Control method for quality and safety of colloidal bismuth pectin pharmaceutical composition
A quality control method, the technology of colloidal bismuth pectin, applied in the field of preparation and quality control of colloidal bismuth pectin dry suspension, can solve the problem that the curative effect of colloidal bismuth pectin cannot be further improved, and the control range of intrinsic viscosity is not specified. , Intrinsic viscosity standards are not specified, etc., to achieve the effect of eradicating Helicobacter pylori, scientific, reasonable and controllable quality standards, and improving safety
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[0050] 1. Preparation of colloidal pectin bismuth
[0051] (1) Add 166.67g purified water to the reaction flask, add 29.22g of bismuth nitrate; add about 23.78g of 40% potassium hydroxide solution, adjust the pH to 6-8, and make the hydrolysis complete (that is, the retest pH is constant) Then, filter to obtain the filter cake bismuth hydroxide; then put 40.56g of purified water and 17.89g of sorbitol into the beaker. After the sorbitol is dissolved, add the filter cake bismuth hydroxide, stir and add 40% potassium hydroxide About 50g of the solution, stir to make it fully dissolved, and get the bismuth salt solution for later use;
[0052] (2) Add the bismuth salt solution prepared in step (1) to the reaction flask, stir, add 49ml purified water, add pectin soft material at room temperature, after the addition, heat up to about 40 ℃ and stir, keep warm and react for 0.5 hours, then add 105g of purified water, temperature controlled at 30-35°C and stirred for 1.5 hours; after the ...
Embodiment 2
[0054] Example 2. Preparation of colloidal bismuth pectin dry suspension
[0055] Prescription: colloidal pectin bismuth 1000 (based on 150g bismuth)
[0056] Mannitol 455g
[0057] Disodium hydrogen phosphate 15g
[0058] Production method: 1) Weigh the ingredients in the prescription on an electronic scale according to the ratio in the prescription; 2) Put the weighed colloidal bismuth pectin, disodium hydrogen phosphate and mannitol into the total mixer in turn Mix, the mixing time is 30 minutes, the speed of the total mixer is 50Hz; 3) After mixing, sample the product (sampling volume is about 30g) for testing. After passing the test, divide it into 1000 bags, vacuum seal, label, store, Packaging and storage.
Embodiment 3
[0059] Example 3. Preparation of colloidal bismuth pectin dry suspension
[0060] Prescription: Colloidal pectin bismuth 900kg
[0061] Mannitol 409.5kg
[0062] Disodium hydrogen phosphate 13.5kg
[0063] Specification: 150mg (calculated as bismuth)
[0064] Production method: 1) Weigh the ingredients in the prescription on an electronic scale according to the ratio in the prescription; 2) Put the weighed colloidal bismuth pectin, disodium hydrogen phosphate and mannitol into the total mixer in turn Mix, the mixing time is 30 minutes, and the speed of the total mixer is 50Hz; 3) After mixing, sample the product (sampling volume is about 30g) for testing. After passing the test, divide it into 900,000 bags, vacuum seal, label, and store ,Packaging and storage.
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