The Pharmaceutical utility of the Fiber Drink Jelly®(FDJ) gel which consists of gelatin and indigestible dextrin was investigated as a possible material for an oral dosage form for elderly patients. The gel formation was studied as a function of the variety of sugars added and the concentration of FDJ or sugar added. The gel formation was affected by the variety of sugars added, such as ribose, xylose, fructose, mannose, galactose and glucose. The rate of gelation seemed to be correlated to the number of equatorial hydroxyl groups of each sugar molecule. The FDJ or sugar content also affected the rate of gelation of the FDJ solution. Rheological properties of FDJ gel were evaluated using a creep meter. The variety of the sugar added affected the breaking stress of FDJ gel. From differential scanning calorimetry (DSC), the melting temperature of FDJ gel was observed to be affected by the variety of the sugars added and/or the concentration of the sugars. FDJ gel containing benfotiamine (BTMP) was prepared. The release behavior of BTMP from FDJ gel was studied as a function of the variety of the sugars added and the content of indigestible dextrin. The release rate of BTMP from FDJ gel was retarded with the increase of the number of equatorial hydroxyl groups of the sugar molecule and the content of indigestible dextrin. On the basis of the sensory test, FDJ gel prepared in glucose or mannose solution is considered to be adequate for the practical dosage form.

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An in vitro evaluation system for the commonly used medical drugs for allergic reaction was developed. Anti-DNP monoclonal IgE antibody sensitized cultured rat basophilic leucocyte cell line RBL-2H3 was stimulated by DNP-linked human serum albumin in the presence of various concentrations of the commonly used medical drugs, and the amounts of released histamine were estimated by HPLC.
An antipyretic, aspirin and an anti-histamine, chlorpheniramine maleate were found to reduce the allergen-induced release of histamine; and a β-blocker, propranolol and an αβ-stimulant, ephedrine hydrochloride were seen to enhance histamine release. Other drugs tested including NO-producing drugs, nitroglycerin and hydralazine, a Ca⁺⁺ channel blocker, diltiazem, a loop diuretic, furosemide and a Ca⁺⁺ drug, elcatonin, were found to have no effect on the allergen-induced release of histamine from basophilic leucocytes.
Since these reactions could be explained by their molecular mode of actions, this system could be applied to the evaluation of the effects of general drugs on the first-step allergy reaction.

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One of three fat-soluble vitamins, tocopherol, ubidecarenone, and retinol palmitate was added to improve the photostability of vitamin K₁ (K₁) in model infusion fluids. The time courses of photodegradation of K₁ and the vitamin added in infusion fluid under the irradiation of monochromatic light or fluorescent lamp were followed by using high-performance liquid chromatographic method. K₁ and retinol palmitate in infusion fluid were more photolabile within the wavelength range of 300-400 nm, while tocopherol and ubidecarenone were stable at wavelengths above 320 nm. The photolytic degradation of K₁ was inhibited most effectively by the addition of ubidecarenone, whereas no satisfactory inhibition effect was obtained for tocopherol. The degradation rate constant of K₁ decreased remarkably with the increase in amount of ubidecarenone added. The photostabilizing effect was thus closely related to the photostability and light absorption properties of the vitamins added.

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The compatibility of irinotecan hydrochloride injection (Topotecin^® injection) was studied regarding changes in pH following the addition of 0.1N NaOH or 0.1N HC1 solution along with changes in external appearance, pH and contents of both irinotecan and admixed drugs following mixing with 20 kinds of other injections. Study on stability of the drug with a change in pH showed that irinotecan hydrochloride was stable under the acidic condition. Admixtures of irinotecan hydrochloride injection with each of the 20 kinds of the injections showed neither a change in external appearance nor a change in pH over a 24-h period under the study conditions.
With the admixture with Solu-Medrol^® or Ipsilon S^® pH was raised to more than 6.5, and the contents of irinotecan fell to 90% until 3-h after mixing. Accordingly, mixing with these injections should be avoided. However, there was no change in the content of irinotecan hydrochloride in the other admixtures except the two injections. This study suggests that the compatibility of irinotecan hydrochloride injection depends on the delactonization reaction of the drug. Mixing irinotecan hydrochloride with alkaline injections should be avoided. Notably, compatibility of irinotecan hydrochloride injection with other injections is predictable by observating the pH immediately after mixing.

