Insulin spray for oral cavity and its prepn process
An oral spray and preparation technology, which is applied in the direction of aerosol delivery, medical preparations containing active ingredients, peptide/protein components, etc., can solve the problems of insufficient stability of preparations and affecting absorption rate, etc., and achieve safe use, The hypoglycemic effect is good, and the effect of hypoglycemic effect is better
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Embodiment 1
[0018] Insulin 20000u
[0019] Soy Lecithin 30.0g
[0020] Propylene glycol 45.0g
[0021] Borneol 1.2g
[0022] Absolute ethanol 3.0ml
[0023] Phenol 2.0g
[0024] Phosphate buffer (pH=7.4) appropriate amount
[0025] Full volume 1000ml
[0026] Take soybean lecithin according to the prescription, add propylene glycol and ethanol solution of borneol, stir evenly and add 555ml of phenol-containing phosphate buffer solution with pH=7.4, the above components are used as excipients in the insulin oral spray formula, and conduct ultrasonic for 1.5 hours, the ultrasonic conditions are: the duty cycle is 60%, the temperature is controlled at 50°C-60°C, and the ultrasonic frequency is 18KHz. Insulin was dissolved in 345 ml of phenol-containing phosphate buffer, pH = 7.0, and slowly added to the sonicated excipient solution, and sonication was continued for 4 minutes.
[0027] The insulin oral spray prepared according to this formula is stored in a refrigerator at 2-8°C for 1 ...
Embodiment 2
[0030] Insulin 40000u
[0031] Soy Lecithin 25.0g
[0032] Propylene glycol 75.0g
[0033] Borneol 1.2g
[0034] Absolute ethanol 4.0ml
[0035] Phenol 2.0g
[0036] Phosphate buffer (pH=7.4) appropriate amount
[0037] Full volume 1000ml
[0038] Get soybean lecithin according to the prescription, add the ethanol solution of propylene glycol and borneol, stir and add 540ml of phenol-containing phosphate buffer solution with pH=7.4, the above components are used as excipients in the insulin oral spray formula, and conduct ultrasonic Treat for 1 hour, the ultrasonic conditions are: the duty cycle is 50%, the temperature is controlled at 40-55°C, and the ultrasonic frequency is 20KHz. Insulin was dissolved in 360 ml of phenol-containing phosphate buffer, pH=7.4, and slowly added to the sonicated excipient solution, and sonication was continued for 5 minutes.
[0039] The insulin oral spray prepared according to this formula is stored in a refrigerator at 2-8°C for 1 year wi...
Embodiment 3
[0042] Insulin 60000u
[0043] Soy Lecithin 35.0g
[0044] Propylene glycol 80.0g
[0045] Borneol 1.4g
[0046] Absolute ethanol 4.0ml
[0047] Phenol 2.0g
[0048] Phosphate buffer (pH=7.4) appropriate amount
[0049] Full volume 1000ml
[0050] Take soybean lecithin according to the prescription, add the ethanol solution of propylene glycol and borneol, stir evenly and add 545ml of phenol-containing phosphate buffer solution with pH=7.4, the above components are used as excipients in the insulin oral spray formula, and conduct ultrasonic After 2 hours of treatment, the ultrasonic conditions are: the duty cycle is 70%, the temperature is controlled at 55°C-70°C, and the ultrasonic frequency is 25KHz. Insulin was dissolved in 360 ml of phenol-containing phosphate buffer, pH=7.5, and slowly added to the sonicated excipient solution, and sonication was continued for 3 minutes.
[0051] The insulin oral spray prepared according to this formula is stored in a refrigerator ...
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