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Compound diisopropylamine dichloroacetate freeze-dried powder injection medicinal composition for injection

A technology of diisopropylamine dichloroacetate and freeze-dried powder injection, which is applied in the field of medicine, can solve the problems of physical harm to patients, complexity of prescriptions, difficulty in drug quality control, and increase in production costs of preparations, etc., achieving guaranteed safety, The quality of preparations is easier to control and the effect of reducing production costs

Inactive Publication Date: 2015-08-12
山东北大高科华泰制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Adding excipients to the lyophilized preparation is beneficial to the molding of the preparation and the feasibility of the process, but the addition of excipients is obviously insufficient: (1) increases the production cost of the preparation; (2) increases the complexity of the formulation and improves the quality control of the drug (3) A large amount of exogenous substances are introduced into the patient's body during intravenous injection, which increases the possibility of causing harm to the patient's body

Method used

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  • Compound diisopropylamine dichloroacetate freeze-dried powder injection medicinal composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] Prescription: (1000 vials, containing diisopropylamine dichloroacetate 20mg and sodium gluconate 19mg)

[0092] Diisopropylamine dichloroacetate 20g

[0093] Sodium Gluconate 19g

[0094] Water for injection, add appropriate amount to 1000ml

[0095] Preparation Process:

[0096] 1. Under clean conditions, take freshly prepared water for injection (about 80% of the prescription), lower the temperature to below 40°C, add the prescribed amount of diisopropylamine dichloroacetate and sodium gluconate, and stir to dissolve;

[0097] 2. Add 0.1% activated carbon for needles according to the prepared amount, stir and absorb for 15 minutes, then filter and decarbonize;

[0098] 3. Add water for injection below 40°C to the prescribed amount, stir well, and filter to sterilize with a 0.22μm microporous membrane;

[0099] 4. Fill in vials at 1ml / bottle, place in a freeze dryer, and freeze-dry according to the following freeze-drying process:

[0100] a. Cool down to -40°C at...

Embodiment 2

[0104] Prescription: (1000 vials, containing diisopropylamine dichloroacetate 40mg and sodium gluconate 38mg)

[0105] Diisopropylamine dichloroacetate 40g

[0106] Sodium gluconate 38g

[0107] Water for injection, add appropriate amount to 2000ml

[0108] Preparation Process:

[0109] 1. Under clean conditions, take freshly prepared water for injection (about 80% of the prescription), lower the temperature to below 40°C, add the prescribed amount of diisopropylamine dichloroacetate and sodium gluconate, and stir to dissolve;

[0110] 2. Add 0.1% activated carbon for needles according to the prepared amount, stir and absorb for 15 minutes, and decarbonize by filtration:

[0111] 3. Add water for injection below 40°C to the prescribed amount, stir well, and filter to sterilize with a 0.22μm microporous membrane;

[0112] 4. Fill in vials at 2ml / bottle, place in a freeze dryer, and freeze-dry according to the following freeze-drying process:

[0113] a. Cool down to -50°C ...

Embodiment 3

[0117] Prescription: (1000 vials, containing diisopropylamine dichloroacetate 10mg and sodium gluconate 9.5mg)

[0118] Diisopropyl dichloroacetate 10g

[0119] Sodium Gluconate 9.5g

[0120] Water for injection, add appropriate amount to 1000ml

[0121] Preparation Process:

[0122] 1. Under clean conditions, take freshly prepared water for injection (about 80% of the prescription), lower the temperature to below 40°C, add the prescribed amount of diisopropylamine dichloroacetate and sodium gluconate, and stir to dissolve;

[0123] 2. Add 0.05% activated carbon for needles according to the prepared amount, stir and absorb for 30 minutes, and filter for decarbonization;

[0124] 3. Add water for injection below 40°C to the prescribed amount, stir well, and filter to sterilize with a 0.22μm microporous membrane;

[0125] 4. Fill in vials at 1ml / bottle, place in a freeze dryer, and freeze-dry according to the following freeze-drying process:

[0126] a. Cool down to -30°C a...

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Abstract

The invention relates to a compound diisopropylamine dichloroacetate freeze-dried powder injection medicinal composition for injection. The freeze-dried powder injection medicinal composition includes diisopropylamine dichloroacetate, sodium gluconate, and an optionally selected acidifying or alkalizing agent. A weight ratio of diisopropylamine dichloroacetate to sodium gluconate is 40:30-50. The invention relates to a preparation method of the compound diisopropylamine dichloroacetate freeze-dried powder injection medicinal composition for injection. The method comprises the steps of liquid preparation and freeze drying. The compound diisopropylamine dichloroacetate freeze-dried powder injection medicinal composition for injection can be used for treating fatty liver, intrahepatic cholestasis, acute and chronic hepatitis, hepatomegaly and early hepatic cirrhosis. The freeze-dried powder injection medicinal composition has expected good properties.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a freeze-dried powder injection pharmaceutical composition for protecting the liver, which can be used for fatty liver and intrahepatic cholestasis. This product is used for acute and chronic hepatitis, hepatomegaly, and early liver cirrhosis. In particular, the present invention relates to a pharmaceutical composition of compound diisopropylamine dichloroacetate freeze-dried powder for injection. The active ingredients of the composition include: diisopropylamine dichloroacetate and sodium gluconate. The freeze-dried powder injection pharmaceutical composition of the present invention has expected good properties. Background technique [0002] Diisopropylamine Dichloroacetate is diisopropylamine dichloroacetate (1:1), its molecular formula is C8H17O2NCl2, its molecular weight is 230.14, and its CAS registration number is 660-27-5. The chemical structural formula of diisopropylam...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/191A61K9/19A61P1/16A61K31/19A61K31/131
Inventor 满春兰李锐吴彦丽夏肖丽迟春颜
Owner 山东北大高科华泰制药有限公司
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