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A clinical pharmacy servise was performed by the pharmacist using therapeutic drug monitoring (TDM) of phenytoin (PH) and phenobarbital (PB) for a patient with gliobrastoma during cancer chemotherapy. The cancer chemotherapeutic regimen with intraarterial or intravenous infusion was performed six times, which included a short-interval chemotherapy (from the first treatment to the third one with 1 day interval) and a long-interbal chemotherapy (from the fourth treatment to the sixth one with about 2-month interval), to the patient chronically administered with PH and PB.
In each chemotherapy, total and free concentrations of PH and PB in plasma or CSF did not change. In the short-interval chemotherapy, total and free, concentrations of PH and PB in plasma or CSF decreased sharply. The free concentrations of PH and PB in plasma or CSF were equal. On the other hand, the total and free concentrations of PH and PB in plasma or CSF increased gradually in the long-interval chemotherapy. Especially, the total concentration of PH in CSF at the sixth treatment increased to 3 times larger than that at the first treatment. Total protein CSF increased from 122.7 mg/ml to 760.0mg/ml. The bound concentrations of PH in CSF correlated with the total protein in CSF, but the free concentrations of PH and PB in plasma and CSF did not change. The monitoring of PH and PB during the cancer chemotherapy was necessary to minimized the seizure for decreased level of anticonvulsant.

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The contents of glycyrrhizin, paeoniflorin, and ephedrine as common indicator components to commercially available kakkon-to and Sho-seiryu-to extract preparations were determined. In addition, the content of the active ingredient schizandrin of known pharmacological action in the Sho-seiryu-to extract preparations was also determined. The contents of glycyrrhizin, paeoniflorin, and ephedrine varied from one brand to another of the kakkon-to and Sho-seiryu-to extract preparations (p<0.01). The content of paeoniflorin, in particular, in the kakkon-to extract preparations widely ranged from 37.3 mg to 75.2mg (p<0.01). The content of ephedrine in these some preparations also markedly ranged from 8.5mg to 20.9mg (p<0.01). On the other hand, the content of ephedrine in the Sho-seiryu-to extract preparations markedly changed from lot to lot with some brands.
The content of schizandrin showed a pronounced variation among brands of these preparations (p<0.01). These results indicate the need for establishing proper standards of formulation medicines and the specification of the content of active ingredients other than the indicator components.

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Monoethanolamine oleate injection containing 50% Iopamiron 370 (50% IP370-EO) has been previously prepared for endoscopic sclerotherapy of esophageal varices on X-ray TV monitor. However, the dischargeable pressure of this sclerosing agent was slightly insufficient during clinical use. We therefore prepared monoethanolamine oleate injection containing 50% Iomeron 350 (50% IM350-EO) or 75% Iomeron 350 (75%IM350-EO), and measured the physical characteristics such as viscosity and osmotic pressure of this agent. The time required to discharge a given volume of each agent through a syringe, a tube and a puncture needle under the pressure of 2kg/2.6cm² was measured. The ability to visualize this process was observed in patients with esophageal varices by X-ray.
The viscosity, which was inversely related to the injectability into varices, of 50% IM 350-EO was lower than that of 50% IP370-EO. The viscosity of 75% IM350-EO was also lower than that of 75% IP370-EO. The osmotic pressure ratio of 50% IM350-EO and 75% IM350-EO were lower than those of 50% IP370-EO and 75% IP370-EO, respectively. The time required to discharge 50% IM350-EO was the shortest. Good fluoroscopic visualization was obtained in all preparations. Better contrast was obtained in the cardiac zone with 75% IM350-EO than with 75% IP370-EO.
These results suggest that 50% IM350-EO and 75% IM350-EO are more useful agents for endoscopic sclerotherapy of esophageal varices.

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In Fujinomiya City General Hospital, new computerized ordering systems and dispensing systems have been employed since April 1994. In the present study, we examined the effects of the computerized systems on the hospital waiting time of outpatients treated in multiple departments (patients-M). The mean total time of staying in the hospital of the patients-M was markedly longer compared with that of the total patients examined. The treatment waiting time and that for drugs decreased in the patients-M as well as the total patients following the computerization. Thus, in the total patients, the total time for staying in hospital markedly decreased after the computerization. And in the patients-M, the time interval between the treatments increased after the computerization, while a total time to staying in hospital decreased.

