Creatine phosphate sodium lipidosome freeze-dried preparation and preparation method thereof

A technology of creatine phosphate sodium and liposome freeze-drying, which can be used in liposome delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., and can solve the problem of liposome particle size increase and poor hydration resolubility , liposome leakage and other problems, to achieve the effect of improving stability, product quality and reducing 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

[0013] In view of the poor stability of the current creatine phosphate sodium solution, the object of the present invention is to provide a lyophilized preparation of creatine phosphate sodium liposomes, which can be prepared into liposomes and freeze-dried to solve the above problems. The use of specific liposome encapsulation materials and lyophilized support agents further overcomes the common problems of liposome lyophilization, such as liposome leakage, poor hydration reconstitution, and liposome particle size change. Large and other shortcomings

Method used

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  • Creatine phosphate sodium lipidosome freeze-dried preparation and preparation method thereof
  • Creatine phosphate sodium lipidosome freeze-dried preparation and preparation method thereof
  • Creatine phosphate sodium lipidosome freeze-dried preparation and preparation method thereof

Examples

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Embodiment 1

[0031] Embodiment 1 Preparation of creatine phosphate sodium liposome freeze-dried preparation

[0032] Prescription (100 bottles): Sodium Creatine Phosphate 50g

[0033] Soy Lecithin 75g

[0034] Cholesterol 20g

[0035] Vitamin E 10g

[0036] Mannitol 40g

[0037] Preparation Process

[0038](1) Weigh 75g of soybean lecithin, 20g of cholesterol and 10g of vitamin E and dissolve them in 800ml of acetone, heat and melt, add a pH value of 7.8 phosphate buffer solution, heat to evaporate the acetone, transfer to a tissue masher, and stir at a high speed for 10 minutes, filter, sterilize, and sonicate for 10 minutes;

[0039] (2) In a sterile room, under 100-grade conditions, add 50 g of sterilized creatine phosphate sodium and 40 g of mannitol and dissolve, filter, fill in a vial, and freeze-dry to obtain creatine phosphate sodium liposome jelly Dry powder injection.

Embodiment 2

[0040] Embodiment 2 Preparation of creatine phosphate sodium liposome freeze-dried preparation

[0041] Prescription (100 bottles): Sodium Creatine Phosphate 100g

[0042] Egg Yolk Lecithin 150g

[0043] Cholesterol 25g

[0044] Sodium bisulfite 37.5g

[0045] Glycine 100g

[0046] Mannitol 100g

[0047] Preparation Process

[0048] (1) Weigh 150g of egg yolk lecithin and 25g of cholesterol, dissolve it in 1000ml of a mixture of tert-butanol and isopropanol with a volume ratio of 1:1, heat and melt, add a phosphate buffer solution with a pH value of 7.8, heat and distill off tert-butanol and isopropanol Alcohol, transferred to a tissue masher, stirred at high speed for 30 minutes, filtered, sterilized, and ultrasonicated for 20 minutes;

[0049] (2) Add 100 g of sterilized creatine phosphate sodium, 37.5 g of sodium bisulfite, 100 g of lyophilized support agent glycine and 100 g of mannitol in a sterile roo...

Embodiment 3

[0050] Example 3 Preparation of Creatine Phosphate Sodium Liposome Lyophilized Preparation

[0051] Prescription (100 bottles): Sodium Creatine Phosphate 50g

[0052] Hydrogenated egg yolk lecithin 25g

[0053] Ascorbyl Palmitate 37.5g

[0054] Glycine 31g

[0055] Mannitol 31g

[0056] Preparation Process

[0057] (1) Weigh 25g of hydrogenated egg yolk lecithin and 37.5g of ascorbyl palmitate, dissolve them in 500ml of a mixture of tert-butanol and isopropanol with a volume ratio of 1:1, heat and melt, add a pH value of 7.8 phosphate buffer solution, heat and evaporate tert-butanol and isopropanol, transferred to a tissue masher, stirred at high speed for 20 minutes, filtered, sterilized, and ultrasonicated for 10 minutes;

[0058] (2) In a sterile room, under the condition of grade 100, add 50 g of sterilized creatine phosphate sodium and 31 g of freeze-dried support agents glycine and 31 g of mannitol and dissolve the...

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Abstract

The invention relates to a creatine phosphate sodium lipidosome freeze-dried preparation and a preparation method thereof. The creatine phosphate sodium lipidosome freeze-dried preparation is characterized by comprising the following components in portion by weight: 10 to 20 portions of creatine phosphate sodium, 10 to 40 portions of phospholipids, 0 to 10 portions of cholesterol, 1 to 10 portions of antioxidant, and 5 to 20 portions of cryoprotectant.

Description

technical field [0001] The invention relates to a liposome preparation, in particular to a lyophilized creatine phosphate liposome preparation and a preparation method thereof. Background technique [0002] Creatine phosphate (CP) is an important biologically active substance in the human body. It mainly exists in myocardium, skeletal muscle, brain and other organs or tissues. Replenish energy, and ATP is the most important energy source in any cellular metabolic process. [0003] At present, the sodium salt compound of creatine phosphate, i.e., creatine phosphate sodium (phosphate creatinesodium, PCS), as an effective cardioprotective drug, has been widely used clinically. Sodium creatine phosphate is suitable for the treatment of myocardial ischemia, cardiac surgery Protect the myocardium and other diseases with abnormal myocardial energy metabolism, the molecular formula is: C 4 h 8 N 3 Na 2 o 5 P, molecular weight: 255.08, molecular structure formula is as follows:...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K31/664A61K47/28A61K47/36A61P9/10
Inventor 王明
Owner HAINAN LINGKANG PHARMA CO LTD
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