CN106177416B - A kind of traditional Chinese medicinal composition with effect of reducing blood sugar and preparation method thereof - Google Patents
A kind of traditional Chinese medicinal composition with effect of reducing blood sugar and preparation method thereof Download PDFInfo
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- CN106177416B CN106177416B CN201610717477.0A CN201610717477A CN106177416B CN 106177416 B CN106177416 B CN 106177416B CN 201610717477 A CN201610717477 A CN 201610717477A CN 106177416 B CN106177416 B CN 106177416B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61K36/815—Lycium (desert-thorn)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8968—Ophiopogon (Lilyturf)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The invention discloses a kind of traditional Chinese medicinal composition with effect of reducing blood sugar and preparation method thereof.The Chinese medicine composition mainly consists of the following compositions: 20-60 parts of potentilla discolor, 20-50 parts of the root bark of Chinese wolf-berry, and Radix Ophiopogonis 10-40 part, 10-30 parts of Radix Astragali, 10-20 parts of fructus lycii.Chinese medicine composition the preparation method is as follows: step (1) is divided into potentilla discolor, Radix Ophiopogonis and Radix Astragali, three groups of drugs of fructus lycii, every group is separately added into purified water and impregnates, decocts, decoction liquor filtering, it is concentrated after merging filtrate, obtains concentrate I, step (2) root bark of Chinese wolf-berry is extracted using ethyl alcohol, is concentrated to get concentrate II；Step (3) merges concentrate I and II, and medicinal clarifying agent is added, and mixes, siphon supernatant, and gauze coarse filtration removes floccule, and refined filtration obtains supernatant liquid, is concentrated into liquid extract.It is good that Chinese medicine composition provided by the invention not only acts as blood sugar decreasing effect, the symptoms such as can also improve dry dry throat tongue caused by diabetes, polydipsia and polydipsia, lack of energy and shortness of breath.
Description
Technical field
The present invention relates to Traditional Chinese medicine for reducing blood glucose technical field more particularly to a kind of traditional Chinese medicinal composition with effect of reducing blood sugar and its preparation sides
Method.
Background technique
Diabetes are a kind of chronic, multiple common diseases, and more obstinate, are endocrine that is common and having genetic predisposition
Metabolic disease.Different type, the diabetic's symptom that can have weight different of different stadium, less serious case can have no to feel, weight
Person can influence to live, and disease incidence has the tendency that increasing year by year, it is with cancer, same to be considered as worldwide three big for cardiovascular disease
Disease.
Currently, the drug for the treatment of diabetes is mostly based on Western medicine, though its is quick, its is palliative, but also has
There is stronger side effect, long-term use can cause very big damage to kidney.For the defect for avoiding diabetes treatment by western medicine, China
Chinese medicine is proposed many herbal prescriptions very early, for treating diabetes, achieves preferable curative effect.
Chinese medicine potentilla discolor (Potentilla Discolor Bunge) is the band root of rosaceae potentilla plants potentilla discolor
Herb.Compendium of Material Medica carries its effect: smell is sweet, slight bitter, mild-natured, nontoxic, there is clearing heat and detoxicating, cooling blood and hemostasis effect.Cure mainly lung
Heat-syndrome cough asthma, dysentery, hemoptysis, haematemesis, carbuncle sore tumefacting virus etc..In recent years, civil popular potentilla discolor is soaked drinks treatment diabetes, has
Hypoglycemic effect.It is reported at present according to lot of documents, through pharmacological research, potentilla discolor has the function of hypoglycemic, effect really
Mechanism and hypoglycemic chemical component have defined substantially.
Disclosing a kind of drug for treating diabetes application No. is the Chinese patent application of CN201310345420.9 is to belong to
In the drug for the treatment of diabetes.The drug is made of following bulk pharmaceutical chemicals: potentilla discolor 30-40g, glutinous rehmannia 30-40g, pueraria lobata 20-
30g, Radix Astragali 2-10g, Radix Notoginseng 2-10g, root bark of Chinese wolf-berry 30-50g, Radix Rehmanniae 12-18g, Radix Ophiopogonis 2-10g, sea otter 10-15g, Radix Polygalae 6-
20g, Gorgon fruit 8-16g, Fructus Aurantii 5-10g.Although the drug is in hypoglycemic aspect good effect, the not scientific conjunction of the composition of the patent
Reason.The interpretation of the cause, onset and process of an illness of Chinese medicine analysis of diabetes be yin jin loss, scorching inclined Sheng, and then scorching yin-damaging and Qi consuming and cause deficiency of both qi and yin, show
For dry throat tongue is dry, polydipsia and polydipsia, the symptoms such as lacks of energy and shortness of breath, the hypoglycemic ingredient of above-mentioned patent is mainly potentilla discolor, be equipped with glutinous rehmannia,
Radix Rehmanniae, Radix Ophiopogonis play the role of nourishing Yin and promoting production of body fluid；It is equipped with the root bark of Chinese wolf-berry and plays the role of clearind deficient heat；It is equipped with Radix Astragali and plays the role of tonifying Qi.Its
He seems extra if pueraria lobata, Radix Notoginseng, sea otter, Radix Polygalae, Gorgon fruit, Fructus Aurantii are in side by drug, " there's no such thing as a totally safe medicine ", and drug is eaten more
More, the adverse reaction of generation is more, and 12 herbal medicine compatibilities, and the compatible change that drug occurs will be extremely complex, holds
It is also easy to produce and is unfavorable for the case where treating diabetes.And the dosage form of the patent is using single, only decoction, is unfavorable for promoting and applying.
