To confirm the safety of intravenous human immunoglobulin preparations (IVIG) with respect to transmission of human immunodeficiency virus (HIV), opinions for the counterplan in each pharmaceutical company were collected by a questionnaire (as of May, 1987), and also HIV antibody and HIV antigen in IVIG were detected.
According to their answers, all the pharmaceutical companies performed the screening of the collected blood and of the final preparations for HIV antibody, but no companies performed the screening for HIV antigen.
we performed the screening of IVIG for HIV antibody by three methods (ELISA, PA, Western-blot), and obtained different result by each method. The HIV antibody was detected in 6 lots out of 38 lots by ELISA (Organon), 12 out of 39 by ELISA (Abbott), 21 out of 39 by PA test, and 20 out of 39 by Western-blot test. However, HIV antigen was not detected in any IVIG lots. We recommend pharmaceutical companies to use plasma collected domestically and to apply new techologies such as heat-treatment, as much as possible to the IVIG synthesizing, in the near future.

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Sodium Valproate (VPA-Na) rectal suppositories are sometimes requested for to epileptic patients who have difficulties in oral administration. So, VPA-Na suppositories were prepared with these different bases-Polyethylene Glycol (S-1), Witepsol H-15 alone (S-2) and Witepsol H-15 containing Polyoxyethylene Lauryl Ether (S-3). The in vitro release rate from S-3 was higher than those from other bases. In rats, the bioavailability of the suppository prepared with S-3 was as high as that of the syrup. In the clinical application of the VPA-Na suppositories, it is suggested that the suppository prepared with S-3 was more effective than those with other bases.

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Because a Norfloxacin tablet is often used by grinding although it is film-coated in consideration of stability to moisture absorption and light, its stability, after grinding was determined. Norfloxacin powder prepared by grinding was divided and packed using 2 kinds of powder papers, and then stored under 3 different conditions;they were, prevention of light at room temperature, 30°C and 92% of relative humidity (RH), and exposure to fluorescent light (800 lx) at room temperature. After that, the observation of appearances, the measurement of hygroscopic degree, and the measurement of Norfloxacin content and the identification and quantification of decomposition products by high-performance liquid chromatography were undertaken.
As a result, there were no changes when stored under prevention of light at room temperature. On the other hand, the powder became colored and decomposed when stored under exposure to fluorescent light at room temperature, or rapidly lost its fluidity due to moisture absorption when stored under 30°C and 92% RH. These results suggested that we should be careful with moisture absorption and light to store this drug after grinding.

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200mg of valproic acid (VPA) was orally administered to 7 healthy adults at 9 a.m. and 9 p.m. for 5 days. On the 6th day, blood samples were collected at 0, 10, 20, 30, 45, 60, 90, 180 and 360 min and the obtained 63 sera were prepared for analysis. There was a significant relationship between VPA dose and total VPA concentration in the serum, the regression curve was y=0.330x²+22.051 (r=0.469, p<0.001). After the last dose, maximum change of total VPA concentration reached at 60 min and the value was 84.0±29.9%(mean±S.D. n=7). Maximum change of unbound VPA fraction reached at 90 min and the value was 26.6±33.2%(mean±S.D. n=7).At 360 min, the coefficient of variation of total VPA concentration change was 30.7% and that of unbound VPA fraction change was 191.5%. Protein binding of VPA showed a tendency to depend on its total concentration in the serum.

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Intestinal absorption characteristics of atenolol (AT) were measured by the plasma concentrations after oral and small intestinal administrations and monitoring its disappearance from in situ intestinal loops in anesthetized rat. Relative AUC of AT after oral administration in rat was 24% as compared to AUC value of intravenous administration. However, relative AUC for small intestinal administration in the anesthetized rat was 76%. Following administration of AT into duodenal, jejunal and ileal loops, AUC calculated from blood levels was 705, 613, and 838μg·min/ml, respectively, and the order was consistent with the absorption rate.
Disappearance rate constants were 3-0.5h^-1. The result shows that there is no difference in absorption from each segment of intestine. Rat intestinal AT transport showed concentration dependency, especially up to 25μg/ml in the mucosal medium, in an experiment using in vitro everted rat intestinal sac prepared from duodenum, jejunum and ileum.

