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Pharmaceutical composition containing sodium picosulfate, magnesium oxide, citric acid and/or potassium bicarbonate and preparation method thereof

A technology of sodium picosulfate and potassium bicarbonate, applied in the field of pharmaceutical preparation, can solve the problems of unavoidable risks, poor mixing uniformity, unstable products and the like

Active Publication Date: 2021-11-16
YANGTAI PHARMA SHANDONG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This quality difference brings greater risk to the product
First, magnesium oxide cannot be adsorbed to the surface of citric acid in sufficient amount, and a large amount of unadsorbed fine powder magnesium oxide in the product leads to poor mixing uniformity; second, the surface of citric acid is not fully covered by magnesium oxide, Lead to increased contact with sodium picosulfate, leading to product instability
Although in the patent CN101820859, the apparent volume and particle size of magnesium oxide and other materials have been fully studied and the scope is specified, the above risks cannot be avoided

Method used

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  • Pharmaceutical composition containing sodium picosulfate, magnesium oxide, citric acid and/or potassium bicarbonate and preparation method thereof
  • Pharmaceutical composition containing sodium picosulfate, magnesium oxide, citric acid and/or potassium bicarbonate and preparation method thereof
  • Pharmaceutical composition containing sodium picosulfate, magnesium oxide, citric acid and/or potassium bicarbonate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Table 2. Composition of Embodiment 1 (unit dose packaging, every bag)

[0029] Example 1 materials weight Sodium picosulfate 10mg magnesium oxide 3.5g citric acid 12g potassium bicarbonate 0.5g sodium saccharin 60mg essence 60mg

[0030] Embodiment 1 preparation method:

[0031] Put 24kg of citric acid and 7kg of magnesium oxide into 10kg of water, heat and dissolve at 65°C to form a clear solution. Dry with spray drying equipment, the spray speed is 2.5ml / min, and the drying temperature is 140°C to obtain solid powder 1.

[0032] 1 kg of potassium bicarbonate was pulverized with a pulverizer, and added into the fluidized bed with solid powder 1, and 20 g of sodium picosulfate was dissolved in 4 kg of purified water. The sodium picosulfate solution is atomized and sprayed into the fluidized bed to granulate the materials in the fluidized bed. Dry until the material temperature is 40° C., use a 0.6 mm sieve...

Embodiment 2-9

[0038] Table 3. The concrete composition of embodiment 2-9

[0039]

[0040] The preparation method of embodiment 2-9:

[0041]Take 12 g of citric acid and put it into 150 g of purified water, stir and dissolve, then add 3.5 g of magnesium oxide, add a pH regulator, and finally add 10 mg of sodium picosulfate to obtain a mixed solution.

[0042] Investigation on the stability of sodium picosulfate content

[0043] Measure the solution pH and content change of embodiment 2-9 and see the following table:

[0044] Sodium picosulfate content stability investigation table

[0045] sample 0 January March Example 2 93.3 89.1 79.6 Example 3 94.6 91.5 85.9 Example 4 98.5 97.6 97.5 Example 5 98.9 98.6 98.5 Example 6 98.7 98.1 97.9 Example 7 86.3 85.3 84.7 Example 8 90.1 89.7 89.4 Example 9 95.4 93.1 91.8

[0046] By using different pH regulators to adjust to different pHs, the content of sodium pico...

Embodiment 10-13

[0048] Table 4. Compositions of Examples 10-13 (unit dose packaging, per bag)

[0049] Example 10 Example 11 Example 12 Example 13 materials weight weight weight weight Sodium picosulfate 10mg 10mg 10mg 10mg magnesium oxide 3.5g 3.5g 3.5g 3.5g citric acid 12g 12g 12g 12g potassium bicarbonate 0.5g 0.5g 0.5g 0.5g sodium saccharin 60mg 60mg 60mg 60mg essence 60mg 60mg 60mg 60mg Triethylamine 2.5mg 2.5mg 2.5mg 2.5mg Dry material temperature °C 35 40 45 50

[0050] Embodiment 10-13 preparation method:

[0051] Put 24kg of citric acid, 7kg of magnesium oxide and 5g of triethylamine into 10kg of water, heat and dissolve at 65°C to form a clear solution. Dry with spray drying equipment, the spray speed is 2.5ml / min, and the drying temperature is 140°C to obtain solid powder 1.

[0052] 1 kg of potassium bicarbonate was pulverized with a pulverizer, and added int...

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Abstract

. The invention belongs to the technical field of medicine preparation, and particularly relates to a pharmaceutical composition containing sodium picosulfate, magnesium oxide, citric acid and / or potassium bicarbonate and a preparation method thereof The preparation method comprises the following steps: dissolving citric acid and magnesium oxide in water, and adjusting the pH value to obtain a magnesium citrate solution; then obtaining magnesium citrate solid powder through a proper drying method, smashing potassium bicarbonate and then performing one-step granulation with the magnesium citrate solid powder through a sodium picosulfate aqueous solution, adding other auxiliary materials and obtaining the pharmaceutical composition. According to the method, the step of adsorbing and coating citric acid by magnesium oxide is avoided, and the product with good uniformity and stable quality is obtained.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a medicine composition containing sodium picosulfate, magnesium oxide, citric acid and / or potassium bicarbonate and a preparation method thereof. Background technique [0002] Compound Sodium Picosulfate Granules is a new drug developed by Huiling Pharmaceutical Company, trade name: PREPOPIK TM , Bi Lishi, used for colonoscopy, X-ray examination before intestinal cleansing preparation. Launched in China in October 2018. Specifications: Each bag contains 10mg of active ingredient sodium picosulfate, 3.5g of magnesium oxide, 12.0g of citric acid, and the auxiliary material is potassium bicarbonate. After the product is dissolved, magnesium oxide and citric acid will react to form magnesium citrate to exert a laxative effect. Sodium picosulfate is a prodrug, which is transformed into an active metabolite by bacteria in the colon after oral administration:...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/08A61K9/16A61K47/02A61K47/18A61P1/10A61K31/4402A61K31/194
CPCA61K31/4402A61K33/08A61K31/194A61K9/1682A61K9/1611A61K9/1617A61P1/10A61K2300/00
Inventor 孙迎基王玉广王海燕刘格张路李铁军
Owner YANGTAI PHARMA SHANDONG
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