Summary of the invention
In view of the deficiencies of the prior art, the invention discloses a kind of traditional Chinese medicinal composition with effect of reducing blood sugar and preparation method thereof.Institute
It is obvious to state Chinese medicine composition blood sugar decreasing effect, it is almost without side-effects, it is better than existing sugar-reduction traditional Chinese medicine composition.
Technical scheme is as follows: a kind of traditional Chinese medicinal composition with effect of reducing blood sugar, the Chinese medicine composition is mainly by following
Parts by weight at being grouped as: 30-50 parts of potentilla discolor, 20-40 parts of the root bark of Chinese wolf-berry, Radix Ophiopogonis 15-35 part, 10-30 parts of Radix Astragali and fructus lycii
10-20 parts.
Preferably, the Chinese medicine composition is mainly composed of the following components in parts by weight: 30-40 parts of potentilla discolor, ground bone
20-30 parts of skin, Radix Ophiopogonis 20-30 part, 15-20 parts and fructus lycii 15-20 parts of Radix Astragali.
The present invention mainly studies the prescription curative effect and preparation process of other Chinese medicines of potentilla discolor compatibility.Chinese medicine analyzes glycosuria
The interpretation of the cause, onset and process of an illness of disease is yin jin loss, scorching inclined Sheng, so scorching yin-damaging and Qi consuming and cause deficiency of both qi and yin, show as that dry throat tongue is dry, polydipsia
The symptoms such as drink more, lack of energy and shortness of breath.According to the combination principle of Chinese medicine, the present invention uses potentilla discolor for monarch drug in a prescription, plays hypoglycemic master
It acts on；The root bark of Chinese wolf-berry is ministerial drug, has clearind deficient heat, effect of quenching one's thirst；Radix Astragali is adjutant, plays the role of tonifying Qi qi-restoratives；Radix Ophiopogonis and Chinese holly
Matrimony vine is to make medicine, is respectively provided with nourishing Yin and promoting production of body fluid and nourishing liver and kidney effect, five medicine compatible uses not only act as hypoglycemic work
With the symptoms such as dry dry throat tongue caused by diabetes, polydipsia and polydipsia can also be improved, are lacked of energy and shortness of breath.Fructus lycii especially in side, it is existing
Show that polysaccharides is by preventing the damage of endoplasmic reticulum that protein synthesis and removing toxic substances is promoted to make with hepatoprotective effect for pharmacological research
With restoring the function of liver cell, and promote the regeneration of liver cell, for chronic disease this for diabetes, other can be reduced
Drug takes caused adverse reaction for a long time.This side's compatibility of drugs is more reasonable, before having larger application and development value and market
Scape.By Potentilla discolor Bge, the root bark of Chinese wolf-berry, Radix Ophiopogonis, Radix Astragali, fructus lycii control in ratio range provided by the invention, hypoglycemic effect can
Reach the even better than prior art.
Although also hypoglycemic drug is prepared using Potentilla discolor Bge, the root bark of Chinese wolf-berry, Radix Ophiopogonis and Radix Astragali in the prior art, according to Chinese medicine
Pathogenic analysis and treatment to diabetes, other drugs seem if pueraria lobata, Radix Notoginseng, sea otter, Radix Polygalae, Gorgon fruit, Fructus Aurantii are in side
It is extra, increase cost, and " there's no such thing as a totally safe medicine ", drug are eaten more, the adverse reaction of generation is more, and 12 taste medicines
Object compatibility, the compatible change that drug occurs will be extremely complex, it is possible to produce antagonism pharmacologically occurs being unfavorable for controlling
The case where treating diabetes.
The present invention also provides the dosage forms of the Chinese medicine composition, preferably granule, capsule, tablet and decoction.
The present invention also provides the preparation method for traditional Chinese medicinal composition with effect of reducing blood sugar, the preparation method operation is such as
Under:
Step (1) by weight crude drug potentilla discolor, Radix Ophiopogonis, Radix Astragali and fructus lycii is weighed respectively, after cleaning, cleaning respectively,
It is divided into potentilla discolor, Radix Ophiopogonis and Radix Astragali, three groups of drugs of fructus lycii, every group of drug is separately added into purified water and impregnates, decoct, decoction liquor mistake
Filter, merging filtrate, then filtrate is concentrated, concentrate I is obtained,
The potentilla discolor is steamed 0.5~1 hour before impregnating using 100 DEG C of flowing steams, is steamed potentilla discolor, is made potentilla discolor group
Softening expansion is knitted, effective component when decoction in potentilla discolor can be leached sufficiently, but if steaming time is too long, medicinal material is easy not
Molding, and its effective component is destroyed, influence drug effect.
The potentilla discolor, Radix Ophiopogonis and Radix Astragali, three groups of drugs of fructus lycii are separately immersed in the water that 14-16 times is measured, when immersion
Between be 30-60 minutes, when dose is excessive, can according to need and be adjusted soaking time.
The potentilla discolor, Radix Ophiopogonis and Radix Astragali, three groups of drugs of fructus lycii decoct 2-3 times respectively, decoct 1-2 hours every time, close
And three groups of filtered medical fluids, filtrate are concentrated into drug and water quality ratio 1:4~6.When dose is excessive, can according to need into
Row adjustment decocting time.
