Promethazine hydrochloride microenema prescription and preparation method thereof

Abstract

The invention discloses a promethazine hydrochloride microenema prescription and a preparation method thereof. The preparation method comprises the following steps of: dissolving hydroxypropyl methylcellulose, or polyethylene glycol 6000 or polyvinylpyrrolidone in purified water to form a solution A; dissolving sodium bisulfite, sodium sulfite, vitamin C and EDTA-2Na (Ethylene Diamine TetraaceticAcid-2Na) in purified water, then adding promethazine hydrochloride and dissolving to form a solution B; dissolving ethylparaben in a small amount of boiled water to form a solution C; and adding thesolution C to the solution B to form a solution D, adding the solution D to the solution A, stirring and adding purified water to form a solution and stirring evenly, inspecting and subpackaging. Thepromethazine hydrochloride microenema prescription is convenient to use, is easy to adjust the administration dose to adapt to sick children of different ages, and has better clinical applicability and convenience, thereby ensuring safe and reasonable medication; and the promethazine hydrochloride microenema prescription can overcome the defect in convenience of tablets and rectal suppositories in dose adjustment and the like, overcomes the defect of syrup in stability, is especially applicable to pediatric patients, and is easy to adjust the dose according to the condition of patients to meet the individual requirement on treatment.

Description

technical field [0001] The invention relates to a medicine and a preparation method thereof, in particular to a promethazine hydrochloride miniature enema prescription and a preparation method thereof. Background technique [0002] Promethazine hydrochloride is one of the most commonly used drugs in pediatric clinical practice. It is mainly used to treat symptoms caused by the release of histamine, such as skin and mucous membrane allergies, allergic rhinitis, vasomotor rhinitis, and for lowering body temperature, Anti-emetic, anti-motion sickness, sedative and hypnotic, etc. It is also used to shorten the course of treatment for children with acute bronchitis, prevent children with acute diarrhea, and children with febrile convulsions. At present, the domestic dosage forms of this drug for clinical use include injections, tablets, oral syrups, and granules. There are also two specifications of suppositories for clinical use abroad. In view of the inhibitory effect of the d...

AI Technical Summary

Problems solved by technology

Domestic survey results show that nearly 35% of children need to divide the tablet into several pieces when oral tablets are used, which often causes inaccurate dosage and produces toxic and side effects; Thiazides are unstable in nature, easily oxidized and discolored, and the prepared syrup can only last for 6 days at room temperature, so they can only be prepared in the preparation room of the hospital for clinical application

Studies on the pharmacokinetics and bioavailability of rectal suppositories in adults have shown that there is no significant difference in the pharmacokinetics of various specifications of suppositories, but the relative bioavailability of individuals varies greatly, ranging from 74% to 394%. Therefore, it is believed that In addition to individual differences, the important reason for the difference is the dosage form and the composition of the prescription. Because the absorption of the drug in the suppository must go through the melting of the matrix and the process of drug dissolution, the composition, properties and preparation process of the matrix may affect the content of promethazine hydrochloride in the suppository. The release and absorption have a greater impact; at the same time, the suppository is not flexible enough for dosage adjustment

[0003] Therefore, need a kind of promethazine hydrochloride dosage form applicable to pediatric patients, can overcome the deficiencies in convenience of use such as dosage adjustment of tablet, rectal suppository, overcome the deficiencies in the stability of syrup, be easy to carry out dosage according to patient's condition Adjust to meet the individual requirements of treatment

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