Evaluation was made on the newly developed Emit Qst assay with the use of tobramycin (TOB), gentamicin (GM), and amikacin (AMK). Items examined were stability and accuracy of the standard curve, reproducibility, and correlation with Emit assay.
The standard curves of TOB, GM and AMK prepared by a calibrator for Emit Qst assay were all stable for at least ten weeks. As for reproducibility, the coefficients of variation were all lower than 10% at all concentrations except for GM at 1μg/ml whose coefficient of variation was 21.7%. A high correlation was observed between Emit Qst assay and Emit assay with r=0.993 for TOB, r=0.997 for GM, and r=0.976 for AMK.
It was confirmed that in cmparison with Emit assay, Emit Qst assay has a higher applicability in making determination in an emergency and of a small number of samples having no need to prepare a standard curve on each occasion, and is superior economically with the loss of the reagent being smaller.

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In recent years, allergic rhinitis caused by various drugs has been of concern on dispensing. Diastase preparation generates dust and is one of the sources of allergic rhinitis. The results were compared with the dust of a commercial diastase preparation and newly developed fine granules of diastase. The generated dust particle sizes were larger than 5 pm and 10, um in diameter and these were mainly Dextrin particles with adhered diastase particles. The newly developed fine granules generated little dust and are considered to be an effective means in reducing allergic rhinitis by diastase.

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The effects of various additives to protect Soya lecithin granules from moisture were investigated. Additives used were Adsolider-101^®, Aerosil R-972^® Neusilin UFL-2^® and carnauba wax (mean diameter: 3μm). Weight increase, angle of repose, aggregation rate and disintegration time of the lecithin granules were measured to evaluate the effect of additives on moisture protection and fluidity.
The hygroscopicity of the lecithin granules decreased with an increase in the amount of additives. Aerosil R-972^® was not adhered uniformly to the lecithin granules. The addition of 2-3% of Adsolider-101^® and Neusilin UFL-2^® prevented the hygroscopicity and enhanced the fluidity of lecithin granules, though the appearance changed to white. It was considered. that carnauba wax in the proportion of 5% was very useful for the prevention of hygroscopicity and the enhancement of fluidity of the lecithin granules.

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The precision and accuracy studies for theophylline (TP) determinations with Seralyzer System (S. S.) applying apoenzyme reactivation immunoassay were performed and clinical evaluations of the S. S. were also examined. Within-and between-day precision studies of S. S. using the samples of TP spiked in normal human plasma showed a good reproducibility having less than 7 % as the coefficient of variation. TP plasma samples, which were obtained from 6 healthy volunteers, were determined by S. S. and the results were compared with those obtained by high-performance liquid chromatography (HPLC). A good correlation between HPLC and S. S. was obtained (n=42, y= 0.942x+ 0.902, r =0.986, p<0.001).
The specificity of S. S. for TP determination was assessed by measuring TP spiked plasma samples including 4 different metabolites or 6 analogues each, and the effect of ascorbic acid (AA) which has a reducing activity was also examined. The cross reactivity of S. S. was somewhat larger, compared with that of commercially available TP immunoassays. It was found that AA decreases TP levels, however, normal AA concentration range in plasma may not affect TP determination.
On the other hand, it was revealed that S. S. was affected by the concentration of protein in the sample, the lower results were obtained in the low protein concentration. These findings were supported in the case of ultrafiltered plasma or saliva. The TP levels were observed significantly low with S. S. than those with the other method. Based on those observations, S. S. might be a useful method for clinical routine or emergent plasma TP determinations.

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The fibrinolytic activities of some commercially available urokinase preparations were compared using thrombelastgraph, and relationships between the stability of urokinase activity and additives contained in preparations, and between the specific activity and the difference of molecular weight of urokinase were studied. Results were as follows: 1) low molecular weight urokinase (LUK) was more stable than high molecular weight urokinase (HUK). 2) HUK was kept most stable, when albumin was added. 3) The stability of LUK did not depend on additives. 4) When the urokinase solution was freezed and then thawed, specific activity of gelatinadded HUK was decreased to 50%, and that of albumin-added HUK to 90%. It was proved that the fibrinolytic activity of urokinase could be measured by thrombelastgraph.

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In the outpatient reception counter of the University of Tokyo Hospital, prescription data have been inputted by clerks at computer terminals for the medical accounting. The data will be useful for a survey of prescribed drugs, such as a drug history. Therefore, it is necessary to investigate the rate of errors on the inputted data. The inputted data were checked with the original prescribed sheets by pharmacists every day during 3 months. The detected errors were completely corrected by the clerks being informed by pharmacists. A total of 35192 prescribed sheets were checked for 3 months, and in 2053 sheets 2245 input errors were detected. In an intermittent preliminary survey before the check study, input errors were found in about 10% of prescribed sheets per day. At the beginning of the check study, the rate of input errors was abut 8%, and by the every-day check throughout 3 months, it decreased gradually, and finally became 5%. The corrected data mentioned above were checked again by pharmacists. Then, pharmacists found extra errors, which had been missed at the previous check, in about 1% of the data.

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It is desirable that theophylline dosage regimen is based on individual pharmacokinetic parameters for management of the outpatient with chronic asthma to avoid toxicity due to overdosage. This study was conducted to design theophylline dosage regimen by single serum sample monitoring.
Four healthy volunteers were given choline theophylline 200 mg (theophylline 126.6mg) and serum theophylline concentration was measured 8 times (as specified) foi determining pharmacokinetic parameters. Average values of Ka (absorption rate constant), Vd (distribution volume), and Kel (excretion rate constant) were obtained to be 8.31/hr, 0.441 1/kg, and 0.081/hr, respectively. Individual theophylline dosage regimen was designed with these parameters. The predicted and measured concentrations of theophylline were compared with each other after multiple oral doses. The errors were within the range of -9.3 to + 12.1%. Asthmatic outpatient's Kel was calculated from single sample monitoring data and average values of Vd and Ka of healthy volunteers. Monitoring time was 4 hours after administration of choline theophylline to avoid the effect of Ka. A new dosage regimen was designed with these parameters for 14 asthmatic outpatients who had already taken theophylline. After changing dosage regimen the predicted concentrations were compared with the measured ones. The errors were within the range of -18.3 to + 18.5%,
This method of theophylline dosage regimen by single serum sample monitoring is significantly useful in clinical practice to avoid the toxicity. It is applicable to design the dosage regimen of the drug with large values of Ka and Kel, and fixed value of Vd.

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Ethanolamine oleate injection has been used as a sclerosing agent in the treatment of esophageal varices. We prepared 4 kinds of sclerosing agents for visualizing varices by mixing ethanolamine oleate with contrast media, iopamidol and meglumine amidotrizoate injections. The viscosities and osmotic pressures of these agents were measured. The time required to discharge a given volume of each agent through a syringe, a tube and a puncture needle under the pressure of 2 kg/ 2. 6 cm² was measured. The ability of visualization was observed by X-ray fluoroscopy. Ethanolamine oleate injection containing 30% iopamidol (EO-IP30) was less viscous. Furthermore, the value of osmotic.pressure of EO-IP30 was almost the same as that of normal saline. The viscosity of the agent was related to the time required discharge a given volume of the agent. The time for a discharge of EO-IP30 was shortest. Good fluoroscopic visualization was obtained in all preparations. These results suggest that EO-IP30 is a usefulagent for injection sclerotherapy of esophageal varices.

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