Step (2) weighs root bark of Chinese wolf-berry medicine materical crude slice by weight, is extracted after cleaning using 50~70% ethyl alcohol, extracting solution is concentrated to give
To concentrate II；
Before the root bark of Chinese wolf-berry is extracted using ethyl alcohol, is steamed 1~2 hour using 100 DEG C of flowing steams, steam and can remove ground
Harmful components in bone skin, and root bark of Chinese wolf-berry tissue can be softened, guarantee that effective component sufficiently leaches when extracting.
Step (3) merges concentrate I and concentrate II, and medicinal clarifying agent is added, and mixes, siphon supernatant, and gauze is thick
It filters off and removes floccule, then refined filtration obtains supernatant liquid；
Medicinal clarifying agent is added under the conditions of concentrate is 50~70 DEG C；The medicinal clarifying agent is ZTC1+1 clarifying agent,
The component A additional amount of ZTC1+1 clarifying agent be concentrate weight 4~8%, B component additional amount be concentrate weight 2~
4%.
Supernatant liquid is concentrated under reduced pressure into liquid extract by step (4).
The process for producing granula of the Chinese medicine composition is as follows: weighing liquid extract, dextrin, solvable is added in liquid extract
Property starch and steviol glycoside after mixing evenly wetting agent is added, softwood is made, granulation, dry, whole grain obtain Chinese medicine composition
Granule；
The liquid extract and dextrin, soluble starch mixture ratio be 1:1~3, and dextrin and soluble starch
Ratio is 1.5~2.5:1, and the amount for additionally incorporating steviol glycoside is 0.2~0.4%.
Chinese medicine generallys use one pot of decoction, and one pot of decocting process is simple, and it is convenient to decoct, but medicine group provided by the invention
It closes and is easy to inhibit the leaching of effective component in Potentilla discolor Bge and the root bark of Chinese wolf-berry in decoction process due to Radix Ophiopogonis and Radix Astragali in object, and one
If fructus lycii decocting time is too long in pot decoction process, polysaccharides isoreactivity components Component is easy inactivation, loses drug effect.And ground bone
Contain sodium oxalate in skin, according to decocting, sodium oxalate is dissolved in water and enters in drug, and oxalic acid easily causes after chelating with calcium molecule
Kidney, bladder and urethral calculus also will affect the absorption of some other inorganic salts, and sodium oxalate does not dissolve in ethyl alcohol, therefore the present invention adopts
The effective component in the root bark of Chinese wolf-berry is extracted with ethyl alcohol, avoids sodium oxalate from being dissolved in drug extract, while can sufficiently extract the root bark of Chinese wolf-berry
Effective component, Chinese medicine composition component is in addition divided into potentilla discolor, Radix Ophiopogonis and Radix Astragali, three groups of fructus lycii carry out separating decoction,
Potentilla discolor first carries out steaming pretreatment before decocting, and makes organization softening, leaches convenient for effective component, is obtained using the method for the present invention
Active constituent content is more in liquid extract, effectively improves the utilization rate of drug.
Compared with prior art, the invention has the following advantages:
(1) by Potentilla discolor Bge, the root bark of Chinese wolf-berry, Radix Ophiopogonis, Radix Astragali, fructus lycii control in ratio range provided by the invention, hypoglycemic
Effect can reach the even better than prior art.
(2) in Preparation Technology of Granules provided by, the effective component in each medicinal material can be sufficiently extracted using decocting method,
Method is simple, and cost is relatively low, is suitable for pharmaceutical factory mass production.And by potentilla discolor, Radix Ophiopogonis and Radix Astragali, fructus lycii property is identical
Drug is put together and is decocted respectively, and the effective component of each drug can be sufficiently extracted, and does not easily cause mutual between ingredient
Interference.Fructus lycii principle active component is polysaccharides and vitamin B1、B2And C, the number of decoction and time are compared with other four traditional Chinese medicines
Object is few, can prevent the decomposition of its effective component from destroying.
(3) ZTC1+1 natural clarifying agent is added in the purification process of herbal extract, for the tannin in extracting solution, egg
Thorough removing can be obtained in white, grease, suspension solid content impurity, the unstable impurity in solution system, and solution is easy to filter, with
Traditional aqueous extraction-alcohol precipitation technology is compared, and production cost can reduce, easy to use, and process is simplified, with short production cycle, expense is low, tool
There is fairly obvious economic benefit.
(4) health care particle prepared using the technique of the invention is uniform in size, color is consistent, good water solubility.In order to cover
The disagreeable taste of Chinese medicine is added stevioside in auxiliary material, improves the mouthfeel of granule, be particularly suitable for diabetic.
Specific embodiment
Further details of the technical solution of the present invention combined with specific embodiments below.
Potentilla discolor is adopted in Yunnan Province Chuxiong Mt. Zixi, is accredited as through Chuxiong Medical Junior College's Chinese traditional medicine identification room
The herb of medicine potentilla discolor (Potentilla Discolor Bunge)；The root bark of Chinese wolf-berry, Radix Astragali, Radix Ophiopogonis, fructus lycii (Sichuan golden mean of the Confucian school medicine
The production of industry Co., Ltd, lot number: 20120601)
The preparation of 1 liquid extract of embodiment
Potentilla discolor pretreatment: 100 DEG C of flowing steams will be used to steam 0.5 hour after potentilla discolor cleaning and chopping.
