Oral soft capsule compound preparations for curing cold

A soft capsule and solvent technology, which is applied in the directions of capsule delivery, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of unsuitable soft capsule preparations, precipitation, and unsuitable preparation requirements.

Active Publication Date: 2008-10-08
江苏万高药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] WO9805314A teaches the use of propylene glycol, polyethylene glycol 400, water and sodium acetate to dissolve acetaminophen. The ratio of the three is 30%: 40%: 30%, and sodium acetate is also added, which can only dissolve paracetamol at most. 200mg/ml of acetaminophen; if the soft capsule is prepared according to the above concentration, on the one hand, such a large amount of water cannot be used (during the drying process of the soft capsule, the water will migrate into the skin of the soft capsule and be removed); The use of sodium acetate can easily lead to leakage of soft capsules
Illustrate by WO9805314A, low-molecular-weight alcohols are limited to promoting the dissolution of paracetamol in polyethylene glycol solution, even if can further increase the solubility of paracetamol in polyethylene glycol by means of sodium acetate, also still Cannot exceed the limit of 200mg/ml
[0005] Using basic excipients to increase the solubility of liquid preparations containing acetaminophen is easy for those skilled in the art, because acetaminophen water injection uses sodium hydroxide as a solubilizer Yes, but as we all know, the acetaminophen raw material itself can only remain stable under the condition of neutral pH, overacid or overalkaline will cause it to decompose and change color, and the composition is red or even black, although it is easy to However, how to solve the stability problem of acetaminophen while ensuring the solubility remains to be further studied by those skilled in the art
[0006] The carbohydrates or polyhydric alcohols used in CN1348359A just utilize the sweet taste and refreshing feeling brought by it, and the effect is only to cover up the unpleasant taste brought by the active ingredients (including acetaminophen), and the effect is exerted. The reason is that during the chewing process, the soluble components dissolve due to

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Acetaminophen 81.25g

[0069] Pseudoephedrine Hydrochloride 7.5g

[0070] Dextromethorphan Hydrobromide 3.75g

[0071] Macrogol 400 120g

[0072] Propylene glycol 60g

[0073] Xylitol 20g

[0074] BHT 2g

[0075] Sodium acetate appropriate amount

[0076] Appropriate amount of water

[0077]

[0078] Makes 1000 capsules

[0079] Preparation method: Take xylitol and water, heat until completely dissolved, add the prescribed amount of polyethylene glycol 400, propylene glycol and BHT, stir until completely soluble, heat while keeping warm. Add the prescribed amount of acetaminophen, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide, and stir until completely dissolved while keeping warm. The solution should be a clear liquid. Add sodium acetate to adjust the pH of the solution, and add an appropriate amount of defoamer if necessary. Squeeze, dry after shaping, wash the pills, and pack after passing the inspect...

Embodiment 2

[0081] Acetaminophen 81.25g

[0082] Pseudoephedrine Hydrochloride 7.5g

[0083] Dextromethorphan Hydrobromide 3.75g

[0084] Macrogol 400 180g

[0085] Propylene glycol 80g

[0086] Xylitol 30g

[0087] Tween-80 5g

[0088] Appropriate amount of pigment

[0089] Appropriate amount of water

[0090]

[0091] Makes 1000 capsules

[0092] Preparation method: take xylitol and water, heat until completely dissolved, add the prescribed amount of polyethylene glycol 400, propylene glycol and Tween-80, stir until completely soluble, heat while keeping warm. Add the prescribed amount of acetaminophen, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide, and stir until completely dissolved while keeping warm. The solution should be a clear liquid. Add pigment to adjust the color of the solution, and add antifoaming agent if necessary. Squeeze, dry after shaping, wash the pills, and pack after passing the inspection.

Embodiment 3

[0094] Acetaminophen 162.5g

[0095] Pseudoephedrine Hydrochloride 15.0g

[0096] Dextromethorphan Hydrobromide 7.5g

[0097] Macrogol 400 300g

[0098] Propylene glycol 160g

[0099] Sorbitol 5g

[0100] Povidone 25g

[0101] BHT 5g

[0102] Sodium acetate appropriate amount

[0103] Appropriate amount of pigment

[0104]

[0105] Makes 1000 capsules

[0106] Preparation method: take the prescribed amount of polyethylene glycol 400, propylene glycol and BHT, stir until they dissolve completely, add sorbitol and povidone, and heat until completely dissolved while stirring. Add paracetamol, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide in the prescribed amount, stir until completely dissolved while heating and insulated, the solution should be a clear liquid, add sodium acetate to adjust the pH of the solution, add pigment to adjust the color of the solution, and then Press after degassing, dry after setting the ...

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PUM

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Abstract

The invention provides a medicine composition. The medicine composition is a soft capsule that can effectively treat cold and comprises active drug components, a solvent and a co-solvent. The soft capsule can not only solve the problems of leakage and crystallization existing in existing preparation and remarkably improve the beneficial effects of the medicine composition. Compared with products sold in the market, the medicine composition provided by the invention has more remarkable stability and better treat result.

Description

technical field [0001] The invention relates to a pharmaceutical composition which can effectively treat colds, and the composition can significantly enhance the preparation stability and clinical effect of the composition. Background technique [0002] As a national basic medical insurance drug, national essential drug and OTC Class A product, Fenmamei Soft Capsule is currently widely used clinically. Due to its definite clinical curative effect, its research and continuous development and discussion are increasingly attracting people skilled in the art. of great interest. [0003] Acetaminophen is the most used in the prescription, and the other two chemical raw materials, dextromethorphan hydrobromide and pseudoephedrine hydrochloride, are used in small amounts and have good solubility, so the preparation is much simpler and easier than acetaminophen and paracetamol is white to off-white crystalline powder state, through the solubility experiment research to raw material...

Claims

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Application Information

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IPC IPC(8): A61K31/485A61K9/48A61K47/34A61K47/42A61P31/00A61P29/00A61P11/00A61K31/137A61K31/167A61K47/10
Inventor 姚俊华
Owner 江苏万高药业股份有限公司
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