Oral medicine emulsion for treating pediatric epilepsy, and preparation method thereof
An anti-epileptic drug and a technology for epilepsy, which are applied in the field of preparation of oral emulsions for treating epilepsy in children and oral emulsions for treating epilepsy in children, can solve the problems of difficulty in using on time, inaccurate doses, fear of children and the like, and achieve availability. and the effects of improved compliance, better absorption, and better dosage form selection
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Embodiment 1
[0051]
[0052]
[0053] The preparation method of the oral emulsion of the treatment children's epilepsy medicine of present embodiment 1, specifically implement according to the following steps: weigh the following components: (phase inversion emulsification method)
[0054] Step 1, weighing, weighing the following components: 10g of caprylic acid triglyceride, 2g of sodium valproate, 5.4g of phospholipid, 0.1g of vitamin E, 0.54g of poloxamer 188, 2.5g of glycerin, and the balance is Purified water, the total amount of the above is 100ml;
[0055] Step 2, prepare the oil phase, mix the oil-soluble ingredients weighed in step 1 caprylic capric triglyceride, sodium valproate, phospholipid, and vitamin E evenly to prepare the oil phase, keep it warm at 40-80°C for later use; Poloxamer 188, glycerin and water are mixed and dissolved, then added to the oil phase, magnetically stirred at 40-80°C for 10-60 minutes, cut with a high-speed shear for 1-30 minutes, potted and ste...
Embodiment 2
[0057]
[0058] The preparation method of the oral emulsion of the drug for treating epilepsy in children of the present embodiment 2 is specifically implemented according to the following steps: weighing the following components: ultrasonic emulsification
[0059] Step 1, weighing, weighing the following components: magnesium valproate 10g, glycerol monooleate 1g, sodium stearate 30g, sodium oleate 20g, glyceryl monostearate 20g, sodium metabisulfite 0g; the balance For purified water, the above total amount is 100ml;
[0060] Step 2, prepare the oil phase, mix the oil-soluble components of magnesium valproate weighed in step 1, glycerol monooleate, sodium stearate, sodium oleate, and sodium metabisulfite evenly to prepare the oil phase for later use; Purified water and glyceryl monostearate are mixed and dissolved, then added to the oil phase, dispersed by an ultrasonic emulsifier, 100W-1000W, 1-5min, repeated three times, potted, sterilized, and the product is obtained. ...
Embodiment 3
[0062]
[0063] The preparation method (microfluidization method) of the treatment children's epilepsy medicine oral emulsion of present embodiment 3, specifically implement according to the following steps:
[0064] Step 1, weighing, weighing the following components: topiramate 0.1g, castor oil 50g, triglyceride fatty acid ester 0.05g, gelatin 0.05g, sodium carboxymethylcellulose 0.1g, sodium alginate 0g, sodium bisulfite 0g; the balance is purified water, the above total amount is 100ml;
[0065] Step 2. Prepare the oil phase, mix topiramate, castor oil, triglyceride fatty acid ester, gelatin, and sodium bisulfite oil-soluble components weighed in step 1, and preheat at 40-80°C to prepare the oil phase for later use ;Under slow stirring, add purified water containing sodium carboxymethyl cellulose and sodium alginate preheated at 40-80°C to the preheated oil phase in a fine jet to form a stable O / W type Emulsion, potting, sterilization, ready-to-product.
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