CN108653501A - A kind of manufacture craft of Zhixinkang preparation - Google Patents
A kind of manufacture craft of Zhixinkang preparation Download PDFInfo
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- CN108653501A CN108653501A CN201810672732.3A CN201810672732A CN108653501A CN 108653501 A CN108653501 A CN 108653501A CN 201810672732 A CN201810672732 A CN 201810672732A CN 108653501 A CN108653501 A CN 108653501A
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- 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
- A61K36/482—Cassia, e.g. golden shower tree
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/16—Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
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- 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)
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- 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)
- A61K36/35—Caprifoliaceae (Honeysuckle family)
- A61K36/355—Lonicera (honeysuckle)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/42—Cucurbitaceae (Cucumber family)
- A61K36/424—Gynostemma
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- 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)
- A61K36/884—Alismataceae (Water-plantain family)
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- 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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- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- 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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Abstract
The invention discloses a kind of manufacture craft of Zhixinkang preparation, the Zhixinkang preparation is made of cassia seed, lotus leaf, gynostemma pentaphylla, rhizoma alismatis, honeysuckle, Ilex Latifolia Thunb, ginkgo leaf and auxiliary material.The present invention is according to the property of each drug in Zhixinkang preparation prescription, and effect of the drug played in prescription, the specific manufacture craft and parameter of Zhixinkang preparation are improved, so that the 23 acetylalisol B of active ingredient of rhizoma alismatis is easy to measure, and the 23 acetylalisol B amounts measured are high, so that this drug more refines, drug effect is more notable, and clinical efficacy is good.
Description
Technical field
The invention belongs to the field of Chinese medicines, and in particular to a kind of manufacture craft of Zhixinkang preparation.
Background technology
Traditional Chinese medicine extraction is a kind of common method in herbal pharmaceutical, and chemical composition of Chinese materia medica is extremely complex, need to be mixed from complicated
It closes in object and extracts to the effective active ingredient of Chinese herbs of human body.To improve drug effect.
Zhixinkang preparation is mainly made of Radix Codonopsis, the stir-fry dried immature fruit of citron orange, rhizoma alismatis, coloured malt and stir-baked FRUCTUS CRATAEGI；Work(with spleen benefiting and stimulating the appetite
Effect is used for weakness of the spleen and the stomach, abdominal fullness and distention, the diseases such as anorexia and loose stool.
The glad recovering particles of fat by cassia seed, lotus leaf, gynostemma pentaphylla, rhizoma alismatis, honeysuckle, Ilex Latifolia Thunb, ginkgo leaf and auxiliary material prepare and
At.Has the function of heat-clearing eliminating the phlegm.There is definite curative effect for diseases such as treatment retention of phlegm-heat in the interior, hyperlipidemias.Existing production fat is glad
The method recorded in the drug standards (WS-10358 (ZD-0358) -2002) is usually used in the method for recovering particles, is by all medicines
Material decocts extraction jointly.The i.e. above seven flavor medicine material, adds water to cook secondary, and 2 hours every time, collecting decoction, filtration, filtrate was concentrated into
Relative density is the thick paste of 1.30~1.38 (80~85 DEG C), and dextrin, Steviosin is added, and mixing is made particle, it is dry to get.
But inventor has found in the course of the research, is made in Zhixinkang preparation using existing extraction process, rhizoma alismatis has
Effect ingredient Alisol B monoacetate is not easy to measure so that the clinical efficacy of Zhixinkang preparation is ideal not enough.
Invention content
The present invention provides a kind of manufacture crafts of Zhixinkang preparation.The present invention is according to each drug in Zhixinkang preparation prescription
The effect played in prescription of property and the drug, the specific manufacture craft and parameter of Zhixinkang preparation are changed
Into so that the active ingredient Alisol B monoacetate of rhizoma alismatis is easy to measure, and the Alisol B monoacetate amount measured is high so that this
Drug more refines, and drug effect is more notable, and clinical efficacy is good.