Root bark of Chinese wolf-berry pretreatment: it is steamed 1 hour after root bark of Chinese wolf-berry medicine materical crude slice is cleaned using 100 DEG C of flowing steams.
60.00 grams of potentilla discolor are weighed, 30.00 grams and 20.00 grams of Radix Astragali of Radix Ophiopogonis, 20.00 grams of fructus lycii are divided into three groups, wash
Only, the water for being separately added into 14 times of amounts impregnates 30 minutes.Potentilla discolor, Radix Ophiopogonis and Radix Astragali decoct three times respectively, and it is small to decoct 1.5 every time
When, filtration；Fructus lycii decocts secondary, each to decoct 1.0 hours, filtration, and the filtrate of three groups of drugs of merging is concentrated to get concentrate
I；
40.00 grams of the root bark of Chinese wolf-berry ethyl alcohol using 10 times of amounts 50% extracts, and extracts twice, extracts 1.5 hours every time, merging mentions
It takes liquid to be concentrated under reduced pressure, obtains concentrate II,
Concentrate I and concentrate II is merged, crude drug in concentrate after merging: water=1:5.
At 65 DEG C, by the prepared medicinal clarifying agent of 8% addition, (- II type of ZTC1+1 natural clarifying agent is bought in Beijing
Positive day is at clarification technique Co., Ltd) B component, it mixes.Interval is added prepared medicinal clear after 2 hours by the 4% of concentrate
4-6h is stood after clear agent (- II type of ZTC1+1 natural clarifying agent) component A, after stirring evenly (or to be centrifuged with tube centrifuge, without quiet
Set), siphon supernatant, gauze coarse filtration removes big floccule, and then refined filtration is concentrated to get supernatant liquid, then by filtrate decompression
It is the liquid extract of 1.18~1.20 (80 DEG C of measurements) to relative density.
The preparation of 2 liquid extract of embodiment
The preprocess method of potentilla discolor and the root bark of Chinese wolf-berry is the same as embodiment 1；
60.00 grams of potentilla discolor are weighed, 30.00 grams and 20.00 grams of Radix Astragali of Radix Ophiopogonis, 20 grams of fructus lycii are divided into three groups, it cleans, point
Not Jia Ru 15 times amount water impregnate 60 minutes.Potentilla discolor decocts three times, decocts 1.5 hours every time, filtration；Radix Ophiopogonis and Radix Astragali decoct
Three times, it decocts 1.5 hours every time, filtration；Fructus lycii decocts three times, decocts 40min every time, filters, and merges the filter of three groups of drugs
Liquid is concentrated to get concentrate I；
40.00 grams of the root bark of Chinese wolf-berry ethyl alcohol using 8 times of amounts 60% extracts, and extracts twice, and each extraction time is 1 hour, closes
And extracting solution is concentrated under reduced pressure, and obtains concentrate II；
Filtrate I and concentrate II is merged, crude drug in the concentrate after merging: water=1:5.
Prepared medicinal clarifying agent (- II type of ZTC1+1 natural clarifying agent) B component is added by 8% at 70 DEG C, mixes.
Prepared medicinal clarifying agent (- II type of ZTC1+1 natural clarifying agent) component A is added after 2 hours, by the 4% of concentrate in interval
Afterwards, 4-6h (or being centrifuged with tube centrifuge, without standing) is stood after stirring evenly, siphon supernatant, gauze coarse filtration removes big wadding
Shape object, then refined filtration is to get supernatant liquid, then concentrating filtrate to relative density is 1.18~1.20 (80 DEG C of measurements)
Liquid extract.
The preparation of 3 liquid extract of embodiment
The preprocess method of potentilla discolor and the root bark of Chinese wolf-berry is the same as embodiment 1；
80.00 grams of potentilla discolor are weighed, 50.00 grams and 40.00 grams of Radix Astragali of Radix Ophiopogonis, 30 grams of fructus lycii are divided into three groups, it cleans, point
Not Jia Ru 16 times amount water impregnate 30 minutes.Potentilla discolor, Radix Ophiopogonis and two groups of drugs of Radix Astragali decoct three times respectively, decoct 1.5 every time
Hour, filtration；Fructus lycii decocts secondary, each to decoct 1 hour, filtration, and the filtrate of three groups of drugs of merging is concentrated into crude drug: water
=1:5 obtains concentrate I；
60.00 grams of the root bark of Chinese wolf-berry ethyl alcohol using 10 times of amounts 50% extracts, and extracts twice, and each extraction time is 1.5 hours,
Combined extract is concentrated to get concentrate, obtains concentrate II；
Filtrate I and concentrate II is merged, crude drug in the concentrate after merging: water=1:5.
Prepared medicinal clarifying agent (- II type of ZTC1+1 natural clarifying agent) B component is added by 8% at 60 DEG C, mixes.
Interval is not required to consider the lifting situation of temperature after 2 hours, and prepared medicinal clarifying agent (ZTC1+1 is added by the 4% of concentrate
- II type of natural clarifying agent) 4-6h (or being centrifuged with tube centrifuge, without standing), siphon supernatant are stood after component A, after stirring evenly
Liquid, gauze coarse filtration remove big floccule, and then refined filtration is to get supernatant liquid, then concentrates filtrate to relative density and be
The liquid extract of 1.18~1.20 (80 DEG C of measurements).
