Ofloxacin vaginal swelling suppository, as well as preparation method and detection method thereof

Abstract

The invention relates to an ofloxacin vaginal swelling suppository, as well as a preparation method and a detection method thereof. The swelling suppository comprises ofloxacin, a drug-containing matrix formed by a matrix, and a swelling carrier, wherein an inclusion complex is formed by ofloxacin and beta-cyclodextrin, so that the solubility and stability of ofloxacin can be improved; the hygroscopicity of ofloxacin can be reduced due to addition of calcium glycerophosphate in the drug-containing matrix, and the stability of the suppository can be improved; the drug-containing matrix of the suppository further comprises a specific hardening agent. The ofloxacin vaginal swelling suppository provided by the invention adopts six original advanced technologies, is high in stability and durable in curative effect, and has the beneficial effects of preventing a liquid medicine from draining, avoiding secondary infection and the like.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to an ofloxacin vaginal expansion suppository and a preparation method and detection method thereof. Background technique [0002] Ofloxacin is a white to slightly yellow crystalline powder; odorless and tasteless; it changes color when exposed to light, and has poor stability; poor water solubility, low absorption, and low bioavailability; it is mainly used clinically for the treatment of bacterial vaginosis. Among the currently marketed preparations, the dosage forms of ofloxacin mainly include tablet, capsule, ointment and suppository; after the tablet is inserted into the vagina, ofloxacin is difficult to dissolve and is difficult to play a role; the same problem exists in the capsule; and the ointment also It is unfavorable for intravaginal use, so the application of suppositories is the most extensive at present, and is accepted by the majority of patients. There are not ...

AI Technical Summary

Problems solved by technology

[0002] Ofloxacin is a white to light yellow crystalline powder; odorless and tasteless; gradually changing color when exposed to light, poor stability; poor water solubility, less absorption, and low bioavailability; it is mainly used clinically for the treatment of bacterial vaginosis

Among the currently marketed preparations, the dosage forms of ofloxacin mainly include tablets, capsules, ointments and suppositories; after the tablets are inserted into the vagina, ofloxacin is difficult to dissolve and play a role; the same problem exists in capsules; It is not conducive to intravaginal use, so suppositories are currently the most widely used and accepted by the majority of patients

There are not many studies on ofloxacin suppositories in the prior art. At the same time, due to the unstable nature of ofloxacin itself, the stability of the suppository is poor after being made; ; The contact surface between the active ingredient and the human body is small, resulting in insufficient absorption, failure to exert the best curative effect of the formula and other technical problems

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