Dextromethorphan hydrobromide and guaiacol glycerin ether oral liquid and preparation method thereof
A technology of guaiacol glycerol ether and dextromethorphan hydrobromide is applied in the directions of pharmaceutical formulations, ether/acetal active ingredients, medical preparations containing active ingredients, etc. Methorphan guaiacol glycerol ether solution drug stability and other issues, to achieve the effect of less impurities and high safety
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Embodiment 1
[0047] This example provides a study on the drug stability of dextromethorphan hydrobromide and guaiacol at different pH values and the compatibility of raw materials and excipients used therein.
[0048] The following is the drug stability study of dextromethorphan hydrobromide and guaiacol at different pH values.
[0049] image 3 It is the result figure that the dextromethorphan hydrobromide in the embodiment carries out influence factor test under the condition that pH range is 3-7, Figure 4 It is the result figure of the influence factor test that the guaiacol glycerin in the embodiment is carried out under the condition of pH range 3-7, Figure 5 It is the result figure that the dextromethorphan hydrobromide in the embodiment carries out influence factor test under the condition of pH range 4.0-5.5, Figure 6 It is the result figure that the guaiacol glyceryl ether in the embodiment carries out the influence factor test under the condition that the pH range is 4.0-5...
Embodiment 2
[0068] In this example, the following formula was used to prepare 1000 mL of dextromethorphan guaiacol glyceryl ether oral liquid:
[0069]
[0070] 2N hydrochloric acid or sodium hydroxide solution to adjust the pH value of the solution to the range of 4.0-5.5, and the rest is purified water.
[0071] The preparation steps of dextromethorphan guaiacol glyceryl ether oral liquid of the present embodiment are as follows:
[0072] Dissolve 4.5g stevia, 1.5g dextromethorphan hydrobromide, 10g guaiacol glyceryl ether, 1.5g methylparaben, 1.5g ethylparaben, 2g mint essence, 6mg sunset yellow in 800ml purified water and stir After dissolving, then add 1 g of activated carbon and stir for 10 min, then remove the activated carbon by filtration to obtain solution 1;
[0073] Using 2N hydrochloric acid solution or sodium hydroxide solution to adjust the pH value of solution 1 to the range of 4.0-5.5 to obtain solution 2;
[0074] Add purified water into solution 2 until the volume ...
Embodiment 3
[0079] In this example, the following formula was used to prepare 1000 mL of dextromethorphan guaiacol glyceryl ether oral liquid:
[0080]
[0081] 2N hydrochloric acid solution or sodium hydroxide solution to adjust the pH of the solution to the range of 4.0-5.5, and the rest is purified water.
[0082] The preparation steps of dextromethorphan guaiacol glyceryl ether oral liquid of the present embodiment are as follows:
[0083] Dissolve 3.0g sucralose, 1.5g dextromethorphan hydrobromide, 10g guaiacol glyceryl ether, 1.5g methylparaben, 1.5g ethylparaben, 2g orange essence, 6mg tartrazine in 800ml purified water After stirring and dissolving, then add 1 g of activated carbon and stir for 10 minutes, then remove the activated carbon by filtration to obtain solution 1;
[0084] Using 2N hydrochloric acid solution or sodium hydroxide solution to adjust the pH value of solution 1 to the range of 4.0-5.5 to obtain solution 2;
[0085] Add purified water into solution 2 unti...
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