一、【Background of Research and Development】In order to increase the water solubility of posaconazole, sulfobutyl-β-cyclodextrin is used in the preparation of injections at home and abroad. It has been reported in the literature that this excipient has certain hemolytic, renal toxicity and carcinogenicity, and it may also have more serious side effects, which is not known to us, because it should be used more carefully.The pH of Posaconazole injection is about 2-3, which is beyond the tolerance range of human body, and the administration process will stimulate blood vessels greatly, which has potential clinical drug safety risks.
二、【Clinical advantages】HCPO05 is the precursor drug of posaconazole, its water solubility is much higher than posaconazole, in the preparation process does not need to add cosolvent, can be well dissolved in water, so that the number of ingredients in the formula can be reduced in order to reduce the patient may produce side reactions, improve drug safety.Moreover, the pH of the preparation prepared by HCP005 is in the range of human tolerance, reducing vascular irritation and toxic side effects.
三、【Classification】Chemical drug registration 2.1 class
四、【Patent Situation】13.14.18.21
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