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Levoxiracetam sustained-release capsule with good release uniformity and preparation method thereof

A slow-release capsule and uniform technology, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc. Achieving problems such as sustained-release preparations, achieving the effects of good content uniformity of the main drug, simple and feasible preparation process, and reducing the number of doses

Active Publication Date: 2020-06-05
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The existing levoxiracetam sustained-release preparations mainly have the disadvantage 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. Technical problems such as poor content uniformity of main ingredients in traditional Chinese medicine

Method used

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  • Levoxiracetam sustained-release capsule with good release uniformity and preparation method thereof
  • Levoxiracetam sustained-release capsule with good release uniformity and preparation method thereof
  • Levoxiracetam sustained-release capsule with good release uniformity and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] A levoxiracetam sustained-release capsule with good release uniformity is prepared according to the following steps:

[0023] Element Dosage Levoxiracetam 1 copy lactose 1.3 parts Hypromellose K4M 1.0 copies Hypromellose K15M 1.5 servings carnauba wax 0.5 parts stearyl alcohol 0.08 copies

[0024] 70% ethanol solution 2.3 servings

[0025] Make 1000 capsules

[0026] Preparation process:

[0027] 1. Pretreatment of raw and auxiliary materials: Dissolve levo-oxiracetam with 3 to 7 times the amount of water to form a solution for later use; take the prescribed amount of slow-release matrix material and blocker, add levo-oxiracetam aqueous solution, stir and mix 10min to 15min, put it in a blast drying oven, set the temperature at 40°C to 60°C, dry until the water content is ≤3%, take it out, put it in a mixer grinder and mix it into a fine powder (all pass through a No. 5 sieve and can pass through...

Embodiment 2

[0068] A levoxiracetam sustained-release capsule with good release uniformity is prepared according to the following steps:

[0069] Element Dosage Levoxiracetam 1 copy lactose 1.5 servings Carboxypropylmethylcellulose K4M 1.3 parts Carboxypropylmethylcellulose K15M 1.8 servings carnauba wax 0.7 parts stearyl alcohol 0.18 parts 70% ethanol solution 2.7 servings

[0070] Make 1000 capsules

[0071] 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 All are less than 5%, and the RSD of each point content uniformity is all less than 1%. The stability test results show that the s...

Embodiment 3

[0073] A levoxiracetam sustained-release capsule with good release uniformity is prepared according to the following steps:

[0074] Element Dosage Levoxiracetam 1 copy lactose 1.4 parts Carboxypropylmethylcellulose K4M 1.2 parts Carboxypropylmethylcellulose K15M 1.7 servings carnauba wax 0.6 parts

[0075] stearyl alcohol 0.12 parts 70% ethanol solution 2.5 servings

[0076] Make 1000 capsules

[0077] 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 All are less than 5%, and the RSD of each point content uniformity is all less than 1%. The stability test results...

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Abstract

A levorotatory oxiracetam slow-release capsule with good releasing rate uniformity is characterized in that the levorotatory oxiracetam slowly-released capsule is prepared from the following raw materials in parts by weight: 1 part of levorotatory oxiracetam, 1.2 to 1.7 parts of lactin, 0.8 to 1.6 parts of hydroxypropylmethylcellulose K4M, 1.1 to 2.0 parts of hydroxypropylmethylcellulose K15M, 0.3 to 0.8 part of brazil palm wax, 0.05 to 0.2 part of stearyl alcohol, and 2.1 to 2.8 parts of ethanol solution with the volume fraction of 50 to 70%; the levorotatory oxiracetam slow-release capsule prepared according to the preparation method provided by the invention has a good releasing uniformity, each time point releasing rate RSD (Relative Standard Deviation) among different samples is less than 5%, releasing speed is slow, the releasing period can reach 12 hours, and thus medicine taking times of the levorotatory oxiracetam slowly-released capsule can be reduced to once a day through comparing with traditional preparations, main drug content uniformity is good, the RSD of the main drug content is less than 1% during a mixing process; meanwhile, the levorotatory oxiracetam slow-release capsule is good in stability, the shelf-life can reach 24 months, a preparation process is simple and feasible, and the capsule is worth market popularizing.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a levoxiracetam sustained-release capsule and a preparation method thereof. Background technique [0002] Oxiracetam (S-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 has the function of activating, protecting or promoting nerve cells. Functional recovery can improve the memory and learning functions of patients with mental retardation, and the drug itself has no direct vasoactive or central excitatory effect, and its effect on learning and memory is a lasting promotion effect. [0003] The drug was launched in Italy in 1987, and the listed dosage forms are tablet, 800mg; capsule, 800mg; injection, 5ml: 1g. At present, only oxiracetam capsules and injections are on the market in China, and the main active ingredients used are...

Claims

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Application Information

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