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Pharmaceutical composition containing human parathyroid hormone administered through oral mucosa

A parathyroid hormone and oral mucosa technology, applied in the field of biomedicine, can solve the problems of undisclosed rhPTH, oral mucosa drug delivery system, slow progress, technical difficulties, etc., to achieve improved compliance, good clinical application prospects, no drug administration pain effect

Active Publication Date: 2020-03-27
CHENGDU JINKAI BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the oral mucosal drug delivery system has been extensively studied, the progress of the oral mucosal drug delivery system for protein and polypeptide drugs is slow, and there is no protein or polypeptide drug that is absorbed through the oral mucosa on the market.
[0007] The prior art does not disclose the administration information of rhPTH(1-34) oral mucosa. It can be known that rhPTH(1-34), as a biological macromolecular polypeptide drug, is affected by the structure of oral mucosa and the physiological environment of the oral cavity during the administration of oral mucosa Larger, difficult to be directly absorbed into the blood circulation through the oral mucosa, and there are great technical difficulties in administering the drug through the oral mucosa

Method used

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  • Pharmaceutical composition containing human parathyroid hormone administered through oral mucosa
  • Pharmaceutical composition containing human parathyroid hormone administered through oral mucosa
  • Pharmaceutical composition containing human parathyroid hormone administered through oral mucosa

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Pharmaceutical composition containing rhPTH(1-34)

[0045] Table 1. The ratio of each component of the pharmaceutical composition A-X

[0046]

[0047]

[0048]

[0049] Thaw the recombinantly prepared rhPTH(1-34) protein stock solution (purity 98%, concentration 2mg / ml) and rhPH20 protein stock solution (purity 98%, concentration 2mg / ml) respectively at room temperature or 2-8°C, and after thawing, Store at 2-8°C.

[0050] Accurately weigh the mucosal adsorbents according to the proportions of the ingredients of the pharmaceutical composition A-X in Table 1, dissolve them in water for injection and prepare a mixed solution, add the thawed rhPH20 protein stock solution, mix well, and finally add rhPTH (1-34) Stir and mix the protein stock solution, filter and sterilize with a filter membrane with a pore size of 0.22 μm under aseptic conditions to obtain pharmaceutical compositions A-X respectively.

[0051] According to the requirements of preparation product...

Embodiment 2

[0066] Example 2 Osmotic absorption detection

[0067] According to the literature report (Portero A.Pharm Res, 2002,19(2):169-174), TR146 esophageal squamous carcinoma cells (derived from ATCC) were used as oral mucosal epithelial cell permeation and transport model to detect Example 1 and comparative The osmotic absorbability of the pharmaceutical composition obtained in Examples 1-4.

[0068]Aspirate the DMEM culture solution in the upper and lower chambers of the insert culture dish, and wash the TR146 cells with HBSS buffer. Then add HBSS solution into the upper and lower chambers respectively, and after equilibrating for 1 hour, suck out the HBSS solution in the upper chamber, and add 2 mL of the test sample (pharmaceutical composition A-X, pharmaceutical composition C1-C4). Take a sample of 100 μL from the lower chamber at the set time, and immediately add an equal amount of HBSS solution. Using chromatographic method, sample injection analysis, record the obtained pe...

Embodiment 3

[0078] Example 3. Effects of different enzymatic activities on the penetration and absorption of rhPTH(1-34) through TR146 oral mucosal epithelial cells by the absorption penetration enhancer rhPH20

[0079] According to the composition ratio of D1-D10 in the following table 6.1, the enzyme activity of the absorption penetration enhancer rhPH20 is 300, 600, 1000, 2000, 5000, 8000, 12000, 20000 U / ml respectively, and the same method as in Example 1 is adopted Compositions containing rhPH20 with different enzymatic activities were prepared, and the effect of rhPH20 with different enzymatic activities on the osmotic absorption of rhPTH(1-34) through TR146 oral mucosal epithelial cells was detected using the same method as in Example 2.

[0080] The experimental results are shown in Table 6.2 and figure 1 As shown, the pharmaceutical composition D1-D10, when the rhPH20 enzyme activity is 1000~20000U / ml, can effectively promote the penetration and absorption of rhPTH (1-34) through...

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Abstract

The invention relates to a human parathyroid hormone containing medicine composition delivered via an oral mucosa. The medicine composition comprises high-concentration human parathyroid hormone, an absorption penetrating promoter, a mucosa absorbent, a thickening agent, a buffer solution, an antioxidant and a stabilizing agent. The medicine composition has excellent stability, permeation absorbency and biological activity and is high in bioavailability and safe and nontoxic in formula.The invention further provides a preparation method of the medicine composition, and application of the medicine composition in preparing a medicine for treating and / or preventing osteoporosis. The medicine composition is convenient to use, has no toxicity or stimulation in a using process, takes effect quickly, and can significantly improve clinical medication compliance of a patient.

Description

technical field [0001] The present invention relates to the field of biomedicine, more specifically, the present invention relates to a pharmaceutical composition containing human parathyroid hormone administered through oral mucosa and a preparation method thereof, and the use of the pharmaceutical composition in the treatment and / or prevention of osteoarthritis Uses for Porosis. Background technique [0002] Osteoporosis is a common systemic disease characterized by low bone mass, increased bone fragility, and susceptibility to fractures due to low bone mass healthy. At present, more than 200 million people in the world suffer from osteoporosis, and its incidence has jumped to the sixth place among the common and frequently-occurring diseases. The number of osteoporosis patients in my country ranks first in the world, with about 90 million people. The incidence rate is about 15.7% in people over 50 years old and about 56% in people over 60 years old. The incidence rate o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/29A61K9/00A61K47/42A61P19/10
CPCA61K9/006A61K38/29A61K47/42
Inventor 彭飞魏薇徐小萍李晓鹏何太平张宝华
Owner CHENGDU JINKAI BIOTECH CO LTD
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