Racetam pharmaceutical composition containing buffering agent

A buffer and composition technology, applied in the field of medicine, can solve problems such as non-conformity, inability to apply clinically, and quality changes, and achieve the effect of solving high temperature resistance, low price, and safe price

Active Publication Date: 2018-03-06
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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  • Racetam pharmaceutical composition containing buffering agent
  • Racetam pharmaceutical composition containing buffering agent
  • Racetam pharmaceutical composition containing buffering agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1: Stability research test

[0038] Prepare the racetam drug composition: the total mass volume percentage of the racetam drug and mannitol is in the range of 20% to 30%, place it at room temperature (25°C) and 4°C, and observe the crystallization state after 10 days; at the same time Another batch was frozen at -20°C for 2 days, and then placed at 40°C for 2 days to observe the reconstitution state. 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] Dissolve piracetam and mannitol in the prescribed amount according to Table 1, dissolve in sterile water for injection, add 0.5% (w / v) activated carbon, absorb at 100°C for 30min, filter while hot, potting, and sterilize at 121°C for 8min .

[0041] Table 1 Basic Prescription

[0042]

[0043] The control group is a mannitol solution with a conce...

Embodiment 2

[0059] Embodiment 2: diuresis test

[0060] 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:

[0061] Male Wistar rats, weighing 200±20g, 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 hours before the experiment. Following the diuretic screening method introduced by Aston, 2.2mL / 100g 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, and those whose urine...

Embodiment 3

[0067] Embodiment 3: sodium acetate-dilute hydrochloric acid buffer solution

[0068] 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.

[0069] Table 7 Basic Prescription

[0070]

[0071] Sodium acetate-dilute hydrochloric acid buffer preparation method: Weigh 1.64g sodium acetate into a 100mL 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, 5.00, 5.50, 6.00, 6.50, 7.00 to make sodium acetate-dilute hydrochloric acid buffer solutions with different pH values.

[0072] Preparation method: Dissolve piracetam and mannitol in the prescribed amount according to Table 7, dissolve in sterile water for injection, add 0.5% (w / v) activated carbon, absorb at 100°C for 30min, filter while hot, add buffer, and stir Uniform, potted, sterilized at 121°C for 8 minutes, measured the pH value before and after sterilizat...

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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, which can be regarded as cyclic derivatives of gamma-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, Piracetam, the first racetam drug with nootropic activity, was officially launched. In 1972, Corneliu Giurgea also proposed the concept of "nootropics" based on piracetam. [0003] Raceta...

Claims

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Application Information

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Patent Type & Authority Applications(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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