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

A kind of tiopronin freeze-dried powder injection and preparation method thereof

A technique for tiopronin and freeze-dried powder injection, which is applied in the field of tiopronin freeze-dried powder injection and its preparation, can solve the problem that freeze-dried powder cannot meet the stability requirements, cannot improve the stability of tiopronin, freeze-dried powder Difficult to redissolve and other problems, to achieve the effect of shortening the freeze-drying time, ensuring stability, and improving stability

Active Publication Date: 2018-01-02
MAANSHAN BBCA PHARMA
View PDF7 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] (3) Selecting hydrochloric acid and sodium hydroxide as pH regulators cannot improve the stability of tiopronin
[0016] (4) The freeze-drying time exceeds 22 hours during the freeze-drying process. The longer the freeze-drying time, the longer tiopronin is in a non-dry state, the more unstable the product quality, and the greater the energy consumption and the higher the production cost
[0021] Experiments on the above-mentioned related patents found that none of the freeze-dried powders provided by the above-mentioned patents can meet the stability requirements, and the prepared freeze-dried powders may be difficult to reconstitute (that is, there are visible foreign objects), or insoluble particles appear after reconstitution, and the stability is poor

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
  • A kind of tiopronin freeze-dried powder injection and preparation method thereof
  • A kind of tiopronin freeze-dried powder injection and preparation method thereof
  • A kind of tiopronin freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1: Tiopronin freeze-dried powder injection

[0052]1. Raw materials: tiopronin 1000g, glycine 100g, sodium carbonate 50g, polyethylene glycol 200200g, water for injection to 10000ml.

[0053] 2. Preparation method:

[0054] 2.1 Preparation of injection: Measure 5000mL of water for injection at 15°C, adjust the pH value to 1.8-2.2 (pH regulator: 5%H 2 SO 4 solution), add the prescribed amount of tiopronin, and dissolve to obtain a solution ①; weigh the prescribed amount of polyethylene glycol, glycine, and sodium carbonate, add about 4000 mL of water for injection, stir and dissolve, add 2‰ activated carbon, and heat to 70±2 ℃, keep warm for 15 minutes, filter and decarbonize, cool to 15 ℃ to obtain solution ②; combine solution ① and solution ②, use water for injection below 20 ℃ to make up the volume to the total amount, filter through a 0.22 μm pore size sterile filter to storage Cans, after passing the inspection of intermediate products, 1ml per bottle ...

Embodiment 2

[0063] Embodiment 2: Tiopronin freeze-dried powder injection

[0064] 1. Raw materials: tiopronin 1500g, glycine 150g, sodium carbonate 70g, polyethylene glycol 200400g, water for injection to 10000ml.

[0065] 2. Preparation method:

[0066] 2.1 Preparation of injection: Measure 5000mL of water for injection at 13°C, and adjust the pH value to 1.8-2.2 (pH regulator: 5%H 2 SO 4 solution), add the prescribed amount of tiopronin, and dissolve to obtain a solution ①; weigh the prescribed amount of polyethylene glycol, glycine, and sodium carbonate, add about 4000 mL of water for injection, stir and dissolve, add 2‰ activated carbon, and heat to 70±2 ℃, keep warm for 15 minutes, filter and decarbonize, cool to 13 ℃ to obtain solution ②; combine solution ① and solution ②, use water for injection below 20 ℃ to make up the volume to the total amount, filter through a 0.22 μm pore size sterile filter to storage Cans, after passing the inspection of intermediate products, 1ml per bo...

Embodiment 3

[0075] Embodiment 3: Tiopronin freeze-dried powder injection

[0076] 1. Raw materials: 2000g tiopronin, 200g glycine, 100g sodium carbonate, 200800g polyethylene glycol, and add water for injection to 10000ml.

[0077] 2. Preparation method:

[0078] 2.1 Preparation of injection: Measure 5000mL of water for injection at 16°C, adjust the pH value to 1.8-2.2 (pH regulator: 5%H 2 SO 4 solution), add the prescribed amount of tiopronin, and dissolve to obtain a solution ①; weigh the prescribed amount of polyethylene glycol, glycine, and sodium carbonate, add about 4000 mL of water for injection, stir and dissolve, add 2‰ activated carbon, and heat to 70±2 ℃, keep warm for 15 minutes, filter and decarbonize, cool to 16 ℃ to obtain solution ②; combine solution ① and solution ②, make up the volume to the total amount with water for injection below 20 ℃, filter through a 0.22 μm pore size sterile filter to storage Cans, after passing the inspection of intermediate products, 1ml per...

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

No PUM Login to View More

Abstract

The invention relates to a tiopronin freeze-dried powder injection and a preparation method thereof. The raw material of the freeze-dried powder injection contains the following components: tiopronin, glycine, sodium carbonate, polyethylene glycol and water for injection. The freeze-dried powder injection provided by the invention meets the requirements of the national drug standards, and the six-month stability acceleration test has all the indicators in line with the requirements of the national drug standards.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing tiopronin, in particular to a freeze-dried powder injection of tiopronin and a preparation method thereof. Background technique [0002] Tiopronin chemical name: N-(2-mercaptopropionyl)-glycine; molecular formula: C 5 h 9 NO 3 S; molecular weight: 163.20. [0003] Tiopronin is a thiol-containing drug similar in nature to penicillamine, and has the effect of protecting liver tissue and cells. Animal experiments have shown that tiopronin can prevent liver damage caused by carbon tetrachloride, ethionine, paracetamol, etc. by providing sulfhydryl groups, and can inhibit the accumulation of triglycerides in chronic liver damage. Tiopronin can reduce the activity of ATPase in the mitochondria of liver cells, thereby protecting the structure of liver mitochondria and improving liver function. In addition, tiopronin can also scavenge free radicals through the reversible combination of thiol...

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
Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/198A61K47/02A61K47/18A61K47/10A61J3/02A61P1/16A61P39/02A61P27/12
Inventor 尹双青刘永宏刘熙璞
Owner MAANSHAN BBCA PHARMA