Concentrations of carbamazepine (CBZ) in plasma were measured by AMES TDA^TM carbamazepine kit, a newly developed substrate-labeled fluorescent immunoassay (SLFIA). The study produced results which showed good correlation with those of homogeneous enzyme immunoassay (EMIT) and high-performance liquid chromatography (HPLC). There was a significant correlation in the plasma concentrations between SLFIA and EMIT methods (n= 92, r= 0.994, p<0.01), whereas a high correlation between SLFIA and HPLC was also found (n=92, r= 0.990, p<0.01).
For the determination of plasma concentrations of antiepileptics in the clinical field, SLFIA procedure seems to have considerable advantages over hitherto available method: This method requires only 50μl of plasma for a single determination and is quite a simple method for monitoring plasma concentrations of antiepileptics.
Concentrations of CBZ in plasma after administration of CBZ alone were compared with those after concurrent administration of antiepileptics, including CBZ, phenobarbital (PB) and phenytoin (PHT). From these results, it was found that plasma concentrations of CBZ administered concurrently with PB and PHT were significantly lower than those after administration of CBZ alone.

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In order to investigate the importance of chemical indicators (CI) in the confirmation of the reliability of sterilization process for pharmaceutical solutions which have different heat penetrations depending upon the container sizes or autoclaves, containers in 3 different capacities (0.5, 1, 3 liters) filled with purified water were autoclaved at 115° for 10 to 60 minutes. In the containers commercial CI's (products A, B and C) were immersed. Sensuous decision, color difference (ΔE) and LIF, which was found in our previous paper to be useful for the determination of sterilization time in large volume solutions, were evaluated.
Autoclaving time at which CI gives the confirmation evidence by sensuous decision was shortest when measured in chamber and the time required for products A and B was 15 minutes. Autoclaving time in solution was different among the products in the following order: C> A> B. But in all products the larger the capacity of containers becomes, the longer the time becomes. Linear relationship between ΔE of product A and of B and log of LIF was observed, even if the container size or autoclaving time is different.
LIF, therefore, can be estimated from ΔE. It is proved that when product A or B gives the confirmation evidence for sterilization to solution by sensuous decision, its solution was autoclaved at more than 7 or 6 of LIF, respectively.
Though products A and B should be used for sterilization of materials such as surgical instruments by saturated steam, it was found that when the method to immerse CI in a filling solution was chosen, the use of these CI's in addition to the thermometer gives greater validity to verifying sterility of parenteral solution in hospital pharmacy.

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The effects of chenodeoxycholic acid (CDCA) and ursodeoxycholic acid (UDCA) on enzymic activity of lipase, as well as the relationship between the lipase activity and the concentration of bile acids in bile, were studied. In the presence of bile administered CDCA, the lipase activity was enhanced significantly. A correlation between the lipase activity and the common logarithm of the concentration of total bile acid and CDCA in bile was observed, correlation coefficients being 0.723 (n=30) and 0.732 (n=30), respectively. In addition, it was observed from the result of multiple regression that CDCA and UDCA increased the lipase activity.

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5% ethanolamine oleate (EO) as sclerosant in the treatment of esophageal varices was prepared under various conditions, and the stability of the solution at room temperature for 7 or 8 weeks was studied. Oleic acid in EO was meausred as an indicator for stability of the solution by means of gas chromatograph. It was found that dissolved oxygen-removed EO was more stable than untreated one. Neither treatment of N₂ gas exchange in vial cavity nor autoclaving was essential to keep the content of oleic acid in EO for 8 weeks.
24 (88.9%) out of 27 patients with esophageal varices treated with endoscopic embolization using 5% EO made by our pharmacy were successfully treated. Frequency of complications and abnormal laboratory findings after treatment with the solution showed a rate which is roughly similar to the results reported by other researchers.

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Phenytoin (PHT) fine granule, which has the same bioavailability as the tablet, has recently been marketed. We projected a change of PHT dosage form from usual powder to fine granule. In view of the fact that 97% of PHT products prescribed and marketed are available in fine granules, 50% PHT preparations were produced in hospital pharmacy. 5 kinds of preparations using various lactoses as diluents were prepared and tested for their quality. Among them, the preparation from Aleviatin fine granule passing through a 42-mesh sieve and EFC lactose showed the best results in the mixing property and various sense tests. The change to this dosage form and its bioavailability tests were carried out by a cooperation of doctors and pharmacists. Serum PHT levels of all patients, assayed by EMIT method, showed a 20% to 30% increase after the administration of the new preparation (50% PHT fine granule with EFC lactose).

