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A technology of bismuth citrate ranitidine and bismuth citrate is applied in the field of pharmaceutical compound preparation, can solve problems such as unsatisfactory control, and achieve the effects of avoiding pollution, shortening reaction process and improving product quality
Active Publication Date: 2014-07-02
CHANGZHOU LANLING PHARMA
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Problems solved by technology
[0011] For the largest single compound, the control of the existing technology is not ideal, and the minimum can only be controlled at about 1.0%, barely meeting the requirements of the "Chinese Pharmacopoeia"
Method used
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Examples
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example 1）
[0027] This example is the preparation of detection reagents.
[0028] Take 0.1g of Congo red, add 80mL of water, shake to dissolve, and the dark color will appear, after cooling, add 1.1g of sodium bisulfite, then add 1mL of concentrated hydrochloric acid, stir, then add activated carbon, stir, suction filter, add 20mL of water to the filtrate , the resulting colorless solution is the detection reagent.
（ example 2）
[0030] This example is the preparation of self-made absolute ethanol.
[0031] Take 2000mL of commercially available industrial grade absolute ethanol, add 20g of sodium bisulfite, heat to 30°C and stir for 2h.
[0032] Take 5mL of the solution sample, add 10mL of the detection reagent prepared in Example 1, and it is still colorless after 5min, indicating that it is qualified.
[0033] Filter to obtain homemade anhydrous ethanol.
Embodiment 1）
[0035] The preparation method of the bismuth citrate ranitidine of the present embodiment has the following steps:
[0036] ①Add 12g of ranitidine hydrochloride to a 500mL flask, then add 32mL of purified water and stir, and then add 2.4g of ammonia water after the ranitidine hydrochloride is completely dissolved. At this time, the pH value is 10.5, and continue stirring for 30 minutes , to obtain a solution containing ranitidine; then add 15 g of bismuth citrate, heat to 95° C. under stirring and keep it warm for 10 minutes to obtain a solution containing bismuth ranitidine citrate.
[0037] ② Cool down the solution containing bismuth ranitidine citrate obtained in step ① to 55° C., add 2.4 g of activated carbon, and keep it warm for 30 minutes for decolorization.
[0038] ③ Suction filtration, add the filtrate to 1000mL of self-made absolute ethanol prepared in Example 2, stir at low temperature (0-20°C, the same below) for 2-3 hours, crystallize, suction filtration, and dry...
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Abstract
The invention discloses a preparation method of ranitidine bismuth citrate. The preparation method concretely comprises the following steps: (1) reacting ranitidine with bismuth citrate at the temperature of 90-95DEG C to obtain a solution containing ranitidine bismuth citrate; (2) cooling the solution containing ranitidine bismuth citrate to 50-60DEG C, adding activated carbon, preserving heat and decoloring for 20-30min; (3) carrying out suction filtration, adding the filtrate into homemade absolute ethyl alcohol and stirring and crystallizing, carrying out suction filtration, and drying a filter cake to obtain ranitidine bismuth citrate. The homemade absolute ethyl alcohol is obtained by adding sodium salt into the commercially available industrial-grade absolute ethyl alcohol, and stirring and filtering. According to the method, the trace impurities in the absolute ethyl alcohol can be greatly decreased, and further the maximum individual impurity in the ranitidine bismuth citrate can be reduced, the content of the maximum individual impurity can be reduced to less than 0.5%, and minimally to less than 0.3%, and the quality of products can be greatly improved.
Description
technical field [0001] The invention belongs to the technical field of preparation of pharmaceutical compounds, and in particular relates to a preparation method of bismuth ranitidine citrate. Background technique [0002] The chemical name of bismuth ranitidine citrate is: N-[2-[5-[(dimethylamino)methyl]-2-furylmethylthio]ethyl]-N-methyl-2 -Nitro-1,1-ethylenediamine 2-hydroxyl-1,2,3-bismuth tricarboxylate, its structural formula is as follows: [0003] . [0004] Unlike a mixture consisting of ranitidine and bismuth citrate, bismuth ranitidine citrate is a salt obtained by reacting ranitidine with bismuth citrate. [0005] For ranitidine, one of the reaction raw materials, Chinese patent documents CN1039419A, CN1236779A, CN1569847A, CN1903850A, CN102304107A, CN102408398A all disclose the preparation of citric acid by directly using ranitidine (base) as the starting material and bismuth citrate. bismuth ranitidine. Due to the relatively high price of ranitidine (alkali...
Claims
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Application Information
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