To achieve the goals above, the present invention provides the following technical solutions：A kind of manufacture craft of Zhixinkang preparation, it is described
Zhixinkang preparation calculates by weight, mainly by 30 parts of cassia seed, 40 parts of lotus leaf, 30 parts of gynostemma pentaphylla, 20 parts of rhizoma alismatis, honeysuckle 10
Part, 10 parts of Ilex Latifolia Thunb, 10 parts of ginkgo leaf and auxiliary material are made；The production method of the Zhixinkang preparation is：Rhizoma alismatis is soaked with soak
After bubble, clear water is cleaned, and with hot water ultrasonic extraction 2-3 time, extracting solution merges, and filters, relative density is when being condensed into 50-60 DEG C
1.12-1.13 thick paste, obtain rhizoma alismatis thick paste；Lotus leaf adds water to cook, filtration, and filtrate decompression is condensed into medicinal extract, then ethyl alcohol is added to make to contain
Alcohol amount reaches 50%-75%, is stirred continuously, and stands, and filtering, decompression filtrate recycling ethanol is simultaneously condensed into medicinal extract, with hydrochloric acid tune pH, protects
Temperature, tipping supernatant, filtering, it is 3-4 that precipitation, which is washed with water to pH, is condensed into medicinal extract, obtains lotus leaf medicinal extract；Remaining cassia seed, strand
Indigo plant, honeysuckle, Ilex Latifolia Thunb and ginkgo leaf, add water to cook it is secondary, 2 hours every time, collecting decoction, filtration, filtrate is concentrated into 80~
Auxiliary material, system is added in the thick paste that relative density is 1.30~1.38 at 85 DEG C, thick paste and above-mentioned rhizoma alismatis thick paste, lotus leaf medicinal extract mixing
At pharmaceutical preparation.
In the manufacture craft of Zhixinkang preparation above-mentioned, the rhizoma alismatis thick paste is prepared：Rhizoma alismatis is impregnated with soak
It after 4-6h, is cleaned with clear water, then uses 80-90 DEG C of hot water ultrasonic extraction 2-3 times, each 30-40min, solid-liquid ratio 1：(40-
50)；Ultrasonic extraction power is 700-800W, and extracting solution merges, filtering, and relative density is 1.12-1.13 when being condensed into 50-60 DEG C
Thick paste, obtain rhizoma alismatis thick paste.
In the manufacture craft of Zhixinkang preparation above-mentioned, the soak is prepared：By the weight of fermented glutinous wine and green tea slag
Amount is than being 3：8 by fermented glutinour rice slag and green tea slag mixing, is sealed by fermentation 5-7 days, and filtering, filter residue discards, collection filtrate to get.
In the manufacture craft of Zhixinkang preparation above-mentioned, the lotus leaf medicinal extract is prepared：Lotus leaf adds 7-12 times to measure decocting
It boils 2-4 times, 1-3 hours each, filtration, merging filtrate, relative density is the medicinal extract of 1.05-1.10 when being concentrated under reduced pressure into 50 DEG C,
Add ethyl alcohol that alcohol content is made to reach 50%-75%, be stirred continuously, stand 12-48 hours, filtering, decompression filtrate recycling ethanol simultaneously concentrates
To the medicinal extract that relative density at 50 DEG C is 1.05-1.10, it is 2,40-60 DEG C with hydrochloric acid tune pH and keeps the temperature 3-8 hours, tipping supernatant
Liquid, filtering, precipitation be washed with water to pH be 3-4, when being condensed into 60-70 DEG C relative density be 1.05-1.10 medicinal extract to get.
In the manufacture craft of Zhixinkang preparation above-mentioned, the pharmaceutical preparation is oral preparation.
In the manufacture craft of Zhixinkang preparation above-mentioned, the oral preparation be granule, pill, tablet, capsule or
Granule.
