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Medicine composition soft capsule and its preparing process

A technology of soft capsules and compositions, applied in the field of pharmaceutical composition soft capsules and their preparation, can solve the problems of poor absorption, low bioavailability, incomplete dissolution of oral loxoprofen sodium tablets, etc., and achieve stable absorption , Accurate dosage, and the effect of improving bioavailability

Inactive Publication Date: 2006-11-08
宛六一 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Its existing oral loxoprofen sodium tablet has incomplete dissolution rate, poor absorption and low bioavailability

Method used

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  • Medicine composition soft capsule and its preparing process

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Loxoprofen Sodium 10g

[0026] PEG400 200g

[0027] Ethanol 10g

[0028] After the loxoprofen sodium and ethanol of the above formula amount are mixed and dissolved, add PEG400 and put in a colloid mill to mix evenly to obtain the contents of the soft capsule. With gelatin: glycerin: water = 1: 0.5: 0.8 as the capsule material, the soft capsule is prepared by molding method. Capsules and soft capsules are solidified by cold air, dried, washed with an appropriate solvent, and finally dried to obtain 1000 soft capsules.

Embodiment 2

[0030] Loxoprofen Sodium 30g

[0031] PEG600 200g

[0032] Hydroxypropyl beta-cyclodextrin 15g

[0033] Propylene glycol 10g

[0034] After the loxoprofen sodium and hydroxypropyl β-cyclodextrin of the above formula quantity are mixed and clathrated, add PEG400, propylene glycol and put in a colloid mill and mix evenly to obtain the contents of the soft capsule, with gelatin: glycerol: water: sorbitol=1 : 0.4: 0.9: 0.03 is the capsule material, and the soft capsules are prepared by molding method. The soft capsules are solidified by cold air, dried, washed with an appropriate solvent, and finally dried to obtain 1000 soft capsules.

Embodiment 3

[0036] Loxoprofen Sodium 60g

[0037] PEG400 300g

[0038] Ethanol 30g

[0039] Glycerin 20g

[0040] The loxoprofen sodium and ethanol in the above formula amount are mixed and dissolved, then added with PEG400 and glycerin and placed in a ball mill to mix evenly to obtain the contents of the soft capsule. The capsule material is prepared by molding with gelatin: glycerin: water = 1: 0.4: 0.9 Soft capsules, the soft capsules are solidified by cold air, dried, washed with an appropriate solvent, and finally dried to obtain 1000 soft capsules.

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Abstract

The present invention relates to medicine composition soft capsule with loxoprofen sodium as active component and its preparation process. The soft capsule is prepared through preparing the inclusion with the mixture of loxoprofen sodium and several of diluent, co-solvent, solubilizer, suspending agent and surfactant; and the subsequent preparing soft capsule. The soft capsule has high stability of loxoprofen sodium, raised medicine leaching quantity, high bioavailability, high safety and high effectiveness.

Description

technical field [0001] The invention relates to a pharmaceutical composition soft capsule whose active substance is loxoprofen sodium and a preparation method thereof. Background technique [0002] Loxoprofen sodium is a phenylpropionic acid non-steroidal anti-inflammatory drug, which has excellent analgesic and anti-inflammatory effects. Its analgesic effect is strong, and its anti-inflammatory and antipyretic effects are similar to other similar drugs. It was approved for listing in 1986. It is absorbed into the blood through the digestive tract in an inactive form, and is quickly transformed into a biologically active trans-OH body, which produces anti-inflammatory and analgesic effects, so it is less irritating to the gastrointestinal tract. After oral administration, it is rapidly absorbed and distributed in the liver, kidney, and blood plasma at a high concentration, and then most of it becomes the original gluconic acid conjugate or hydroxylated gluconic acid conjuga...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/192A61K47/00
Inventor 宛六一
Owner 宛六一
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