A kind of stable levoxiracetam sustained-release capsule and preparation method thereof

A sustained-release capsule and stable technology are applied in the field of stable levooxiracetam sustained-release capsules and their preparation, which can solve the requirements that the sustained-release preparation cannot be met, the release degree cannot be well controlled, and the product quality varies greatly, etc. The problem is that the preparation process is simple and feasible, the release speed is slow, and the number of doses is reduced.

Active Publication Date: 2020-09-08
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The existing oxiracetam oral preparations mainly have technical problems such as that the release rate cannot be well controlled and cannot meet the requirements of sustained-release preparations. The release rate of different samples in the same batch of products varies greatly, resulting in large differences in product quality and other technical problems.

Method used

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  • A kind of stable levoxiracetam sustained-release capsule and preparation method thereof
  • A kind of stable levoxiracetam sustained-release capsule and preparation method thereof
  • A kind of stable levoxiracetam sustained-release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] A kind of levoxiracetam sustained-release capsule with good stability is prepared according to the following steps:

[0024] Element Dosage Levoxiracetam 1 copy lactose 1.6 servings Hypromellose K4M 1.3 parts Hypromellose K15M 1.1 copies

[0025] carnauba wax 0.6 parts stearyl alcohol 0.12 parts 60% ethanol solution 2.0 copies

[0026] Make 1000 capsules

[0027] Preparation process:

[0028] 1. Pretreatment of raw and auxiliary materials: Take the main drug, slow-release matrix material and blocker in the prescription amount, mix and grind them into fine powder (the amount that can pass through the No. 5 sieve and the No. 6 sieve must not be less than the total 95% of the amount), sieved;

[0029] 2. Granulation: Add binder, mix and granulate with 18-mesh sieve, place the wet granules in a hot air oven, set the temperature at 40-60°C, dry until the moisture content of the granules is ≤3%, and g...

Embodiment 2

[0063] A kind of levoxiracetam sustained-release capsule with good stability is prepared according to the following steps:

[0064] Element Dosage Levoxiracetam 1 copy lactose 1.8 servings Carboxypropylmethylcellulose K4M 1.6 servings Carboxypropylmethylcellulose K15M 1.5 servings

[0065] carnauba wax 0.8 parts stearyl alcohol 0.16 parts 70% ethanol solution 2.3 servings

[0066] Make 1000 capsules

[0067] Preparation process: prepared according to the preparation process of Example 1. According to the test method of Example 1, the release measurement and the sample stability test were carried out respectively. The release measurement test results showed that levoxiracetam was released slowly, and the release time was as long as 12 hours. The release RSD of each sample at different time points Both are less than 5%, and the stability test results show that the quality of the sample is stable in June a...

Embodiment 3

[0069] A kind of levoxiracetam sustained-release capsule with good stability is prepared according to the following steps:

[0070] Element Dosage Levoxiracetam 1 copy lactose 1.7 servings Carboxypropylmethylcellulose K4M 1.5 servings Carboxypropylmethylcellulose K15M 1.3 parts carnauba wax 0.7 parts stearyl alcohol 0.13 parts 60% ethanol solution 2.1 parts

[0071] Make 1000 capsules

[0072] Preparation process: prepared according to the preparation process of Example 1. According to the test method of Example 1, the release measurement and the sample stability test were carried out respectively. The release measurement test results showed that levoxiracetam was released slowly, and the release time was as long as 12 hours. The release RSD of each sample at different time points Both are less than 5%, and the stability test results show that the quality of the sample is stable in June after acceleration, and th...

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PUM

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Abstract

A L-oxiracetam sustained release capsule with high stability is characterized by being prepared from the following raw materials and auxiliary materials in parts by weight: 1 part of L-oxiracetam, 1.5 to 1.9 parts of lactose, 1.2 to 1.8 parts of hydroxypropyl methyl cellulose K4M, 0.9 to 1.8 parts of hydroxypropyl methyl cellulose K15M, 0.5 to 0.9 part of carnauba wax, 0.1 to 0.2 part of stearyl alcohol and 1.8 to 2.5 parts of an ethanol solution with the volume fraction being 50 percent to 80 percent. The L-oxiracetam sustained release capsule provided by the invention has high release uniformity, the release rate RSD of different samples at different time points is less than 5 percent, the release speed is low and the release cycle is up to 12 hours, so the taking times of the product can be reduced compared with the taking times of the traditional preparation, and the product is taken for once per day; meanwhile, the product has high stability, the shelf life is up to 24 months and the preparation process is simple, practicable and worthy of market popularization.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a stable levoxiracetam sustained-release capsule and a preparation method thereof. Background technique [0002] Oxiracetam is a synthetic cyclic derivative of hydroxyaminobutyric acid (BABOB), which is only used in the central nervous system, mainly distributed in the cerebral cortex and hippocampus, and can activate, protect or promote the functional recovery of nerve cells , to improve the memory and learning function of mentally handicapped patients, and the drug itself has no direct vascular activity, nor does it have a central excitatory effect, and the effect on the learning and memory ability is a lasting promotion effect. [0003] Oxiracetam (oxiracetam, CAS NO.: 62613-82-5), the chemical name is 2-(4-hydroxy-2-oxo-1-pyrrolidinyl)acetamide, was established in 1974 by the Italian ISFS.P.A company The anti-hypoxic nootropic drug (compound disclosed in US4118396) s...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K31/4015A61K47/26A61K47/38A61K47/44A61K47/10A61P25/28
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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