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Diclofenac potassium dry suspension and preparation method thereof

A technology of diclofenac potassium and dry suspension, applied in the directions of anti-inflammatory agents, pharmaceutical formulations, non-central pain relievers and the like

Inactive Publication Date: 2011-03-30
HANGZHOU SHARPLY PHARM R&D INSTIT +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no dry suspension or similar dosage form for clinical use in China

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1: prepare 1000 bags of diclofenac potassium dry suspension, adopt following prescription:

[0021] Diclofenac Potassium 50g Acrylic Resin E100 10g

[0022] Xanthan Gum: 3g Potassium Bicarbonate 22g

[0023] Aspartame 10g Mint flavor 5g

[0024] Orange Flavor 10g Mannitol 250g

[0025] Magnesium stearate 3g ethanol appropriate amount

[0026] Preparation Process:

[0027] 1. Dissolve the prescription amount of acrylic resin E100 in 95% ethanol solution to prepare 10% E100 alcohol solution, 90% as coating material and 10% as adhesive;

[0028] 2. Put the prescribed amount of Diclofenac Potassium into the coating pan, use the coating material to coat, and sieve through a 40-mesh sieve to obtain the coating raw material granules;

[0029] 3. Pass other materials through 80-mesh sieve for later use;

[0030] 4. Potassium bicarbonate and mannitol are used as binders to prepare soft materials, passed through a 40-mesh sieve to granulate, and the granules are ...

Embodiment 2

[0033] Embodiment 2: prepare 1000 bags of diclofenac potassium dry suspension, adopt following prescription:

[0034] Diclofenac Potassium 25g Hypromellose 10g

[0035] Sodium carboxymethyl cellulose 3g Potassium bicarbonate 22g

[0036] Xylitol 10g Peppermint essence 5g

[0037] Lemon essence 10g Lactose 250g

[0038] Talcum powder 3g ethanol appropriate amount

[0039] Preparation Process:

[0040] 1. Dissolve the prescribed amount of hydroxypropyl cellulose in 75% ethanol solution to prepare a 3% alcohol solution, 90% of which is used as a coating material and 10% as a binder;

[0041] 2. Put the prescribed amount of diclofenac potassium into the coating pan, use the coating material to coat, and pass through a 40-mesh sieve to obtain the coating raw material granules;

[0042] 3. Pass other materials through 80-mesh sieve for later use;

[0043] 4. Make potassium bicarbonate and lactose into a soft material with a binder, pass through a 40-mesh sieve to granulate, an...

Embodiment 3

[0045] Embodiment 3: prepare 1000 bags of diclofenac potassium dry suspension, adopt following prescription:

[0046] Diclofenac Potassium 30g Maltitol 12g

[0047] Sodium Alginate 4g Potassium Bicarbonate 18g

[0048] Sorbitol 8g Peppermint essence 4g

[0049] Pineapple flavor 10g Starch 230g

[0050] Talcum powder 3g ethanol appropriate amount

[0051] Preparation Process:

[0052] 1. Dissolve the prescribed amount of maltitol in an aqueous solution to prepare a 3% aqueous solution, of which 90% is used as a coating material and 10% is used as a binder;

[0053] 2. Put the prescribed amount of diclofenac potassium into the coating pan, use the coating material to coat, and pass through a 40-mesh sieve to obtain the coating raw material granules;

[0054] 3. Pass other materials through 80-mesh sieve for later use;

[0055] 4. Make potassium bicarbonate and starch into a soft material with a binder, pass through a 40-mesh sieve to granulate, and dry the granules in a ci...

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Abstract

The invention relates to a diclofenac potassium dry suspension and a preparation method thereof. The diclofenac potassium dry suspension comprises 1.0%-3.0% of main medicine diclofenac potassium, 0.2%-1% of high molecular material, 0.5%-2% of suspending agent, 70%-92% of filler and 3%-15% of flavoring agent. Since the diclofenac potassium has poor taste, which possibly causes poor administration compliance, raw materials are coated with a proper high molecular material firstly, and under the condition of not influencing the release of the medicine, the main medicine is coated in the high molecular material completely to separate the medicine from taste buds to isolate bad flavor; in addition, the proper suspending agent, the flavoring agent, the filler and a lubricant are matched to finally obtain the dry suspension. The diclofenac potassium dry suspension obtained by the invention has good administration compliance and achieves the advantages of fast effect taking, good analgesic effect, stable absorption, high biological availability and the like in comparison with diclofenac sodium.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a diclofenac potassium dry suspension and a preparation method thereof. Background technique [0002] Diclofenac potassium is a new type of non-steroidal anti-inflammatory drug with significant anti-inflammatory and analgesic effects, and its mechanism of action is mainly to inhibit the synthesis of prostaglandins. After joint and muscle sprain, tooth extraction and operation, it can cause aseptic inflammation, tissue edema and pain. With the generation of inflammation, the prostaglandin synthesized and released in the injured part increases. [0003] Diclofenac potassium can reduce the prostaglandins synthesized and released in the wounded area, play an anti-inflammatory and analgesic effect, and have a better therapeutic effect than similar drugs. The pharmacokinetic studies conducted abroad have compared diclofenac potassium and diclofenac sodium (Voltaren) , found ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/196A61K47/32A61K47/34A61K47/36A61K47/38A61K47/40A61K47/42A61P29/00A61K47/10
Inventor 范敏华刘华徐海李丹王丽霞
Owner HANGZHOU SHARPLY PHARM R&D INSTIT
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