Clindamycin phosphate lipidosome freeze-dried preparation and preparation method thereof

A technology of clindamycin phosphate and phospholipid, which is applied in the field of liposome pharmaceutical preparations, can solve problems such as difficult to meet the quality requirements of the validity period and poor stability, and achieve the improvement of drug therapeutic index, stability, and reduction of The effect of drug side effects

Inactive Publication Date: 2009-09-16
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] In view of the poor stability of the current clindamycin phosphate solution, it is difficult for the current marketed preparations to meet the quality requirements of the expiration date

Method used

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  • Clindamycin phosphate lipidosome freeze-dried preparation and preparation method thereof
  • Clindamycin phosphate lipidosome freeze-dried preparation and preparation method thereof
  • Clindamycin phosphate lipidosome freeze-dried preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Preparation of clindamycin phosphate liposome freeze-dried preparation

[0037] Prescription (100 bottles): Clindamycin Phosphate 30g

[0038] Dimyristic acid lecithin 80g

[0039] Cholesterol 20g

[0040] Vitamin E 10g

[0041] Mannitol 40g

[0042] Preparation Process

[0043] (1) Weigh 75g of myristic acid lecithin, 20g of cholesterol and 10g of vitamin E, dissolve them in 800ml of tert-butanol, heat and melt, add a phosphate buffer solution with a pH value of 6.8, heat and evaporate to remove tert-butanol, transfer to tissue and pound In a grinder, stir at high speed for 20 minutes, filter, sterilize, and sonicate for 10 minutes; (2) In a sterile room, under 100-grade conditions, add 30 g of sterilized clindamycin phosphate and 40 g of mannitol and dissolve, filter , filled in vials, freeze-dried to obtain clindamycin phosphate liposome freeze-dried agent.

Embodiment 2

[0044] Example 2 Preparation of clindamycin phosphate liposome lyophilized formulation

[0045] Prescription (100 bottles): Clindamycin Phosphate 60g

[0046] Dimyristic acid lecithin 30g

[0047] Cholesterol 6g

[0048] Propyl gallate 15g

[0049] Glycine 20g

[0050] Sorbitol 20g

[0051] Glucose 20g

[0052] Preparation Process

[0053] (1) Weigh 30g of lecithin myristicate, 6g of cholesterol and 15g of propyl gallate, dissolve in 500ml of a mixture of tert-butanol and isopropanol with a volume ratio of 1:1, heat and melt, add pH 6.8 phosphate Buffer solution, heated to remove tert-butanol and isopropanol, transferred to a tissue masher, stirred at high speed for 10 minutes, filtered, sterilized, and ultrasonicated for 20 minutes;

[0054] (2) In a sterile room, under the condition of grade 100, add 60 g of sterilized clindamycin phosphate and 20 g of ternary freeze-dried support agent glycine, 20 g of sorbitol, and 20 g of glucose...

Embodiment 3

[0055] Example 3 Preparation of clindamycin phosphate liposome lyophilized formulation

[0056] Prescription (100 bottles): Clindamycin Phosphate 90g

[0057] Dimyristic acid lecithin 120g

[0058] Cholesterol 25g

[0059] tert-Butyl-p-Hydroxyanisole 12g

[0060] Glycine 40g

[0061] Sorbitol 40g

[0062] Glucose 40g

[0063] Preparation Process

[0064] (1) Weigh 120g of lecithin myristicate, 25g of cholesterol and 12g of tert-butyl-p-hydroxyanisole and dissolve in 1000ml of a mixture of tert-butanol and isopropanol with a volume ratio of 1:1, heat and melt, and add pH 6.8 Phosphate buffer solution, heated to remove acetone, transferred to a tissue masher, stirred at high speed for 10 minutes, filtered, sterilized, and ultrasonicated for 10 minutes;

[0065] (2) In a sterile room, under 100-grade conditions, add 90 g of sterilized clindamycin phosphate, 40 g of ternary freeze-dried support agent glyc...

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Abstract

The invention relates to a clindamycin phosphate lipidosome freeze-dried preparation and a preparation method thereof. The clindamycin phosphate lipidosome freeze-dried preparation is characterized by comprising the following components in portion by weight: 15 to 25 portions of clindamycin phosphate, 10 to 40 portions of dimyristyl acid lecithin, 1 to 10 portions of cholesterol, 1 to 5 portions of antioxidant, and 5 to 25 portions of cryoprotectant.

Description

technical field [0001] The invention relates to a liposome pharmaceutical preparation, in particular to a freeze-dried preparation of clindamycin phosphate liposome and a preparation method thereof. Background technique [0002] Clindamycin Phosphate, whose chemical name is (2S-trans)-6-(1-methyl-4-propyl-2-pyrrolidinecarbonamido)-1-thio-methyl-7- Chloro-6,7,8-trideoxy-L-threo-α-D-galactopyranoside-2-dihydrogen phosphate, the molecular formula is C 18 h 34 ClN 2 o 8 PS, the structural formula is: [0003] [0004] Clindamycin phosphate is a derivative of clindamycin, and it is mostly used clinically to treat infections caused by Gram-positive cocci and anaerobic bacteria. It is also effective for bacteria resistant to penicillin, tetracycline, and erythromycin. The outstanding effect of anaerobic bacteria is the characteristic of this product, and it is also the first choice for the treatment of Staphylococcus aureus osteomyelitis. Soft tissue, bone tissue, biliary ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K31/7056A61K47/28A61P31/04
Inventor 王明
Owner HAINAN LINGKANG PHARMA CO LTD
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