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mix for quality control of the medicine 'Glycine tablets for sublingual applying 0.1' and its preparation method

机译:药“舌下甘氨酸片0.1”的质量控制混合剂及其制备方法

摘要

The invention relates to the chemical-pharmaceutical industry and specifically to mix for quality control of the medicine "Glycine tablets for sublingual applying 0,1" and its preparation method. The method involves process of analysis by dissolution of 2,5g of porphyrized tablets in 250 ml of purified water and light transmission spectrophotometer examination at a wave length of 700±2 in a cuvet with layer thickness of 10 mm relative to purified water. Process of dissolution takes 20 minutes and is carried out at a temperature of 370°C in the apparatus for dissolving determination at a paddle rotation speed of 150 rpm. After mix is dissolved it is allowed for 10 minutes then there are selected 4ml for light transmission analysis. Mix for quality control deludes water in a ratio 100:1 to porphyrized tablets, containing in one tablet 0,101 g microcapsules of non-agglomerated crystals of amino-acetic acid covered with polymeric film of water-soluble methylcellulose, MC-100 and 0,001 g of magnesium stearate. Mix light transmission coefficient is within the limits of 50 to 70 % in comparison with purified water at a wave length 700±2 nm for 4 ml of mix and with layer thickness of 10 mm.
机译:本发明涉及化学制药工业,尤其涉及一种用于质量控制的混合物“舌下施用甘氨酸0.1的甘氨酸片剂”及其制备方法。该方法涉及通过将2.5g的卟啉化的片剂溶解在250ml的纯净水中并且在相对于纯净水的层厚度为10mm的小盒中以700±2的波长的透光分光光度计检查的分析过程。溶解过程需要20分钟,并且在用于溶解测定的设备中以370rpm的桨叶转速在370℃的温度下进行。混合物溶解后,静置10分钟,然后选择4ml进行透光分析。用于质量控制的混合物可制成与卟啉化片剂的比例为100:1的水,在一粒片剂中包含0.1101克微囊化的非乙酸氨基乙酸晶体,上面覆盖有水溶性甲基纤维素,MC-100和0.001克硬脂酸镁。与4 ml混合物的波长为700±2 nm的纯净水和层厚为10 mm的混合物相比,混合物的透光系数在50%到70%的范围内。

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