Nicorandil-containing pharmaceutical composition

A technology of nicorandil and composition, applied in the field of pharmaceutical composition containing nicorandil, can solve problems such as less than 1 year, and achieve the effect of reducing risk

Inactive Publication Date: 2014-04-30
MOCHIDA PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As will be described later, for the freeze-dried preparation of nicorandil, the storage conditions of 30 days at 40°C are considered to be equivalent to the storage conditions of about one year at 25°C, so the shelf life of this preparation at room temperature is estimated to be less than one year
As

Method used

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  • Nicorandil-containing pharmaceutical composition
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  • Nicorandil-containing pharmaceutical composition

Examples

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Embodiment

[0075] Next, although an Example is shown and this invention is demonstrated more concretely, this invention is not limited to this.

preparation example 1

[0077] Weigh 300 mg of Nicorandil in the Japanese Pharmacopoeia, 75 mg of D-mannitol (trade name: Mannit S, Mitsubishi Corporation Furd Teck Co., Ltd.) and 300 mg of sodium citrate hydrate (Wako Pure Chemical Industries, Ltd.), and dissolve in To distilled water for injection, citric acid (Wako Pure Chemical Industries, Ltd.) and / or sodium hydroxide (Wako Pure Chemical Industries, Ltd.) were added as necessary to adjust the pH to a range of 7.0 to 8.5 to make the total volume 50 mL. After filtering this solution with a 0.22 μm membrane filter, 8 mL per bottle was dispensed into glass vials with a bottle diameter of 33.0 mm, and a freeze-drying device (trade name: TriomasterII-A04, Kyowa Vacuum Technology Co., Ltd.) was used to dry at -40 ℃ for pre-freezing and freeze-drying. In the initial cooling step in the freeze-drying step, heat treatment (annealing) was performed twice for 6 hours at a product temperature (product temperature) of 0°C. During the heat treatment step, the...

preparation example 2、6、7、11、13、14

[0079] According to the production method of formulation example 1, a freeze-dried formulation was obtained with the formulation shown in Table 1 (content of each component per glass vial).

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Abstract

A pharmaceutical composition containing nicorandil, mannitol, and the alkali metal salt of an organic carboxylic acid, wherein (1) "the peak value of the delta crystals of mannitol at 9.8 DEG +-0.3 DEG (2[theta]) in X-ray diffraction "/"the peak value of nicorandil crystals at 10.6 DEG +-0.3 DEG (2[theta]) in X-ray diffraction" is 2.0 or less or (2) "the peak intensity at 1.01 THz +-0.2 THz of the secondary derivative spectrum in the absorption spectrum of the delta crystals of mannitol measured by means of terahertz transmission spectroscopy"/" the peak intensity at 0.95 THz +-0.2 THz of the secondary derivative spectrum in the absorption spectrum of nicorandil crystals measured by means of terahertz transmission spectroscopy" is 1.5 or less. This pharmaceutical composition exhibits excellent storage stability.

Description

Technical field [0001] The present invention involves a drug composition and its manufacturing method containing Nichel with excellent preservation stability. Background technique [0002] For Nicole (chemical name N-(2-hydroxyl ethyl) nattide nitrite), oral medicated tablets for angina pectoris therapeutic agent, and intravenous veins of the therapeutic agent of unstable angina pectoris and acute heart failureThe intra -doping frozenids are provided clinically in Japan.Nichel is also unstable in the aquatic solution as the coronary arteries dilatation agent of Nitrochia. Therefore, when administration in the vein, the frozen drying preparation needs to be used during use.The solvent is dissolved and the solution is prepared. [0003] As the specifications of the Nichel frozenidsmid preparation, the quantitative value of the Nicotidur during dissolving is 95.0 to 115.0%of the label, and the amount of nitrate ion in the purity test is below 0.8%(Nicole with the label amount.Dier i...

Claims

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Application Information

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IPC IPC(8): A61K31/455A61K9/19A61K47/10A61K47/12A61P9/04A61P9/10
CPCA61K47/10A61K47/26A61K31/455A61K9/19A61K47/12A61P9/04A61P9/10
Inventor 由良隆行桥本雄树兼广秀生
Owner MOCHIDA PHARM CO LTD
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