Sulfotanshinone IIA sodium lyophilized powder injection preparation and preparation method thereof

A technology of freeze-dried powder injection and sodium sulfonate, which is applied in freeze-dried delivery, pharmaceutical formulation, powder delivery, etc., can solve the problems of increasing insecurity, increasing production cost, poor product stability, etc., and reducing solid powder and bubbles. Mixture, safety for clinical use, effect of shortening dispensing time

Active Publication Date: 2016-04-20
华益泰康药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Though solve the dissolving problem, because tanshinone Ⅱ A sodium sulfonate solubility is little in alcoholic solvent, make the concentration of tanshinone Ⅱ A sulfonate sodium in the intermediate solution only be 4mg / mL, when preparing the product of same unit dose, increased The volume during filling and the height of the solution increase, which requires a large extension of the freeze-drying time and increases the production cost
Organic solvents are used in the production process. In the production process, not only explosion-proof measures must be adopted, but also the organic solvents in the product must be removed, which greatly increases the unsafety in the production process.
[0009] A large amount of stability research work of the present inventor shows that commercially available samples are very poor in stability, and the technology in the existing patent literature cannot solve the problem of poor product stability

Method used

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  • Sulfotanshinone IIA sodium lyophilized powder injection preparation and preparation method thereof
  • Sulfotanshinone IIA sodium lyophilized powder injection preparation and preparation method thereof
  • Sulfotanshinone IIA sodium lyophilized powder injection preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0085] Prescription: specification (10mg / bottle, 1000 bottles)

[0086] Sodium Tanshinone Ⅱ A Sulfonate

10g

Mannitol

60g

sulfuric acid

0.2g

Water for Injection

Add to 2000mL

[0087] Preparation:

[0088] Dosing: Take 1900mL water for injection, mix tanshinone IIA sodium sulfonate and mannitol, add it to the above-mentioned water for injection stirred in a vortex shape at a temperature of 25°C, stir to dissolve it; add the prescribed amount of sulfuric acid, stir evenly, Adjust the pH to 3.5-4.5; add water for injection to the full amount; filter with a 0.22 μm microporous membrane;

[0089] Freeze-drying: Fill in 7mL vials, 2mL per bottle, half-tightened, put into a freeze-dryer, and freeze-dry according to the designed freeze-drying curve; after freeze-drying, press the bottle stopper, deflate, and take out the sample , crimping and packaging to obtain tanshinone IIA sodium sulfonate freeze-dried powder.

[0090] The desi...

Embodiment 2

[0097] Prescription: specification (40mg / bottle, 1000 bottles)

[0098] Sodium Tanshinone Ⅱ A Sulfonate

10g

Mannitol

100g

sulfuric acid

0.5g

Water for Injection

Add to 2000mL

[0099] Preparation:

[0100] Dosing: with embodiment 1;

[0101] Freeze-drying: Fill in 20mL vials, 8mL per bottle, half-tightened, put into a freeze-dryer, and freeze-dry according to the designed freeze-drying curve; after freeze-drying, press the bottle stopper, deflate, and take out the sample , crimping and packaging to obtain tanshinone IIA sodium sulfonate freeze-dried powder.

[0102] The designed freeze-drying curve is as follows:

[0103] Pre-freezing stage: the plate layer is cooled at full speed, and the temperature of the product reaches about -30°C, and it is maintained for 2 hours to completely freeze the sample;

[0104] Pre-freezing to sublimation: Turn on the condenser, and when the temperature of the condenser drops below -40°C, t...

Embodiment 3

[0109] Prescription: specification (60mg / bottle, 1000 bottles)

[0110] Sodium Tanshinone Ⅱ A Sulfonate

10g

glucose

200g

sodium sulfate

0.5g

Water for Injection

Add to 2000mL

[0111] Preparation:

[0112] Dosing: with embodiment 1;

[0113] Freeze-drying: Fill in 30mL vials, 12mL per bottle, half-tightened, put into a freeze-dryer, and freeze-dry according to the designed freeze-drying curve; after freeze-drying, press the bottle stopper, deflate, and take out the sample , crimping and packaging to obtain tanshinone IIA sodium sulfonate freeze-dried powder.

[0114] The designed freeze-drying curve is as follows:

[0115] Pre-freezing stage: the plate layer is cooled at full speed, and the temperature of the product reaches about -40°C, and it is maintained for 3 hours to completely freeze the sample;

[0116] Pre-freezing to sublimation stage: Turn on the condenser, and when the temperature of the condenser drops below -...

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Abstract

The invention belongs to the field of pharmaceutical preparations and particularly relates to a sulfotanshinone IIA sodium lyophilized powder injection preparation and a preparation method thereof. The lyophilized powder injection preparation comprises the following components: 1 part by weight of sulfotanshinone IIA sodium, 4-30 parts by weight of a skeleton support agent and 0.015-0.1 parts by weight of a pH regulator, wherein the pH regulator contains one or more of sulfuric acid or sulfate. The pH regulator is added, so that the pH of the preparation can be stabilized in a proper range, and the stability of the preparation is improved greatly.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and more specifically relates to a freeze-dried powder injection prepared by taking tanshinone IIA sodium sulfonate as a raw material drug, and also relates to a preparation method of the freeze-dried powder injection. Background technique [0002] Sodium tanshinone ⅡA sulfonate is obtained by sulfonating tanshinone ⅡA extracted from Danshen. The water solubility of the drug is enhanced and the curative effect is enhanced. Its structural formula is as follows: [0003] [0004] Sodium tanshinone Ⅱ A sulfonate can increase coronary flow, improve the collateral circulation and local blood supply of ischemic myocardium, improve the metabolic disorder of hypoxic myocardial infarction, improve the myocardial hypoxia tolerance, inhibit platelet aggregation and antithrombotic formation, shrink The area of ​​ischemic myocardial infarction can also enhance myocardial contractility at a certai...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/58A61K47/26A61K47/04A61P9/10
CPCA61K9/0019A61K9/19A61K31/58A61K47/02A61K47/26
Inventor 徐国杰蒋传真高春荣诸弘刚谭海松
Owner 华益泰康药业股份有限公司
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