The preparation method of bismuth citrate ranitidine
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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, improving product quality, and shortening reaction process
Active Publication Date: 2015-11-18
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"
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example 1）
[0027] This example is the preparation of detection reagents.
[0028] Take 0.1 g of Congo red, add 80 mL of water, shake to dissolve, and it becomes dark. After cooling, add 1.1 g of sodium bisulfite, then add 1 mL of concentrated hydrochloric acid, stir, then add activated carbon, stir, suction filtration, and add 20 mL of water to the filtrate , the obtained colorless solution is the detection reagent.
（ example 2）
[0030] This example is the preparation of self-made absolute ethanol.
[0031] Take 2000 mL of commercially available industrial grade absolute ethanol, add 20 g of sodium bisulfite, heat to 30 °C and stir for 2 h.
[0032] Take 5 mL of the solution sample, add 10 mL of the detection reagent prepared in Example 1, and it is still colorless after 5 minutes, indicating that it is qualified.
[0033] Filter to obtain self-made absolute ethanol.
Embodiment 1）
[0035] The preparation method of the bismuth ranitidine citrate of the present embodiment has the following steps:
[0036] ①Add 12g of ranitidine hydrochloride to the 500mL flask, then add 32mL of purified water and stir, after the ranitidine hydrochloride is completely dissolved, add 2.4g of ammonia water, the pH value at this time is 10.5, and continue stirring for 30min , to obtain a solution containing ranitidine; then add 15 g of bismuth citrate, heat to 95° C. under stirring, and keep the reaction for 10 min to obtain a solution containing bismuth citrate ranitidine.
[0037] ② The solution containing bismuth ranitidine obtained in step ① was cooled to 55° C., 2.4 g of activated carbon was added, and the solution was kept for decolorization for 30 min.
[0038] 3. Suction filtration, add the filtrate into 1000 mL of self-made absolute ethanol prepared in Example 2, stir at low temperature (0-20°C, the same below) for 2-3 hours, crystallize, filter with suction, 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, in particular to a preparation method of bismuth ranitidine citrate. Background technique [0002] The chemical name for bismuth ranitidine citrate is: N-[2-[5-[(dimethylamino)methyl]-2-furylmethylthio]ethyl]-N-methyl-2 -Nitro-1,1-ethylenediamine·2-hydroxy-1,2,3-bismuth propanetricarboxylate, its structural formula is as follows: [0003] . [0004] Unlike the 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 citrate by directly using ranitidine (base) as the starting material and reacting with bismuth citrate Bismuth ranitidine. On the one hand, the price of ranitidine (base) ...
Claims
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