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Vaginal-applied interferon table and its preparing process

An interferon, vaginal technology, applied in the directions of drug combination, pharmaceutical formula, medical preparation containing active ingredients, etc., can solve the problems of complex process, high production equipment requirements, long production cycle, etc.

Inactive Publication Date: 2002-11-27
武汉迪生生物制剂工程有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, its process is complex, the production cycle is long, the requirements for production equipment are high, and the batch production is small.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] 1. Prescription

[0028] Interferon 1.5×10 8 IU

[0029] Mannitol 640g

[0030] Hypromellose 320g

[0031] Sodium carboxymethyl starch 10.4g

[0032] Boric acid 60g

[0033] Liquid paraffin 3g

[0034] Magnesium Stearate 15g

[0035] 4% hypromellose aqueous solution 300g

[0036] Makes 1000 capsules

[0037] 2. Preparation

[0038] ①Preparation of swellable particles

[0039] Weigh hypromellose and mannitol according to the prescribed amount and put them in the material pot of the rapid stirring granulator, close the lid, start the machine and mix for 2-3 minutes, turn off the machine, add 4% hypromellose aqueous solution, start the mixer and cut Reamer for 8-10 minutes, stop after the particles are formed.

[0040] Pack the granules, ventilate and dry them at 60°C for 1-2 hours, then raise the temperature to 75°C for drying, and control the weight loss of the dry granules between 1-2%.

[0041] ②Dry mix

[0042] Take an appropriate amount of swellable dry ...

Embodiment 2

[0046] 1. Prescription

[0047] Interferon 1.5×10 8 IU

[0048] Mannitol 700g

[0049] Hypromellose 100g

[0050] Sodium bicarbonate 35g

[0051] Tartaric acid 28g

[0052] Boric acid 7g

[0053] Magnesium Stearate 18g

[0054] 4% hypromellose aqueous solution 300g

[0055] 15% povidone absolute ethanol solution 9g

[0056] Sodium carboxymethyl starch 100g

[0057] Makes 1000 pieces

[0058] 2. Preparation

[0059] ① Preparation of soluble (swellable) particles:

[0060]Take 700g of mannitol and 100g of hypromellose and mix evenly, add 300g (±20%) of 4% hypromellose solution, stir evenly, pass through a 16-mesh sieve to make granules, and dry at 70°C.

[0061] ②Preparation of alkaline-coated granules: take 35g of sodium bicarbonate, add 6g of 15% povidone ethanol solution, stir evenly, pass through a 18-mesh sieve, and dry at 70°C. After drying, the granules are crushed and passed through an 80-mesh sieve.

[0062] ③ Preparation of acid-coated granules: Take 28 g ...

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PUM

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Abstract

A vaginal-applied interferon tablet for treating cervicitis, cervical erosion and viral vaginitis and its preparing process and disclosed. Its advantages are high curative effect and stability, simple preparing process and high solubility.

Description

technical field [0001] The invention relates to an interferon vaginal administration tablet and a preparation process. technical background [0002] Interferon is a broad-spectrum anti-viral and anti-tumor biological product, which has good therapeutic effects on a variety of viral diseases, such as viral hepatitis and herpes zoster. In addition, studies have shown that the incidence of cervicitis in women is closely related to HSV and HPV-16 infection. There are four types of interferon preparations currently on the market: injections, suppositories, eye drops and gels. But so far there is no interferon tablet available for vaginal administration, which is applied to the treatment of women's chronic cervicitis, cervical erosion, viral vaginitis and other gynecological diseases. [0003] Interferon is an active protein, which is very sensitive to light, heat, pH, chemical substances, etc., which can easily cause inactivation or affect the activi...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K38/21A61P15/00A61P15/02
Inventor 王春生吴晶林元通程汉强
Owner 武汉迪生生物制剂工程有限公司
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