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Propyl gallate freeze-dried powder-injection and its preparation method

A technology of propyl gallate and freeze-drying, which is applied in the direction of freeze-drying transportation, medical preparations containing active ingredients, powder transportation, etc., and can solve problems such as wall hanging, main drug content decline, and vascular obstruction

Inactive Publication Date: 2005-03-23
BEIJING BOERDA BIO TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

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-term storage, and fast redissolving speed. Jilin Aodong Pharmaceutical Group Yanji Co., Ltd., Fujian Mindong Jiexun Pharmaceutical Co., Ltd. and other manufacturers produce, but the commercially available products generally have oily precipitation after redissolving, resulting in the phenomenon of hanging on the wall. This precipitation not only makes the main drug content decreased, and there is a risk of vascular obstruction after infusion

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0010] Example 1 Low molecular weight dextran as co-solvent and freeze-drying support agent

[0011] Prescription: Propyl gallate 6g

[0012] Low Molecular Dextran 10g

[0013] Add water for injection to 300ml

[0014] A total of 100 pieces were made

[0015] Preparation method: Weigh the prescribed amount of dextran, add 290ml of water for injection, and stir to dissolve completely. Then add the prescribed amount of propyl gallate, gradually add in portions, and stir while adding. After the addition, continue to heat (80°C) and stir for 20 minutes to completely dissolve. Control the pH of the liquid to 3.0-5.0, and add water for injection to 300ml. Use 0.1% (w / v) activated carbon, adsorb at 50°C for 15 minutes, decarbonize and filter; the obtained filtrate is continued to be filtered with a 0.22 μm microporous membrane, and the semi-finished product inspection is carried out on the obtained clear filtrate. Fill the qualified semi-finished liquid medici...

Embodiment 2

[0026] Example 2 Low molecular weight dextran as co-solvent and freeze-drying support agent

[0027] Prescription: Propyl gallate 6g

[0028] Low Molecular Dextran 15g

[0029] Add water for injection to 300ml

[0030] A total of 100 pieces were made

[0031] Preparation method: with embodiment 1.

[0032] Dissolve one of the above-mentioned samples with 3ml of water for injection, observe the dissolution and measure the content at 0, 4, 8, and 24 hours, and then dissolve one of the above-mentioned propyl gallate for injection and mix it with 250ml of 0.9% sodium chloride injection , After 0, 4, 8, and 24 hours, observe the dissolution and determine the content. The results are shown in Table 2.

[0033] 0h

Embodiment 3

[0034] Example 3 Cyclodextrin as cosolvent

[0035] Prescription: Propyl gallate 6g

[0036] Hydroxypropyl-β-cyclodextrin 24g

[0037] Mannitol 10g

[0038] Add water for injection to 300ml

[0039] A total of 100 pieces were made

[0040] Preparation method: Weigh the prescribed amount of hydroxypropyl-β-cyclodextrin, add 290ml of water for injection, and stir to completely dissolve. Then add the prescribed amount of propyl gallate, gradually add in portions, and stir while adding. After the addition, continue to heat (70°C) and stir for 30 minutes to completely dissolve. Add the prescribed amount of mannitol, stir to dissolve, add water for injection to 300ml, and control the pH of the liquid to 3.0-5.0. Use 0.1% (w / v) activated carbon, adsorb at 50°C for 15 minutes, decarbonize and filter; the obtained coarse filtrate continues to be filtered with a 0.22 μm microporous membrane, and the semi-finished product inspection is carried out on the obt...

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PUM

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Abstract

A freeze-dried powder injection of gallopropylate is prepared from gallopropylate, cosolvent chosen from dextran, cyclodextrin, and polysorbate 80, and freeze-drying supporting agent chosen from detran, mannitol, glucose, lactose and sodium chloride.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a propyl gallate freeze-dried powder for injection and a preparation method thereof. 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 advant...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/215A61P7/02A61P9/10A61P9/12A61P9/14
Inventor 张成飞
Owner BEIJING BOERDA BIO TECH DEV
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