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Troxerutin freeze-dried powder injection and preparation method thereof

A freeze-dried powder injection and prescription technology, applied in the field of troxerutin freeze-dried powder injection and its preparation, can solve the problems of high energy consumption, unstable product quality, high production cost, etc., to avoid content reduction and increase fixed assets The effect of investing and increasing production capacity

Active Publication Date: 2018-05-22
MAANSHAN BBCA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] 3. The freeze-drying time exceeds 26 hours in the freeze-drying process. The longer the freeze-drying time, the longer the troxerutin is in a non-dry state, the more unstable the product quality, and the greater the energy consumption and the higher the production cost

Method used

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  • Troxerutin freeze-dried powder injection and preparation method thereof
  • Troxerutin freeze-dried powder injection and preparation method thereof
  • Troxerutin freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Embodiment 1 Troxerutin freeze-dried powder injection and preparation method thereof

[0058] The batch number of the product is 110703; the output is 10,000 bottles.

[0059] 1. Prescription

[0060] Troxerutin 300g, cysteine ​​hydrochloride 5g, 2-hydroxypropyl-β-cyclodextrin 300g, water for injection was added to 20000ml.

[0061] 2. Production process and operation process

[0062]Take 15000mL of water for injection below 20°C, adjust the pH value to 5.8-6.2 (pH regulator: 5% HCL solution or 5% NaOH solution), add the prescribed amount of 2-hydroxypropyl-β-cyclodextrin, stir to dissolve , then add activated carbon with a solution volume of 1.0‰, stir at room temperature for 20 minutes, filter and decarbonize to obtain solution ①; weigh the prescribed amount of troxerutin and cysteine ​​hydrochloride, add them to solution ①, stir to dissolve, and obtain solution ① ②; solution ② is made up to the total volume with water for injection below 20°C, filtered through a 0...

Embodiment 2

[0075] Embodiment 2 Troxerutin freeze-dried powder injection and preparation method thereof

[0076] The batch number of the product is 110705; the output is 10,000 bottles.

[0077] 1. Prescription

[0078] Troxerutin 600g, cysteine ​​hydrochloride 8g, 2-hydroxypropyl-β-cyclodextrin 600g, water for injection was added to 20000ml.

[0079] 2. Production process and operation process

[0080] Take 15000mL of water for injection below 20°C, adjust the pH value to 5.8-6.2 (pH regulator: 5% HCL solution or 5% NaOH solution), add the prescribed amount of 2-hydroxypropyl-β-cyclodextrin, stir to dissolve , then add activated carbon with a solution volume of 1.0‰, stir at room temperature for 20 minutes, filter and decarbonize to obtain solution ①; weigh the prescribed amount of troxerutin and cysteine ​​hydrochloride, add them to solution ①, stir to dissolve, and obtain solution ① ②; solution ② is made up to the total volume with water for injection below 20°C, filtered through a ...

Embodiment 3

[0094] Embodiment 3 troxerutin freeze-dried powder injection and preparation method thereof

[0095] Product batch number 110707; output 10,000 bottles.

[0096] 1. Prescription

[0097] Troxerutin 1000g, cysteine ​​hydrochloride 10g, 2-hydroxypropyl-β-cyclodextrin 1000g, water for injection was added to 20000ml.

[0098] 2. Production process and operation process

[0099] Take 15000mL of water for injection below 20°C, adjust the pH value to 5.8-6.2 (pH regulator: 5% HCL solution or 5% NaOH solution), add the prescribed amount of 2-hydroxypropyl-β-cyclodextrin, stir to dissolve , then add activated carbon with a solution volume of 1.0‰, stir at room temperature for 20 minutes, filter and decarbonize to obtain solution ①; weigh the prescribed amount of troxerutin and cysteine ​​hydrochloride, add them to solution ①, stir to dissolve, and obtain solution ① ②; solution ② is made up to the total volume with water for injection below 20°C, filtered through a 0.22 μm pore size ...

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Abstract

The present invention provides a new formula of troxerutin freeze-dried powder injection. The raw materials in the freeze-dried powder injection are calculated by weight: troxerutin 300-1500, cysteine ​​hydrochloride 5-15 and 2 ‑Hydroxypropyl‑β‑Cyclodextrin 300‑1500. The auxiliary material in the present invention adopts cysteine ​​hydrochloride, which is beneficial to the stability of troxerutin. In the liquid preparation process, 2-hydroxypropyl-β-cyclodextrin is used to protect troxerutin on the one hand, and on the other hand, it can be used as a freeze-drying excipient to make freeze-drying shape, thereby improving the Product stability ensures product quality. Troxerutin is added after the auxiliary material 2-hydroxypropyl-β-cyclodextrin solution is treated with activated carbon, which avoids the problems such as the content reduction of troxerutin caused by the adsorption of activated carbon. The invention shortens the freeze-drying time from 26 hours to 18-20 hours through the improved freeze-drying process, so that the troxerutin can be released from the non-dried state as soon as possible, and the stability of the troxerutin can be guaranteed.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a troxerutin freeze-dried powder injection and a preparation method thereof. Background technique [0002] Troxerutin, the chemical name is 3′,4′,7-tris[O-(2-hydroxyethyl)-5-hydroxyflavone-3]-rutin, aliased as trioxyethyl rutin and tokerutin Ding, the molecular formula is C 33 h 42 o 19 , molecular weight 742.68. Troxerutin can inhibit platelet aggregation and prevent thrombosis. At the same time, it can resist vascular damage caused by 5-hydroxytryptamine and bradykinin, increase capillary resistance, reduce capillary permeability, and prevent edema caused by increased vascular permeability. For ischemic cerebrovascular disease, cerebral thrombosis, cerebral infarction caused by cerebral embolism, central retinitis, arteriosclerosis, coronary heart disease, thrombophlebitis, varicose veins, chronic venous insufficiency, etc. [0003] Intramuscular injection or intraveno...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7048A61K47/40A61K47/16A61K9/19A61P7/02A61P9/10A61P9/14
Inventor 尹双青刘永宏刘甜甜
Owner MAANSHAN BBCA PHARMA