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Potassium citrate sustained release tablet and preparation method thereof

A technology of potassium citrate and sustained-release tablets, which is applied in the fields of pharmaceutical formulation and drug delivery, which can solve the problems of hidden dangers in product quality control and large measurement errors, and achieve the effects of stable and controllable quality, improved release rate, and definite curative effect

Active Publication Date: 2013-07-10
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
  • Potassium citrate sustained release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Prescription optimization: On the basis of the Urocit-K prescription and its stability test results, screen the dosage of the sustained-release matrix in the prescription, so as to control the release of the drug in the sustained-release tablets more effectively and improve the stability of the sustained-release tablets. 3 hours release.

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

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

[0054] (2) Weighing the mixture of above-mentioned potassium citrate and micropowder silica gel, and glyceryl behenate were placed in a blender and mixed for 10 minutes;

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

[0056] (4) After being cooled to room tempe...

Embodiment 2

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

[0067] According to the preparation process described in Example 1, the sustained-release tablet samples were prepared and the release rate was tested. The results are shown in Table 2.

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

[0069]

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

Embodiment 3

[0072] Screening of preparation process parameters: the slow-release matrix glyceryl behenate has a melting point of 75-80°C, and the melting temperature recommended by the excipient manufacturer is 80-85°C. Considering that the different heating temperatures of melt granulation may lead to differences in the molecular arrangement of the sustained-release material, thereby affecting the release rate, three heating temperatures were initially set: 80°C, 90°C, and 100°C, according to prescription 2c and Example 1. The preparation method prepares the sustained-release tablet sample and detects the release rate, and the results are shown in Table 3.

[0073] Table 3 Melt granulation heating temperature and release results

[0074]

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

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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 for preventing and treating urinary system calculi and has slow-release characteristics and a preparation method thereof, in particular to a potassium citrate sustained-release tablet and a preparation method thereof. Background technique [0002] Urinary system calculus, also known as urolithiasis, is one of the common diseases of the urinary system. The treatment of urinary tract stones is mainly divided into surgical treatment and medical treatment. Although surgical treatment (lithotripsy etc.) is safe and effective, it can only remove calculus, but cannot remove the etiology of calculus, so the recurrence rate is high. Clinical reports show that: 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 highest recurrence rate can reach 41.8% in 5 years. Therefore, how to prevent stone recurrence is an urgent problem...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/22
Inventor 阎松侯雪梅陈乔柏吴起娟
Owner LIVZON GROUP LIVZON PHARMA FACTORY
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