In the manufacture craft of Zhixinkang preparation above-mentioned, the granule makes in this way：After rhizoma alismatis is impregnated with soak, clearly
Water is cleaned, and with hot water ultrasonic extraction 2-3 time, extracting solution merges, filtering, and relative density is 1.12-1.13 when being condensed into 50-60 DEG C
Thick paste, obtain rhizoma alismatis thick paste；Lotus leaf adds water to cook, filtration, and filtrate decompression is condensed into medicinal extract, then adds ethyl alcohol that alcohol content is made to reach
50%-75% is stirred continuously, and is stood, and filtering, decompression filtrate recycling ethanol is simultaneously condensed into medicinal extract, and with hydrochloric acid tune pH, heat preservation is inclined
Supernatant is abandoned, is filtered, it is 3-4 that precipitation, which is washed with water to pH, is condensed into medicinal extract, obtains lotus leaf medicinal extract；Remaining cassia seed, gynostemma pentaphylla, gold
Honeysuckle flower, Ilex Latifolia Thunb and ginkgo leaf, add water to cook it is secondary, 2 hours every time, collecting decoction, filtration, when filtrate is concentrated into 80~85 DEG C
The thick paste that relative density is 1.30~1.38, thick paste and above-mentioned rhizoma alismatis thick paste, lotus leaf medicinal extract mixing, are added dextrin, Steviosin, mix
It is even, be made particle, it is dry to get.
In the manufacture craft of Zhixinkang preparation above-mentioned, the pill makes in this way：After rhizoma alismatis is impregnated with soak, clear water
It cleans, with hot water ultrasonic extraction 2-3 time, extracting solution merges, filtering, and relative density is 1.12-1.13's when being condensed into 50-60 DEG C
Thick paste obtains rhizoma alismatis thick paste；Lotus leaf adds water to cook, filtration, and filtrate decompression is condensed into medicinal extract, then adds ethyl alcohol that alcohol content is made to reach 50%-
75%, it is stirred continuously, stands, filtering, decompression filtrate recycling ethanol is simultaneously condensed into medicinal extract, with hydrochloric acid tune pH, heat preservation, tipping supernatant
Liquid, filtering, it is 3-4 that precipitation, which is washed with water to pH, is condensed into medicinal extract, obtains lotus leaf medicinal extract；Remaining cassia seed, gynostemma pentaphylla, honeysuckle, hardship
Fourth tea and ginkgo leaf, add water to cook it is secondary, 2 hours every time, collecting decoction, filtration, filtrate is concentrated into relatively close at 80~85 DEG C
Degree is 1.30~1.38 thick paste, and thick paste and above-mentioned rhizoma alismatis thick paste, lotus leaf medicinal extract mixing, pill is dry, polishing to get.
In the manufacture craft of Zhixinkang preparation above-mentioned, the tablet makes in this way：After rhizoma alismatis is impregnated with soak, clear water
It cleans, with hot water ultrasonic extraction 2-3 time, extracting solution merges, filtering, and relative density is 1.12-1.13's when being condensed into 50-60 DEG C
Thick paste obtains rhizoma alismatis thick paste；Lotus leaf adds water to cook, filtration, and filtrate decompression is condensed into medicinal extract, then adds ethyl alcohol that alcohol content is made to reach 50%-
75%, it is stirred continuously, stands, filtering, decompression filtrate recycling ethanol is simultaneously condensed into medicinal extract, with hydrochloric acid tune pH, heat preservation, tipping supernatant
Liquid, filtering, it is 3-4 that precipitation, which is washed with water to pH, is condensed into medicinal extract, obtains lotus leaf medicinal extract；Remaining cassia seed, gynostemma pentaphylla, honeysuckle, hardship
Fourth tea and ginkgo leaf, add water to cook it is secondary, 2 hours every time, collecting decoction, filtration, filtrate is concentrated into relatively close at 80~85 DEG C
Degree is 1.30~1.38 thick paste, the starch mixing of thick paste and above-mentioned rhizoma alismatis thick paste, lotus leaf medicinal extract and the amount of being made 10-20%, pressure
Piece, it is dry to get.
