CN108042569A - A kind of method of impurity in separation gel class Chinese medicine - Google Patents
A kind of method of impurity in separation gel class Chinese medicine Download PDFInfo
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- CN108042569A CN108042569A CN201711477393.5A CN201711477393A CN108042569A CN 108042569 A CN108042569 A CN 108042569A CN 201711477393 A CN201711477393 A CN 201711477393A CN 108042569 A CN108042569 A CN 108042569A
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/32—Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
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- A—HUMAN NECESSITIES
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- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/36—Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/58—Reptiles
- A61K35/586—Turtles; Tortoises, e.g. terrapins
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Abstract
The invention discloses a kind of methods of impurity in separation gel class Chinese medicine, after the glue coarse filtration that glue class Chinese medicine obtains is decocted, relative density is concentrated into as 1.02~1.15, glue after concentration is handled into glue by the way of the removal of impurities of high temperature and pressure stratification, impurity from glue is separated, glue purifying is made to meet the requirements.The method of the present invention not only overcomes the shortcomings that traditional glue class Purification of traditional Chinese herbs process efficiency is low, the cycle is long, substantially increases dust removal rate, shortens the purification process cycle.And can realize continuous large-scale production, make glue more pure, significantly improve glue class Chinese medicine color and luster and transparency.
Description
Technical field
The present invention relates to Chinese medicine production technical field, more particularly to a kind of method of impurity in separation gel class Chinese medicine.
Background technology
Glue class Chinese medicine is the traditional Chinese medicine for having typical ethnic characteristic, wide in the prevention and treatment application of modern clinic disease
It is general, it is curative for effect.Glue class Chinese medicine be generally animal tissue's (Animal Skin, angle, first, bone etc.) containing collagen component, through decoct, it is dense
Solid gum made of contracting, common glue class Chinese medicine have donkey-hide gelatin, deer horn glue, colla carapacis et plastri testudinis, oxhide gelatin etc..
Glue class Chinese medicine production process generally comprises raw material cleaning piecemeal, decocts extraction, glue purifying, concentration, solidification plastic
Etc. processes.Wherein during extraction is decocted, the impurity such as raw material particulate, poultry hair, fat are more or less proposed, if do not removed
These impurity, not only increase the content of the impurity such as ash content, water-insoluble in donkey-hide gelatin, and also affect the mouthfeel of glue, color and luster,
Smell and transparency etc. therefore it is necessary to remove impurity by purification process, ensure glue class Quality Evaluation of Chinese Medicinal.
For traditional glue purifying process for glue is placed in caldron, constantly heating keeps slightly boiling, makes grease etc. insoluble
Property impurity gradually floats from glue under conditions of slightly boiling and is gathered in glue surface, then is excluded supernatant with instrument, such as
This Xun Huan, until detecting in glue until impurity removal qualification.As glue class Chinese medicine beats foam purification process.Foam is beaten not only to take
Long, energy consumption height, personnel labor intensity are big, and also generating a large amount of steam influences site work environments.Also there are Some Enterprises in glue
Purification process adds in the phenomenon that alum, using alum electrolytic flocculation suction-operated in aqueous solution, accelerates glue dedoping step.It is bright
Aluminium in alum is not trace element necessary to human body, and Excess free enthalpy aluminium element generates harm to human body, affects in glue class
The security of medicine.
The content of the invention
For overcome the deficiencies in the prior art, the separative efficiency of impurity in glue class Chinese medicine is improved, the present invention provides one kind
The fast and effective separated method of new glue class Chinese medicine impurity, efficiently can quickly prepare in the glue class met the requirements of the standard
Medicine.
Technical scheme is as follows：
The method of impurity, includes the following steps in a kind of separation gel class Chinese medicine：
(1) glue of coarse filtration glue class Chinese medicine removes solid impurity, obtains coarse filtration glue；
(2) the coarse filtration glue in the step (1) is concentrated, until the relative density of the coarse filtration glue is 1.02~1.15,
Obtain concentration glue；
(3) the concentration glue in the step (2) is carried out to height under 100~130 DEG C of temperature, 0.1~0.3MPa of pressure
Warm 0.5~3h of HIGH PRESSURE TREATMENT；
(4) glue after the step (3) high temperature high pressure process is stood into 1~2h, after the glue AUTOMATIC ZONING, point
From upper strata and the impurity part of lower floor, the pure glue in interlayer is obtained.
