Unlock instant, AI-driven research and patent intelligence for your innovation.

Prednisone acetate tablet and in-vitro dissolution curve detection method thereof

A technology of prednisone acetate tablets and prednisone acetate, which is applied in the fields of pharmaceutical formula, color/spectral characteristic measurement, medical preparations of non-effective ingredients, etc., can solve the problem of inability to effectively control the quality consistency between batches and batches of preparations, It cannot accurately reflect the real situation between batches and batches of preparations, and the dissolution curve has no discrimination, etc.

Inactive Publication Date: 2021-08-31
CISEN PHARMA
View PDF4 Cites 1 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Because prednisone acetate is a poorly soluble drug, the detection of the dissolution curve in vitro usually adopts adding a certain amount of surfactant (such as sodium lauryl sulfate) to accelerate its dissolution rate in the medium, but the addition of surfactant makes Its dissolution rate is too fast, and the measured dissolution curve is indiscriminate, which cannot accurately reflect the real situation between batches of preparations and within batches, and cannot effectively control the consistency of quality within batches of preparations.
And most of the tablets are usually stirred by the paddle method, but the dissolution process of this product is a corrosion process, without disintegration. During the dissolution process, the tablets adhere to the bottom of the dissolution cup, and there is accumulation phenomenon, which is easy to cause the false impression of large RSD

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Prednisone acetate tablet and in-vitro dissolution curve detection method thereof
  • Prednisone acetate tablet and in-vitro dissolution curve detection method thereof
  • Prednisone acetate tablet and in-vitro dissolution curve detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] The prednisone acetate tablet prepared in the present embodiment comprises the following mass compositions: 20 kg of prednisone acetate, 140 kg of cornstarch, 140 kg of sucrose, 16 kg of dextrin, and 1.2 kg of magnesium stearate. Appropriate amount of ethanol and purified water were used as wetting agents, and finally dried to remove.

[0012] The parameter of prednisone acetate tablet is: content 101.0% (because there is certain error in the total mass of prednisone acetate tablet in tablet process, cause the active ingredient in prednisone acetate tablet also to have deviation), friability≤ 0.5%, dissolution ≥70%, loss on drying ≤5.0%.

[0013] Dissolution curve detection method:

[0014] Dissolution method: according to the dissolution and release determination method (Chinese Pharmacopoeia 2020 Edition Four General Rules 0931 Second Method), with water, pH1.2 hydrochloric acid solution, pH4.5 acetate buffer, pH6.8 phosphate buffer 600ml of liquid is the dissolutio...

Embodiment 2

[0022] The prednisone acetate tablet prepared in the present embodiment comprises the following mass components: 30 kg of prednisone acetate, 210 kg of cornstarch, 210 kg of sucrose, 24 kg of dextrin, and 1.8 kg of magnesium stearate. Appropriate amount of ethanol and purified water were used as wetting agents, and finally dried to remove.

[0023] The parameter of prednisone acetate tablet is: content 100.1% (because there is certain error in the total mass of prednisone acetate tablet in tableting process, cause the active ingredient in prednisone acetate tablet also to have deviation), friability≤ 0.5%, dissolution ≥70%, loss on drying ≤5.0%.

[0024] Dissolution curve detection method:

[0025] Dissolution method: According to the dissolution and release determination method (Chinese Pharmacopoeia 2020 Edition Four General Rules 0931 Second Method), respectively, with water, pH1.0 hydrochloric acid solution, pH4.5 acetate buffer, pH6.8 phosphate buffer 600ml of liquid is...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
Wavelengthaaaaaaaaaa
Login to View More

Abstract

The invention discloses a prednisone acetate tablet and a detection method of an in-vitro dissolution curve of the prednisone acetate tablet. The prednisone acetate tablet contains 5 parts by mass of prednisone acetate, 35 parts by mass of corn starch, 35 parts by mass of cane sugar, 4 parts by mass of dextrin and 0.3 part by mass of magnesium stearate. In the preparation process of the prednisone acetate tablet, ethanol and purified water are used as wetting agents, and finally the prednisone acetate tablet is removed by drying. The method for detecting the in-vitro dissolution curve of the prednisone acetate tablet comprises the following steps: respectively putting the prednisone acetate tablet into four media, namely water, a hydrochloric acid solution with the pH value of 1.0 or 1.2, an acetate buffer solution with the pH value of 4.5 and a phosphate buffer solution with the pH value of 6.8, and carrying out dissolution test; an ultraviolet-visible spectrophotometric method is adopted for detection, and the detection wavelength is 243 nm. The invention solves the problem that prednisone acetate is not easy to be quickly absorbed by human body in the prior art, and provides an effective in-vitro dissolution curve evaluation mode.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a prednisone acetate tablet and a detection method for its in vitro dissolution curve. Background technique [0002] Prednisone acetate is an adrenal corticosteroid drug suitable for connective tissue diseases, systemic lupus erythematosus, severe polymyositis, severe bronchial asthma, dermatomyositis, vasculitis and other allergic diseases, which can inhibit the proliferation of connective tissue, Reduces capillary ratio and cell membrane permeability, reduces inflammatory exudation. Mainly used for allergic and inflammatory diseases. [0003] But prednisone acetate is insoluble in water, because its solubility in water is relatively poor, as active component, when being directly taken by human body, only can get good absorption in human body if it can dissolve in water fast. Typically, prednisone acetate is mixed with starch and taken as a tablet, but the ...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): A61K9/20A61K31/573A61K47/36A61K47/26G01N21/33A61P43/00A61P37/02A61P11/06A61P17/00A61P21/00A61P9/14A61P37/08A61P29/00
CPCA61K31/573A61K9/2059A61K9/2018A61P43/00A61P37/02A61P11/06A61P17/00A61P21/00A61P9/14A61P37/08A61P29/00G01N21/33
Inventor 郝秋芬杜爽
Owner CISEN PHARMA