Properties of commercial digestive enzyme capsules (Aczym, Berizym, Excelase, Feltase, Holmilase, Panatose, Politose, 7E, Stomilase, Toughmac-E) were examined. The gastric layers of the preparations were separated from the enteric cores, and their digestive activities (protease, amylase, lipase) were compared with each other. The enzyme combination ratio was also determined from weight and protease potency variation. The results were as follows: 1) The specific activities were recognized of amylase in Aczym, lipase in Berizym, protease in Toughmac-E, and total enzyme in Politose. 2) All the preparations showed a narrow weight variation range and conformed to the provisions of J.P. IX. 3) Aczym, Excelase and Panatose had a narrow variation range of the enzyme combination ratio and were on the market as a hombgeneous preparation. However, Feltase, 7E, Stomilase and Toughmac-E had a wide variation range, whereas Berizym, Holmilase and Politose showed narrow range except some lots.
In consideration of the difference among lots, we should evaluate repeatedly the quality of digestive enzyme capsule preparations at regular intervals.

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The quality of 5 kinds of commercial spironolactone tablets was evaluated by several tests, such as dissolution, weight variation, content, content uniformity, disintegration and hardness. 2 kinds of apparatus were used in dissolution test: one described in U. S. P. XIX (rotating basket method) and the other in U. S. P. XX (paddle method). 50% dissolution time (T50) differed amo ng samples tested, where the times by rotating basket method were from 3.9 to 120 min or longer and those by paddle method were from 3.6 to 28.2 min., The difference of the apparatus on the dissolution test has an influence on the dissolution rate and T50, whereas T50 of the high dissolution rate samples was nearly equal by either method, but of the low rate samples it was smaller by paddle method than by rotating basket method. Weight variation was 0.6-2.0%, while the disintegration time was less than 7.9 min. Those tests met the requirements in J. P. IX. The content was 98-101% which was within the U. S. P. limits (95-105%), while the content uniformity also satisfied the U. S. P. limits. The hardness was 2.1-7.7kg/cm².

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The acid resistance as well as the heat resistance of 2 kinds of powder (A and B) and 1 kind of granules (C) containing β-galactosidase were compared. The acid-resistance of samples B and C was better than that of A. At the optimum pH of 3.3, the enzyme activity of samples B and C was reduced by 20%. Then, the enzyme activity was measured under the cruel conditions (30°, RH 92%), and at room temperature conditions (24-30°, RH 70-75%) for 6 weeks. The enzyme activity of the 3 preparations was reduced about 30% under the cruel conditions, and about 20% under the room temperature conditions. Under the cruel conditions, the water content of samples A, B and C after 6 weeks increased 10, 6 and 3%, respectively.

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Recently, different kinds of intravenous γ-globulin are introduced to medical field, where they are used in combination with antibiotics for infections, autoimmune disease, malignant tumors and so forth.γ-Globulin preparations are manufactured by various pharmaceutical companies in different prescription, method of preparation and reconstruction, and kits and containers for reconstruction.
Considering the safety of drug in use, we investigated the stability and effervescence at dissolution of 5 commercial intravenous γ-globulin products, change with time in effervescence volume as well as sensitive manual test method on product handling from the standpoint of the drug management. In addition, problems related to intravenous γ-globulin in use were studied to make an overall evaluation of γ-globulin.

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It was reported that in a clinical study prothrombin time in patients under anticoagulant therapy changed after intake of green vegetables. The relation between anticoagulant warfarin potassium, vitamin K and prothrombin time was investigated. Vitamin K₂ was administered intravenously to the rabbits with hypoprothrombinemia caused by the oral administration of warfarin potassium. As a result, remarkable suppression of prolongation of prothrombin time was shown. When a spinach extract was given to these rabbits, the same effect was observed. Therefore, it was considered that prothrombin time in patients taking anticoagulants was influenced by the intake of green vegetables rich in vitamin K such as spinach.

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Lyophilized phenytoin was mixed with Witepsol H-15, S-55 and glycerogelatin to manufacture suppositories, and physical properties as well as release and rectal absorption in rabbits were studied. Phenytoin suppositories mixed with Witepsol H-15 and glycerogelatin showed a similar release action, while not a significant difference was observed in C (max) and A. U. C. Phenytoin suppositories combined with Witepsol S-55 showed a significant difference in a release action, C (max) and A. U. C. from other suppositories. Not asignificant difference in blood concentration was shown between the suppository and oral administration except the level after use of Witepsol S-55.

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Requests for tablet identification, one of the drug information services, compose as much as 32% of the total requests made to our drug information office. It is often difficult for hospital pharmacists to identify when no information is labelled on the tablet and on the package. In order to settle the difficulty, the contents of tablets were identified by the UV absorption technique, which proved more reliable than the conventional method. As the spectrophotometry is easy to operate and versatile to apply, the technique is one of the most practically useful methods of the tablet identification.

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In order to study a change in mixed injection solution, stability of aqueous solution of injectable sodium cefapyrin (Cefatrexyl, CEPR), a cefalosporin antibiotic, was investigated at 15°, room temperature (20°±5°) and 37°, and degradation products as an indication of the stability were monitored with thin-layer chromatography, bioautography and absorption spectrophotometry. The residual potency was also measured by bioassay. The following results were obtained: 1) Changes in appearance and pH were not opserved in the CEPR solution for 7 days, and the residual potency was 96.4% after 24 hrs the potency was 98.3% and color intensity was increased. The potency at 20° and 37° was 94.3 and 67.3%, respectively. 2) The CEPR solution produced a white precipitate at pH 5.00, and the color intensifies at alkaline pH. It was stable for 24 hrs at pH 6.00-10.00 at 5°, and at pH 6.00-9.00 at 20°. 3) The CEPR solution produced desacetyl cefapyrin, a desacetyl group of CEPR, at 20° 14 days after its preparation, and at 37° 7 days after.

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Incompatibility of sodium cefapyrin (CEPR) with 22 kinds of commercial intravenous drip infusion solutions, 44 kinds of injections and clinically used mixed injections was studied. The stability of this product was examined with thin-layer chromatography, bioautography and bioassay. The results are as follows: The CEPR solution, a mixed injection not containing unfusion solution, generally reduces its potency and changes appearance with time. The clinically used CEPR solutions containing infusion soultion remain stable for 6 hrs showing no change in appearance, pH and potency. Marked reduction in potency was, however, observed in 24 hrs in the CEPR solution containing amino acids or tathione (600mg).

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Noise generated by dispensing machines in the hospital pharmacy was measured and analyzed by the 1/ 3 octave band in order to examined its effect on workers in the pharmacy. The results obtained were as follows: 1) When all the machines in the pharmacy were in operation, loudness of the noise in the center of the room was 72-73 dB (C), while that near the source of noise was 80-83 dB (C). 2) The noise, as measured by the 1/ 3 octave band, had a peak of 63 dB at 160 Hz in the center of the room, and under 60 dB on the average in the room. 3) In the area near the source of noise, the peak of noise was 71 dB at 2, 000 Hz when one packing machine was operated, and 72 dB when two packing machines were in operation. The loudness was decreased to 63 dB at 250 Hz when no packing machine was operated.
When all the machines, not only packing machines but air conditioners and cleaners, were in full operation, a loud noise of ca. 75 dB was generated at 2, 000 Hz, and over 70 dB at 50, 125, 500, and 1, 600-2, 500 Hz. These are close to the permissible noise exposure standard for acoustic protection recommended by the Japanese Society for Industrial Hygiene, and the measurements for reduction of noise in the pharmacy should be taken.

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