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Butylbenzene phthalein concentrated solution for injection and its making method

A technology of butylphthalide and concentrated solution, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc. speed, etc.

Inactive Publication Date: 2007-11-21
何瑞恒
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, butylphthalide is only available in the market as soft capsules, which is to disperse mixed butylphthalide with vegetable oil and then directly fill and seal soft capsules. Although this dosage form can cover up the bad smell of the drug, its content is poorly dispersed in the water phase, and it is difficult to greatly affect the rate of drug absorption
At the same time, no matter whether it is treating diseases caused by cerebral ischemia or treating thrombosis, the drugs used need to be released quickly and achieve the therapeutic effect quickly, so injections are the most commonly used clinical dosage forms for such diseases. Butylphthalide is insoluble in water. Currently, only soft capsules are available on the market for oral use, which cannot meet the clinical needs in the acute stage of cerebral ischemia.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment 1: the preparation of injection butylphthalide concentrated solution (5ml: 40mg)

[0047] Prescription: Butylphthalide 40g Polyoxyethylene Castor Oil 2635mg

[0048] Add absolute ethanol to 5000ml

[0049] Makes 1000 bottles

[0050] Preparation:

[0051] 1. Take the butylphthalide of prescription quantity, add the polyoxyethylene (35) castor oil of prescription quantity, add dehydrated alcohol proper amount, stir to make dissolving completely.

[0052] 2. Add absolute ethanol to a sufficient amount.

[0053] 3. Add 0.05% activated carbon for needles, stir at room temperature for 10 minutes, and decarbonize by coarse filtration.

[0054] 4. Use 0.22μm microporous membrane to fine filter to clear liquid.

[0055] 5. After checking the pH value and content of the filtrate to pass the test, put it into 10ml vials, the theoretical filling volume is 5ml / bottle, press the stopper, and roll the cap.

[0056] 6...

Embodiment 2

[0057] Embodiment 2: the preparation of injection butylphthalide concentrated solution (5ml: 40mg)

[0058] Prescription: Butylphthalide 40g Tween-80 2500ml

[0059] Add absolute ethanol to 5000ml

[0060] Makes 1000 bottles

[0061] The preparation method is the same as in Example 1.

Embodiment 3

[0062] Embodiment 3: the preparation of injection butylphthalide concentrated solution (5ml: 40mg)

[0063] Prescription: Butylphthalide 40g Tween-80 2500ml

[0064] Add EDTA 0.5g absolute ethanol to 5000ml

[0065] Makes 1000 bottles

[0066] The preparation method is the same as in Example 1, wherein step 1 is to weigh the prescribed amount of butylphthalide and EDTA, add the prescribed amount of polyoxyethylene (35) castor oil, add an appropriate amount of absolute ethanol, and stir to completely dissolve.

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PUM

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Abstract

The invention is concerned with the injection thick solution and the preparation method that is made of butyl phthalide.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to the preparation of a concentrated solution for injection using butylphthalide as a raw material. Background technique [0002] Butylphthalide is the main component of celery and its seeds. It can be extracted from natural celery seed oil or obtained through artificial synthesis. Butylphthalide has the function of regulating the function of NOS-NO-cGMP system and the metabolism of arachidonic acid in nerve cells after cerebral ischemia. It has been used as a drug to prevent and treat diseases caused by cerebral ischemia. Butylphthalide is an oily liquid, insoluble in water, with a strong celery smell, the molecule contains a chiral carbon atom, so it has two optical isomers, namely L-butylphthalide and D-butylphthalide . At present, butylphthalide is only available in the market as soft capsules, which is to disperse mixed butylphthalide with vegetable oil and then dir...

Claims

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Application Information

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IPC IPC(8): A61K31/365A61K9/08A61K47/30A61K47/10A61K47/12A61P9/10
Inventor 何瑞恒
Owner 何瑞恒
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