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A kind of preparation method of propyl gallate for injection

A technology of propyl gallate and injection, which is applied in the field of preparation of propyl gallate for injection, can solve problems such as difficult to ensure decarburization effect, decrease of main drug content, complex decarburization operation, etc., achieve good solubility and simplify production Good technology and recycling effect

Active Publication Date: 2021-07-13
GUANGDONG JIANXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The present invention is to overcome that when preparing the freeze-dried powder injection of propyl gallate in the prior art, after adding activated carbon to remove the heat source, it is necessary to perform decarbonization and filtration, and it is difficult to completely remove the activated carbon after filtration, often requiring multiple filtrations to decarbonize The operation is complicated, and it is difficult to ensure the decarburization effect; and the propyl gallate freeze-dried powder injection prepared in the prior art has poor solubility, inconvenience to use, and easy to precipitate after redissolving, which not only reduces the content of the main ingredient, but also There is also the problem of the risk of vascular obstruction after infusion, and a preparation method of propyl gallate for injection is provided, which makes it easy to remove the activated carbon after removing the pyrogen, and the prepared propyl gallate for injection will not precipitate after redissolving

Method used

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  • A kind of preparation method of propyl gallate for injection
  • A kind of preparation method of propyl gallate for injection
  • A kind of preparation method of propyl gallate for injection

Examples

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Embodiment 1

[0038] Preparation of magnetic activated carbon: Soak the activated carbon in 5% hydrochloric acid for 24h and rinse it with deionized water to neutrality; add the treated activated carbon to Fe 3+ with Fe 2+ The molar ratio of FeCl is 2:1 3 ·6H 2 O and FeSO 4 ·7H 2 In the mixed solution of O, stir for 1.5h, in which activated carbon and FeCl 3 ·6H 2 The mass ratio of O is 1:2.3; add 5mol / L NaOH solution dropwise to the mixed solution under stirring at 75°C, so that the mass ratio of NaOH to activated carbon is 4.2:1, and age at 100°C for 4h after the reaction; The precipitate was magnetically separated under the action of an external magnetic field, washed with deionized water until neutral, and dried at 80°C for later use. Before use, boil with water for injection for 35 minutes, dry at 75°C, and then bake at 180°C for 2.5 hours. .

[0039] Preparation of propyl gallate for injection:

[0040] (1) Weigh 70% water for injection at 95°C, add dextran 40, edetate disodi...

Embodiment 2

[0049] Preparation of magnetic activated carbon: Soak the activated carbon in 8% hydrochloric acid for 18 hours and then rinse it with deionized water until neutral; add the treated activated carbon to Fe 3+ with Fe 2+ The molar ratio of FeCl is 2.5:1 3 ·6H 2 O and FeSO 4 ·7H 2 In the mixed solution of O, stir for 1h, wherein activated carbon and FeCl 3 ·6H 2 The mass ratio of O is 1:2; add 2.5mol / L NaOH solution dropwise to the mixed solution under stirring at 70°C, so that the mass ratio of NaOH to activated carbon is 4:1, and age at 100°C for 2 hours after the reaction ; The precipitate was magnetically separated under the action of an external magnetic field, washed with deionized water until neutral, and dried at 80°C for later use. Before use, boil with water for injection for 30 minutes, dry at 70°C, and then bake at 170°C for 2 hours. .

[0050] Preparation of propyl gallate for injection:

[0051] (1) Weigh 70% water for injection at 90°C, add dextran 40, ede...

Embodiment 3

[0060] Preparation of magnetic activated carbon: Soak the activated carbon in 10% hydrochloric acid for 12 hours and then rinse it with deionized water to neutral; add the treated activated carbon to Fe 3+ with Fe 2+ The molar ratio of FeCl is 3:1 3 ·6H 2 O and FeSO 4 ·7H 2 In the mixed solution of O, stir for 2h, wherein activated carbon and FeCl 3 ·6H 2 The mass ratio of O is 1:3; add 4mol / L NaOH solution dropwise to the mixed solution under stirring at 80°C, so that the mass ratio of NaOH to activated carbon is 5:1, and age at 100°C for 6h after the reaction; The precipitate was magnetically separated under the action of an external magnetic field, washed with deionized water until neutral, and dried at 80°C for later use. Before use, boil with water for injection for 40 minutes, dry at 80°C, and then bake at 190°C for 3 hours.

[0061] Preparation of propyl gallate for injection:

[0062] (1) Weigh 70% water for injection at 100°C, add dextran 40, edetate disodium ...

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Abstract

The invention relates to a pharmaceutical preparation, and discloses a preparation method of propyl gallate for injection. The steps are as follows: sequentially weigh dextran 40, disodium edetate and propyl gallate, dissolve them in water for injection at 90-100°C, and adjust the solution pH to 3.5-4.0; adding magnetic activated carbon to remove heat source and recovering magnetic activated carbon under the action of an external magnetic field; sterilization and filtration; filling; pre-freezing; sublimation drying; re-drying. The invention adopts magnetic activated carbon to remove the heat source, which has good adsorption and removal effects on the heat source, and after the heat source is removed, the magnetic activated carbon can be directly removed and recovered from the solution under the action of an external magnetic field, which improves the decarburization effect and simplifies the production process and adopt proper pre-freezing, sublimation drying and re-drying methods, so that the prepared propyl gallate product for injection has a long shelf life and good solubility, and is not easy to separate out after redissolving, which facilitates the use of the product and improves product safety.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to a preparation method of propyl gallate for injection. Background technique [0002] Propyl gallate is a derivative of gallic acid ester, the active ingredient in the traditional Chinese medicine Radix Paeoniae Rubra. It is a drug with stronger biological effects obtained by modifying the structure of gallic acid ester. It has been widely used in ischemic cerebrovascular diseases (such as acute cerebral infarction, chronic cerebral thrombosis, lacunar infarction, cerebral insufficiency), sequelae of cerebral coma, traumatic brain injury, concussion, etc. Prevention and treatment of coronary heart disease, angina pectoris, hypertension, heart failure, pulmonary heart disease, certain peripheral vascular diseases (such as thrombophlebitis). Propyl gallate is easy to degrade in water, so it is made into freeze-dried powder injection, which has the advantages of good stability, long-ter...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K47/02A61K47/04A61K47/36A61K31/235A61P9/10A61P7/02A61P25/00A61P9/12A61P9/04A61P11/00B01J20/20B01J20/28B01J20/30
CPCA61K9/0019A61K9/19A61K31/235A61K47/02A61K47/36A61P7/02A61P9/04A61P9/10A61P9/12A61P11/00A61P25/00B01J20/0229B01J20/20B01J20/28009
Inventor 黄邦信
Owner GUANGDONG JIANXIN PHARMA
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