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Injectable drug combination and preparation method thereof

A composition and injection technology, which can be used in drug combinations, antipyretics, antitumor drugs, etc., can solve problems such as affecting cardiovascular function, long-term safety inspection of stabilizers and excipients, and reduce potential safety hazards. , good safety, the effect of preventing side effects

Inactive Publication Date: 2012-02-01
SHANGHAI INST OF PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the active drug used in this patent is magnesium salvianolic acid B, and magnesium ions will affect cardiovascular function to a certain extent; in addition, this patent does not have long-term safety for the stabilizers and excipients added in injections sexual investigation

Method used

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  • Injectable drug combination and preparation method thereof
  • Injectable drug combination and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Preparation of freeze-dried powder injection:

[0032] 29.5g Na 3 PO 4 Dissolve in 1800ml water for injection to make 0.1mol / L Na 3 PO 4 solution; another appropriate amount of 1mol / L NaOH solution was prepared for subsequent use; 200g salvianolic acid B was weighed, and the above-mentioned 0.2mol / L NaOH solution was added 3 PO 4 Solution 1800ml, after stirring evenly, then add dropwise the above 1mol / L NaOH solution to pH 4.0, add 0.5% activated carbon for injection to remove heat source, add water for injection to 2000ml. Filter with a 0.22um microporous membrane, dispense into 10ml freeze-drying bottles, and freeze-dry.

[0033] Freeze-drying curve:

[0034] -40°C, 5h (minimum eutectic point -12.3°C)

[0035] -25℃, 14h

[0036] 0°C, 3h

[0037] 20℃, 2h

[0038] Stability: The freeze-dried powder injection of salvianolic acid B was placed under the accelerated conditions of temperature 40°C and relative humidity 75% for three months. Taking the crude drug a...

Embodiment 2

[0040] Dissolve 14.4g NaOH in 1800ml water for injection to make a 0.2mol / L NaOH solution; prepare an appropriate amount of 1mol / L NaOH solution for later use; weigh 200g salvianolic acid B and add the above 0.2mol / L NaOH solution 1800ml, after stirring evenly, then dropwise add the above 1mol / L NaOH solution to pH 5.0, add 0.5% activated carbon for injection to remove heat source, add water for injection to 2000ml. Filter with a 0.22um microporous membrane, dispense into 10ml freeze-drying bottles, and freeze-dry.

[0041] Freeze-drying curve:

[0042] -40°C, 5h (minimum eutectic point -8.3°C)

[0043] -20℃, 14h

[0044] 0°C, 3h

[0045] 20℃, 2h

[0046] Stability: The freeze-dried powder injection of salvianolic acid B was placed under the accelerated conditions of temperature 40°C and relative humidity 75% for three months. Taking the crude drug as the standard, the content of salvianolic acid B in the sample was determined by the HPLC external standard method, and it ...

Embodiment 3

[0048] Dissolve 14.4g NaOH in 1800ml water for injection to make a 0.2mol / L NaOH solution; prepare an appropriate amount of 1mol / L NaOH solution for later use; weigh 200g salvianolic acid B and add the above 0.2mol / L NaOH solution 1800ml, after stirring evenly, then dropwise add the above 1mol / L NaOH solution to pH 7.0, add 0.5% activated carbon for injection to remove heat source, add water for injection to 2000ml. Filter with a 0.22um microporous membrane, dispense into 10ml freeze-drying bottles, and freeze-dry.

[0049] Freeze-drying curve:

[0050] -40°C, 5h (minimum eutectic point -8.3°C)

[0051] -20℃, 14h

[0052] 0°C, 3h

[0053] 20℃, 2h

[0054]Stability: The freeze-dried powder injection of salvianolic acid B was placed under the accelerated conditions of temperature 40°C and relative humidity 75% for three months. Taking the crude drug as the standard, the content of salvianolic acid B in the sample was determined by the HPLC external standard method, and the ...

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Abstract

The invention provides an injectable drug combination and a preparation method thereof. The injection preparation which is a freeze-dried powder injection comprises salvianolic acid B and a pharmacologically allowable pH regulator, without other excipients. The addition of the pH regulator is pH being 4-5 in the pre-freeze drying system. The salvianolic acid B injection preparation provided by the invention selects a proper pH range without the addition of a supporting agent to ensure the stabilization of the injection as well as the pharmacological acceptability of the injection. The invention has advantages of safe clinical use, no bad effect of inducing hemolysis, good safety and stable quality for long-term storage with the stability and safety completely meeting the requirement of the injection preparation and the requirement of clinical application. The injection prepared by the technology needs no addition of auxiliary materials such as a stabilizer, a freeze-drying excipient and so on and the hidden danger of the injection is decreased. The invention avoids the use of magnesium salt and the side effect of magnesium ion to cardiovascular system can be prevented.

Description

technical field [0001] The invention relates to an injection preparation of salvianolic acid B, in particular to a freeze-dried powder injection of salvianolic acid B. Background technique [0002] Salvianolic Acid B (Salvianolic Acid B) is the phenolic acid compound with the highest content and the strongest activity in the water-soluble components of Danshen, which can improve kidney function, prevent cardiovascular disease, prevent liver damage, resist ischemic damage, and resist platelet aggregation , anti-oxidation, anti-tumor, anti-inflammatory and other pharmacological effects. [0003] At present, most of the salvianolic acid B preparations on the market are compound preparations of traditional Chinese medicines. Only in the salvianolic acid salt for injection of Shanghai Green Valley Pharmaceutical Co., Ltd., the contained salvianolic acid B magnesium content is relatively high (80%); But so far there is no unilateral preparation of salvianolic acid B on the market...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/343A61K47/16A61K47/02A61P1/16A61P7/02A61P9/00A61P9/10A61P13/12A61P29/00A61P35/00A61P39/06
Inventor 奚泉魏湘寅陈林李继安金方
Owner SHANGHAI INST OF PHARMA IND
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