Potassium citrate sustained release tablet and preparation method thereof

A technology of potassium citrate and sustained-release tablets, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve problems such as hidden dangers in product quality control and large measurement errors, and achieve Stable and controllable quality, improved release, and obvious slow-release characteristics

Active Publication Date: 2011-11-16
LIVZON GROUP LIVZON PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Experiments show that the process of the sample prepared by the prescription of the potassium citrate sustained-release tablet is stable, and all inspections are qualified, but according to the requirements of the quality standard for the release rate, the release rate of the sample should be above 80% in 3 hours, while the three batches of the sample The 3-hour average release rate is 90%, 90% and 84.8%, and the release rate of individual samples is only 82%, which is close to the lower limit required by the quality standard
At the same time, since the detection instrument is an atomic absorption spectrophotometer, the measurement error is relatively large. If the release rate is close to the lower limit, it is likely to bring hidden dangers to the quality control of the product.

Method used

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  • Potassium citrate sustained release tablet and preparation method thereof
  • Potassium citrate sustained release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Prescription optimization: Based on the Urocit-K formulation and its stability test results, the dosage of the sustained-release matrix in the formulation is screened, so as to more effectively control the release of the drug in the sustained-release tablet to improve the sustained-release tablet 3 hours release.

[0052] The preparation process of sustained-release tablets is as follows:

[0053] (1) Mix and crush potassium citrate crude drug with 2 / 3 prescription amount of micro-powdered silica gel, pass through an 80-mesh sieve, and set aside;

[0054] (2) Weigh the above-mentioned mixture of potassium citrate and micro-powdered silica gel and glyceryl behenate in a total mixer and mix for 10 minutes;

[0055] (3) Add the mixture in step (2) to a jacketed heating pot, adjust the temperature to a material temperature of 80-90°C, stir slowly, and melt for 30 minutes;

[0056] (4) After cooling to room temperature, add the prescribed amount of microcrystalline cellulose, stir ev...

Embodiment 2

[0066] Further optimization of the prescription: In order to further adjust the release rate, it is planned to add crospovidone in the melt granulation step on the basis of the prescription 2.

[0067] The sustained-release tablet sample was prepared according to the preparation process described in Example 1 and the release test was performed. The results are shown in Table 2.

[0068] Table 2 Composition and release results of each prescription

[0069] Prescription 2a

[0070] According to the results of prescription screening, the addition of a certain amount of crospovidone further improved the 3-hour release of the sustained-release tablet. When the mass ratio of glyceryl behenate to crospovidone was 2:1 (that is, the prescription 2c), the result of release is the best.

Embodiment 3

[0072] Selection of preparation process parameters: The melting point of the sustained-release base glycerol behenate is 75-80℃, and the melting and heating temperature recommended by the auxiliary material manufacturer is 80-85℃. Considering that different heating temperatures for melt granulation may lead to differences in the molecular arrangement of the sustained-release material, which affects the release rate, three heating temperatures are initially set: 80°C, 90°C, and 100°C, according to prescription 2c and Example 1. The preparation method prepared samples of sustained-release tablets and tested the release degree. The results are shown in Table 3.

[0073] Table 3 Heating temperature and release results of melt granulation

[0074]

[0075] It can be seen from the above results that there is no significant difference in the release degree of the three samples. From the aspects of energy efficiency and equipment parameter control error, it is preferable to set the heating...

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PUM

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Abstract

The invention provides a potassium citrate sustained release tablet and a preparation method thereof. A weight ratio of potassium citrate to a waxy sustained release matrix is 10:0.7-1.1, preferably 10:0.83-1.0, and most preferably 10:1.0. The sustained release tablet allows the concentration of citric acid radical in urine to be effectively increased, the fluctuation of the concentration of citrate in the urine to be reduced, and a stable and high level of the citrate concentration to be kept. More importantly, the three-hour release rate, the tabletting performance and the moisture resistance of the sustained release tablet are further improved.

Description

Technical field [0001] The invention relates to an oral pharmaceutical preparation with slow-release characteristics for preventing and treating urinary calculi and a preparation method thereof, in particular to a potassium citrate sustained-release tablet and a preparation method thereof. Background technique [0002] Urinary calculi, also known as urolithiasis, is one of the common diseases of the urinary system. The treatment of urinary calculi is mainly divided into surgical treatment and medical treatment. Although surgical treatment (lithotripsy, etc.) is safe and effective, it can only remove the stones, but not the cause of the stones, so the recurrence rate is high. The clinical report shows: 1 year after lithotripsy, the stone recurrence rate is 6.7% to 7.3%, and it increases by 5% every year for 2 to 5 years, and the maximum recurrence rate in 5 years is 41.8%. Therefore, how to prevent the recurrence of stones is a problem that needs to be solved urgently. [0003] M...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/191A61K47/38A61P13/04
Inventor 阎松侯雪梅陈乔柏吴起娟
Owner LIVZON GROUP LIVZON PHARMA FACTORY
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