Fluorohydrocortisone acetate tablet and preparation method thereof

A technology of fludrocortisone acetate and fludrocortisone tablets, which is applied in the field of fludrocortisone acetate tablets and its preparation, can solve the problems of increased impurities in the degradation of pine and affect product safety, and avoid negative effects , Improve storage stability, use safety guarantee effect

CN114569569AActive Publication Date: 2022-06-03湖南醇健制药科技有限公司
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
Publication Date
2022-06-03

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Abstract

The fluhydrocortisone acetate tablet is mainly prepared from fluhydrocortisone acetate, lactose, a disintegrating agent, a flow aid and a lubricant, the disintegrating agent is directly pressed starch, and the fluhydrocortisone acetate tablet does not contain ionic auxiliary materials. The preparation method comprises the following steps: (1) sieving the fluorohydrocortisone acetate and the lactose, adding the sieved fluorohydrocortisone acetate and lactose into a mixer, and then adding the directly pressed starch for mixing; (2) adding a flow aid into the mixed material obtained in the step (1), and continuously mixing; (3) adding a lubricant into the mixed material obtained in the step (2), and carrying out final mixing; and (4) tabletting and molding the mixed material obtained in the step (3) to obtain the hydrocortisone acetate tablet. The direct-pressed starch is innovatively adopted to replace a traditional ionic auxiliary material to serve as a disintegrating agent, so that negative effects caused by the use of the ionic auxiliary material can be avoided, and the storage stability of the hydrocortisone acetate tablet can be improved under the condition of ensuring that the dissolution rate of the product is consistent with that of an original developed agent; and the use safety of the product is further ensured.
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Description

technical field

[0001] The invention belongs to the field of pharmaceutical preparation, in particular to a fludrocortisone acetate tablet with high storage stability and a preparation method thereof. Background technique

[0002] Fludrocortisone acetate tablets are used for the treatment of salt-depriving congenital adrenal hypersensitivity and salt-depriving chronic adrenal insufficiency (Addison's disease).

[0003] The original preparation of fludrocortisone acetate tablets is Florinef Funeng Tablet produced by Aspen Japan K.K. According to the instructions, the excipients used in the original preparation are: calcium hydrogen phosphate dihydrate, corn starch, talc, magnesium stearate, sodium benzoate, anhydrous lactose and lactose monohydrate. The stability of the original preparation agent is poor, and fludrocortisone acetate is easily degraded. In the original preparation agent, it is necessary to strictly control the storage temperature to control the degradation im...

Examples

Embodiment 1

[0032] A fludrocortisone acetate tablet of the present invention is mainly composed of fludrocortisone acetate (manufacturer: Henan Lihua Pharmaceutical), lactose (model 11SD, produced by mass ratio of 1:800:150:40:9) supplier: DMF), amylose starch (model Shanjie, manufacturer: Colorcon), talc (manufacturer: Guangxi Longsheng Huamei Talc Development Co., Ltd.) and magnesium stearate (Anhui Shanhe Pharmaceutical Excipients Co., Ltd. ) are prepared.

[0033] The preparation method of the fludrocortisone acetate tablet of the present embodiment comprises the following steps:

[0034] (1) with fludrocortisone acetate and lactose, sieve with 40 mesh sieves, join in mixer;

[0035] (2) adding amylose starch in the mixer and mixing, the control mixing speed is 12rpm, and the one-way mixing is 30min;

[0036] (3) in the material after step (2), add talcum powder and continue to mix, and the control mixing speed is 12rpm, and one-way mixing is 5min;

[0037] (4) in the material afte...