Preferably, the glue of step (1) the glue class Chinese medicine is prepared by the raw material of glue class Chinese medicine through decocting method.
It is furthermore preferred that the raw material of the glue class Chinese medicine is donkey hide, tortoise plastron or deer horn.
Preferably, the mode of the coarse filtration is husky filter or Bag filter.
It is furthermore preferred that the medium of the husky filter is one or both of stainless steel substrates and stainless steel sand.
It is furthermore preferred that the mesh size of the cloth bag is 80~150 mesh.
Preferably, concentration concentrates for film described in step (2), and the pressure of the film concentration is 780~900mbar.
It is furthermore preferred that the film concentration is polyamide high temperature NF membrane with film, the aperture of the film is less than 1000Da.
Preferably, the temperature of the high temperature high pressure process is 110~125 DEG C, and pressure is 0.2~0.25MPa.
Preferably, separated mode described in step (4) is liquid separation or centrifugation.
Compared with prior art, the present invention has the following advantages：
The present invention provides a kind of method that impurity is separated in glue class Chinese medicine, the glue coarse filtration that decoction glue class Chinese medicine is obtained
Afterwards, relative density is concentrated into as 1.02~1.15.The glue after concentrating is handled by the way of high temperature and pressure removal of impurities, accelerates collagen
Hydrolysis.Collagen is constantly hydrolyzed to peptide fragment or amino acid, and hydrophily becomes strong, fats, keratoprotein and insoluble particulates
Separation is constantly precipitated in matter, separates from glue insoluble impurities by separating, obtains pure glue.This method is not only
The shortcomings that traditional glue class Purification of traditional Chinese herbs process efficiency is low, the cycle is long is overcome, dust removal rate is substantially increased, shortens at purifying
Manage the cycle.Improve site environment using closed container during isolating and purifying, be more in line with glue class Chinese medicine production requirement, and can
It realizes continuous large-scale production, makes glue more pure, significantly improve glue class Chinese medicine color and luster and transparency.And separation process
In need not add in additional component, glue point obtained by collagen average molecular weight and traditional processing mode in glue after purification
Son amount no significant difference, will not cause final products composition transfer, safe.
Specific embodiment
In order to improve the separative efficiency of impurity in glue class Chinese medicine, the present invention provides a kind of sides of separation gel class Chinese medicine impurity
Method includes the following steps：
(1) glue of coarse filtration glue class Chinese medicine removes solid impurity, obtains coarse filtration glue；
(2) the coarse filtration glue in the step (1) is concentrated, until the relative density of the coarse filtration glue is 1.02~1.15,
Obtain concentration glue；
(3) the concentration glue in the step (2) is carried out to height under 100~130 DEG C of temperature, 0.1~0.3MPa of pressure
Warm 0.5~3h of HIGH PRESSURE TREATMENT；
(4) glue after the step (3) high temperature high pressure process is stood into 1~2h, after the glue AUTOMATIC ZONING, point
From upper strata and the impurity part of lower floor, the pure glue in interlayer is obtained.
In the present invention, the glue of the glue class Chinese medicine is preferably prepared by the raw material and water decoction of glue class Chinese medicine.
In the present invention, the raw material of the glue class Chinese medicine is donkey hide, tortoise plastron or deer horn, the glue of corresponding glue class Chinese medicine for Ah
Glue, colla carapacis et plastri testudinis and deer horn glue.The present invention is not particularly limited the source of glue class Chinese medicine, using commercially available glue class Chinese medicine.
The present invention is not particularly limited the decoction method of glue class Chinese medicine, using decoction well-known to those skilled in the art
Mode, by glue class decocting for Chinese herbal medicine into the glue of liquid.In the present invention, it is preferred to the mass ratio that glue class Chinese medicine material is mixed with water
Example is preferably 1:2~5, more preferably 1:3.In the present invention, the temperature of the glue class decocting for Chinese herbal medicine is preferably 110~135 DEG C, more
Preferably 120~125 DEG C.The time of decoction is preferably 2~10h, more preferably 4~8h.The glue dissolved after decoction.