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Instrucitons for taking mdicines are very important when using pharmaceutical drugs. Such instructions, however, have include technical terms which are too difficult for patients to understand. Assuming that the level of knowledge acquired after completing compulsory education is a measure of the social kowledge standard, we questioned patients and 3 rd year junior high school students on 20 technical terms. The numbr of correct answers was 6.7±3.0 (mean±SD) for junior high school students and 8.4±5.1 for patients. The ratio of correct answers was high in “before each meal”, “effect” and “purgative”, but low in “half-life”, “when necessary” and “heart-sealed pack” . It is therefore necessary to add interpretations of these terms, or replace these terms with other more conventionally used words. The questionnaire results suggest that medical staff are required to address the job of confirming whether patients understand the medical terms and interpret them correctly, and, at the same time, contribute to patient and junior high school studnet education.

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It has been confirmed that the combination of pH-dependent slow-release nifedipine fine granules (KB-1712P) with some types of antacids results in changes in the in vitro dissolution profile of nifedipine (evaluated by modified Fuchs' method). Maalox^® affected the in vitro dissolution profile of nifedipine, while Kolantyl^® granules did not. In the present study, we conducted in vivo study on normal healthy volunteers to confirm the effect of antacids on serum nifedipine concentration.
The antacids used in this study were Maalox^® and Kolantyl^® granules. The trial was conducted in three groups, the Maalox^®, Kolantyl^® and control groups, using the 3-way crossover method. Prior to initiation of the study, volunteers underwent medical examinations and were confirmed to be healthy and not suffering from either gastric hyperacidity or hypochlorhydria. In the control group, KB-1712P was ingested with 200ml of water, and in the antacid-treated group, one of the antacids and KB-1712P was ingested with 100 ml, respectively. The serum nifedipine concentration was then measured over time. The results showed no difference between the groups in any of the pharmacokinetic parameters of nifedipine, suggesting that the serum nifedipine concentration was little affected by the concomitant use of antacids and KB-1712P.

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Cases and results of prescription changes made as a result of clinical pharmacy services are report guidance or counsel in medication was given to to 274 patients totally of the Internal Ward by the Pharmaceutical Division of the National Sanatorium Tsuruga Hospital between November 1994 and October 1995. The prescription was changed as a result of pharmaceutical consultations between physicians with pharmacists or because of the pharmaceutical information provided by pharmacists to physicians in 61, or 22.3%, of these patients.
Clinical pharmacy services were considered to be useful for supporting physicians in conducting drug therapies and, thus, providing individual and flexible medical care. In clinical pharmacy services, it is important to offer guidance to patients to answer the questions thery have about their prescriptions.

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The contentes of medication instruction given for 50 infant patients with epilepsy, who had been hospitalized in the Department of Child Neurology for 10 months from the first of October 1993 to the end of July 1994, were analyzed. The average age of the patients was 6.2 (0-17) years old, and the average number of days of hospitalization was 68.7 (8-279) days. Conducted during this time were 386 of medication instructions, explanations and guidances in response to 719 questions raised by the patients' families. Most medication instructions were mainly given to the patients' families. The content of the medication instruction consisted of the name and dosage of medicine (198 cases), pharmacological effects (125 cases), methods for taking medicine (123 cases), and side effects (111 cases). There were high level and variable questions from patients' families expressed during the medication instruction, including the problem on setting the medication time based on the pharmacokinetics, stability of the medicine, and relationship between drug and side effects induced by the drug-drug interaction. From these results, it is suggested that medication instruction to be given to the infant patient with epilepsy offers accurate information on the principal and side effects of the drug used, and informs the patients of the importance of compliance in the antiepileptic drug treatment, which is also useful for the epileptic patient undergoing antiepileptic drug treatment.

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A ground mixture of tolperisone hydrochloride (TH) (Muscalm S^®) and dantrolene sodium (DS) (Dantrium^®) was prepared for a 4-year-old patient with cerebral paralysis. Seven days later, a change of color from orange to yellow was found. Therefore, we examined the compatibility of TH and DS in the preparation. Samples were stored for 7-30 days under the following four different conditions in a dark box: 23%, 75% of relative humidity (RH) at 37°C and 25°C. TH and DS were measured by high-performance liquid chromatography with a UV spectromonitor. The color of the ground mixture changed after 7 days under all conditions except at 25°C and 23% RH. When stored under the condition of 75% RH at 37°C for 30 days, TH and DS contents in the preparation significantly decreased by 38% and 12%, respectively. When lactose was added to ground TH and DS, respectively, TH content decreased over 10%, but DS content remained unchanged for 30% days. But, the colors of these preparations did not change. These results suggest that (1) the color of DS is affected by TH and (2) TH content is decreased by both DS and lactose.

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