Hydrochloric clindamycin nano granule formulation for injections and preparation thereof

A technology of clindamycin hydrochloride and nanoparticles, which is applied in the field of medicine, can solve problems such as poor stability of clindamycin hydrochloride, unsafe clinical medication, and inconspicuous effect, and achieve rapid and simple reaction process, low cost and high product quality. stable effect

Inactive Publication Date: 2008-12-17
HAINAN YONGTIAN PHARMA INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the poor stability of clindamycin hydrochloride, especially very sensitive to light and heat, serious quality changes occur in these common marketed preparations during long-term storage. Even if various additives are added, the effect is not obvious, and the side effects are relatively serious. Large, leading to unsafe clinical medication

Method used

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  • Hydrochloric clindamycin nano granule formulation for injections and preparation thereof
  • Hydrochloric clindamycin nano granule formulation for injections and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] prescription:

[0027] Clindamycin Hydrochloride 75g

[0028] β-cyclodextrin 5g

[0029] poloxamer188 5g

[0030] Sodium sulfate 25g

[0031] Propyl cyanoacrylate 150g

[0032] Mannitol 10g

[0033] 1. Preparation process

[0034] (1) Weigh 75g of clindamycin hydrochloride, 5g of β-cyclodextrin and 5g of poloxamer188, add 500ml of water for injection to dissolve, adjust the pH value to 2.1 with 1mol / L hydrochloric acid solution, and stir evenly;

[0035] (2) Slowly add 150g propyl cyanoacrylate under electromagnetic stirring, continue stirring at room temperature for 3 hours, add 25g sodium sulfate, continue stirring for 3 hours, adjust the pH value to 4.9 with 1mol / L sodium hydroxide solution, and stir evenly ;

[0036] (3) Add 10g of mannitol, stir to dissolve, then add needle-use charcoal with 0.1g needle-use charcoal according to 100ml solution, stir at room temperature for 10 minutes, filter for decarburization, and then use 0.22μm microporous membrane filte...

Embodiment 2

[0045] prescription:

[0046] Clindamycin Hydrochloride 300g

[0047] Dextran 80g

[0048] Povidone K30 80g

[0049] Sodium sulfate 200g

[0050] Methyl cyanoacrylate 800g

[0051] Glucose 400g

[0052] 1. Preparation process

[0053] (1) Take by weighing 300g of clindamycin hydrochloride, 80g of dextran and 80g of povidone K30, add 3000ml of water for injection to dissolve, adjust the pH value to 2.3 with a 1mol / L hydrochloric acid solution, and stir evenly;

[0054] (2) Slowly add 800g methyl cyanoacrylate under electromagnetic stirring, continue to stir at room temperature for 3 hours, add 200g of sodium sulfate, continue to stir for 3 hours, adjust the pH value to 4.8 with 1mol / L sodium hydroxide solution, and stir well ;

[0055] (3) Add 400 g of glucose, stir to dissolve, then add 0.3 g of needle charcoal to 100 ml of solution, stir at room temperature for 15 minutes, filter for decarburization, and then fine filter with a 0.22 μm microporous membrane to obtain gram...

Embodiment 3

[0060] prescription:

[0061] Clindamycin Hydrochloride 900g

[0062] Poloxamer 188 150g

[0063] Hydroxypropyl-β-cyclodextrin 150g

[0064] Sodium sulfate 450g

[0065] Ethyl cyanoacrylate 1800g

[0066] Lactose 1000g

[0067] 1. Preparation process

[0068] (1) Weigh 900g of clindamycin hydrochloride, 150g of Poloxamer188 and 150g of hydroxypropyl-β-cyclodextrin, add 6000ml of water for injection to dissolve, adjust the pH value to 2.5 with 1mol / L hydrochloric acid solution, and stir evenly;

[0069] (2) Slowly add 1800g of ethyl cyanoacrylate under electromagnetic stirring, continue to stir at room temperature for 3 hours, add 450g of sodium sulfate, continue to stir for 3 hours, adjust the pH value to 4.7 with 1mol / L sodium hydroxide solution, and stir evenly ;

[0070] (3) Add 1000 g of lactose, stir to dissolve, then add 0.5 g of charcoal for needles per 100 ml of solution, add charcoal for needles, stir at room temperature for 30 minutes, decarburize by filtratio...

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Abstract

The invention discloses a clindamycin hydrochloride nano-particle preparation; the preparation is prepared by the raw materials with the following parts by weight: 75-900 parts of clindamycin hydrochloride, 10-300 parts of stabilizing agent, 25-450 parts of sodium sulfate, 150-1,800 parts of polyalkylcyano-acrylate and 10-1,000 parts of excipient. The invention further discloses a preparation method thereof. The preparation is prepared by nano-particles and has fine stability and high safety.

Description

technical field [0001] The invention relates to a clindamycin hydrochloride nanoparticle preparation for injection and a preparation method, belonging to the technical field of medicine. Background technique [0002] Clindamycin Hydrochloride is a lincomycin antibiotic. As a derivative of lincomycin, its antibacterial spectrum is the same as that of lincomycin, and its antibacterial activity is 4 to 8 times stronger than that of lincomycin. It has high antibacterial activity against Gram-positive bacteria such as Staphylococcus (including penicillin-resistant strains), Streptococcus, Bacillus diphtheriae, and Bacillus anthracis. It also has good antibacterial activity against Gram-negative anaerobic bacteria. Most Bacteroides, including Bacteroides fragilis, Fusobacterium, Peptococcus, Peptostreptococcus, and Clostridium perfringens, are highly sensitive to this product. Gram-negative aerobic bacteria including Haemophilus influenzae, Neisseria and Mycoplasma are resistant...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/7056A61K47/16A61K47/40A61P31/04
Inventor 王明
Owner HAINAN YONGTIAN PHARMA INST
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