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A kind of tedizolid phosphate composition tablet

A technology of tedizolid phosphate and composition, which is applied in the field of tedizolid phosphate composition tablet, can solve problems such as unsatisfactory transportation and storage, unstable quality of finished products, inaccurate dosage forms, etc. Application, low cost, and improved antibacterial activity against MRSA

Active Publication Date: 2020-03-20
SHANDONG YUXIN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, the applicant found through experiments that although CN105496976 A adopts the powder direct compression process to avoid the heat and humidity in the wet granulation process, the tablet produced by it has a phenomenon of reduced hardness during the stability placement process, which leads to the long-term failure of the finished product. During the storage process, the quality is unstable and fragile, which cannot meet the requirements of transportation and storage, which indirectly leads to inaccurate dosage forms and affects clinical efficacy

Method used

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  • A kind of tedizolid phosphate composition tablet

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0046] The investigation of experimental example 1 tablet hardness stability

[0047] Get the prepared tablet samples of Example 1, Example 3, Comparative Example 1, Comparative Example 2, Comparative Example 3, and Comparative Example 4, under packaging (aluminum-plastic packaging, put in a carton), at 40 ° C, Place it under 75% relative humidity for 6 months, take samples at 0, 1, 2, 3, and 6 months, and measure the tablet hardness. The results are shown in Table 1.

[0048] Table 1 tablet hardness investigation result

[0049]

[0050] The accelerated test was conducted for 6 months, and the hardness measurement results showed that the hardness of the tablet of the present invention remained unchanged under long-term storage conditions, and the stability of the preparation was significantly improved.

experiment example 2

[0051] Experimental example 2, dissolution test

[0052] Dissolution measurement method: the dissolution rate of the test product and the reference product was investigated according to the second appendix XD of the "Pharmacopoeia of the People's Republic of China" 2015 edition. 900ml of 0.05M phosphate buffer solution, pH 6.80±0.05 was used as the dissolution medium, the temperature was 37°C, the rotation speed was 50 rpm, and the amount of drug in each sample to be tested was 30mg. Samples were taken at 45 minutes by ultraviolet spectrophotometry for dissolution determination. The detection wavelength was 274nm, and the linear relationship was good within 5-25mg·L-1. The recovery rate and precision experiments all met the methodological requirements. The test results are shown in Table 2.

[0053] Table 2 Dissolution test results

[0054] Dissolution % Dissolution % Example 1 99.6 Comparative example 1 97.5 Example 2 99.5 Comparative example...

experiment example 3

[0055] Experimental Example 3: Efficacy and Safety Evaluation of Treatment for MRSA Pneumonia

[0056] Refer to the patent CN 105085570 A method for detection, and the test results are shown in Table 3-5.

[0057] Table 3 Comparison of Clinical Curative Effects of Patients (Example)

[0058] group Total effective rate, % group Total effective rate, % Example 1 88.15 Comparative example 1 82.05 Example 2 87.95 Comparative example 2 83.27 Example 3 87.99 Comparative example 3 86.23 Example 4 87.84 Comparative example 4 87.12 Example 5 88.07

[0059] Table 4 Comparison of Bacteriological Curative Effects of Patients (Example)

[0060] group Bacterial clearance rate, % group Bacterial clearance rate, % Example 1 95.16 Comparative example 1 78.43 Example 2 95.08 Comparative example 2 80.15 Example 3 95.11 Comparative example 3 91.45 Example 4 95.23 Comparative example...

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Abstract

The invention belongs to the field of medical preparation, and more specifically discloses a tedizolid phosphate composition tablet. The tedizolid phosphate composition tablet comprises tedizolid phosphate, pregelatinized starch, sucrose, tyrosine, polacrilin potassium, and sodium lauryl sulfate. The stability of the tedizolid phosphate composition tablet is improved obviously. It is found via experiments that, compared with the prior art, the tedizolid phosphate composition tablet possesses following advantages: the curative effect is better, the adverse reaction is reduced, and antimicrobialactivity on MRSA is increased obviously.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a tedizolid phosphate composition tablet. Background technique [0002] The treatment of infectious diseases such as skin and soft tissue infections (SSSIs), pneumonia, sepsis, and endocarditis caused by Gram-positive bacteria is still facing severe challenges in today's advanced modern medicine. Taking methicillin-resistant Staphylococcus aureus (MRSA) as an example, MRSA appeared 2 years after the clinical application of methicillin, and after more than 50 years, the bacteria has been widely spread in hospitals all over the world. Since the early 1990s, community-acquired MRSA (CA-MRSA) appeared and spread globally, changing the old idea that MRSA infection only occurs in hospital settings. The problem of drug resistance in Gram-positive bacteria is not limited to MRSA, including challenges posed by vancomycin-resistant enterococci (VRE), macrolide-resistant group A beta-hemo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K47/18A61K31/675A61P31/04
Inventor 李环宇侯善波宋庆国田德建
Owner SHANDONG YUXIN PHARMA CO LTD
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