Alfacalcidol injection and preparation method thereof
A technology for alfacalcidol and alcohol injection, which is applied in the field of alfacalcidol injection and its preparation, can solve the problems of low bioavailability, monotonous dosage form, and cannot exist stably for a long time, and achieves reduction in dosage and bioavailability. The effect of increasing the degree of
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Embodiment 1
[0037] Example 1 Alfacalcidol Injection
[0038] The prescription is:
[0039] Alfacalcidol 0.5mg
[0040] Polyvinylpyrrolidone K30 1.2g
[0041] Hypromellose aqueous solution 18g
[0042] Sodium Lauryl Sulfate 1.2g
[0044] Sodium chloride appropriate amount
[0045] Add water for injection to 100g
[0046] The preparation method is:
[0047] 1) Weigh 70% of the prescribed amount of distilled water, add the prescribed amount of hypromellose aqueous solution, and stir well; continue to add the prescribed amount of polyvinylpyrrolidone K30 and sodium lauryl sulfate, and stir at 45°C for 15 minutes until completely dissolved ;
[0048] 2) Raise the temperature to 60°C, add the prescribed amount of alfacalcidol at a stirring speed of 500rpm, and continue stirring for 20 minutes until it is completely dissolved;
[0049] 3) Add the prescribed amount of sodium sulfite and appropriate amount of sodium chloride, stir to dissolve; then add 0.1% ac...
Embodiment 2
[0051] Example 2 Alfacalcidol Injection
[0052] The prescription is:
[0053] Alfacalcidol 0.5mg
[0054] Polyvinylpyrrolidone K30 1.6g
[0055] Hypromellose aqueous solution 24g
[0056] Sodium Lauryl Sulfate 1.7g
[0057] Sodium bisulfite 0.1g
[0058] Glucose Appropriate amount
[0059] Add water for injection to 100g
[0060] The preparation method is:
[0061] 1) Weigh 80% of the prescribed amount of distilled water, add the prescribed amount of hypromellose aqueous solution, and stir well; continue to add the prescribed amount of polyvinylpyrrolidone K30 and sodium lauryl sulfate, and stir at 55°C for 15-25min to all dissolved;
[0062] 2) Raise the temperature to 70°C, add the prescribed amount of alfacalcidol at a stirring speed of 1000rpm, and continue stirring for 40 minutes until it is completely dissolved;
[0063] 3) Add the prescribed amount of sodium bisulfite and an appropriate amount of glucose, stir to dissolve; then add 0.1% activated carbon of the t...
Embodiment 3
[0065] Example 3 Alfacalcidol Injection
[0066] The prescription is:
[0067] Alfacalcidol 0.5mg
[0068] Polyvinylpyrrolidone K30 1.4g
[0069] Hypromellose aqueous solution 20g
[0070] Sodium Lauryl Sulfate 1.5g
[0071] Sodium metabisulfite 0.1g
[0072] Moderate amount of mannitol
[0073] Add water for injection to 100g
[0074] The preparation method is:
[0075] 1) Weigh 75% of the prescribed amount of distilled water, add the prescribed amount of hypromellose aqueous solution, and stir evenly; continue to add the prescribed amount of polyvinylpyrrolidone K30 and sodium lauryl sulfate, and stir at 50°C for 20 minutes until completely dissolved ;
[0076] 2) Raise the temperature to 65°C, add the prescribed amount of alfacalcidol at a stirring speed of 800rpm, and continue stirring for 30 minutes until it is completely dissolved;
[0077] 3) Add the prescribed amount of sodium metabisulfite and an appropriate amount of mannitol, stir to dissolve; then add 0.1%...
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