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Freeze-dried powder injection of vitamin B6 and preparation method thereof

A technology of freeze-dried powder injection and vitamin, which is applied in the field of freeze-dried powder injection of vitamin B6 and its preparation, which can solve the problems of high production cost, low potency, and large difference in pH value, etc., achieve stable product quality, and improve production The effect of increasing production capacity and reducing production cost

Active Publication Date: 2013-01-16
MAANSHAN BBCA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] 3. When 5% NaOH alkaline solution is used to adjust the pH, the local alkaline concentration of the liquid is too high, the stability of vitamin drugs will be affected, and the potency will easily decrease; and 5% HCl solution or 5% NaOH solution is used for pH adjustment There is a large difference between the pH value of the drug solution and the pH value of the reconstituted product after freeze-drying
[0018] 4. At the same time, the freeze-drying time exceeds 22 hours during the freeze-drying process, and the longer the freeze-drying time, the vitamin B 6 The longer the time in the non-dry state, the more unstable the product quality, the greater the energy consumption, and the higher the production cost
[0019] 5. Vitamin B 6 During storage of lyophilized preparations, vitamin B 6 The content has decreased significantly, and the content has decreased by more than 6.0% within the validity period, and the clarity is unqualified

Method used

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  • Freeze-dried powder injection of vitamin B6 and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] 1. Raw materials: vitamin B 6 50g; L-arginine 5g; mannitol 15g; phosphate buffer saline 2g (composed of sodium dihydrogen phosphate and disodium hydrogen phosphate in a weight ratio of 2:1); water for injection was added to 1000ml.

[0069] 2. Preparation process:

[0070] 2.1 Prepare the solution:

[0071] Weigh 15g of mannitol in a stainless steel bucket, add 500ml of water for injection to dissolve, add 0.2% activated carbon, boil, keep warm for 15 minutes, filter and decarbonize to obtain solution ①;

[0072] Add 5g of L-arginine to solution ①, stir to dissolve, and cool to below 10°C to obtain solution ②.

[0073] Take the prescribed amount of phosphate buffered saline, add 200ml of cold water for injection below 10°C to dissolve, and then add the prescribed amount of vitamin B 6 , dissolved to obtain a solution ③.

[0074] Slowly pour solution ② and solution ③ into the batching tank, and then make up the volume with cold water for injection to a total of 1000m...

Embodiment 2

[0087] Example 2: Vitamin B 6 Freeze-dried powder injection (batch number 100521; output 1000 bottles)

[0088] 1. Raw materials: vitamin B 6 100g; L-arginine 8g; mannitol 10g; phosphate buffer saline 4g (composed of sodium dihydrogen phosphate and disodium hydrogen phosphate in a weight ratio of 2:1); water for injection was added to 1000ml.

[0089] 2. Preparation process:

[0090] 2.1 Solution preparation process:

[0091] Weigh 10g of mannitol in a stainless steel barrel, add 400ml of water for injection to dissolve, add 0.2% activated carbon, boil, keep warm for 15 minutes, filter and decarbonize to obtain solution ①.

[0092] Add 8g of L-arginine to solution ①, stir to dissolve, and cool to below 10°C to obtain solution ②.

[0093] Weigh the prescribed amount of phosphate buffered saline, add 300ml of cold water for injection below 10°C to dissolve, and then add the prescribed amount of vitamin B 6 , dissolved to obtain a solution ③.

[0094] Slowly pour solution ②...

Embodiment 3

[0107] Example 3: Vitamin B 6 Freeze-dried powder injection (batch number 100522; output 1000 bottles)

[0108] 1. Raw materials: vitamin B 6 200g; L-arginine 10g; mannitol 20g; phosphate buffer saline 6g (composed of sodium dihydrogen phosphate and disodium hydrogen phosphate in a weight ratio of 2:1); water for injection was added to 1000ml.

[0109] 2. Preparation process:

[0110] 2.1 Solution preparation process:

[0111] Weigh 20g of mannitol into a stainless steel bucket, add 400ml of water for injection to dissolve, add 0.2% activated carbon, boil, keep warm for 15 minutes, filter and decarbonize to obtain solution ①.

[0112] Add 10g of L-arginine to solution ①, stir to dissolve, and cool to below 10°C to obtain solution ②.

[0113] Weigh the prescribed amount of phosphate buffered saline, add 400 ml of cold water for injection below 10°C to dissolve, and then add the prescribed amount of vitamin B 6 , dissolved to obtain a solution ③.

[0114] Slowly pour solut...

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PUM

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Abstract

The invention relates to a freeze-dried powder injection of vitamin B6 and a preparation method thereof. The freeze-dried powder injection is made from a 1000 ml water solution comprising the following components in parts by weight: 50-200 parts of the vitamin B6, 5-10 parts of L-arginine, 10-20 parts of mannitoland 2-6 parts of phosphoric acid buffer salt. The finally prepared freeze-dried powder injection of the vitamin B6 meets requirements of national drug standards by adopting the composition in the preparation method, namely the proportion.

Description

technical field [0001] The present invention relates to vitamin B 6 In the field of formulations, specifically related to vitamin B 6 Freeze-dried powder injection and preparation method thereof. Background technique [0002] Vitamin B for Injection 6 , English name: Vitamin B 6 for Injection, molecular formula: C 8 h 11 NO 3 • HCl, molecular weight: 205.64. Its ingredients: each bottle contains vitamin B 6 0.1g, excipients are mannitol, L-arginine, water for injection. Properties: This product is white or off-white loose lump. Indications are: Vitamin B 6 Prevention and treatment of deficiency, prevention and treatment of isoniazid poisoning; it can also be used for vomiting caused by pregnancy, radiation sickness and anticancer drugs, seborrheic dermatitis, etc.; total parenteral nutrition and malnutrition caused by insufficient intake, progressive B vitamins for weight loss 6 Supplement; the following conditions on vitamin B 6 Increased requirement: pregnancy...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4415A61K47/18A61P3/02
Inventor 尹双青刘永宏
Owner MAANSHAN BBCA PHARMA
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