Preparation method for vitamin C bulk pharmaceutical

Abstract

The invention relates to a preparation method for a vitamin C bulk pharmaceutical. The method comprises the following steps of: I, stirring vitamin C and sodium carbonate in 70-75 percent ethanol and water for injection till fully dissolving, adding ethylene diamine tetraacetic acid in an amount which is 0.05-0.1 percent of the total feeding weight of the vitamin C, decolorizing with active carbon, filtering a solution, performing aseptic filtration on a filtrate, and pressing into a crystallizing boiler; II, heating the crystallizing boiler in a water bath to 40-50 DEG C, adding absolute ethanol, stirring for 15-30 minutes, cooling the water bath to 5-15 DEG C, and adding vitamin C aseptic powder, wherein the weight ratio of crude vitamin C to the aseptic powder is (5-7):1; and III, filtering a feed liquid, soaking a filter cake which is a crystal with absolute ethanol for 5-10 minutes, leaching, crystalizing, drying in a baking oven, cooling, and sieving a crystal to obtain an aseptic bulk pharmaceutical of the vitamin C. Due to the adoption of the method, the long-term stability, pH value uniformity and content uniformity of a preparation are ensured.

Description

technical field

[0001] The invention relates to the field of pharmaceutical preparations, in particular to a method for preparing a vitamin C raw material drug, and provides a vitamin C preparation for injection. Background technique

[0002] Vitamin C (Vitamin C), also known as L-ascorbic acid, is a water-soluble vitamin. Vitamin C can participate in the metabolism of amino acids, the synthesis of neurotransmitters, the synthesis of collagen and tissue interstitium, can reduce the permeability of capillaries, accelerate blood coagulation, stimulate blood coagulation, promote iron absorption in the intestine, and promote blood lipids Decrease, increase the body's resistance to infection, participate in the detoxification function, and have the effect of antihistamine and prevent the formation of carcinogens (nitrosamines). It can be used for the prevention and treatment of scurvy, various acute and chronic infectious diseases, and purpura. Large doses of intravenous inject...

Examples

Embodiment 1

[0026] Step 1: Add 20L sterile 70-75% ethanol aqueous solution and 75L water for injection into the feeding pot, start stirring, and heat to 40-45°C. Weigh 50Kg of crude vitamin C and put it into the feeding pot, then slowly add 15Kg of anhydrous sodium carbonate, stir until completely dissolved, add 30g of EDTA and 1.0Kg of activated carbon powder, and decolorize for 15-30 minutes. Filter the solution, pump it into the storage tank, and then filter it through a 0.22μm filter membrane aseptically, and press it into the crystallization pot in the clean area.

[0027] Step 2: The crystallization pot is turned on and stirred, heated in a water bath to 40-50°C and kept warm. Add 40L of absolute ethanol dropwise, add seed crystals after the dropwise addition, then add 260L of absolute ethanol dropwise, and continue stirring for 15-30 minutes after the dropwise addition. Cool the crystallization pot to 5~15°C and grow the crystal for 2~3 hours. Add 10Kg of sterilized vitamin ...

Embodiment 2

[0031] Step 1: Add 10L 70-75% ethanol and 40L water for injection into the feeding pot, start stirring, and heat to 40-50°C. Weigh 25Kg of vitamin C crude product, put it into the feeding pot for stirring, then slowly add 5Kg of anhydrous sodium carbonate, stir until completely dissolved, then add 30g of EDTA. Weigh 0.5Kg767 activated carbon powder and decolorize for 15-30 minutes. The solution is filtered and pumped into a storage tank. The crude filtrate is filtered and pressed into the crystallization pot in the clean area.

[0032] Step 2: The liquid is poured into the crystallization pot, the stirring is turned on, and the water bath is heated to 40-50°C. Add 200L of absolute ethanol dropwise, and continue stirring for 15-30 minutes after the dropwise addition. Cool the crystallization pot to 5~15°C and grow the crystal for 2~3 hours. Add 5Kg of sterile vitamin C raw materials, and stir for 5 to 10 minutes.

[0033] Step 3: Filter the uniformly stirred material ...

Embodiment 3

[0035] Step 1: Add 15L of 70-75% ethanol and 60L of water for injection into the feeding pot, start stirring, and heat to 40-50°C. Weigh 35Kg of vitamin C crude product, put it into the feeding pot and stir, then slowly add 8Kg of anhydrous sodium carbonate, stir until completely dissolved, then add 30g of EDTA. Weigh 0.75Kg767 activated carbon powder and decolorize for 15-30 minutes. The solution is filtered and pumped into a storage tank. The crude filtrate is filtered and pressed into the crystallization pot in the clean area.

