Multivitamin parenteral nutritional agent nanosphere freeze-dried injection and preparation method thereof
A freeze-dried injection and parenteral nutrition technology, which is applied in freeze-dried delivery, pharmaceutical formulations, medical preparations with inactive ingredients, etc., can solve the problems of poor product stability, toxic and side effects of antioxidants, unfavorable storage and transportation, etc. To achieve the effect of easy operation of production process, easy and simple preparation process, and convenient clinical application
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Embodiment 1
[0050] Embodiment 1 A kind of multivitamin parenteral nutrition nanosphere freeze-dried injection and preparation method thereof
[0051] The formula of a multivitamin parenteral nutrition lyophilized preparation is shown in Table 1.
[0052] Table 1 The formula of multivitamin parenteral nutrition lyophilized preparation
[0053]
[0054]
[0055] Preparation:
[0056] The whole operation process is protected from light, and the illumination is ≤100LX.
[0057] Step 1, under nitrogen protection, the prescribed amount of vitamin A, vitamin E, vitamin D 3 , Vitamin K 1 Add to the prescribed amount of medium-chain triglycerides and mix, then add the prescribed amount of polyethylene glycol 15-hydroxystearate and soybean lecithin, heat to 60±10°C, and continue to stir until dissolved and clarified to form an oil phase mixture. The whole process is protected from light, and the illumination is ≤100LX.
[0058] Step 2, under the protection of nitrogen, stir slowly, add ...
Embodiment 2
[0071] Embodiment 2 A kind of multivitamin parenteral nutrition nanosphere freeze-dried injection and preparation method thereof
[0072] The formula of a multivitamin parenteral nutrition lyophilized preparation is shown in Table 2.
[0073] Table Formulas of freeze-dried formulations of multivitamin parenteral nutrition
[0074]
[0075]
[0076] Preparation method: The whole operation process is protected from light, and the illumination is ≤100LX.
[0077] Step 1, under nitrogen protection, the prescribed amount of vitamin A, vitamin E, vitamin D 3 , Vitamin K 1 Add to the prescribed amount of medium-chain triglycerides and mix, then add the prescribed amount of polyethylene glycol 15-hydroxystearate and soybean lecithin, heat to 60±10°C, and continue to stir until dissolved and clarified to form an oil phase mixture. The whole process is protected from light, and the illumination is ≤100LX.
[0078] Step 2, under the protection of nitrogen, stir slowly, add a m...
Embodiment 3
[0091] Example 3 A kind of multivitamin parenteral nutrition nanosphere freeze-dried injection and its preparation method
[0092] The formula of a multivitamin parenteral nutrition lyophilized preparation is shown in Table 3.
[0093] Table 3 The formula of multivitamin parenteral nutrition lyophilized preparation
[0094]
[0095]
[0096] The preparation method is the same as in Example 1.
[0097] The product obtained in this example is plump in appearance, full in appearance, orange-yellow loose block, low in moisture, good in resolubility, fast, osmotic pressure of 295mOsmol / kg, good in stability, and can be stored at room temperature. Each bottle uses 5ml of water for injection Isotonic after reconstitution, high safety.
[0098] The liquid medicine in this example before freeze-drying has a transparent appearance, no opalescence, and no layering. The particle size is detected, and the average particle size is 46nm. After reconstitution of the multivitamin pare...
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