EX, BE and FE) of multiple digestive enzyme Capsules. 1) Amylase: Gastric-soluble pellets of FE showed a strong and stable digestive activity in broad pH range, but enteric-soluble pellets had a weak activity. Gastric-and enteric-soluble pellets of 3 other products showed an equal digestive activity, but alkaline amylase activity of SV and EX became inactive in acidic solution. 2) Protease: Gastric-soluble pellets of BE and enteric-soluble pellets of FE had weaker digestive activity, and all other products had an equally strong digestive activity and stability. 3) Lipase: Gastric-soluble pellets of FE showed a strong and stable activity in broad acidic area, and digestive activity of entericsoluble pellets was rated in the order of EX>SV=BE>FE. Stability of lipase of 4 products lowered in proportion to increase in pH value of alkaline solution, but the strong lipase activity of the 4 products persisted for a long time in a weak acidic solution. 4) Cellulose: Cellulose, contained in only gastric-soluble pellets of 4 products, showed an equal digestive activity and stability, except for strong digestive activity of BE and excellent stability of FE. 5) Dissolution of enzymes contained in enteric coated pellets: FE showed excellent dissolution and BE had less dissolution of some pellets. Dissolution of enzymes from some enteric coated pellets of EX was noted in acidic solution. The above findings indicated that BE and EX contain heterogeneous pellets.

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The in-vitro dissolution patterns of 5 commercial diazepam tablets (2mg) were examined by means of J. P. IX disintegration apparatus. The disintegration times of the tablets investigated varied between 30 and 660 sec. However, the dissolution patterns were not significantly related to the disintegration time, though they were dependent principally on the fluids used as dissolution media. In an acidic medium (ie, 1st fluid of J. P. IX), a rapid and similar dissolution pattern was observed with all the tablets; more than 92% of the final amount (dissolved in 120 min) dissolved within the first 10 min. But in a neutral and weakly alkaline medium (water and 2nd fluid of J. P. IX), some retarded and different patterns were observed. These results were discussed in view of the pharmaceutical factors and bioavailability.

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Residual ethylene oxide gas on catheters was determined and the surface of catheters was examined with electron microscope. The amount of residual ethylene oxide varied depending on the preservation condition of catheters and increased with repeated sterilization. Among 4 types of commercially available catheters examined, the residual amount of ethylene oxide was found largest on Nelaton's catheter, followed by that on the stomach catheter, cardiac catheter and polytetrafluoroethylene tube. Electron microscopic observation showed that the surface of Nelaton's catheters was roughened with repeated ethylene oxide sterilization, suggesting that the residual amout of the gas corresponds to the roughness of the surface of the catheters.

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Basic solutions (IVH-1A and -1B) for hyperalimentation were compared with control solutions prepared in combination of various agents, in respect of: 1) time required for admixture; 2) microbial contamination, and 3) particulate contamination to be caused during the admixture. The results: 1) The time required for admixture of a bottle of IVH-1A solution averaged 8 min and 38 sec shorter than that for the 1A control solution, and the time for IVH-1B solution was 8 min and 8 sec shorter than that for the 1B control. When 5 bottles of the 2 basic solutions were prepared respectively in as efficient manner as possible, the time for admixture of IVH-1A solution was 44 min and 26 sec shorter on average than that for its control solution, and the time for IVH-1B solution was 39 min and 47 sec shorter than the control. Thus, IVH solutions were easier than the control solutions to prepare in large number of bottles. 2) In all of 200 each bottles of respective solutions prepared, microbial contamination was not detected. 3) The particle count in IVH-1A solution was about one 4th of that in the 1A control, and the count in IVH-1B solution was about one 6th of the 1B control.

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At Osaka University Hospital, trace element injections for intravenous hyperalimentation (IVH) were prepared and quality tests were conducted on their content uniformity and sterility. The composition of the injections was: IVH-Zn: Zn 20μmal; IVH-M: Zn 20μmol, Mn 40μmol, Cu 5μmol, I 1μmol. The ingredients were filtrated through 0.45μm membrane filter, filled and wet-sterilized at 121° for 20 minutes. The content uniformity was determined by Atomic Absorption Spectrophotometry. The standard contents of the elements in the injections were determined in the range of 90 to 110w/v%. All lots were negative to Sterility Test (J. P. IX).

