Levorotatory oxiracetam slow-release capsule with good releasing rate uniformity and preparation method thereof

A technology of sustained-release capsules and uniformity, which is applied in the directions of non-active ingredient 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: 2017-03-22
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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  • Levorotatory oxiracetam slow-release capsule with good releasing rate uniformity and preparation method thereof
  • Levorotatory oxiracetam slow-release capsule with good releasing rate uniformity and preparation method thereof
  • Levorotatory oxiracetam slow-release capsule with good releasing rate uniformity and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0023] Element Dosage Levooxiracetam 1 serving lactose 1.3 servings Hypromellose K4M 1.0 servings Hypromellose K15M 1.5 servings carnauba wax 0.5 servings octadecanol 0.08 servings

[0024] 70% ethanol solution 2.3 servings

[0025] 1000 capsules

[0026] Formulation process:

[0027] 1. Pretreatment of raw and auxiliary materials: Dissolve L-Oxiracetam into a solution with 3 to 7 times the amount of water for use; take the formulation amount of slow-release matrix material and blocker, add L-Oxiracetam aqueous solution, stir and mix 10min~15min, put in blast drying oven, set temperature 40℃~60℃, dry to moisture ≤3%, take out, put in mixing pulverizer and mix and pulverize into fine powder (all pass through No. 5 sieve and can pass 6 The amount of No. sieve shall not be less th...

Embodiment 2

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

[0069] Element Dosage Levooxiracetam 1 serving lactose 1.5 servings Carboxypropyl methylcellulose K4M 1.3 servings Carboxypropyl methylcellulose K15M 1.8 servings carnauba wax 0.7 servings octadecanol 0.18 servings 70% ethanol solution 2.7 servings

[0070] 1000 capsules

[0071] Preparation process: according to the preparation process of Example 1, it was prepared. According to the test method of Example 1, the release rate measurement and the sample stability test were respectively carried out. The release rate measurement test results showed that levoxiracetam was released slowly, and the release time was as long as 12 hours. The release rate of each sample at different time points RSD All are less than 5%, and the content uniformity RSD of each point is less than 1%. The results of t...

Embodiment 3

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

[0074] Element Dosage Levooxiracetam 1 serving lactose 1.4 servings Carboxypropyl methylcellulose K4M 1.2 servings Carboxypropyl methylcellulose K15M 1.7 servings carnauba wax 0.6 servings

[0075] octadecanol 0.12 servings 70% ethanol solution 2.5 servings

[0076] 1000 capsules

[0077] Preparation process: according to the preparation process of Example 1, it was prepared. According to the test method of Example 1, the release rate measurement and the sample stability test were respectively carried out. The release rate measurement test results showed that levoxiracetam was released slowly, and the release time was as long as 12 hours. The release rate of each sample at different time points RSD All are less than 5%, and the content uniformity RSD of each point is less than 1...

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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 hydroxyaminobutyric acid (BABOB) cyclic derivative, which is only used in the central nervous system, mainly distributed in the cerebral cortex and hippocampus, and has the functions of activating, protecting or promoting nerve cells. Function recovery, improve memory and learning function of patients with intellectual disabilities, and the drug itself has no direct vascular activity, nor central excitatory effect, the impact on learning and memory ability is a lasting promoting 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 u...

Claims

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Application Information

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