The glue of coarse filtration glue class Chinese medicine removes solid impurity.The present invention is not particularly limited the mode of coarse filtration, using this
Coarse filtration mode known to field technology personnel.In the present invention, the glue of glue class Chinese medicine is preferably subjected to husky filter or Bag filter.
Since quartz sand has dissolution risk, in order to adapt to pharmaceutical production requirement, the present invention is preferably when sand is filtered by the stone in sandfiltration pot
Sand is changed to stainless steel filler material, is more in line with GMP requirements.The present invention is not spy to the granularity and loading of stainless steel filler material
It is different to limit, using the ordinary operation mode in this field.The stainless steel filler material can be stainless steel substrates and/or stainless
Steel sand.The mode of Bag filter can also be used in coarse filtration in the present invention, and the mesh of the cloth bag is preferably sized to 80~150 mesh,
More preferably 100~120 mesh.The impurity of coarse filtration removal is the graininess impurity such as the slag wool in glue.
Glue after coarse filtration is concentrated into relative density as 1.02~1.15.Concentration densities are excessive, gelatin viscosity increase, glue
Impurity in liquid is not readily separated；Concentration densities are too small, and glue is excessively dilute, glue volume to be separated caused to become larger, mask work amount
Increase, separative efficiency reduces, and impurity not easily collecting and separation.The above-mentioned concentration densities of the present invention can ensure glue follow-up
High temperature high pressure process during, have a higher impurity separative efficiency, reduce disengaging time.
In the present invention, preferably glue is concentrated by the way of film concentration.The film is preferably the high winner of polyamide
Filter membrane, the aperture of the film are less than 1000Da.The pressure of film concentration is preferably 780~900mbar, more preferably 800~
850mbar.Film concentration can remove extra salt in removing glue liquid, reduce solubility salt impurity, it is miscellaneous to can obviously reduce product ash content
Matter content.
The glue of concentration is carried out high temperature high pressure process by the present invention, accelerates hydrolytic process.Hydrolytic process and the temperature of glue,
Pressure and processing time are related.In the present invention, the temperature of above-mentioned high temperature high pressure process is 100~130 DEG C, is preferably 110~125
℃；The pressure of high temperature high pressure process is 0.1~0.3MPa, more preferably 0.2~0.25MPa；The time of high temperature high pressure process is
0.5~3h, more preferably 1~2h.Temperature is higher, and hydrolysis is faster, but pressure is also bigger simultaneously, and device security reduces；And temperature
It is excessively high easily glue to be caused to be gelatinized, influence glue smell.Temperature crosses that low in hydrolysis is too slow, and processing time is long.Processing time length easily causes
The impurity such as grease type are combined with collagen, emulsion occur, it more difficult to separate impurity.In the process, the collagen in glue
Albumen is constantly hydrolyzed to peptide fragment or amino acid under these conditions, and hydrophily becomes strong, fats, keratoprotein and insoluble granule
Separation is constantly precipitated in substance.
The pressure vessel of glue high temperature high pressure process is not particularly limited in the present invention, using the normal pressures in this field
Container, it is preferred to use there is the pressure vessel of agitating function, such as rotary spherical digester.
By the glue stratification after high temperature high pressure process.In the present invention, the time of the stratification is 1~2h, more
Preferably 1.5h.After layering, upper strata is oil substances, and interlayer is glue, lower floor is particulate contaminant.Upper strata is separated under
The impurity of layer, obtains more pure glue.The present invention to separate impurity mode be not particularly limited, may be employed liquid separation and from
The mode of the heart separates the upper and lower impurity.Glue after processing is layered through standing, and direct liquid separation can be used
The glue in interlayer is collected in processing.Also three phase centrifugation processing, it is preferable to use disk centrifugal separator progress, the centrifugation can be used
Frequency is preferably 3000~6000 revs/min, more preferably 4000~5000 revs/min.
