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Recombinant human interferon alpha2b vagina expansive suppository, and preparation method and detection method thereof

A technology of recombinant human interferon and vaginal expansion suppository, which is applied in the direction of suppository delivery, drug combination, pharmaceutical formulation, etc., can solve the problems of easily polluted clothes, structural damage, loss of activity, etc., to avoid secondary infection, increase stability, The effect of improving usability

Active Publication Date: 2015-11-04
哈尔滨田美药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The dosage form development of recombinant human interferon α2b has been very unsatisfactory, which has affected the application of recombinant human interferon α2b. The current marketed preparations mainly include tablets and suppositories; after the tablet is inserted into the vagina, recombinant human interferon α2b is difficult to dissolve and play a role. effect, and the adaptability of the tablet to the human vagina is not good; while the general suppository has the disadvantages of slow disintegration, difficulty in absorption, inconvenient use, slow onset of action, and contamination of clothes. The therapeutic effect is affected by the position of the patient when using it. The affected area on the ventral side of the posterior fornix is ​​difficult to access the drug
In addition, due to the unstable nature of recombinant human interferon α2b itself, after being made into suppositories, the stability is poor, the structure is easily destroyed and inactivated, and the bioavailability is low. Therefore, human serum albumin is often used as a protective agent. However, the source of human serum albumin Difficult, expensive, and risk of infection with blood viruses; and ordinary recombinant human interferon α2b suppositories are not easy to clean and easily contaminate clothes; the active ingredient has a small contact surface with the human body, resulting in insufficient absorption and not giving full play to the best performance of the suppository. efficacy and other technical issues

Method used

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  • Recombinant human interferon alpha2b vagina expansive suppository, and preparation method and detection method thereof
  • Recombinant human interferon alpha2b vagina expansive suppository, and preparation method and detection method thereof
  • Recombinant human interferon alpha2b vagina expansive suppository, and preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0090]

[0091] Preparation:

[0092] 1) Put the poloxamer and hypromellose in a water bath to heat and melt at 60°C to obtain a melt, and lower it to 38°C for use;

[0093] 2) Slowly add recombinant human interferon α2b into the molten material obtained in step 1), and at the same time, slowly stir evenly to avoid the generation of bubbles as much as possible, and obtain a drug-containing matrix;

[0094] 3) Pour the drug-containing matrix into the suppository mold, insert the expansion carrier, cool and shape, and make 100 conical suppositories, each weighing about 1.67g.

Embodiment 2

[0096]

[0097] Preparation method: make 150 rod-shaped suppositories according to the method in Example 1, each weighing about 3.8g.

Embodiment 3

[0099]

[0100] Preparation:

[0101] 1) Put the poloxamer and sodium carboxymethylcellulose in a water bath to heat and melt at 70°C, and mix them uniformly to obtain a melt;

[0102] 2) Add kaempferol-3-O-β-D sophorin and sodium lauryl sulfate to the melt prepared in step a, mix evenly, and drop the resulting mixture to 45°C for use;

[0103] 3) Slowly add recombinant human interferon α2b to the mixture obtained in step b, and at the same time, slowly stir evenly to avoid the generation of air bubbles as much as possible to prepare a drug-containing matrix;

[0104] 4) Pour the drug-containing matrix into the suppository mold, insert the expansion carrier, cool and shape, and make 80 stick-shaped suppositories, each weighing about 2.46g.

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Abstract

The invention relates to a recombinant human interferon alpha2b vagina expansive suppository, and a preparation method and a detection method thereof. The recombinant human interferon alpha2b vagina expansive suppository comprises a medicine-containing matrix mainly composed of recombinant human interferon alpha2b and a matrix, and an expansive carrier; herba corydalis bungeanae extract is added into the medicine-containing matrix, excellent synergistic effect with recombinant human interferon alpha2b is achieved, and after adding of the herba corydalis bungeanae extract, disease-resistant effect of one hundred thousand units of recombinant human interferon alpha2b is equal to that of three hundred thousand units of recombinant human interferon alpha2b; the medicine-containing matrix also comprises a mixture of kaempferol-3-O-beta-D sophoroside and lauryl sodium sulfate, and magnetic microspheres prepared from a crosslinked substance composed of magnetic iron crosslinked esterfied cassava modified starch and chitin-methyl cellulose; and curative effect of the recombinant human interferon alpha2b vagina expansive suppository is increased. According to the recombinant human interferon alpha2b vagina expansive suppository, six advanced original technologies are adopted, medicine liquid leakage is prevented, stability is high, curative effect lasts long, and secondary infection is prevented.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, and in particular relates to a recombinant human interferon α2b vaginal expansive suppository, a preparation method and a detection method thereof. Background technique [0002] Recombinant human interferon α2b is a kind of multifunctional and highly active inducible protein produced by white blood cells and lymphocytes, which is unstable when exposed to light and humidity; it is mainly used in the treatment of cervicitis clinically, mainly relying on its broad Spectrum antiviral effect and immune regulation function on the body. The dosage form development of recombinant human interferon α2b has been very unsatisfactory, which has affected the application of recombinant human interferon α2b. The current marketed preparations mainly include tablets and suppositories; after the tablet is inserted into the vagina, recombinant human interferon α2b is difficult to dissolve and play a role. effec...

Claims

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Application Information

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IPC IPC(8): A61K38/21A61K9/02G01N33/15G01N5/04A61P15/02A61P15/00A61P35/00A61K36/66
Inventor 邱学良邱明世
Owner 哈尔滨田美药业股份有限公司
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