A method was developed to determine the dissolution and release of ingredients of suppositories by using ^99mTc, a short-life radionuclide, as a tracer. Suppositories on the market were melted at as low temperature as 45-50°, and poured into a plastic suppository tray. Tracer was added to the product which was cooled to 4°to remold. The resultant product was used as suppositories for testing.
The melted suppositories contain in each 20g Na^99mTcO₄ about 500μCi and sulpyrine 500 mg. Remolded suppositories weigh about 1.3g each. The ingredient-releasing characteristics were determined in terms of the amount of 99mTc in the suppositories released into water at 37°through cellulose membrane in the form of ^99mTcO₄^-. The dissolution of ingredients was measured in terms of the amount of ^99mTcO₄^-eluated into water at 37°without passing through the membrane. As a result, significant difference in dissolution and relasing was observed not only among the same category of drugs but among same brand of drugs.

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Compatibility of Gastropylore (GP, lamb's gastric mucosal extract) with other preparations was studied in terms of its residual protease activity. The admixtures were stored at relative humidity 75%, and temperature 20°, and at 92% and 30°, respectively. The protease activity of GP, stored alone at RH 92% at 30°, was stable for 2 weeks in spite of considerable damping. However, when GP was compounded with alkaline preparations, its protease activity became distinctly unstable after the storage at RH 92% at 30°. A statistically significant negative correlation was suggested between the basic degree of gradients and percentage of residual protease activity of the GP admixtures. It is not recommended that under the poor condition of moisture-proof GP is compounded with such antacids as sodium bicarbonate.

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The stability of dexamethasone (DMS) in vanishing creams of various pH was studied. Vanishing creams containing 1% MDS were exposed to air at 40° and stability of DMS was measured by using high speed liquid chromatography (HSLC). The conditions of HSLC were as follows: model: JASCO FLC-350; detector: UVIDEC-1; wavelength: 239nm; column: HP-01 (copolymer of styrene-divinylbenzene) 4.5×250 mm; mobile phase: MeOH; flow rate: 1 ml/min; pressure: 40kg/cm² (at room temperature). The extracted DMS was directly injected into the HSLC column and its stability was determined from the peak height of DMS on the chromatogram. It was found that DMS in vanishing creams was unstable under the basic condition and the decomposition product of DMS in vanishing creams was 3, 17-ketosteroid.

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Nine brands of cephalexin granule were compared in regard to change in appearance, weight, pH value and potency under a fixed condition and after their dissolution in water. Two of the 9 brands were found to fall short of the labeled standard of fine granules. When the granules were stored at 25° at relative humidity 50%, no significant change was observed in appearance, weight, pH and residual potency. When the granules were dissolved in water, no brands showed marked reduction in potency in 14 days, but some were inactivated in 14-30 days.

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Six brands of multiple digestive enzyme capsules were tested for their stability of weight, disintegration of capsules, enzyme activity and dissolution in the solutions of pH 6.5, 5.0 3.0, and the 2nd fluid of J. P. IX after storage in press-through pack (PTP) at room temperature for one year. After storage, properties of some preparations were degraded. When stored in simple packs prepared by the manufacturers, the preparations maintained better stability than the storage in PTP, though slightly degraded in quality.
AC and PT were tested for the change with time in their activity and dissolution through the storage at 30°, 80% RH, and at 35°, 80% RH in and out of PTP. At 30°, their enzyme activity seemed to be stable for 4 weeks, though the color and odor of the content of capsules increased gradually. Acid resistance of enteric coating of PT, which was initially excellent, was gradually lowered. After storage for 6 weeks at 35°, AC and PT changed solubility of capsules, and their odor became practically intolerable.

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The bioavailability of 2 kinds of digoxin tablets (0.25mg) on the Japanese market was compared. Two tablets were given daily in empty stomach to 3 each of healthy men and women. Serum levels of digoxin were measured by radioimmunoassay before and 0.5, 1, 2, 4 and 6 hours after the administration. In vitro tests were performed to determine the weight variation, hardness, content, disintegration time and dissolution time of the tablets. As a result, some differences in the test items were found although they might be caused by additives in the tablets.
There was no statistically significant difference in the serum level among the products because of the fact that the difference among the human subjects was larger than that among the products. Therefore, it can be said on the basis of the in vitro and in vivo tests that the two products are interchangeable. But the blood level of digoxin should occasionally be determined in patients under this therapy because of individual difference in bioavilability.

