Medicinal sustained-release preparation for treating osteomyelitis and preparation method and application thereof

A slow-release preparation and osteomyelitis technology, which is applied in the direction of anti-inflammatory agents, drug combinations, drug delivery, etc., to achieve the effects of convenient use, significant therapeutic effect, and simple prescription

Active Publication Date: 2012-07-25
广州南峰生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The slow-release preparation can be directly implanted into the affected area after trauma or osteomyelitis debridement, which solves the disadvantage that it is difficult for antibiotics to penetrate to the local bone to form an effective antibacterial concentration, and avoids the need for high systemic doses of antibiotics and long-term intravenous application in the clinical treatment of osteomyelitis4 ~6 weeks of malady, and does not require secondary surgery to remove

Method used

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  • Medicinal sustained-release preparation for treating osteomyelitis and preparation method and application thereof
  • Medicinal sustained-release preparation for treating osteomyelitis and preparation method and application thereof
  • Medicinal sustained-release preparation for treating osteomyelitis and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] A drug sustained-release preparation for preventing and treating osteomyelitis, which is made of the following raw materials in the mass ratio w / w:

[0058] Raw material mass ratio w / w

[0059] Racemic polylactic acid The molecular weight of racemic polylactic acid is 40,000-120,000, 66.67%-90%

[0060] Levofloxacin 10%-33.33%

[0061] A kind of preparation method of the drug sustained release preparation of preventing and treating osteomyelitis, its steps are:

[0062] A. Cut the racemic polylactic acid material into fragments of equal size (such as 5×5mm 2 ), add the corresponding mass of levofloxacin powder, place it in an organic solvent with 4 to 5 times the w / v of the total mass of the blended material and stir at a constant speed until it is completely dissolved. Fast volatilization, the powder blend of racemic polylactic acid and levofloxacin is attached to the container wall and dried;

[0063] B. Heat the blend of racemic polylactic acid and levofloxacin i...

experiment example 1

[0073] Experimental example 1: In vitro drug release experiment of racemic polylactic acid and levofloxacin blended sustained-release tablets 1

[0074] Sampling: set the mass of racemic polylactic acid and levofloxacin blended slow-release tablets to be 100 mg, get the racemic polylactic acid with molecular weights of 4, 6, 8, 10, and 120,000 respectively, and the ratio of racemic polylactic acid and levofloxacin is 8: 3 pieces of 2w / w tablets were placed in test tubes respectively, 10ml of 0.1M phosphate buffer (pH 7.4) was added to each, 37°C, rotating speed 60r / min to simulate in vivo movement. The phosphate buffer was changed at 1, 2, 4, 8, and 12 hours after the experiment started; the phosphate buffer was changed every day from the 1st to 15th day of the experiment, and every 2 days from the 16th to 31st day; On the 32nd day, the phosphate buffer was changed every 3 days until 46 days after release. After the liquid was taken out and centrifuged, the supernatant liquid...

experiment example 2

[0079] Experimental Example 2: In vitro drug release experiment of racemic polylactic acid and levofloxacin blended sustained-release tablets 2

[0080] Sampling: Set the mass of racemic polylactic acid and levofloxacin blended sustained-release tablets to 60 mg, and the ratios of racemic polylactic acid and levofloxacin are 54:6, 51:9, 48:12, 45:15 and 42:18w / w respectively Each of the 3 tablets was placed in a test tube, and 10ml of 0.1M phosphate buffer (pH 7.4) was added to each of them, at 37°C, at a speed of 60r / min to simulate the movement in the body. The phosphate buffer was changed at 1, 2, 4, 8, and 12 hours after the experiment started; the phosphate buffer was changed every day from the 1st to 15th day of the experiment, and every 2 days from the 16th to 31st day; On the 32nd day, the phosphate buffer was changed every 3 days until 46 days after release. After the liquid was taken out and centrifuged, the supernatant was taken into a test tube and packaged, and s...

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Abstract

The invention discloses a medicinal sustained-release preparation for treating osteomyelitis and a preparation method and application thereof. The medicinal sustained-release preparation is prepared by compressing poly DL-lactic acid (PDLLA) and levofloxacin in a ratio. The preparation method comprises the following steps of: A, cutting the PDLLA, placing the PDLLA together with levofloxacin powder with corresponding mass into an organic solvent, and mixing at a constant speed until the PDLLA and the levofloxacin powder are dissolved; B, heating a blend in an oven so as to volatilize the organic solvent, and scraping off the dried blend from the wall of a container; C, cutting the blend into proper blocks, and placing into a metal mould for primary compression, so that the blend blocks are closely combined into a whole; D, heating the mould and the blend in the mould together in the oven, compressing the mould for forming, taking the mould out, putting the mould into a latex glove andputting into tap water for cooling, and demoulding to obtain a blend medicinal tablet of the PDLLA and the levofloxacin; and E, packaging the medicinal tablet by using a plastic bag, and sterilizing by using 60Co25KGy. The method is easy to realize, and the medicinal sustained-release preparation is convenient to take, has an obvious treating effect, high safety and long medicinal effect time, and is suitable to prevent and treat acute and chronic osteomyelitis.

Description

technical field [0001] The present invention relates to the field of orthopedics, in particular to a drug slow-release preparation for preventing and treating osteomyelitis, and also relates to the preparation method of the drug, and also relates to the use of the slow-release preparation. The drug is suitable for preventing and treating acute and chronic osteomyelitis . Background technique [0002] Acute hematogenous osteomyelitis and osteomyelitis caused by open fracture infection are common clinical and frequently-occurring diseases. Because it is difficult for antibiotics to penetrate into the affected area, it is difficult to form an effective antibacterial concentration in the local area. Therefore, the clinical treatment of osteomyelitis often requires high-dose systemic antibiotics and long-term application of antibiotics for 4 to 6 weeks. Excessively high doses of long-term intravenous administration will increase the effect of antibiotics. Systemic toxicity and s...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K31/5383A61K47/34A61P19/08A61P29/00
Inventor 汪晖陈廖斌曹洪修涵刘岩松
Owner 广州南峰生物科技有限公司
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