The preparation of 4 liquid extract of embodiment
Potentilla discolor pretreatment: 100 DEG C of flowing steams will be used to steam 50 minutes after potentilla discolor cleaning and chopping；
Root bark of Chinese wolf-berry pretreatment: it is steamed 1.5 hours after root bark of Chinese wolf-berry medicine materical crude slice is cleaned using 100 DEG C of flowing steams；
100.00 grams of potentilla discolor are weighed, 70.00 grams and 60.00 grams of Radix Astragali of Radix Ophiopogonis, 40 grams of fructus lycii are divided into three groups, it cleans,
The water for being separately added into 15 times of amounts impregnates 50 minutes.Potentilla discolor, Radix Ophiopogonis and two groups of drugs of Radix Astragali decoct three times respectively, decoct every time
1.5 hours, filtration；Fructus lycii decocts secondary, each to decoct 1.0 hours, filtration, and the filtrate of three groups of drugs of merging is concentrated to get
Concentrate I；
80.00 grams of the root bark of Chinese wolf-berry ethyl alcohol using 10 times of amounts 60% extracts, and extracts twice, extracts 1.5 hours every time, merging mentions
It takes liquid to be concentrated under reduced pressure, obtains concentrate II；
Filtrate I and concentrate II is merged, crude drug in the concentrate after merging: water=1:5.
Prepared medicinal clarifying agent (- II type of ZTC1+1 natural clarifying agent) B component is added by 8% at 60 DEG C, mixes.
Interval is not required to consider the lifting situation of temperature after 2 hours, and prepared medicinal clarifying agent (ZTC1+1 is added by the 4% of concentrate
- II type of natural clarifying agent) 4-6h (or being centrifuged with tube centrifuge, without standing), siphon supernatant are stood after component A, after stirring evenly
Liquid, gauze coarse filtration remove big floccule, and then refined filtration is to get supernatant liquid, then concentrates filtrate to relative density and be
The liquid extract of 1.18~1.20 (80 DEG C of measurements).
The preparation of 5 liquid extract of embodiment
Potentilla discolor pretreatment: 100 DEG C of flowing steams will be used to steam 1 hour after potentilla discolor cleaning and chopping.
Root bark of Chinese wolf-berry pretreatment: it is steamed 2 hours after the root bark of Chinese wolf-berry is cleaned using 100 DEG C of flowing steams.
100.00 grams of potentilla discolor are weighed, 70.00 grams and 60.00 grams of Radix Astragali of Radix Ophiopogonis, 40 grams of fructus lycii are divided into three groups, it cleans,
The water for being separately added into 16 times of amounts impregnates 60 minutes.Potentilla discolor, Radix Ophiopogonis and two groups of drugs of Radix Astragali decoct three times respectively, decoct 1 every time
Hour, filtration；Fructus lycii decocts secondary, each to decoct 1.0 hours, filtration, and the filtrate of three groups of drugs of merging is concentrated to get concentration
Liquid I；
80.00 grams of the root bark of Chinese wolf-berry ethyl alcohol using 10 times of amounts 70% extracts, and extracts twice, extracts 1.5 hours every time, merging mentions
Liquid is taken to be concentrated under reduced pressure to give concentrate II；
Filtrate I and concentrate II is merged, crude drug in the concentrate after merging: water=1:5.
Prepared medicinal clarifying agent (- II type of ZTC1+1 natural clarifying agent) B component is added by 8% at 70 DEG C, mixes.
Interval is not required to consider the lifting situation of temperature after 2 hours, and prepared medicinal clarifying agent (ZTC1+1 is added by the 4% of concentrate
- II type of natural clarifying agent) 4-6h (or being centrifuged with tube centrifuge, without standing), siphon supernatant are stood after component A, after stirring evenly
Liquid, gauze coarse filtration remove big floccule, and then refined filtration is to get supernatant liquid, then concentrates filtrate to relative density and be
The liquid extract of 1.18~1.20 (80 DEG C of measurements).
The preparation of 6 granule of embodiment
Liquid extract made from Example 1, by medicinal extract: auxiliary material=1.0: dextrin is added in 2.0 amount and soluble starch is mixed
Object is closed, and the ratio of dextrin and soluble starch is 2.0:1.0, the amount for additionally incorporating steviol glycoside is 0.3%.Stirring makes drug
It is uniformly mixed with the auxiliary material being added, softwood is made as wetting agent in the ethyl alcohol that appropriate 70% can be added as needed, then is made
Wet granular, dry complete in 60 DEG C, whole grain dispenses to get granule of the invention.
The preparation of 7 powder of embodiment
1 liquid extract of Example is taken, dry extract is obtained after dry, is crushed, the auxiliary material that specified amount is added is uniformly mixed, mistake
Sieve, divided dose are packed to get powder of the invention.
The preparation of 8 capsule of embodiment
The grain packing of 6 granule of the powder of powder or embodiment is after capsulae vacuus to get of the invention in Example 7
Capsule.
The preparation of 9 tablet of embodiment
The dry extract obtained after 4 liquid extract of Example or liquid extract are dry, the auxiliary material that specified amount is added are uniformly mixed, root
Softwood is made as wetting agent according to the ethyl alcohol for needing to be added appropriate 70%, then wet granular is made, it is dry complete in 60 DEG C, it is whole
Grain, tabletting is after lubricant or disintegrating agent is added to get tablet of the invention.
