Pig blood deproteinized extract enteric-soluble capsule and preparation process thereof

An enteric-coated capsule and preparation technology, which is applied in capsule delivery, drug combination, cardiovascular system diseases, etc., can solve the problems that cannot be directly used in clinical application of patients, easily cause human adverse reactions, and panic caused by bovine-derived biological products. To achieve the effect of prolonging the memory latency, improving cerebral blood supply insufficiency and cranial brain, and reducing the number of memory recognition

Active Publication Date: 2013-02-13
沈阳衡天然生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the drugs for the treatment of the above diseases all use calf blood as the raw material to remove the protein extract. In recent years, due to the raging mad cow disease, the limitation of the detection method of mad cow disease, the limitation of mad cow disease virus inactivation and other factors, the World Health Organization strictly restricts its use. The general public also has a serious panic about bovine-derived biological products. At present, China also strictly restricts the import of bovine-derived products, especially food and medicine from Western countries.
Therefore, in the near future, the clinical application of such varieties will be widely restricted
[0004] Calf serum deproteinized enteric-coated capsules sold in the market is a bovine-derived product, which has potential risks of mad cow disease and prions, and can easily cause adverse reactions in humans
The product contains less excipients, which are easy to absorb moisture and affect the quality of the drug. The product has a slow onset speed and low bioavailability in the body, resulting in a decline in the overall efficacy of the product.
The animal experiments described in the patent No. ZL200510083040.8 and the patent name "calf blood deproteinized capsule and its preparation method" adopt oral administration, because the calf blood deproteinized capsule mentioned in the invention is an enteric-coated capsule shell Controlled drug release, so this oral administration has been decomposed and absorbed in the stomach, which cannot reflect the drug effect of the capsule in the intestinal tract
[0005] Although the deproteinized pig blood extract has the effect of promoting the uptake of oxygen and glucose by cells, it cannot be directly used in clinical applications of patients, and the extract is an aqueous solution with difficult storage conditions. Once the power failure will directly affect its quality
And the existing porcine blood deproteinized extract is an injection preparation, which has the disadvantages that the injection is inconvenient to use and the patient cannot self-medicate

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Comparison of methods for preparing porcine blood deproteinized extract powder:

[0029] 1. Spray drying method

[0030] According to the preparation method described in the patent No. ZL200510046289.1, the title of the invention is "Extracting Active Substances Stimulating Cell Respiration from Pig Blood" to obtain the pig blood protein-free extract solution; the pig blood protein-free extract solution is in The inlet temperature is 120°C, the outlet temperature is 65°C, and the wind speed is 2.5m / s, spray-dried, vacuum-dried at 45-55°C for 24 hours, and sieved with 80 mesh to obtain the pig blood protein-free extract powder. Take pig blood deproteinized extract powder 55, compressible starch 27, carboxymethyl starch sodium 5.5, 5% starch slurry 10, magnesium stearate and talcum powder 2.5, methyl ethyl paraben 0.09, mix according to weight fraction ratio, Granulate with a 16-mesh sieve, vacuum-dry at 45-55°C for 24 hours, granulate with a 20-mesh sieve, put into ente...

Embodiment 2

[0050] To prepare porcine blood deproteinized extract powder:

[0051] According to the preparation method described in the patent No. ZL200510046289.1, the title of the invention is "The method of extracting active substances that stimulate cell respiration from pig blood": take the healthy pigs that have passed the inspection in the non-infected area, use aseptic blood collection, and remove Fibrin, get 100L of defibrinated blood, freeze-thaw repeatedly (-20℃~40℃) 2-4 times; homogenize in a colloid mill at 2-8℃ for 2 minutes, repeat 3 times; take the homogenate in After centrifugation at 4000 rpm for 20 minutes, the precipitate was discarded; the supernatant was taken and ultrafiltered with hollow fiber ultrafiltration columns with molecular weight cut-offs of 100000D, 30000D, 10000D and 6000D respectively to obtain 72L of filtrate; Pressure concentration (to a total solid content above 40mg / ml) to obtain 12L of pig blood deproteinized extract solution; the pig blood deprote...

Embodiment 3

[0053] Prepare 1000 porcine blood protein-free extract enteric-coated capsules (pork blood protein-free extract powder accounts for 45%):

[0054] The contents of the capsule are composed of the following raw materials: pig blood deproteinized extract powder 112.5g, compressible starch 82.6g, sodium carboxymethyl starch 17.5g, 5% starch slurry 30g, magnesium stearate and talcum powder 7.5g, Ethylparaben 0.175g.

[0055] 1. Preparation of porcine blood deproteinized extract enteric-coated capsule content

[0056] Take pig blood deproteinized extract powder 112.5g, compressible starch 82.6g, sodium carboxymethyl starch 17.5g, 5% starch slurry 30g, magnesium stearate and talcum powder 7.5g, methyl ethyl paraben 0.175g, mix , granulated by a granulator, vacuum-dried at 45-55°C for 24 hours, granulated with a 20-mesh sieve, and the content of the porcine blood deproteinized extract enteric-coated capsules was obtained.

[0057] 2. Preparation of porcine blood deproteinized extra...

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Abstract

The invention discloses a pig blood deproteinized extract enteric-soluble capsule and a preparation process thereof, and belongs to the technical field of biological products. The pig blood deproteinized extract enteric-soluble capsule consists of a capsule content and a capsule shell, wherein the capsule content is prepared from the following raw materials in parts by weight: 45 to 65 parts of pig blood deproteinized extract powder, 21 to 33 parts of compressible starch, 4 to 7 parts of carboxymethyl starch sodium, 8 to 12 parts of starch slurry, 2 to 3 parts of magnesium stearate and talc powder, and 0.07 to 0.11 part of methylparaben and ethylparaben; and the capsule shell is an enteric-soluble capsule shell. The pig blood deproteinized extract enteric-soluble capsule has stable property, is convenient to use clinically, and can be used as a first-choice orally administered medicament for treating and adjunctively treating cerebrovascular diseases, and improving neurologic impairment and peripheral blood disorder symptoms caused by cerebral circulation insufficiency and craniocerebra trauma.

Description

technical field [0001] The invention relates to a porcine blood deproteinized extract preparation, in particular to a porcine blood deproteinized extract enteric-coated capsule preparation and a preparation method of the preparation. It is suitable for the treatment of cerebrovascular diseases, improving cerebral blood supply deficiency and neurological deficit caused by craniocerebral trauma, peripheral blood flow disorder and the symptoms caused by it. It is a new dosage form of pig blood deproteinized extract, which belongs to biological products. technology field. Background technique [0002] All countries in the world recognize that cerebrovascular disease is one of the most serious diseases threatening human health. The incidence of cerebrovascular diseases announced by some countries is about 150-200 / 100,000 population / year. The disability rate among survivors of cerebrovascular disease is as high as 60-80%. In addition, there are many patients with cerebrovascula...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K35/14A61K47/36A61P9/10A61P25/00A61P9/00
Inventor 王光李莉万琳琳申福新刘路
Owner 沈阳衡天然生物科技有限公司
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