Since apheresises and blood collection systems were acknowledged by the Ministry of Public Welfare in Japan in April 1986, a lot of plasma or platelet products have been collected from volunteers by these systems. Among these platelet products, platelet rich plasma (PRP) and platelet concentrate (PC) have an apparent weak point which is the contamination of many leukocytes (10⁷-10⁹/bag). Therefore we studied the removal of leukocytes from the apheresis' platelet products by the following two methods and the following results were obtained.
1) The centrifuging method:
The recovery of platelets: 78.9%, The removal of leukocytes: 88.4%.
2) The Imugard filter method:
The recovery of platelets: 89.0%, The removal of leukocytes: 96.0% or more, Thefunctions of platelets: normal.

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In order to investigate the predictability of theophylline concentrations in plasma from those in saliva, the total concentration (bound plus free) in plasma (Pt) and the free (unbound) concentration (Pf) were compared with the concentration in saliva (S), respectively.
Ten healthy males and three females were orally administrated a sustained-release theophylline preparation (Theo-Dur^r®) by a single dose of 8.13mg/kg and then, as the second experiment, six out of the above thirteen volunteers were administrated 400mg of theophylline daily for five days.
In the experiment of the single dose, there was no significant difference in the elimination half-life of theophylline between plasma and saliva.And both the ratios of S/Pt and S/Pf were 0.61, 1.60, respectively, up to 24 hours of dosing.In the case of multiple dose administration, 33.3 and 61.1% of the predicted Pt and Pf values which were calculated from the S/Pt and S/Pf for each volunteer coincided with the measured values within the deviation of ±10%, respectively. Moreover, S/Pt and S/Pf in the second experiment made a great change in comparison with them in the experiment of the single dose.From these results it was concluded that the use of saliva to predict theophylline concentrations in plasma has an substantial error and may lead to incorrect dosage adjustments.

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The purpose of this study is to investigate the influence of food on pharmacokinetics and pharmacodynamics of furosemide after oral administration of at ablet (40mg) 30 minutes before or after breakfast to three healthy male volunteers by measuring plasma concentrations and excretion rates in urine.
The results showed that the pharmacokinetic parameters C_max, t_max, MRT_0-8 (mean residence time) and AUC_0-8 after administration of furosemide before breakfast were significantly different from those after breakfast.Higher volume of urine was observed immediately after oral administration of furosemide before breakfast than that after breakfast, while cumulative volume of urine within a 24-hour period was not significantly different between those before and after breakfast.Therefore, old-age patients with hypertension should be careful when they take furosemide before a meal because of the sudden diuretic effect of furosemide.

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Computerized system for making of labels of drug envelopes was constituted to increase efficiency of works and patients compliance. The system was able to printout directions for signature, dosage and notice of prescribed medicines. Patients attributions, e.g., name, age and clinical division were accepted from patient data base in administration office and interface files based on ID No.as key cord.
Work station in this system is composed of as follows. Two colour equipped with a typed touch pannel systems and two 24×24 dot printers which were connected with hospital host computer FACOM-M36OR were used for making of labels of drug envelopes. In order to reduce input time, 201 kinds of sentences which contain directions for signature, dosage and notice in prescriptions were registerd on touch pannels as replaced codes, and also 68 kinds of set codes were made by the combination of the replaced codes.
Since the total number of prescriptions were also output every 30 minutes for the statistical data analysis, pharmacists were properly arranged for dispensing works.

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The analytical method for aprotinin preparation has been established using reversed phase high performance liquid chromatography, and the characteristics of the four contaminating unknown compounds in this preparation were studied. Aprotinin and the four contaminants were separated by using C18 column (CHEMCOSORB 5-ODS-H) and 13% acetonitrile containing 0.1 M potassium dihydrogenphosphate adjusted to pH 3.0 with phosphoric acid as a mobile phase, or by using a C4 column (CHEMCOSORB 300-7C4) and 10% acetonitrile solution containing the same phosphate buffer as the mobile phase.
Five commercially available aprotinin injection forms were found to be composed of aprotinin and identical ratios of the four contaminants. In addition, the four contaminants had weaker inhibitory activity than aprotinin. These four contaminants were considered to be originated from aprotinin as their amino acid compositions of these contaminants were the same as that of aprotinin. Therefore, the production of these four contaminants may occur through an irreversible or extremely biased equilibrium process.

