Sustained-release transdermal patch containing sodium valproate, preparation method and application thereof

Abstract

The invention discloses sodium valproate-containing sustained-release transdermal patch as well as a preparation method and application thereof. The sustained-release transdermal patch comprises a back lining layer, a medicine-containing layer and a protective layer, wherein the medicine-containing layer comprises sodium valproate, a complexing agent, an adhesive, a transdermal improver, a bacteriostatic agent and a hot-melt pressure-sensitive adhesive. The preparation method comprises the following steps: heating and melting the hot-melt pressure-sensitive adhesive, adding the sodium valproate, the transdermal improver, the adhesive, the complexing agent and the bacteriostatic agent into the hot-melt pressure-sensitive adhesive to dissolve, mixing uniformly, performing ultrasonic degassing, coating the surface of the protective layer with the mixture to form the medicine-containing layer, and covering the surface of the dried medicine-containing layer with the back lining layer; cutting and packaging. The sodium valproate-containing sustained-release transdermal patch can serve as a medicine for treating pediatric epilepsy. The sodium valproate-containing sustained-release transdermal patch has medicine release uniformity and mild and durable effect, can effectively reduce the administration times, is convenient in dosage adjustment, is convenient to carry, has high patient adaptability, and solves the problem that infantile administration is difficult.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a sustained-release transdermal patch containing sodium valproate and a preparation method and application thereof. Background technique [0002] With the development of medical technology, more and more diseases have been overcome, and people enjoy a better life because of this, but there are also some genetic diseases or chronic diseases that are slowly tormenting patients, and epilepsy is a chronic recurrent short-term Brain Dysfunction Syndrome. Seizures are repeated seizures caused by abnormal discharge of brain neurons. Scientific research shows that the incidence of epilepsy is related to age. It is generally believed that the prevalence rate is the highest within 1 year old, and gradually decreases after 1-10 years old. Therefore, this disease is more common in young children. Seizures have a variety of clinical manifestations: generalized tonic-clonic seizures (gran...

AI Technical Summary

Problems solved by technology

Sodium valproate has a variety of dosage forms in anti-epileptic aspects, among which oral sustained-release tablets are the most common, but there are also great limitations: (1) Oral administration has low bioavailability due to the influence of the digestive system and circulatory system , such as gastrointestinal metabolism, liver first-pass effect, etc.

(2) For infants and young children, oral tablets are difficult to swallow; and children need to adjust the dosage (often reduce), but if the sustained-release tablets are broken and fed to children, the sustained-release effect will be affected, and the dosage is difficult to control accurately (3) Intravenous injection is also performed when oral administration is inconvenient. Although intravenous administration has a quick effect, it is easy to cause too high peak concentration, cause side effects, and pose a safety hazard

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