The glue that the method for impurity obtains in separation gel class Chinese medicine of the present invention is semi-finished product glue, and detection is obtained in glue
Water insoluble matter content and content of ashes.The present invention is to the water insoluble matter content in glue and the detection method of content of ashes without spy
It is different to limit, using the routine inspection method in this field.As defined in water insoluble matter content pharmacopeia centrifuge weight method into
Row detection, content of ashes total ash measuring method as defined in pharmacopeia are detected, and molecular weight determination uses exclusion chromatography.Because of glue
Liquid hydrolyzes for animal tissue, and complicated component, impurity is mostly grease, keratoprotein, salt etc..During high-temperature process,
On the one hand it is collagen hydro, separation is precipitated in impurity；On the other hand, the impurity such as excessive lipid and keratin, also can be at high temperature
Emulsion occurs during reason, impurity is caused to be more difficult to separate.
The method of the present invention not only overcomes the shortcomings that traditional glue class Purification of traditional Chinese herbs process efficiency is low, the cycle is long, carries significantly
High dust removal rate shortens the purification process cycle.Improve site environment using closed container during isolating and purifying, more
Meet glue class Chinese medicine production requirement, and can realize continuous large-scale production, make glue more pure, significantly improve in glue class
Medicine color and luster and transparency.
Understand to make the object, technical solutions and advantages of the present invention clearer, with reference to embodiment to the present invention into
Row detailed description, but they cannot be interpreted as limiting the scope of the present invention.
The separation of impurity in 1 donkey-hide gelatin of embodiment (donkey-hide gelatin)
The method of separation gel class Chinese medicine impurity of the present invention, can be applied to the separation of impurity in donkey-hide gelatin (donkey-hide gelatin),
Treatment process is as follows：
1) glue after donkey hide being decocted removes the solid impurities such as slag wool through husky filter tank, exists in husky filter tank filled with granularity
Stainless steel in the range of 0.5~5mm is husky, compactedness 60%.
2) the glue via hole diameter of coarse filtration is less than the polyamide high temperature NF membrane of 1000Da, is concentrated in the case where pressure is 900mbar
It is 1.05 to relative density.
3) glue after concentration is positioned in pressure vessel, temperature is set as 125 DEG C, pressure 0.25MPa, keeps
2h。
4) glue after high temperature high pressure process stands 1.5h, carries out AUTOMATIC ZONING, upper strata is oil substances, and interlayer is
Glue, lower floor are particulate contaminant, and liquid separation obtains the pure glue in interlayer.
After testing, impurity in glue is separated by the method, the content for obtaining water-insoluble in donkey-hide gelatin is 0.65% (standard
It is required that for not higher than 2.0%), ash content is 0.52% (standard requirement is not higher than 1%), and average molecular weight is 32000Da (donkey-hide gelatin
Average molecular weight is 30000-40000Da), purifying is taken as 8h (donkey-hide gelatin glue, which plays foam purifying, need to generally take 32h or so).
The separation of impurity in 2 deer horn glue of embodiment
The method of separating animal's glue class Chinese medicine impurity of the present invention, can be applied to the separation of impurity in deer horn glue, place
Science and engineering skill is as follows：
1) glue after deer horn being decocted removes solid impurity with the Bag filter of 100 mesh.
2) extracting solution via hole diameter is less than the polyamide high temperature NF membrane of 1000Da, and phase is concentrated into the case where pressure is 850mbar
It is 1.10 to density.
3) glue after concentration is positioned in pressure vessel, temperature is set as 120 DEG C, pressure 0.2MPa, handles 2h.
4) glue after high temperature high pressure process stands 1h, layering, and upper strata is oil substances, and interlayer is glue, lower floor
The glue for separating pure for particulate contaminant, three phase centrifugation.
After testing, the impurity in deer horn glue glue is separated by the method, obtaining water insoluble matter content in deer horn glue is
0.85% (standard requirement be not higher than 2.0%), ash content be 0.85% (standard requirement is not higher than 3.0%), average molecular weight
For 28000Da (deer horn glue average molecular weight is 25000-35000Da), purifying takes that (deer horn glue glue beats foam and purifies one for 8h
As need to take 20h or so).
The separation of impurity in 3 colla carapacis et plastri testudinis of embodiment
The method of separating animal's glue class Chinese medicine impurity of the present invention, can be applied to the separation of impurity in colla carapacis et plastri testudinis, place
Science and engineering skill is as follows：
1) glue after tortoise plastron being decocted, extracting solution remove solid impurity through husky filter tank, exist in husky filter tank filled with size
Stainless steel substrates in the range of 0.5~5mm, compactedness 65%
2) extracting solution via hole diameter is less than the polyamide high temperature NF membrane of 1000Da, and phase is concentrated into the case where pressure is 800mbar
It is 1.04 to density.