The preparation of 10 decoction of embodiment
Potentilla discolor pretreatment: 100 DEG C of flowing steams will be used to steam 1 hour after potentilla discolor cleaning and chopping.
Root bark of Chinese wolf-berry pretreatment: it is steamed 2 hours after the root bark of Chinese wolf-berry is cleaned using 100 DEG C of flowing steams.
70.00 grams of potentilla discolor are weighed, 50.00 grams and 40.00 grams of Radix Astragali of Radix Ophiopogonis, 35 grams of fructus lycii are divided into three groups, it cleans, point
Not Jia Ru 15 times amount water impregnate 30 minutes.Potentilla discolor, Radix Ophiopogonis and Radix Astragali decoct three times respectively, decoct 1.5 hours every time, filter
It crosses；Fructus lycii decocts secondary, each to decoct 1.0 hours, filtration, and the filtrate of three groups of drugs of merging is concentrated to get concentrate I；
50.00 grams of the root bark of Chinese wolf-berry ethyl alcohol using 10 times of amounts 60% extracts, and extracts twice, extracts 1.5 hours every time, merging mentions
It takes liquid to be concentrated under reduced pressure, obtains concentrate II；
It is decoction provided by the invention, crude drug in decoction: water=1:5 that concentrate I and concentrate II, which is merged,.
Pharmacodynamics test
The hypoglycemic effect of purpose research potentilla discolor and compound potentilla discolor decoction.
After potentilla discolor decoction and compound potentilla discolor decoction are concentrated method, respectively with 4.1ml.kg-1(1ml contain crude drug 1g) and
5.8ml.kg-1(1ml contains crude drug 2g) compares two groups of rabbit gastric infusion 7d with Minidiab and physiological saline, uses
Determination of glucose oxidase blood glucose observes the change of blood sugar of normal rabbits.
As a result potentilla discolor decoction and compound potentilla discolor decoction, have a significant effect to normal rabbits blood glucose.Normal group is
(0.50±0.32)mmol.L-1, potentilla discolor decoction group is (3.58 ± 1.48) mmol.L-1(P < 0.01), compound potentilla discolor decoction
Group is (4.29 ± 2.21) mmol.L-1(P<0.01)。
Conclusion potentilla discolor decoction and compound potentilla discolor decoction have hypoglycemic effect to normal rabbits.
1 experimental material
(institute of lab animals, Sichuan Academy of Medical Sciences mentions the male rabbit that 1.1 the weight of animals are 1.6~2.2kg
For).
1.2 drugs (reagent) and instrument
Potentilla discolor is adopted in Yunnan Province Chuxiong Mt. Zixi, is identified through Chuxiong Medical Junior College's Chinese traditional medicine identification room teacher
For the herb of Chinese medicine potentilla discolor (Potentilla Discolor Bunge)；The root bark of Chinese wolf-berry, Radix Astragali, Radix Ophiopogonis, fructus lycii are (in Sichuan
Mediocre pharmaceutcal corporation, Ltd's production, lot number: 20120601)；Minidiab (production of Hainan Zan Bang pharmaceutical Co. Ltd, lot number:
A2113E04)；Glucose estimation kit (Mairui Biological Medical Electronic Co., Ltd., Shenzhen, lot number: 141513004)；
CA-400 automatic clinical chemistry analyzer (ancient wild electrical strain gas commercial firm, Japan).
2 experimental methods
2.1 potentilla discolor and the preparation of compound potentilla discolor decoction
Potentilla discolor is cleaned and is shredded, after pressure cooker steams pretreatment, after soaking in water 30 minutes, heating decoction is secondary, often
Secondary to decoct 60 minutes respectively, filtering merges secondary decocting liquid, and concentration is prepared into the solution that raw drug content is 1g/ml.
Chinese medicine preparation is decocted according to the scheme in embodiment 1, obtained filtrate concentration is prepared into raw drug content and is
The solution of 2g/ml.
The grouping of 2.2 experimental animals and dosage regimen
Male rabbit 24 are taken, weight is 1.6~2.2kg, is randomly divided into Normal group, Minidiab group, potentilla discolor soup
Agent group, compound potentilla discolor decoction group.Each group fasting 12h before administration, takes blood 5ml by auricular vein, uses glucose oxidase method
Fasting blood-glucose is measured, as blood glucose value before being administered.Minidiab group (takes 10mg Minidiab molten using 10% Minidiab solution when experiment
In 100ml purified water), with 1.7ml.kg-1Gastric infusion.Potentilla discolor decoction group presses 4.1ml.kg-1(1ml contains crude drug 1g) is given
Potentilla discolor decoction concentrate gastric infusion is given, compound potentilla discolor decoction group presses 5.8ml.kg-1(1ml contains crude drug 2g) gives potentilla discolor
And the decoction concentrate gastric infusion of other compatibility Chinese medicines, this two groups dosage are the doses according to adult, then with
The body surface area of rabbit obtains after calculating.Normal group gives the physiological saline of compound potentilla discolor decoction group equivalent.Each group is every
Day is administered once, and successive administration 7d takes blood 5ml by auricular vein after 7d empty stomach 12h, with determination of glucose oxidase sky
Abdomen blood glucose, blood glucose value after being administered.During the experiment, the food-intake of rabbit is controlled, guarantees the feed of daily every rabbit
Measure it is essentially identical, to reduce experimental error.