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The change of antibacterial activity of antibiotics and the stability of vitamins in intravenous hyperalimentation (I. V. H.) transfusions mixed with cephem-antibiotics and multi-vitamin infusion (M. V. I.) were investigated. No change in appearance and pH was observed 24 hr after the combination of antibiotics and M. V. I. in the I. V. H. transfusions.
The antibacterial activities of antibiotics in the I. V. H. transfusions were not changed in the mixture of M. V. I., latamoxef, cefoperazone, ceftizoxime and cefotaxime after 24 hr. The stability of antibiotics used was studied by not only the antibacterial test method but also by the high performance liquid chromatography method. From our present results, we did not recognize the remarkable difference by these two methods.
Vitamin A in Hicaliq-1, Hicaliq-2 was decomposed by light, but was almost stable by shielding a light. Vitamin B₁ in Paremental A, Paremental B and Paremental B+Proteamin 12 X was decomposed.It seems to be induced by NaHSO3 “preservative” containing in these solutions. Vitamin C in Hicaliq-1, Hicaliq-2 and Hicaliq-2+Proteamin 12X was decomposed by keeping at room temperature, and was also stable under the cold condition.All other vitamins (B₂, B₆, D₂, E, nicotinamide and panthenol) were stable in the I. V. H. transfusions containing antibiotics and M. V. I.

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The effect of the constitution rate of zine oxide ointment (ZO) in the various mixtures of Rinderon DP ointment (RDPO) and ZO on the release of betamethasone dipropionate (BM-DP) was studied. Zinc oxide was added in the concentrations of 0, 10 and 20% to the vehicle of beeswax and soybean oil, which were mixed in the ratio of 20: 70, 25: 65 and 30: 60, to obtain ZO in nine different concentrations for determination of the viscosity, penetration and extensibility. The release of BM-DP from the ointment containing equivalent volumes of ZO and RDPO were measured by HPLC.
The release of BM-DP fitted well into Higuchi's equation, and was shown to be linear in function against square root of time. The release rate constant (K) was greater for mixtures in any of the aforementioned constitution rates than that for RDPO alone. Furthermore, K increased specifically when the content of beeswax was less, soybean oil greater and zinc oxide content greater. However, there was no correlation between the material value of ZO and the rate constant K, suggesting that this increase is attributable to the interactions of constituents of ZO.
As a result, it was suggested that the therapeutic effect might be expected of ZO containing 10 to 20% of zinc oxide, as it retained the physical integrity as an ointment and allowed good release of steroids when mixed with a steroid ointment.

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Ultraviolet (UV), infrared (IR) and nuclear magnetic resonance (NMR) spectrometers were introduced in order to find the errors of dispensation for admixture of pulvis.Analysis of each spectroscopic pattern turned out to be effective and reliable for finding the errors of dispensation even for admixture of pulvis containing much additive.

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Cyclosporin-A (CYA) serum levels have been monitored to prevent graft rejection and its toxicity in organ transplant recipients.
In this study, we measured CYA serum levels by using the fluorescesnce polarization immunoassay (FPIA) method, and compared this new method with the conventional radioimmunoassay (RIA) method and the high-performance liquid chromatography (HPLC) method.
The coefficient of correlation between the values obtained by the HPLC and RIA methods was 0.893 and that between the values obtained by the HPLC and FPIA methods was 0.911, while the values obtained by the RIA and FPIA methods correlated well with 0.906 of correlation.
However, the value of the FPIA method was approximately 1.8-fold higher than that of the HPLC method.It is presumable that the antibody in the FPIA method cross-reacts with the metabolites of CYA.
The recovery of the FPIA method was approximately 100 per cent, and the reproducibility was satisfactory.
In conclusion, we expect the FPIA to be useful as a new method for the routine monitoring of drugs.

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Bioequivalency of newly formulated digoxin powder containing mainly crystalline lactose, which is expected to improve the fluidity of powder, was compared with that of the previous formula containing non-crystalline lactose.The digoxin concentrations in serum of 8 healthy male volunteers were determined by Stratus Immunoassay System after oral administration of either new or old formulation of digoxin powders in a latin square crossover design.The extent and rate of bioavailability of the both digoxin powders were found to be bioequivalent.
It was concluded that both formula had clinically equivalent bioavailability but the power of analysis in this bioequivalency test was lower than the guide-line valve given by the committee on bioequivalency test.

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A quality test was examined on five kalliginogenase preparations and one of their raw materials. And clinical use of these preparations was investigated from the prescriptions of three months in the outpatients of this hospital.
Kinin-liberating activity and kininase activity were measured by the enzyme immunoassay (EIA) utilizing a bradykinin (BK). Kinin-liberating activity was 260-540ng BK/min/U, and kininase activity that was an indicator of impurity was less than 5Ong BK/min/U in all preparations. The result by the enzymatic method (BAEE) that was already reported by us was related very well to the kinin-liberating activity by the EIA method.

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