Enoxacin preparation and preparation process thereof
A technology of enoxacin and preparations, applied in the field of pharmaceutical engineering, can solve problems such as complex preparation process and difficult control of related substances, achieve the effects of expanding the scope of clinical application, simple and convenient production process design, and improving product quality
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example 1
[0029] Take enoxacin 0.1g to about 80ml of water for injection, add 5N acetic acid to adjust the pH of the solution, during the process of adding acetic acid, enoxacin gradually dissolves, when the enoxacin is completely dissolved, the liquid The pH value is 4.85. Continue to add 5N acetic acid, and when the pH of the medicinal solution drops to 2.86, it is found that a small amount of crystallization is separated out in the medicinal solution. Continuing to add acid will continue to increase the amount of crystallization. It can be seen from the above examples that by adjusting the pH value of the medicinal solution with acetic acid, when the pH of the medicinal solution is controlled within a certain range (pH2.86-4.85), the solubility of enoxacin in the aqueous solution can be greater than 100mg / 100ml. Target.
example 2
[0031] Using 10% lactic acid as the pH regulator, using the same operation steps, can also dissolve 0.1g of enoxacin in less than 100ml of water for injection, and with the increase of the amount of lactic acid added, there is no re-crystallization Precipitation phenomenon. Under the conditions of this experiment, the maximum pH value of the drug solution that completely dissolves enoxacin is 4.95.
example 3
[0033] Using 1N hydrochloric acid as the pH regulator, the same operation steps can also dissolve 0.1g of enoxacin in less than 100ml of water for injection, and with the increase of the amount of hydrochloric acid, there is no re-precipitation of crystals . Under the conditions of this experiment, the maximum pH value of the drug solution that completely dissolves enoxacin is 5.02.
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