3) glue after concentration is positioned in pressure vessel, temperature is set as 115 DEG C, pressure 0.15MPa, processing
2.5h。
4) glue after high temperature high pressure process stands 2h, layering, and upper strata is oil substances, and interlayer is glue, lower floor
For particulate contaminant, the glue for separating pure.
After testing, the impurity in colla carapacis et plastri testudinis glue is separated by the method, obtaining water insoluble matter content in colla carapacis et plastri testudinis is
0.75% (standard requirement be not higher than 2.0%), ash content be 0.63% (standard requirement is not higher than 2.0%), average molecular weight
For 27000Da (colla carapacis et plastri testudinis average molecular weight is 25000-35000Da), purifying takes that (colla carapacis et plastri testudinis glue beats foam and purifies one for 10h
As need to take 40h or so).
The above is only the preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
For member, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications also should
It is considered as protection scope of the present invention.
Claims (10)
1. the method for impurity, includes the following steps in a kind of separation gel class Chinese medicine：
(1) glue of coarse filtration glue class Chinese medicine removes solid impurity, obtains coarse filtration glue；
(2) the coarse filtration glue in the step (1) is concentrated, until the relative density of the coarse filtration glue is 1.02~1.15, is obtained
Concentrate glue；
(3) the concentration glue in the step (2) is carried out to high temperature height under 100~130 DEG C of temperature, 0.1~0.3MPa of pressure
0.5~3h of pressure processing；
(4) glue after the step (3) high temperature high pressure process is stood into 1~2h, after the glue AUTOMATIC ZONING, in separation
Layer and the impurity part of lower floor, obtain the pure glue in interlayer.
2. according to the method described in claim 1, it is characterized in that, the glue of step (1) the glue class Chinese medicine is by glue class Chinese medicine
Raw material be prepared through decocting method.
3. according to the method described in claim 2, it is characterized in that, the raw material of the glue class Chinese medicine is donkey hide, tortoise plastron or deer horn.
4. according to the method described in claim 1, it is characterized in that, the mode of the coarse filtration is husky filter or Bag filter.
5. according to the method described in claim 4, it is characterized in that, the medium of the husky filter is in stainless steel substrates and stainless steel sand
One or two.
6. according to the method described in claim 4, it is characterized in that, the mesh size of the cloth bag is 80~150 mesh.
7. according to the method described in claim 1, it is characterized in that, concentration described in step (2) concentrates for film, the film concentrates
Pressure be 780~900mbar.
8. the method according to the description of claim 7 is characterized in that the film concentration is polyamide high temperature NF membrane with film, institute
The aperture for stating film is less than 1000Da.
9. according to the method described in claim 1, it is characterized in that, the temperature of the high temperature high pressure process be 110~125 DEG C,
Pressure is 0.2~0.25MPa.
10. according to the method described in claim 1, it is characterized in that, separated mode described in step (4) for liquid separation or from
The heart.
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| CN201711477393.5A CN108042569A (en) | 2017-12-29 | 2017-12-29 | A kind of method of impurity in separation gel class Chinese medicine |
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| CN112048417A (en) * | 2020-07-27 | 2020-12-08 | 光亚生物科技(广州)有限公司 | Active small-molecule donkey-hide gelatin paste and preparation method thereof |
| CN114002188A (en) * | 2021-10-29 | 2022-02-01 | 山东省分析测试中心 | Analysis method of donkey-hide gelatin water-insoluble substance based on gravimetric analysis |
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| CN112048417A (en) * | 2020-07-27 | 2020-12-08 | 光亚生物科技(广州)有限公司 | Active small-molecule donkey-hide gelatin paste and preparation method thereof |
| CN114002188A (en) * | 2021-10-29 | 2022-02-01 | 山东省分析测试中心 | Analysis method of donkey-hide gelatin water-insoluble substance based on gravimetric analysis |
| CN114002188B (en) * | 2021-10-29 | 2023-11-28 | 山东省分析测试中心 | Analysis method of donkey-hide gelatin water insoluble substances based on gravimetric analysis |
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Application publication date: 20180518 |