The pH values, osmotic pressure and the degrees of hemolysis were studied with 184 brands of commercial injections. There were many products indicated for intramuscular or subcutaneous administration in their package inserts, though they proved in the study to show physiologically unpracticable pH values, excessively low or high osmotic pressure and/or strong hemolytic action. Nineteen brands of injections of an ingredient manufactured by several companies were compared in their physical and hemolytic properties. Notable differences in the properties were observed in 11 of the 19 brands ; and 9 of the 11 showed strong hemolysis though negative or weak hemolysis was claimed in their package inserts.

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The complex formation between pyrazinamide and isoniazid was studied in the Higuchi Lach method. The solubility of pyrazinamide increased in parallel with isoniazid concentration at 25°, indicating a complex formation. The increase in solubility of pyrazinamide is due to a complex formation and continues until the solubility of the complex reaches the limit. The results of the experiment indicate that the complex is formed by pyrazinamide and isoniazid mixed at equal ratio. This is substantiated by the finding that the equilibrium constant in the experiment remained stable in the whole range of concentrations.

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Viscosity and relative suspension value (RSV) of several brands of commercial plasma expanders were studied. At any temperature of 20, 25 and 37°, 10% dextran 40 showed the highest viscosity, followed by 6% dextran 70, hydroxyethyl starch (HES), plasma and isotonic sodium chloride solution, in that order. The higher the viscosity of fluid infusion became, the larger the change of viscosity due to variation of temperature. It is, therefore, desired that high viscosity fluid infusion be warmed up to the body temperature before use, especially in cold winter. Caution should be taken in large-dose administration of high viscosity plasma expanders (eg, 10% dextran 40) to patients predisposed to hyperviscosity of the blood. In the test on RSV, 5 % glucose solution and isotonic sodium chloride solution produced better results than HES and dextran preparations.

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The quality of 6 brands of cephalexin capsules (250mg) was evaluated by dissolution test (U. S. P. XIX) and some other tests in vitro. The dissolution rate of 1 (product F) of the 6 kinds of capsules was about 57% in the first 15 minutes, showing a statistically significant difference (p<0. 01) between the rates (nearly 100%) for the remaining 5. Further, the variations of weight, content and dissolution rate were larger in product F than in the others. The rate of in vitro dissolution may be a decisive factor in the in vivo absorption and excretion. From the viewpoint of uniformity of therapeutic effect, product F is undesirable.

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Fourteen brands of dextran sulfate sodium (DS-Na) tablets of 11 manufacturers (7 brands in sugar-coated tablet and remaining 7 in film-coated tablet) were tested on their pharmaceutical characteristics, heat resistance, moisture resistance and disintegration. In theheat resistance test, 9 brands out of the 14 showed “good” result, while 11 brands were proved “good” in moisture resistance. In the disintegration test after storage, 11 brands underwent no change.

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Efficient purchasing control system of high-price injections has been studied. So far, any injection priced over¥100 per unit has been designated as special control item, which composed as much as 72% in number of total injections and occupied 98% in annual value of purchase. Many hospitals in Japan now try efficient control of injections by selecting (1) items at high unit prices, or (2) items in large annual value of purchase. The combination of the above two criteria for selection proved to offer great advantages.

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The stability of nitrazepam was studied in three different solutions for the assay of the drug. Nitrazepam in the ethanol solution was very stable and showed a linear standard curve at the maximum absorbance of 310 nm. In the first solution (disintegration test, J. P. IX), the ultraviolet (UV) absorption spectrum changed with time. However, no change in absorbance was observed at 252 nm and a linear standard curve was given at this wavelength. In the second solution (J. P. IX), the UV absorption spectrum showed no change.For the assay of nitrazepam in commercial tablets, the first solution, instead of ethanol, is preferable as extraction solvent because of its better extraction effect of nitrazepam from tablet; the wavelength of 252 nm is more precise than the maximum wavelength at about 280 nm for the spectrophotometric asssay of the extracted solution.

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The thin-layer chromatography is convenient to determine the decomposed products of citicoline preparation. The products were spotted on chromato-plates (Avicel-SF). The plates were developed by the ascending technique with the solvent system, acetone-Msodium actate-35% ammonium sulfate-ethylacetate (20: 20: 3: 3, v/v). Citicoline and its products on chromatogram was visualized under short-wave ultraviolet rays.

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Analgesic and anti-inflammatory effects of alclofenac on lumbar pain were studied in double-blind method. Alclofenac was administered in dose of 1, 500 mg/day for the successive 7 days in comparison with diclofenac sodium as a control drug given in dose of 100 mg/day for the same period. The efficacy of both drugs did not differ significantly in the overall evaluation.

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Adenosine triphosphate disodium (ATP) is sensitive to light, temperature and pH. Physicochemical stability of the commercial injectable ATP preparation containing a stabilizer was studied in various hydrogen-ion concentrations regulated with a buffer solution. A mixture of the ATP injection and a buffer solution of pH 2.0 to 13.0 was left to stand at 28°for 1 hour. Physical experiment was carried out by macroscopy and chemical expriment by thin layer chromatography. The injection showed no physicochemical change. It can be concluded that the commercial ATP injection (10mg/2ml) containing a stabilizer is stable in wide range of hydrogen-ion concentrations (pH 2 to 13).

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