In the manufacture craft of Zhixinkang preparation above-mentioned, the capsule makes in this way：After rhizoma alismatis is impregnated with soak, clearly
Water is cleaned, and with hot water ultrasonic extraction 2-3 time, extracting solution merges, filtering, and relative density is 1.12-1.13 when being condensed into 50-60 DEG C
Thick paste, obtain rhizoma alismatis thick paste；Lotus leaf adds water to cook, filtration, and filtrate decompression is condensed into medicinal extract, then adds ethyl alcohol that alcohol content is made to reach
50%-75% is stirred continuously, and is stood, and filtering, decompression filtrate recycling ethanol is simultaneously condensed into medicinal extract, and with hydrochloric acid tune pH, heat preservation is inclined
Supernatant is abandoned, is filtered, it is 3-4 that precipitation, which is washed with water to pH, is condensed into medicinal extract, obtains lotus leaf medicinal extract；Remaining cassia seed, gynostemma pentaphylla, gold
Honeysuckle flower, Ilex Latifolia Thunb and ginkgo leaf, add water to cook it is secondary, 2 hours every time, collecting decoction, filtration, when filtrate is concentrated into 80~85 DEG C
The thick paste that relative density is 1.30~1.38, thick paste and above-mentioned rhizoma alismatis thick paste, the starch of lotus leaf medicinal extract and the amount of being made 10-20%,
Mixing is pelletized, dry, be packed into capsule to get.
Drug is made using cassia seed, lotus leaf, gynostemma pentaphylla, rhizoma alismatis, honeysuckle, Ilex Latifolia Thunb, ginkgo leaf and auxiliary material in the present invention
Preparation, i.e. Zhixinkang preparation, each raw material has to act synergistically well, and manufactured preparation has effects that heat-clearing eliminating the phlegm.It can use
The hyperlipidemia caused by retention of phlegm-heat in the interior, card are shown in：Alliteration, dizziness, body is tired, fat.
The manufacture craft of existing Zhixinkang preparation is：Cassia seed, lotus leaf, gynostemma pentaphylla, rhizoma alismatis, honeysuckle, Ilex Latifolia Thunb, silver
Apricot, add water to cook it is secondary, 2 hours every time, collecting decoction, filtration, filtrate be concentrated into relative density be 1.30~1.38 (80~85
DEG C) thick paste, dextrin, Steviosin is added, mixing is made particle, it is dry to get.But inventor has found in the course of the research,
In this way in manufactured Zhixinkang preparation, the active ingredient of rhizoma alismatis is not easy to measure.So that the clinical of Zhixinkang preparation is treated
Effect is ideal not enough.Inventor also found in technical study, individually be extracted rhizoma alismatis and lotus leaf using the method for the present invention, in this way
In manufactured Zhixinkang preparation, the active ingredient of rhizoma alismatis is easy to measure, and the active ingredient for the rhizoma alismatis measured is high.This allows for making
It obtains this drug more to refine, drug effect is more notable, and clinical efficacy is good.Therefore the technique promotes the dissolution of active ingredient in rhizoma alismatis
The dissolution rate of rate, especially Alisol B monoacetate, Alisol B monoacetate are ingredients important in rhizoma alismatis, have very strong medicine
Reason activity can effectively improve the drug effect of Zhixinkang preparation after the dissolution rate raising of Alisol B monoacetate.
The present invention has carried out a large amount of experimental study, is below the result of experimental study of the present invention：
Experimental example 1：Alisol B monoacetate content is investigated
1 instrument and reagent
The 1.1 glad recovering particles of fat of the present invention, are made as described in Example 1.
The 1.2 existing glad recovering particles of fat：It is made by following techniques：
Prescription：Cassia seed 30g, lotus leaf 40g, gynostemma pentaphylla 30g, rhizoma alismatis 20g, honeysuckle 10g, Ilex Latifolia Thunb 10g, ginkgo leaf
10g, dextrin 85g and Steviosin 4.5g.
Technique：It is to be total to all medicinal materials using the method recorded in the drug standards (WS-10358 (ZD-0358) -2002)
It is extracted with decocting.The i.e. above seven flavor medicine material, adds water to cook secondary, and 2 hours every time, collecting decoction, filtration, filtrate was concentrated into relatively
Density is the thick paste of 1.30~1.38 (80~85 DEG C), and dextrin, Steviosin is added, and mixing is made particle, it is dry to get.