2.3 statistical procedures
The measurement data of experimental data uses variance analysis, and experiment front and back and comparison among groups are examined using t.
3 results
Minidiab group experiment front and back compare, compared with Normal group, blood glucose reduce difference it is statistically significant (P <
0.05), show that Minidiab has hypoglycemic effect to normal rabbits.Potentilla discolor decoction group, compound potentilla discolor decoction group experiment front and back
Compare, compared with Normal group, it is significant (P < 0.01) that blood glucose reduces difference, show it is hypoglycemic to normal rabbits more apparent,
Compared with Minidiab group, no significant difference (P > 0.05) is shown in Table 1.It can thus be assumed that potentilla discolor and compatibility other Chinese medicines
(root bark of Chinese wolf-berry, Radix Astragali, Radix Ophiopogonis, fructus lycii) has hypoglycemic effect after decoction is made as Minidiab.
During experiment, the activity of animal, meal situation are observed, compound potentilla discolor decoction group phenomenon without exception, and
The animal feed of Minidiab group is slightly less than Normal group, because the adverse reaction in the package insert of Minidiab is intestines and stomach disease
Shape (such as nausea, upper abdomen turgor), headache, so experimental animal food-intake can be reduced.It can thus be assumed that compound potentilla discolor
It while decoction plays hypoglycemic effect, has no adverse reaction, long-term treatment effects are better than Minidiab.
In addition, observation to experimental animal weight is it is found that Normal group weight is almost unchanged after experiment, Minidiab group
With potentilla discolor decoction group weight loss, compound potentilla discolor decoction group weight is increased slightly.Each group administration front and back weight compare and with
Normal group compares, and no significant difference (P > 0.05) is shown in Table 2.It is believed that Minidiab and hypoglycemic same of potentilla discolor
When, weight can also be declined therewith, and due to the effect of other Chinese medicines in compound potentilla discolor decoction group, weight does not decline,
It is increased slightly instead, but no significant difference between each group.
The comparison of each experimental group of table 1 experiment front and back blood glucose levelmmol.L-1
Note: (a), after each group administration blood glucose is compared with before experiment, P < 0.01 * P < 0.05, * *；
(b), each group administration front and back blood glucose difference is compared with Normal group, #P < 0.05, ##P < 0.01.
The comparison of each experimental group of table 2 experiment front and back weightkg
Note: front and back weight difference is administered compared with Normal group compared with before experiment in each group administration front and back weight, and P >
0.05。
The hypoglycemic effect of Chinese medicine liquid extract and embodiment 1 that 2~embodiment of embodiment 5 obtains is close.
On the basis of embodiment 1, change experiment condition, obtain traditional Chinese herbal decoction.1~comparative example of comparative example 4 is to implement
On the basis of example 1, potentilla discolor and the root bark of Chinese wolf-berry are pre-processed, and only change decocting condition, obtain decoction liquor, and comparative example 5 is only adopted
With potentilla discolor, and without pretreatment, 3 hours are extended to using 100 DEG C of flowing steam steaming times in the pretreatment of comparative example 6,
Experimental program is as shown in table 3.
Table 3
The filtrate that 1~comparative example of comparative example 6 obtains is condensed into decoction (1ml decoction contains crude drug 2g), the decoction that will be obtained
It is respectively used to the hypoglycemic experiment of normal rabbits, operates same pharmacodynamics test, the results are shown in Table 4 for hypoglycemic.
The comparison of 4 each group of table experiment front and back blood glucose levelmmol.L-1
| Group | Number of cases | Blood glucose before being administered | Blood glucose after administration | Administration front and back blood glucose difference |
| Embodiment 1 | 6 | 5.81±0.77 | 1.52±1.89* | 4.29±2.21# |
| Potentilla discolor decoction group | 6 | 5.23±1.51 | 1.65±1.95* | 3.58±1.48# |
| Comparative example 1 | 6 | 5.37±1.24 | 2.16±1.56* | 3.21±1.67# |
| Comparative example 2 | 6 | 5.63±1.21 | 2.36±1.59* | 3.27±1.39# |
| Comparative example 3 | 6 | 6.23±1.71 | 2.79±1.65* | 3.44±1.74# |
| Comparative example 4 | 6 | 5.72±1.34 | 2.12±1.25* | 3.60±1.51# |
| Comparative example 5 | 6 | 5.96±1.64 | 2.95±1.42* | 3.01±1.80# |
| Comparative example 6 | 6 | 6.35±1.70 | 3.06±1.53* | 3.29±1.64# |
It is compared with embodiment 1 and potentilla discolor decoction group, if potentilla discolor is without steam treatment or steam treatment time mistake
Long, hypoglycemic effect is substantially reduced, if decocted using one pot, or is carried out in the way of 1~comparative example of comparative example 4 pan-fried
It boils, hypoglycemic effect can also reduce, therefore method provided by the invention can maximally utilise crude drug effective component.
Decocting is respectively adopted in the root bark of Chinese wolf-berry and ethyl alcohol extracts, and obtains root bark of Chinese wolf-berry medical fluid, detects two kinds of medical fluid mesoxalic acid sodium
Content.
Decocting method: taking the 10g root bark of Chinese wolf-berry, cleans, 60min is impregnated in 150g water, then decocts 0.5h, repeats to decoct three
It is secondary, merge decoction liquor, is concentrated to get decoction, 1ml decoction contains crude drug 2g.
