Lacosamide liposome freeze-dried powder injection and preparation method thereof

Abstract

The invention discloses a lacosamide liposome freeze-dried powder injection and a preparation method thereof. The lacosamide liposome freeze-dried powder injection is prepared from the following components in parts by weight: 1-4 parts of lacosamide, 10-40 parts of soybean lecithin, 2-8 parts of cholesterol and 1.3-5.2 parts of cane sugar. The encapsulation efficiency of the lacosamide liposome prepared by the method is greater than 80%, the particle size is less than 200nm, the Zeta potential is less than -20mV, and the pH value is 6.0-8.0. The lacosamide is a novel antiepileptic drug. The injection on the market at present is only suitable for replacing oral preparations in a short time, is used for patients who are not suitable for oral administration, and is administrated twice a day,the injection times are over-frequent, the invention provides the safe and non-irritant lacosamide freeze-dried powder injection and the preparation method thereof, the administration frequency can beadjusted from the conventional two times per day to one time per day, the medication compliance of the patient is improved, the conventional injection is prepared into the freeze-dried powder injection, the long-term storage and transportation stability of the preparation is improved, and the good application prospect is provided.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a lacosamide liposome freeze-dried powder injection and a preparation method thereof. Background technique [0002] Epilepsy, commonly known as "shorn wind" or "epilepsy", is a chronic disease in which the sudden abnormal discharge of brain neurons leads to transient brain dysfunction. According to the latest epidemiological data in China, the overall prevalence rate of epilepsy in China is 7.0‰, the annual incidence rate is 28.8 / 100,000, and the prevalence rate of active epilepsy with seizures within one year is 4.6‰. Based on this, it is estimated that there are about 9 million epilepsy patients in China, of which 5 to 6 million are active epilepsy patients, and about 400,000 new epilepsy patients are added every year. In China, epilepsy has become the second most common disease in neurology after headache. sick. [0003] Lacosamide is a new ty...

AI Technical Summary

Problems solved by technology

[0004] The injections currently on the market are only suitable for short-term replacement of oral preparations for patients who are not suitable for oral administration, but the administration is twice a day, and the number of injections is relatively frequent, which reduces the patient's compliance with medication