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A kind of racetam pharmaceutical composition containing buffer

A buffering agent and composition technology, applied in the field of medicine, can solve the problems of quality change, inability to apply clinically, non-conformity, etc., and achieve the effect of safe price, low price, and solving the effect of high temperature resistance

Active Publication Date: 2021-01-15
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, during the research process, the researchers found that the pH value and the amount of related substances of racetams changed significantly before and after sterilization, which did not meet the requirements of the 2015 edition of "Chinese Pharmacopoeia" and could not be used clinically.

Method used

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  • A kind of racetam pharmaceutical composition containing buffer
  • A kind of racetam pharmaceutical composition containing buffer
  • A kind of racetam pharmaceutical composition containing buffer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1: Stability research test

[0038] Preparation of the racetam drug composition: the total mass volume percentage of the racetam drug and mannitol is within the range of 20% to 30%, placed at room temperature (25 o C), 4 o Under C conditions, observe the crystallization state after 10 days; at the same time, put another batch at -20 o C frozen for 2 days, then at 40 o C was placed for 2 days, and the reconstitution state was observed. The results are shown in Tables 2-4.

[0039] The racetam pharmaceutical composition and mannitol described in the present invention can be prepared by the following method, taking piracetam as an example.

[0040] According to Table 1, the piracetam and mannitol of the prescribed amount are dissolved in sterilized water for injection, and 0.5% ( w / v ) activated carbon, 100o C adsorption for 30 min, filtered while hot, potting, 121 o C sterilization for 8 min.

[0041]

[0042] The control group is a mannitol solutio...

Embodiment 2

[0049] Embodiment 2: diuresis test

[0050] For acute diseases, such as acute cerebral edema induced by various etiologies, immediate dehydration is required. At this time, the combination of piracetam and mannitol is required to exert its high efficacy. The inventor selected several groups of compositions with different concentrations and carried out Diuretic test, the specific operation process is as follows:

[0051] Male Wistar rats, weighing 200 ± 20 g, were randomly divided into 18 groups, with 3 rats in each group, placed in metabolic cages for 1 day to adapt to the environment, and observed whether the urine output was stable under the condition of free drinking water. No food or water was allowed 18 h before the experiment. Following the diuretic screening method introduced by Aston, 2.2 mL / 100 g distilled water was administered into the stomach before the drug to maintain a certain water load in the animal body. Urine was collected for 2 hours. If the urine output ...

Embodiment 3

[0054] Embodiment 3: sodium acetate-dilute hydrochloric acid buffer solution

[0055] From Example 1, the mass volume ratio of piracetam to mannitol is 10:15 as an example, and the basic prescription is shown in Table 7.

[0056]

[0057] Sodium acetate-dilute hydrochloric acid buffer preparation method: Weigh 1.64 g sodium acetate into a 100 mL measuring bottle, add sterile injection solution to dissolve in water and dilute to the mark, adjust the pH to 3.00, 3.50, 4.00, 4.50 with dilute hydrochloric acid , 5.00, 5.50, 6.00, 6.50, 7.00 to make sodium acetate-dilute hydrochloric acid buffer solutions with different pH values.

[0058] Preparation method: Dissolve the piracetam and mannitol in the prescription amount according to Table 7 and dissolve them in sterile water for injection, add 0.5% ( w / v ) activated carbon, 100 o C adsorption for 30 min, filter while hot, add buffer, stir evenly, potting, 121 o C sterilized for 8 minutes, measured the pH value before and ...

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Abstract

The invention belongs to the technical field of medicine, and relates to a racetam pharmaceutical composition containing buffering agent. The composition is prepared from the buffering agent, racetammedicine, mannitol and water, and is characterized in that the total massic volume percentage of racetam medicine and mannitol is 10-60% every 100 mL. The buffering agent is composite buffer salts ofone or two types of phosphate, acetate and citrate. The composition with addition of monosodium phosphate-dilute hydrochloric acid and sodium acetate-dilute hydrochloric acid has the optimal stability, the pH value of the buffering agent is 4.50-6.50, and the amount of the buffer salts is 0.5-1.0 mmol every 100 mL liquid. According to the racetam pharmaceutical composition containing the bufferingagent, through addition of the buffering agent into the composition, the stability is improved, the problem that the pH value and the relevant substance content of the racetam medicine significantlychange is solved, and the composition has broad application prospects.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a racetam pharmaceutical composition containing a buffer. Background technique [0002] Racetams belong to the class of pyrrolidones and can be regarded as cyclic derivatives of γ-aminobutyric acid (GABA). In the 1960s, GABA was proved to be an important brain neurotransmitter inhibitor, which attracted people's attention, and the pharmacology related to GABA was introduced into the pharmaceutical industry. UCB, Belgium, synthesized the cyclic derivative of GABA, Piracetam, in 1964, intending to develop it as a sedative. However, it cannot inhibit neurotransmitters and has no sleep-inducing effect. In 1971, after persistent research by neuropharmacologist and chemist Corneliu Giurgea, the first racetam drug with nootropic activity, piracetam, was officially launched. In 1972, Corneliu Giurgea also proposed the concept of "nootropics" based on piracetam. [0003] Racetams are ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4015A61K47/26A61K47/02A61K47/12A61P25/28A61P7/10
CPCA61K31/4015A61K47/02A61K47/12A61K47/26
Inventor 邓意辉李博群刘欣荣
Owner SHENYANG PHARMA UNIVERSITY
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