Mecobalamine oral sustained-release film agent and preparation method thereof
A slow-release film, methylcobalamin technology, applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of incomplete absorption, poor compliance for the elderly and children, etc. It achieves the effect of convenient administration, long maintenance time of blood drug concentration and good compliance
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[0068] The present invention also provides the preparation method of described methylcobalamin oral sustained-release film, comprising the steps of:
[0069] Dissolving the methylcobalamin in water to prepare a methylcobalamin solution;
[0070] mixing the film-forming agent with warm water at 50°C to 60°C, mixing the obtained polymer gel with the adhesive and plasticizer, and cooling the obtained mixture to room temperature to prepare glue;
[0071] Mixing the methylcobalamin solution and the glue solution to obtain a drug-containing solution;
[0072] performing film-forming treatment and drying on the drug-containing solution to prepare the oral sustained-release film of methylcobalamin;
[0073] The above steps were all carried out under the condition of red light.
[0074] In one example, the illuminance of the red light is 1-5 lx.
[0075] In one example, the concentration of the methylcobalamin solution is 0.02-0.05 g / mL.
[0076] In one example, the solid-liquid ra...
Embodiment 1
[0089] This embodiment provides a kind of methylcobalamin oral sustained-release film, and its raw material components are as shown in Table 1:
[0090] Table 1
[0091]
[0092]
[0093] The preparation method of the above-mentioned methylcobalamin oral sustained-release film (all under red light conditions, the illuminance is 4lx):
[0094] 1) Dissolving methylcobalamin in purified water to obtain a methylcobalamin solution with a concentration of 0.05 g / mL, which is set aside.
[0095] 2) Add the film-forming agent copovidone S-630 into warm water at 50° C. under stirring to obtain a polymer gel; the dosage ratio of the film-forming agent to warm water is 1 g: 5 mL. Continue to add binder hypromellose K100M, plasticizer triethyl citrate, flavoring agent sodium saccharin, coloring agent carmine to copovidone S-630 polymer gel under stirring state, and stir Mix well and bring to room temperature.
[0096] 3) Under stirring state, add methylcobalamin solution and stir...
Embodiment 2
[0101] This embodiment provides a kind of methylcobalamin oral sustained-release film, and its raw material components are as shown in Table 2:
[0102] Table 2
[0103]
[0104]
[0105] The preparation method of the above-mentioned methylcobalamin oral sustained-release film (all under red light conditions, the illumination is 5lx):
[0106] 1) Dissolving methylcobalamin in purified water to obtain a methylcobalamin solution with a concentration of 0.02 g / mL, which is set aside.
[0107] 2) Add the film-forming agent copovidone S-630 into warm water at 55° C. under stirring to obtain a polymer gel; the dosage ratio of the film-forming agent to warm water is 1 g: 10 mL. Continue to add binder hypromellose K100M, plasticizer triethyl citrate, flavoring agent sodium saccharin, coloring agent carmine to copovidone S-630 polymer gel under stirring state, and stir Mix well and bring to room temperature.
[0108] 3) Under stirring state, add methylcobalamin solution and st...
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Abstract
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