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Formula and preparation method of preparation delivered through mucous membrane

A mucosal and formulation technology, applied in the field of biomedicine, can solve the problems of economic unfeasibility of active ingredients of drugs

Inactive Publication Date: 2014-02-12
WUHAN INNERSE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This effect can be addressed to some extent by high-dose administration, however, this approach is not economically feasible for many active pharmaceutical ingredients and may lead to many side effects

Method used

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  • Formula and preparation method of preparation delivered through mucous membrane

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The preparation of embodiment 1 protein hydrolyzate

[0032] A: Dissolve 10 grams of lactoferrin in 90 grams of purified water, then adjust the pH of the solution to 2 with 1M hydrochloric acid, heat the resulting solution to 120 ° C, acid hydrolyze, hydrolyze for 1 hour, then cool, and then use 1M hydrochloric acid Adjust the pH to 8.5 with sodium hydroxide, and filter to obtain about 100 grams of a solution of 10% lactoferrin hydrolyzate (10 grams of hydrolyzate in net weight).

[0033] B: 10 g of lactoferrin was dissolved in 90 g of purified water, the resulting solution was adjusted to pH 2 with 1M hydrochloric acid, and then heated to 100° C. for 6 hours for hydrolysis. The hydrolyzate was cooled, and then adjusted to pH 8.5 with 1M sodium hydroxide, and filtered to obtain about 100 g of 10% lactoferrin hydrolyzate (10 g of hydrolyzate in net weight).

[0034] C: Dissolve 10 grams of lactoferrin in 90 grams of purified water, adjust the pH of the resulting aqueous...

Embodiment 2

[0037] Embodiment 2: Exenatide formulation preparation

[0038] 0.5 kg of this formula is prepared according to the following table 1:

[0039] Table 1:

[0040] Element

g / batch

％

MCT (Zhejiang Jiande Qiandao Fine Chemical Industry Co., Ltd.) (Oil)

65

13.00

corn oil (oil)

39.9

7.97

Propylene glycol (oil phase)

53.2

10.64

Potassium sorbate (water phase)

0.7

0.14

Sodium benzoate (water phase)

0.7

0.14

Methylparaben (oil)

0.7

0.14

Propylparaben (oil)

0.7

0.14

Lecithin (94%, oil phase)

48

9.60

Tween 80 (water phase)

66.6

13.32

Benzyl alcohol

3.3

0.66

Exenatide (Shenzhen Haodi Huatuo Biochemical Technology Co., Ltd.)

0.025

0.01

Lactoferrin hydrolyzate solution (see Example 1 D)

221.2

44.24

total

500.0

100.0

[...

Embodiment 3

[0045] Embodiment 3 mixing component prescription preparation

[0046] 0.5 kg of this formula is prepared according to the following table 2:

[0047] Table 2:

[0048]

[0049] Oil Phase: Add ingredients in the following order: Corn Oil, MCTs, Propylene Glycol, Methyl & Propyl Parabens, and Benzyl Alcohol. The mixture was heated to 55-60°C and all ingredients were dissolved with stirring at 250 RPM. Then add lecithin at 55-60°C, mix and dissolve under stirring at 250RPM.

[0050] Water phase: Lactoferrin hydrolyzed solution, potassium sorbate, sodium benzoate and polysorbate 80 (Tween 80) mixed. The pH was maintained at 8.3. Then heat slowly and stir with a stir bar until all the Tween 80 is dissolved. The temperature was maintained at 25-30°C, and the pH was adjusted to 8.3 to 8.5 with 1M sodium hydroxide. Finally add hexarelin and GHRP-6.

[0051] Emulsification: below 40°C, add the oil phase to the water phase, mix and emulsify. Cool the emulsion and add more wa...

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Abstract

The invention relates to a formula and a preparation method of a preparation delivered through a mucous membrane. The formula of the preparation delivered through the mucous membrane is characterized in that substances are mainly delivered through surfaces of oral cavity, vagina and nasal mucous membranes and one or more proteins or hydrolysis products with mucous membrane gluing or mucous membrane penetrability and one or more substances to be delivered are contained in the formula of the preparation. Compared with the prior art, the formula of the preparation delivered through the mucous membrane has the advantages that no toxicity and stimulation are produced in a using process, the preparation delivered through the mucous membrane is easy to use, and medical cost and side effect are obviously reduced, so that the preparation delivered through the mucous membrane is especially applicable to being medically and widely used.

Description

technical field [0001] The invention relates to a formula for mucosal administration and a preparation method thereof, belonging to the field of biomedicine. Background technique [0002] Many substances can be used to improve the health of humans or animals, including therapeutic drugs and nutritional supplements. Usually, the routes of administration of these substances include intramuscular injection, subcutaneous injection and oral administration. [0003] Intramuscular injection or subcutaneous injection has many obvious disadvantages, such as the process of drug administration requires relatively professional skills to complete, it is not suitable for large-scale drug delivery, the process of drug delivery itself is relatively expensive, and some adverse reactions may occur, etc. . Unfortunately, however, many bioactive agents also have to be administered by the injectable route because their efficacy is almost or completely lost after traditional oral administration...

Claims

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Application Information

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IPC IPC(8): A61K47/42
Inventor 李健雄张进军
Owner WUHAN INNERSE PHARMA
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