Precision and accuracy of the enzyme-linked immunosorbent assay (Enzymun-Teste ®) were examined in determination of serum digoxin level. Coefficients of variation for analyses of the 3 levels of digoxin were less than 10% in both of within-run and between-run. Results of the present method was compared with those of radioimmunoassay (RIA) and homogeneous enzyme immunoassay (EMIT ®) in determination of serum digoxin levels in the patients with cardiac failure. It was found that correlations between the results of the present method and those of the others were fairly good.

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The determination of drug concentration in the serum by laser immunochemical system (i-PiT) is based on the inhibition of immunoprecipitation. To study the precision and accuracy of i-PiT method using a new reagent in determination of valproic acid (VPA) concentration, we used patients' sera undergoing VPA therapy. The precision of i-PiT method applied to low, medium and high VPA level specimens, expressed as coefficient of variation, was less than 7.0 % of within-day and 7.8% of between-run. The mean recovery of 10, 50 and 100 μg/ ml VPA spiked sera was 100.3%. Moreover, to study the accuracy of i-PiT method, VPA concentration in 46 patients' sera was determined by i-PiT and EMIT methods. The correlation coefficient and the regression line were 0.995 and y= 0.996x+ 0.329 (y: i-PiT, x: EMIT), respectively.
In terms of precision and accuracy, the new reagent for VPA determination by i-PiT method may be considered as one of the useful reagents for the determination of serum drug concentration in hospital labolatories.

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A high performance liquid chromatograph (HPLC) was used for the quality tests of Ubidecarenone (COQ₁₀) products. The quality tests were conducted under the following conditions: column temperature, 80°; mobile phase, ethanol-water (92: 8); flow rate, 1.2ml/ min; wavelength, 275nm. The amount of COQ₁₀ was determined from a peak area on the chromatogram. The results were as follows: 1) COQ₉ in the sample products ranged from 0.088% to 0.75%.
2) The peaks due to impurities in some sample products were observed on the chromatogram; the relative retentions of these impurities to COQ₁₀ were 0.92 and 1.37.

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A high performance liquid chromatograph (HPLC) was used for the quality test of Ubidecarenone (C_oQ₁₀) products. C_oQ₁₀ products were exposed to light under 2000 lux for 29 days, and their stability to light was studied with HPLC.
The results were as follows: 1) Good separation of C_oQ₁₀. C_oQ₉ and UC₉ was achieved with HPLC. 2) The amount of C_oQ₁₀ in granules and fine granules packed with Pile Packer Film was between 11% and 18% after 29-day exposure to light, whereas C_oQ₁₀ in granules in lightshielded package and that in raw material powder packed with pile packer Film were 74% and 90%, respectively. 3) The main decomposition substance of the granules, the fine granules and raw material powder showed that the relative retention to C_oQ₁₀ was 0.49.

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The relationship between in-vitro pharmaceutical properties and bioavailability of commercially available diclofenac sodium was described in the previous paper showing results of our general pharmaceutical tests and determination of the concentration in human plasma. Further studies were conducted this time to detect residual organic solvents in drugs, to measure the quantity of diclofenac by the ultraviolet absorption method, and to make quantitative analysis of diclofenac by atomic absorption spectrophotometry. The quantitative values of the diclofenac preparations tested were in agreement with one exception where the value was very low. On the other hand, the atomic absorption spectrophotometry study showed that some of the products contained approximately 30% of potassium salt although they were labelled sodium salt. Furthermore, the gas chromatography study showed the presence of 100 ppm or more ethanol and/ or isopropanol residuals in several products.

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The stability of adriamycin in macrogol ointment and hydrophilic ointment was studied for 4 weeks at room temperature and 5° by the bioassay and HPLC methods. Both preparations remained sufficiently stable through the 4 weeks after formulation. The releasability of adriamycin from these 2 ointment preparations was confirmed by using the diffusion tests of adriamycin based on chromatography and agar-agar methods. The results suggest that the diffusion of adriamycin may depend on the ointment base.

