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Tedizolid phosphate composition tablet

A technology of tedizolid phosphate and composition, applied in the field of tedizolid phosphate composition tablet, can solve the problems of inability to meet transportation and storage, unstable product quality, inaccurate dosage form, etc. Application, low cost, low loss effect

Active Publication Date: 2018-01-26
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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  • Tedizolid phosphate composition tablet

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0046] Experimental Example 1 Investigation of tablet hardness and stability

[0047] Take the tablet samples prepared in Example 1, Example 3, Comparative Example 1, Comparative Example 2, Comparative Example 3, and Comparative Example 4, under the conditions of packaging (aluminum-plastic packaging, placed in a carton), at 40 ° C, It was placed under a relative humidity of 75% for 6 months, and samples were taken at 0, 1, 2, 3, and 6 months to measure tablet hardness. The results are shown in Table 1.

[0048] Table 1 Tablet hardness test results

[0049]

[0050] The accelerated test is investigated for 6 months, and the hardness measurement results show that the hardness of the tablet of the present invention remains unchanged under long-term storage conditions, which significantly improves the stability of the formulation.

experiment example 2

[0051] Experimental example 2. Dissolution detection

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

[0053] Table 2 Dissolution test results

[0054]

experiment example 3

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

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

[0057] Table 3 Comparison of clinical efficacy of patients (cases)

[0058] group

[0059] Table 4 Comparison of bacteriological efficacy of patients (cases)

[0060] group

[0061] Table 5 Comparison of adverse reactions in two groups of patients (cases)

[0062] group

[0063] The comparison difference between the embodiment and the comparative example has statistical significance (P<0.05), thus it can be seen that the curative effect and adverse reaction of the tedizolid phosphate composition of the present invention are superior to the prior art, and have significant antibacterial activity to MRSA. improve.

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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 still faces severe challenges in the development of modern medicine. Taking methicillin-resistant Staphylococcus aureus (MRSA) as an example, MRSA appeared 2 years after the clinical application of methicillin, and the bacteria spread widely in hospitals around the world for more than 50 years. Since the early 1990s, community-acquired MRSA (CA-MRSA) has emerged and spread globally, changing the old concept that MRSA infection only occurs in hospital settings. The problem of resistance in Gram-positive bacteria is not limited to MRSA, including vancomycin-resistant enterococci (VRE), macrolide-resistant group A beta-hemolytic streptococci, and penicillin-...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/18A61K31/675A61P31/04
Inventor 侯善波宋庆国田德建
Owner SHANDONG YUXIN PHARMA CO LTD
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