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The effects of suppository bases on the release of atenolol (AT) and its rectal absorption in rat and rabbit were studied. The release profiles of AT from various suppository bases were different by dialysis tubing method. The release of AT from Pharmasol B115 was markedly rapid and after 40 min reached 100%. The order of the release rate was Pharmasol B115>T115>macrogol 4000. The plasma concentrations of AT after rectal administration of various bases were measured for 5hr. In rats, C_max for Pharmasol T115 was higher than those of the other bases, and AUC for Pharmasol B115 was the largest value among the bases tested. Relative AUC for Pharmasol B115, T115, and macrogol 4000 as compared to AUC value of intravenous administration were 34%, 25%, and 9%, respectively. In rabbits, C_max and AUC for Pharmasol T115 was larger than those of the other bases. Relative AUC of AT for macrogol 4000 was below 10% in both rat and rabbit. The plasma level of AT for Pharmasol B115 containing sodium n-caprate considerably increased as compared with that of the base alone for 2hr.

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A sensitive and specific method for the determination of hydrogen peroxide by high performance liquid chromatography is developed. It is based on elimination of the native fluorescence of 5-hydroxytryptamine by an oxidative reaction between 5-hydroxytryptamine and hydrogen peroxide in the presence of peroxidase. Under the described conditions, hydrogen peroxide was determined in the concentration range of 0.5-10μ M; the within-assay coefficients of variation (C.V.s) were 2.41% or less, with a mean recovery of 103.2% against additional hydrogen peroxide in the samples. This system can be utilized for the determination of plasma L-(+)-lactate using L-(+)-lactate oxidase. The detectable range of L-(+)-lactate was 0.5-8.0mM; C.V.s were 6.76% or less.

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In order to examine the efficiency of dispensing work in the stage of dividing and packing of powders, by new automatic dividing and packing machines introduced, Monte Carlo simulation was carried out by a computer. At the same time, the new machines were tested for error of dividing weight, the accuracy of dividing weight in relation to the number of subpacks, and the rate of loss. The machines tested were TOKYOSYOKAI OMP-90 type (OMP) equipped with a linear vibrator to feed powders into the division holes by alternating motion, and YUYAMA YS-63R type (YS) with a linear vibrator to feed into the revolving disk (80rpm), which was formed by gap of V-like. Fine Lactose, SM^®, powder, Crystalline Lactose, MIYA-BM^®, Fine Granule, and Berizyme^®, Granule were selected as the sample for the studies.
As a result of simulation, YS was more efficient than OMP in the service system. YS showed smaller variations of dividing weight than OMP tested. In case of OMP, dividing weight of the third and the third last packages at the turn of linear vibrator, was much heavier than that of other packages. In some of these drugs, errors in dividing weight increased with a greater number of subpacks.For the rate of loss, YS was slightly smaller than OMP tested.
As for the automatic dividing and packing machine, the accuracy of dividing weight is contrary much to efficiency of dividing and packing speed. Therefore, these results suggest that this method is much useful to select a machine by using the two kinds of contrary factors from the practical point of view.

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Stabilities to temperature and humidity of two commercial test papers for glucose in blood were investigated. A₁, A₂ (A₁ was sealed with aluminium foil) and B were used as samples. Tight containers were used for A₁ and B. These samples were stored under condition s 30°C with 80% of relative humidity (RH) or 50°C with 80% RH for 30 days. In the case of the examination of the influence of humidity, the caps of individual samples were opened.
The result were as follows: 1) Blood sugar values of A₁ in the opened or closed containers, and those of A₂ and B in the closed containers were decreased. 2) Those of B in the opened containers were increased.

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The compatibilities of ethanolamine oleate (EO) injection with 4 kinds of contrast media (meglumine amidotrizoate, iopamidol, iohexol and ioxaglic acid), distilled water for injection or isotonic sodium chloride solution which might be admixed in the sclerosing treatment of esophageal varices were tested. We observed the changes in appearance, pH, osmotic pressure, viscosity and the capacity of fluoroscopic visualization, and quantitatively analysed oleic acid and ethanolamine at regular intervals. The capacity of visualization was measured by X-ray fluoroscopy. No change was observed in the mixtures of EO with iopamidol, iohexol or distilled water for injection. The viscosity of the mixtures with iopamidol or iohexol were comparatively low value at 3.3, 2.7 cP respectively, and the discharge of these two mixtures in the process for injection might be easy. But when admixed with meglumine amidotrizoate, ioxaglic acid or isotonic sodium chloride solution, the change in the appearance (whitening or separation into two phases) was observed.

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