Thiamphenicol glycinate hydrochloride freeze-dried powder injection and preparation method thereof
A technology of thiamphenicol hydrochloride and freeze-dried powder injection, which is applied in the field of medicine, can solve unscientific problems, and achieve the effects of low related substances, stable quality, easy transportation and storage
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[0124] Example 1:
[0125] prescription
[0126] Name of raw and auxiliary materials 1000 pieces dosage (g)
[0127] Thiamphenicol hydrochloride glycinate 631.25g
[0128] Add water for injection to 3000ml
[0129] Preparation Process
[0130] 1. Measure 80% of the prescribed amount of water for injection cooled to room temperature, adjust the pH to 1.8-2.4 with hydrochloric acid, add the prescribed amount of thiamphenicol hydrochloride glycinate, stir to dissolve, and add water for injection cooled to room temperature To the full amount.
[0131] 2. Add 0.05% (g / ml) activated carbon to the chemical solution, stir for 30 minutes, decarburize and filter to obtain the filtrate.
[0132] 3. Measure the pH and content of the intermediate solution.
[0133] 4. Filter with 0.22μm microporous membrane.
[0134] 5. Filling.
[0135] 6. Freeze drying:
[0136] (1) Open the front box for refrigeration to reduce the product temperature to below -40℃ and keep it for 2-3h.
[0137] (2) Turn on the box refr...
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[0143] Example 2:
[0144] prescription
[0145] Name of raw and auxiliary materials 1000 pieces dosage (g)
[0146] Thiamphenicol hydrochloride glycinate 631.25g
[0147] Add water for injection to 3000ml
[0148] The preparation process is the same as in Example 1, wherein the temperature of the water for injection is 20°C, and the pH value of the intermediate solution is adjusted to 1.8.
[0149] After testing the intermediate solution and finished product obtained by the above method, the related substances are 0.55% and 0.71% respectively.
Example Embodiment
[0150] Example 3:
[0151] prescription
[0152] Name of raw and auxiliary materials 1000 pieces dosage (g)
[0153] Thiamphenicol hydrochloride glycinate 631.25g
[0154] Add water for injection to 3000ml
[0155] The preparation process is the same as in Example 1, wherein the temperature of the water for injection is 25°C and the pH value of the intermediate solution is adjusted to 2.0.
[0156] After testing the intermediate solution and finished product obtained by the above method, the related substances are 0.49% and 0.68% respectively.
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