Ethanol extraction method: taking the 10g root bark of Chinese wolf-berry, cleans, and is extracted using 60% ethyl alcohol of 100g, extracts twice, extract 1 every time
Hour, after removing ethyl alcohol is concentrated under reduced pressure in extracting solution, appropriate purified water is added and obtains decoction, 1ml decoction contains crude drug 2g.
The root bark of Chinese wolf-berry of 1g and the decoction of 1ml are taken respectively, detect decocting method and ethanol extraction method obtains liquid extract mesoxalic acid sodium
Content, the results are shown in Table 5.
Table 5
| The dry root bark of Chinese wolf-berry | Decocting method | Ethanol extraction method | |
| Oxalic acid sodium content | 5~6mg/g | 4~5mg/mL | 0.5~1mg/mL |
As shown in Table 5, the root bark of Chinese wolf-berry decoction mesoxalic acid sodium content obtained using ethanol extraction method is very low, damage to the body compared with
It is small.
As can be seen from the above embodiments, the root bark of Chinese wolf-berry and potentilla discolor are pre-processed, harmful components and raising can be removed
The leaching of effective component, and potentilla discolor, Radix Ophiopogonis, Radix Astragali and fructus lycii are separately decocted, it can improve to greatest extent effectively
The leaching of ingredient.
Claims (6)
1. a kind of preparation method of traditional Chinese medicinal composition with effect of reducing blood sugar, which is characterized in that the preparation method operation is as follows:
Step (1) after cleaning, cleaning respectively, is divided by weight crude drug potentilla discolor, Radix Ophiopogonis, Radix Astragali and fructus lycii is weighed respectively
Potentilla discolor, Radix Ophiopogonis and Radix Astragali, three groups of drugs of fructus lycii, every group of drug are separately added into purified water and impregnate, decoct, decoction liquor filtering,
Merging filtrate, then filtrate is concentrated to get concentrate I；It is small that the potentilla discolor uses 100 DEG C of flowing steams to steam 0.5 ~ 1 before impregnating
When；
Step (2) weighs root bark of Chinese wolf-berry medicine materical crude slice, cleans, is extracted using 50 ~ 70% ethyl alcohol, extracting solution is concentrated under reduced pressure to give concentrate II；
Before the root bark of Chinese wolf-berry is extracted using ethyl alcohol, steamed 1 ~ 2 hour using 100 DEG C of flowing steams；
Step (3) merges concentrate I and concentrate II, and medicinal clarifying agent is added, and mixes, siphon supernatant, the removal of gauze coarse filtration
Floccule, then refined filtration obtains supernatant liquid；
Supernatant liquid is concentrated under reduced pressure into liquid extract by step (4)；
In aforesaid operations, 30-50 parts of potentilla discolor, 20-40 parts of the root bark of Chinese wolf-berry, Radix Ophiopogonis 15-35 part, 10-30 parts of Radix Astragali and fructus lycii 10-
20 parts.
2. the preparation method of traditional Chinese medicinal composition with effect of reducing blood sugar as described in claim 1, which is characterized in that turned in step (1) white
It is 30-40 parts careless, 20-30 parts of the root bark of Chinese wolf-berry, Radix Ophiopogonis 20-30 part, 15-20 parts and fructus lycii 15-20 parts of Radix Astragali.
3. the preparation method of traditional Chinese medicinal composition with effect of reducing blood sugar as described in claim 1, which is characterized in that step (1) is described to be turned over
White grass, Radix Ophiopogonis and Radix Astragali, three groups of drugs of fructus lycii are separately immersed in the water that 14-16 times is measured, and soaking time is 30-60 minutes.
4. the preparation method of traditional Chinese medicinal composition with effect of reducing blood sugar as described in claim 1, which is characterized in that step (1) is described to be turned over
White grass, Radix Ophiopogonis and Radix Astragali, three groups of drugs of fructus lycii decoct 2-3 times respectively, decoct 1-2 hours every time, and three groups of merging is filtered
Medical fluid, filtrate are concentrated into drug and water quality ratio 1:4 ~ 6.
5. the preparation method of traditional Chinese medicinal composition with effect of reducing blood sugar as described in claim 1, which is characterized in that step (3) is being concentrated
Medicinal clarifying agent is added under the conditions of being 50 ~ 70 DEG C in liquid；The medicinal clarifying agent is ZTC1+1 clarifying agent, the A of ZTC1+1 clarifying agent
Component additional amount is that the B component additional amount of 4 ~ 8%, the ZTC1+1 clarifying agent of concentrate weight is the 2 ~ 4% of concentrate weight.
6. the preparation method of traditional Chinese medicinal composition with effect of reducing blood sugar as described in claim 1, which is characterized in that the Chinese medicine composition
Process for producing granula it is as follows: weigh liquid extract, dextrin, soluble starch and steviol glycoside, stirring be added in liquid extract
After uniformly, wetting agent is added, softwood is made, granulation, dry, whole grain obtain the granule of Chinese medicine composition；
The ratio of the liquid extract and dextrin, soluble starch mixture is 1:1 ~ 3, and the ratio of dextrin and soluble starch is
1.5 ~ 2.5:1, the amount for additionally incorporating steviol glycoside is 0.2 ~ 0.4%.
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