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Enteric coating substances were tested in terms of disintegration time of the preparations. The samples used are 8 brands of multiple digestive enzyme capsules containing enteric coated granules and 5 of enteric coated granules (2 anti-inflammatory enzyme preparations and 1 each preparation of an antipyretic, kallidinogenase and ATP). The dissolution test was also conducted on the digestive enzyme preparations. Although all the samples passed the disintegration test of J. P. IX, the disintegration time of all the samples delayed when pH of the test solution was less than 6.0. After detailed observation, the samples were classified into two groups: group 1 in which disintegration time delayed at 5.25 and stopped at pH 5.0, and group 2 in which the time delayed at pH 5.5 and stopped at pH 5.25. The delayings were also found in the dissolution profiles of active ingredients from the sample preparations. In the analysis of the enteric coating substances by infrared spectra, the substances in group 1 were identified with hydroxypropyl methyl cellulose phthalate and those in group 2 with cellulose acetate phthalate. It is concluded that enteric coating substances used in pharmaceutical preparations are identified by the disintegration time and infrared spectra.

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The study was made on prescribed doses of 317 drug products for oral use which appeared frequently in 6, 594 inpatient prescriptions filled at the University of Tokyo Hospital in 28 days purposively selected from a period of 4 months from March to June 1976. The prescribed doses were compared with usual doses stated in the Pharmacopoeia of Japan and package inserts. The drug products prescribed within usual dose range composed 19.6% of the total products used, the drugs within and above usual dose range 24.3%, within and below 30.5%, within and above and below 20.2%, and out of usual dose range 5.4%. The percentage distribution agreed with a conjecture of pharmacists in practice.

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The relationship between the frequency of the use of drugs and diseases at respective departments of Kumamoto University Hospital was discussed. In the study on the relationship between agents affecting digestive organs and diseases, it was found that for various reasons such agents were used for the diseases other than their own indications. The complexity of the contents of prescriptions in some departments was due to the treatment for complications.

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Some measures were taken at the outpatient counter at Hirosaki University Hospital for dissolution of various troubles with outpatients given drugs at 2 or more departments. Data were obtained from 8, 804 prescriptions issued to the outpatients in February 1978 and the cards of medical examination fee. 1) The outpatients given prescriptions from 2 or more departments numbered 398 who were about twice as many as the number recorded in the previous investigation. 2) The total number of the drugs given was almost equal to that of the drugs given simultaneously. 3) The number of drug interactions that might have caused adverse reactions was larger than the number in the previous study. Also the ratio of the patients given 2 or more drugs with same effect to the patients given prescriptions from 2 or more departments was higher.

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Pharmaceutical incompatibility of Fulaid Fine Granules (TF) with other 67 agents was investigated under various conditions. TF was found to be a stable agent.

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Compatibility of futraful (FT-207) fine granules with 54 commercial preparations was tested under three conditions of constant temperature and relative humidity (A: 30°, 92%; B: 23°, 76%; C: 5°, 50%). As a result, no change was observed in FT-207 fine granules and 30 of 54 preparations under any condition. Some changes such as wetness, coagulation, coloration and liquefaction were observed in 24 preparations under condition A, 11 preparations under condition B and 2 preparations under condition C. Of 24 preparations, the following 4 preparations were considered to develop changes when compounded with FT-207 fine granules magnesium oxide, aminophylline, galantase and sodium bicarbonate. By thin layer chromatography, the decomposed compound (5-fluorouracil) of FT-207 was detected in combination with 10 preparations such as enzyme and vitamin. The rate of decomposition of FT-207 allowed for 30 days under condition A was 2.5-5 % in combination with Popon S and less than 1% in combination with other 9 preparations. But these changes in appearance and potency of FT-207 with packing were less than that without packing. Any of 54 preparations are thought to be compoundable with FT-207 fine granules when sufficient care is taken to protect them from moistening.

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