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Bactericidal effect of mixed disinfectants (10% benzethonium chloride solution: Hyamine-T Solution; 5% chlorhexidine gluconate: Hibitane) was studied. Several strains of Pseudomonas aeruginosa, P. maltophilia, P. cepacia, Escherichia coli and Staphylococcus aureus were used. Minimum inhibitory concentration (MIC) was compared among the two agents and their mixture by the method of Anjo et al. It was found that the mixture showed higher MIC than two other single-entity products, indicating the synergistic effect of the ingredients. The bactericidal effect reached maximum when 10% benzethonium chloride solution and 5% chiorhexidine gluconate were compounded at the ratio of 7: 3.

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Demand for drugs at hospitals, under the inevitable effect of various uncertain factors, shows constant fluctuations. Therefore, in the inventory control of drugs, the forecast for demand has a close relation with the inventory levels. The exponential smoothing, as the extension of the weighted method of moving average, is practically very useful, for example, for the adjustment of the rate of response to the changes in demand. We have applied the second-order system of exponential smoothing in the forecast of the linear model demand in the inventory control of drugs. “ The sum of the absolute value of the forecast errors” and “the absolute value of the running sum of the forecast errors” were calculated. Then, regarding their ranking as the minus points, the 2 smoothing systems were evaluated by adding up those points. In consequence, it was found out that the first-order system of smoothing is apt to cause delayed response and that the second-order system of exponential smoothing may enable to make more accurate estimation of the expected demand.

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The bacterial contamination of bath water used for the water therapy in the rehabilitation department was investigated for the prevention of infection in the hospital. The measurements of the bath tub were 1.8 m long, 0.8 m wide and 0.75 m high. The volume of water in the bath was about 600 L. The water always overflowed at the rate of about 20 L/min. The temperature of water was about 41°. 1 to 3 patients took the bath in a tub at the same time for about 15 min. The bacterial contamination of bath water containing chlorhexidine gluconate in the concentration of 0.005% was compared with the condition of the non-treated water. No contamination was caused in treated water, but non-treated water was contaminated. The number of colony was 10/ml as average in 25 tests. Main causal microorganisms were Stapylococci, Bacilli, Micrococci and Pseudomonas. S. aureus was detected only, once in the period of study. It was confirmed that bacterial contamination of bath water was prevented by adding chlorhexidine gluconate in the concentration of 0.005%.

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Recently Irgasan DP 300 (DP) has been widely used as an inactivator of HBs antigen. Although some literatue reports negative opinions on the effect of the agent, it must be practically used as an antiseptic in HBs antigen positive patients, because there is no other suitable inactivator which may directly contact the skin. In Nagasaki Chuo Hospital, it was suspected that many inpatients had dermatitis after use of 0.5% DP in 70% ethanol. Hence, the investigation was held in the liver disease ward, and the following three kinds of alcohol solutions were used as antiseptics for 50 inpatients for 2 weeks to replace 30 % isopropanol: a) 70% ethanol, b) 0.3% DP alcohol, c) 0.5% DP alcohol. DP was studied in terms of thin-layer chromatography (TLC), pH and UV spectrum. The results were as follows: 1) The usage of 0.3% DP in the ward caused dermatitis in 8 patients and 0.5% DP in 4 patients. The patch test revealed 1 positive patienst DP. But it was impossible to distinguish the irritation potential of 0.3% DP alcohol from that of 0.5%. 2) The pH value of 0.5% DP alcohol showed not a remarkable change after exposure to sunlight. The TLC and UV spectrum also produced no change. It is reported that DP does not cause severe irritation in the skin, but the results of these studies do not support such view so far as alcohol solution of DP is concerned. Hence, the application of DP alcohol must be carefully controlled; particularly it should not be applied to the skin for a long period.

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To clarify the actual condition of bacteruria after operation, statistical analysis was carried out on bacteriuria in 333 inpatients in the department of urology of Yamaguchi University Hospital. The number of the strains isolated from the urine of all the patients during the 4 years from 1975 showed a decreasing tendency, but Serratia and Pseudomonas aeruginosa continued to be observed in many patients. In benign diseases, the postoperative bacteriuria was apparently correlated, respectively, to the period of indwelling catheterization, presence of bacteriuria before operation, age and the combined treatment of β-lactam antibiotics with aminoglycosides. In malignant cases, the correlation was observed only to the 2 former factors above mentioned. The correlation between bacteriuria and the operation procedure was not confirmed from the sample size in this analysis.

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