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The compatibility of cephacetrile with 71 additives was examined in 5% glucose solution con taming Vitamin B complex injections (thiamine hydrochloride, flavin adenine dinucleotide and pyridoxal phosphate injections). Each ampule or vial was dissolved in 50 ml of glucose solution, where a higher concentration was tenfold as high as that of usual preparation. Under this condition, Kanamycin sulfate ® Vistamycin ®, Futraful ®, Diamox ®, Neophyllin ®, Meylon ®, Stronger Neo Minophagen C ®, Proteamin 12X ®, 5-FU ® and Urokinase ® accelerated the degradation of cephacetrile. The compatibility of these additives were reexamined under practical condition in which each injection was admixed in 500 ml of glucose solution, and all the admixtures except for Neophyllin ® showed the residual amounts above 90% after 6 hr and were compatible under practical condition. White turbidity was found in the admixtures of FOY ®, Novamin ® and Wintermin ® which may be due to the formation of the salts of the componen ts with cephacetrile with low solubility.

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A dissolution test for practically insoluble drugs was developed and applied to 4 preparations of glibenclamide. The results showed that with this method it has become possible to evaluate the difference of dissolution rate of the preparations with good reproducibility for dissolution profile. Two preparations of glibenclamide made by 1 manufacturer indicated that their dissolution rates were much lower than those of 2 preparations made by the other.

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Kampo-extracted herbal drugs are available today in pharmacies or drug stores. Among them are several commercial drugs containning the same composition of ingredients. It is reported that they might be even diversified in quality by the difference in the origin of herbal crude materials, the preservation techniques, the manufacturing process or other cases. And there may be a possible existence of microbes in crude herbs used for them. We made therefore fact-finding tests with 4 drugs of Shoseiryu-toh granule or aqueous extracts, which are available commercially. First, from Syakuyaku (Paeony root), Kanzo (Glycyrrhiza) and Mao (Ephedra herb), the analyses of major ingredients such as Paeoniflorin, Glycyrrhizin and Ephedrine were made to determine the quantity of each ingredient by a high-speed liquid chromatography. Secondly the observation and count of bacteria was examined by cultivating them with these drugs in agar medium. The comparison of products by the analysis showed that the quantity of each ingredient differed by products; furthermore, the count test of bacteria number proved that some products held a possibility of microbial contamination.

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Several infusion solutions, such as 5% Dextrose injection, Hartmann's D solution ®, Proteamin XT ® and IVH solution, were experimentally incubated with Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Psuedomonas aeruginosa, and Candida albicans, and were examined for bacterial growth for 24hr. No bacterial growth was observed in these infusion solutions for 6hr. Further, the admixtures with several vitamin intravenous solutions were also examined. Although some interbacterial variance was observed, no bacterial growth was observed in the admixtures for 24hr. Among the bacteria examined in this study, Candida albicans was most potential for survival. These results revealed that once bacterial contamination had occurred during preparation of these infusion solutions, bacteria would survive until the completion of infusion. So we conclude that the methods and the environment involved the preparation of infusion solutions should be carefully monitored in order to minimize bacterial contamination.

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For J. P. Phenol and Zink Oxide Liniment, Tragacanth, a natural product, is used as a suspending agent in the content of 5%. Its viscosity is lowered with passage of time and it is then separated. To eliminate the defects, such physical properties as viscosity, yield value, extensibility, and loss rate of water content were studied; the formula and process of manufacturing of the liniment in caption aiming at how separation and lowering of viscosity with passage of time can be prevented were examined.
It was found that a combination of 1-3% of Tragacanth and 2-4% of CMC-Na as suspending agent is adequate, and as process of manufacturing it is desirable that the mucilage is first prepared by powdered Tragacanth and CMC-Na is subsequently added. When preparing the mucilage by mixing both compounds in powder, the lowering of viscosity is remarkable.

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It was investigated in order to predict the pH-dependent incompatibility (haze formation, precipitation etc.) of the injection in infusion solution. 3 kinds of injections diluted to 500 ml with distilled water and 35 kinds of infusion solutions (500 ml) were titrated with 0.1 N HCl and 0.1 N NaOH, respectively. Then the pH characteristic curve was defined as a continuous curve that consists of 2 kinds of pH titration curves (with 0.1 N HCl and 0.1 N NaOH). Positive or negative equivalent values (that represent acidity or alkalinity) of the injection and infusion solution were determined by using the pH characteristic curve. pH of the admixture was determined by using the pH characteristic curve in which the other equivalent value was plotted. The appearance change of injection in infusion solution was predicted by comparing the estimated pH and the incompatible pH of the admixture was determined preliminarily.

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