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It was found that a 10% AB-PC ointment prepared at this hospital pharmacy demonstrated a remarkable effect on the erosion of woman's vulva. Study was made to determine MIC of AB-PC ointment against phlogistic Streptococcus faecalis. Hitherto, an injection system has been used for determination of MIC of antibiotics. In this study, we tried, to use ointment itself in vitro to determine MIC of AB-PC ointment.
a) 34 strains of S. faecalis were inoculated individually into AB-PC ointments in different concentrations which were laminated on HIA. b) The AB-PC ointments in different concentrations were laminated on the strains in the same number which were inoculated individually into HIA. MIC determined by both methods, a) and b), was 0.32%.
Method a) was technically simpler and easier than method b); therefore, this method can be fully applied for hospital pharmacy to set up and prepare the most effective concentration of antibiotic ointments.

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Much attention has been paid to various factors affecting the stability of active ingredient in the oral liquid preparations, but little consideration has been given to the matter of the quality of water used in dispensing or compounding in hospital pharmacy. City water contains approximately 1.0 ppm of chlorine for disinfection. To clarify the effect of chlorine on drug stability, certain amount of chlorine was added successively to city water to maintain its concentration at 1.0 ppm. This water is nominated as “the Water” in this report. The following results were obtained:
1) 42 preparations out of 51 remained stable either in the Water or distilled water. 2) 6 preparations decreased the content of their ingredients when stored at room temperature, but they maintained the content for 7 to 10 days when preserved in a dark, cool place. These findings were obtained both in the Water and distilled water. 3) 2 preparations were inactivated more when prepared with the Water than when prepared with distilled water. The loss of content was not significant within 7 days, but the Water should be avoided to maintain the contents of these medicines for a long time. 4) 1 preparation showed little loss of content when prepared with distilled water, but showed about 80% loss when prerared with the Water, suggesting that such product should not be prepared with city water.

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The effect of storage condition and the quality of wrapping paper on the moisture protection of pharmaceutical preparations were investigated using a couple of pulverized hygroscopic pharmaceuticals and a few powder preparations having different critical relative humidity. Sodium valproate or potassium L-aspartate tablet was pulverized. Powder preparations used were potato starch, lactose, sodium chloride and fructose. 9 different wrapping papers having various grades of moisture permeability were adopted. The results of the study were as follows:
1) The moisture permeation of wrapped powder preparations is affected by storage conditions. 2) Amount of absorbed moisture decreased when wrapping papers, with low moisture permeability were used; therefore, it became clear that the selection of suitable wrapping papers is important to protect powder preparations against the moisture permeation.

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Temperature changes of heating plate were investigated during the continuous working of an automatic packaging machine for preparative packing of powder preparations. The packaging machine used was Konishi KC-606-F6. 5 kinds of wrapping paper having various grades of moisture permeability were adopted. Sealing temperature was measured by a thermosenser (Toshiba electric Co. Ltd., Model MGB 3A-1619). The results of the study were as follows: 1) The sealing temperature decreased by 30° to 34° in 10 minutes after starting in the case of glassine laminate. 2) The sealing temperature decreased as the thickness of polyethylene layer of wrapping paper increased. 3) In order to minimize moisture permeation through packages, it is necessary to set up a suitable initial temperature.

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The present situation of the alteration of dosage forms in dispensing of oral drug products for inpatients at the hospital was studied. The alterations of dosage forms involved are as follows: tablets and capsules intended for constitution as powders; tablets, powders and capsules as liquids; tablets and powders as capsules. The total number of the oral drug products prescribed for 3 months was 41, 926, including 667 for alterations. The alterations consisted of 69 % for grinding of tablets for constitution as powders, 23% for dissolution of powders as liquids, 4.9% for opening of capsules as powders, and 1.8% for capsule-filling of powders. Fifty-seven percent of the alterations were made for securing a substitute route for oral administration of tablets and capsules in patients treated by the administration through tubes terminating in the stomach.
On the basis of the results of this study, several problems caused by the alteration were discussed, such as loss in weight of tablets on sieving after grinding, method of preparation of liquid products from tablets or powders for the patients administered through the tube, and changes in bioavailability of drugs by the alteration.

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