[0036] Step 2: The liquid is poured into the crystallization pot, the stirring is turned on, and the water bath is heated to 40-50°C. Add 50L of absolute ethanol dropwise, add seed crystals, continue to add 300L of absolute ethanol dropwise, and continue stirring for 15 to 30 minutes after the addition is complete. Cool the crystallization pot to 5~15°C and grow the crystal for 2~3 hours. Add 5Kg of sterile vitamin C raw materials, and s...

technical field

[0001] The invention relates to the field of pharmaceutical preparations, in particular to a method for preparing a vitamin C raw material drug, and provides a vitamin C preparation for injection. Background technique

[0002] Vitamin C (Vitamin C), also known as L-ascorbic acid, is a water-soluble vitamin. Vitamin C can participate in the metabolism of amino acids, the synthesis of neurotransmitters, the synthesis of collagen and tissue interstitium, can reduce the permeability of capillaries, accelerate blood coagulation, stimulate blood coagulation, promote iron absorption in the intestine, and promote blood lipids Decrease, increase the body's resistance to infection, participate in the detoxification function, and have the effect of antihistamine and prevent the formation of carcinogens (nitrosamines). It can be used for the prevention and treatment of scurvy, various acute and chronic infectious diseases, and purpura. Large doses of intravenous inject...

Examples

Embodiment 1

[0026] Step 1: Add 20L sterile 70-75% ethanol aqueous solution and 75L water for injection into the feeding pot, start stirring, and heat to 40-45°C. Weigh 50Kg of crude vitamin C and put it into the feeding pot, then slowly add 15Kg of anhydrous sodium carbonate, stir until completely dissolved, add 30g of EDTA and 1.0Kg of activated carbon powder, and decolorize for 15-30 minutes. Filter the solution, pump it into the storage tank, and then filter it through a 0.22μm filter membrane aseptically, and press it into the crystallization pot in the clean area.

[0027] Step 2: The crystallization pot is turned on and stirred, heated in a water bath to 40-50°C and kept warm. Add 40L of absolute ethanol dropwise, add seed crystals after the dropwise addition, then add 260L of absolute ethanol dropwise, and continue stirring for 15-30 minutes after the dropwise addition. Cool the crystallization pot to 5~15°C and grow the crystal for 2~3 hours. Add 10Kg of sterilized vitamin ...

Embodiment 2

[0031] Step 1: Add 10L 70-75% ethanol and 40L water for injection into the feeding pot, start stirring, and heat to 40-50°C. Weigh 25Kg of vitamin C crude product, put it into the feeding pot for stirring, then slowly add 5Kg of anhydrous sodium carbonate, stir until completely dissolved, then add 30g of EDTA. Weigh 0.5Kg767 activated carbon powder and decolorize for 15-30 minutes. The solution is filtered and pumped into a storage tank. The crude filtrate is filtered and pressed into the crystallization pot in the clean area.

[0032] Step 2: The liquid is poured into the crystallization pot, the stirring is turned on, and the water bath is heated to 40-50°C. Add 200L of absolute ethanol dropwise, and continue stirring for 15-30 minutes after the dropwise addition. Cool the crystallization pot to 5~15°C and grow the crystal for 2~3 hours. Add 5Kg of sterile vitamin C raw materials, and stir for 5 to 10 minutes.

[0033] Step 3: Filter the uniformly stirred material ...

Embodiment 3

[0035] Step 1: Add 15L of 70-75% ethanol and 60L of water for injection into the feeding pot, start stirring, and heat to 40-50°C. Weigh 35Kg of vitamin C crude product, put it into the feeding pot and stir, then slowly add 8Kg of anhydrous sodium carbonate, stir until completely dissolved, then add 30g of EDTA. Weigh 0.75Kg767 activated carbon powder and decolorize for 15-30 minutes. The solution is filtered and pumped into a storage tank. The crude filtrate is filtered and pressed into the crystallization pot in the clean area.

[0036] Step 2: The liquid is poured into the crystallization pot, the stirring is turned on, and the water bath is heated to 40-50°C. Add 50L of absolute ethanol dropwise, add seed crystals, continue to add 300L of absolute ethanol dropwise, and continue stirring for 15 to 30 minutes after the addition is complete. Cool the crystallization pot to 5~15°C and grow the crystal for 2~3 hours. Add 5Kg of sterile vitamin C raw materials, and s...