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Protein freeze-dried powder and solution thereof

A technology of freeze-dried powder and protein, applied in freeze-dried delivery, peptide/protein composition, powder delivery, etc., can solve the problems of unstable substance changes, drug failure, side effects, etc., to ensure stability, improve storage environment, and improve biological The effect of utilization

Pending Publication Date: 2021-09-17
SHANXI JINBO BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the process of atomization inhalation, a compression pump is required for compression. High-intensity compression will cause changes in unstable substances in the liquid medicine, especially macromolecular drugs such as proteins, which cannot withstand temperature and pressure changes and cause denaturation. , resulting in drug failure and even side effects

Method used

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  • Protein freeze-dried powder and solution thereof
  • Protein freeze-dried powder and solution thereof
  • Protein freeze-dried powder and solution thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1: the prescription research of protein freeze-dried powder

[0041] 1. Prescription screening

[0042] Taking EK1 protein as an example, its alkalinity (1mg / mL) is about 8.5, and considering that the theoretical isoelectric point of the protein is about 4.02, the conventional pH range of the combined preparation is 4-9, and the design pH range is 3-10 , the adjusted value is 3.0-10.0 respectively; buffer salt is added in the prescription to increase the pH stability of the preparation, buffer salt selection: sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium bicarbonate, sodium citrate; salt concentration selection: 20mmol / L; the pH regulator is 0.5mol / L hydrochloric acid solution or 0.5mol / L sodium hydroxide solution; appropriate amount of mannitol is added as excipient in the prescription, and the prescription is designed.

[0043] Weigh the prescribed amount of mannitol, sodium dihydrogen phosphate and EK1 protein, add an appropriate amoun...

Embodiment 2

[0089] Embodiment 2: Research on the preparation process of protein freeze-dried powder

[0090] 1. Freeze-drying process

[0091] The eutectic point of the EK1 protein prescription solution is -15°C to -25°C.

[0092] At room temperature and normal pressure, place the EK1 protein prescription solution in a lyophilizer, cool down to -50°C, pre-freeze for 1 hour, and keep for 5-6h; at 0.2-0.4mbar, heat up to -20°C, and keep for 18-24h ; Under the condition of 0-0.2mbar, raise the temperature to 0°C; raise the temperature to 25°C, keep it for 5h, then the freeze-drying can be completed, and the protein freeze-dried powder can be obtained.

[0093] 2. Selection of filter material

[0094] Under normal temperature conditions, to simulate the maximum filtration capacity in the actual filtration production of drugs, according to the adsorption capacity of the hydrophilic polyethersulfone (PES) membrane and hydrophilic polyvinylidene fluoride (PVDF) membrane to the product EK1 prot...

Embodiment 3

[0097] Embodiment 3: investigation of atomization stability

[0098] Atomization device 1: Compression atomizer liquid device (Omron NE-C25S type)

[0099] Test one:

[0100] Test design:

[0101] Compression nebulizer liquid device manufacturer: Omron, model: NE-C25S; liquid medicine filling volume of the liquid medicine cup: 2 ~ 6mL.

[0102] Take 2 bottles of 3 batches of protein freeze-dried powder (prescription 4) (batch numbers: 200501, 200502, 200601), add 3mL of 0.9% sodium chloride injection to dissolve each bottle, shake well, and transfer the solution of 2 bottles to the compression type Mix well in the medicine solution cup of the nebulizer, and the medicine solution cup assembly is sealed and connected to the dropper; add 5mL of water to the 15mL vial as the receiving solution, place the mouth of the dropper under the liquid surface, turn on the nebulizer for atomization sampling, and take 20 minutes Sampling once, sampling twice (the overall atomization time i...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and relates to protein freeze-dried powder and a solution thereof. Specifically, the protein freeze-dried powder is prepared from a prescription solution through a freeze-drying process, and each 1 mL of the prescription solution contains 15 mg of protein, 20-50 mg of an excipient, 1.36-5.50 mg of buffer salt, a pH regulator with the dosage corresponding to the dosage for regulating the pH value of the prescription solution to a set value, and the balance of water for injection. A solution type preparation, such as an aerosol inhalation preparation, can be obtained based on the protein freeze-dried powder, and the preparation can protect the stability of the protein under the action of a compression type atomizer liquid device, so that the protein is prevented from being denatured in the compression process and accurately reaches the lung.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a protein freeze-dried powder and a solution thereof. More specifically, the preparation can protect the stability of the protein under the action of the compressed nebulizer, ensuring that the protein does not undergo denaturation during the compression process and can accurately reach the lungs. Background technique [0002] The protein in the present invention (abbreviated as EK1 protein) is recorded in the patent application with the application number 202010080751.4 and the title of the invention "polypeptide, its preparation method and application". Proteins of novel coronavirus (2019-nCoV). The protein has strong hygroscopicity and weak stability. It is necessary to choose a reasonable formulation method to make it exert its maximum effect. [0003] As we all know, the currently routinely used method to suppress the new coronavirus (2019-nCoV) is to inj...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/16A61K47/10A61K47/26A61P11/00A61P31/14
CPCA61K9/19A61K47/10A61K47/26A61K9/007A61P31/14A61P11/00A61K38/16
Inventor 陆晨阳袁立
Owner SHANXI JINBO BIO PHARMA CO LTD
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