Fludrocortisone acetate oral cavity instant film agent and preparation method thereof

A technology of fludrocortisone acetate and oral quick-dissolving film, applied in the field of medicine, can solve problems such as difficulty in research and development, difficulty in swallowing ordinary tablets, and dangers, and achieves the advantages of accelerating drug absorption, accelerating drug dissolution rate, and reducing impurities. Effect

Inactive Publication Date: 2019-04-12
江苏福锌雨医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For infants and young children, especially those in the neonatal period, it is very difficult to swallow ordinary tablets, and it may even be dangerous
Because flu...

Method used

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  • Fludrocortisone acetate oral cavity instant film agent and preparation method thereof
  • Fludrocortisone acetate oral cavity instant film agent and preparation method thereof
  • Fludrocortisone acetate oral cavity instant film agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] The prescription quantity is 1000 tablets (specification 0.1mg: 10mg).

[0043] Table 1:

[0044] fludrocortisone acetate

0.1g

Hydroxypropyl-β-cyclodextrin

1.5g

polyoxyethylene

0.1g

Hypromellose (E50LV)

4.9g

Dextran

2.4g

Mannitol

1.0g

purified water*

90ml

Absolute ethanol*

10ml

[0045] *Used in prescription but removed during processing.

[0046] 1. Preparation of inclusion compound

[0047] Accurately weigh 1.5g of hydroxypropyl-β-cyclodextrin, add 10ml of purified water and stir to dissolve; take fludrocortisone acetate and dissolve it in 10ml of ethanol to obtain fludrocortisone acetate solution; Add the ethanol solution of fludrocortisone acetate dropwise to the aqueous solution of hydroxypropyl-β-cyclodextrin; after dropping, sonicate for 5 minutes to obtain the inclusion complex of fludrocortisone acetate and hydroxypropyl-β-cyclodextrin substance solution.

[0048] 2. Prepar...

Embodiment 2

[0055] The prescription quantity is 1000 tablets (specification 0.1mg: 10mg).

[0056] Table 2:

[0057] fludrocortisone acetate

0.1g

polyoxyethylene

0.1g

Hypromellose (E50LV)

4.9g

Dextran

3.9g

Mannitol

1.0g

purified water*

90ml

Absolute ethanol*

10ml

[0058] *Used in prescription but removed during processing.

[0059] (1) Dissolve fludrocortisone acetate in 10 ml of absolute ethanol to obtain fludrocortisone acetate solution.

[0060] (2) After dissolving mannitol and dextran in 20ml of purified water, stir to dissolve.

[0061] (3) Then the solutions obtained in steps (1) and (2) were mixed and stirred for 3-5 minutes.

[0062] (4) Next, add polyoxyethylene solution dissolved in 20 ml of purified water to the solution obtained in step (3), and stir evenly.

[0063] (5) Dissolve hypromellose in 50ml of water, mix the obtained hypromellose solution with the solution obtained in step (4), and sti...

Embodiment 3

[0067] The prescription quantity is 1000 tablets (specification 0.1mg: 10mg).

[0068] table 3:

[0069] fludrocortisone acetate

0.1g

polyoxyethylene

0.1g

Hypromellose (E50LV)

5.8g

Dextran

4.0g

purified water*

90ml

Absolute ethanol*

10ml

[0070] *Used in prescription but removed during processing.

[0071] (1) Dissolve fludrocortisone acetate in 10 ml of absolute ethanol to obtain fludrocortisone acetate solution.

[0072] (2) Dissolve dextran in 20ml of purified water, and stir to dissolve.

[0073] (3) Then the solutions obtained in steps (1) and (2) were mixed and stirred for 3-5 minutes.

[0074] (4) Next, add polyoxyethylene solution dissolved in 20 ml of purified water to the solution obtained in step (3), and stir evenly.

[0075] (5) Disperse the hypromellose in 50ml of hot water, after cooling, continue to stir until the hypromellose is completely dissolved. Mix the hypromellose solution obtained...

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Abstract

The present invention discloses a fludrocortisone acetate oral cavity instant film agent. The fludrocortisone acetate oral cavity instant film agent comprises a fludrocortisone acetate clathrate, a film forming material and a filler. The fludrocortisone acetate clathrate is prepared by clathration of cyclodextrin or/and cyclodextrin derivatives and fludrocortisone acetate. Aiming at problems thata fludrocortisone acetate liquid preparation is poor in stability, and marketed tablets are large in volume and slow in dissolution, and unfavorable for use of patients in neonatal period, infants andyoung children, etc., the oral cavity instant film agent is designed to solve problems that in common oral instant film agents, the fludrocortisone acetate is relatively slow in dissolution rate andpoor in stability is poor. The fludrocortisone acetate instant film agent is small in volume and light in mass, can be dissolved once placed at the tip of the tongue, is pleasant in mouthfeel, quick in onset and good in absorption, and satisfies drug administration requirements of the patients in the neonatal period, infants and young children, etc.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an oral instant film of fludrocortisone acetate and a preparation method thereof. Background technique [0002] Congenital adrenal hyperplasia is mainly due to defects in the enzymes necessary for the biosynthesis of adrenocortical hormones, resulting in abnormal synthesis of corticosteroids. In most cases, the adrenal gland secretes insufficient sugar hormones and salt hormones and excessive male hormones, so different degrees of adrenal cortical insufficiency appear clinically, accompanied by virilization in girls, and precocious puberty in boys. Addison's syndrome is primary chronic adrenal insufficiency, which refers to a series of symptoms caused by the destruction of most of the bilateral adrenal glands due to various reasons, resulting in insufficient secretion of adrenal cortex hormones, including systemic Hyperpigmentation of the skin, hyponatremia, hypotension, elevat...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K47/69A61K47/10A61K47/38A61K47/36A61K31/573A61P5/38
CPCA61K9/006A61K9/7007A61K31/573A61K47/10A61K47/36A61K47/38A61K47/6951A61P5/38
Inventor 王方王静张彦卓陈鹏李建华
Owner 江苏福锌雨医药科技有限公司
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