1.3 Shimadzu 2010A types high performance liquid chromatographs (Shimadzu UV detector, LC solution chromatographic work stations)；X
The U-shaped electronic analytical balances of SE205D (Mei Teletuo benefits company of Switzerland)；KQ-400K DE type ultrasonic cleaners (Kunshan
Ultrasonic instrument Co., Ltd of city).Alisol B monoacetate reference substance (Nat'l Pharmaceutical ＆ Biological Products Control Institute)；Test water be
Heartily pure water；Acetonitrile (Merck companies) is chromatographically pure.
2 experimental methods and result
2.1 chromatographic condition
Chromatographic column：Agilent Extend—C18Column (250mm × 46mm, 5 μm)；Mobile phase：Acetonitrile-water (70:30)；Stream
Speed：1.0mL/min；Detection wavelength：210nm；Column temperature：25℃；Sample size：5μL.Number of theoretical plate is based on Alisol B monoacetate peak
Not less than 3000, separating degree is more than 1.5.
The preparation of 2.2 solution
2.2.1 the preparation of reference substance solution
Alisol B monoacetate reference substance (content 98.5%) 11.22mg is weighed, it is accurately weighed, add acetonitrile that quality is made dense
Degree be 22.10 μ g/mL solution to get.
2.2.2 the preparation of test solution 1
Fat of the present invention glad recovering particles 2.0g is taken, it is accurately weighed, it sets in conical flask, acetonitrile 25mL, weighed quality, ultrasound is added
30min is handled, lets cool, then weighed quality, the quality of less loss is supplied with acetonitrile, with 0.45 μm of miillpore filter filtration to get for examination
Product solution 1.
2.2.3 the preparation of test solution 2
Enchashment has fat glad recovering particles 2.0g, accurately weighed, sets in conical flask, is added acetonitrile 25mL, weighed quality, at ultrasound
30min is managed, lets cool, then weighed quality, the quality of less loss is supplied with acetonitrile, with 0.45 μm of miillpore filter filtration to get test sample
Solution 2.
2.2.4 the preparation of negative control solution 1 removes its outside rhizoma alismatis in the glad recovering particles composition ratio of fat of the present invention
By technological requirement the negative sample without rhizoma alismatis is made, then by the preparation method of test solution 1, it is negative right to be made in remaining flavour of a drug
According to solution 1.
2.2.5 the preparation of negative control solution 2 removes remaining outside rhizoma alismatis in the glad recovering particles composition ratio of existing fat
By technological requirement the negative sample without rhizoma alismatis is made, then by the preparation method of test solution 2, negative control is made in flavour of a drug
Solution 2.
2.3 methodological study
Interference test：Precision draws reference substance solution, test solution 1, test solution 2, negative controls molten 1 and the moon
Property reference substance molten 2, by work out method measure, the results show that in test solution chromatography, be that reference substance solution corresponding positions are equipped with
The chromatographic peak of one identical retention time, negative control is noiseless.
Linear relationship is investigated：It is accurate respectively to draw 1,2,5,10,15,20,25 μ L of Alisol B monoacetate reference substance solution,
Liquid chromatograph is injected, peak area is recorded, is abscissa (X, μ g), integrating peak areas value for ordinate using reference substance sample size
(Y) carry out regression analysis, the results showed that, Alisol B monoacetate sample size in 0.0225-0.652 μ g ranges with peak area line
Sexual intercourse is good.
Precision test：Precision draws 10 μ L of reference substance solution, and continuous sample introduction 6 times measures peak area.As a result 23- acetyl
The average peak area value of alisol B is that 209102, RSD is 0.86% (n=6), shows that instrument precision is good.
Stability test：Precision draws same test solution 1, in 0,2,4,8,12, for 24 hours when distinguish 10 μ L of sample introduction, note
Record peak area.As a result it is 0.92% (n=6) that the average value of Alisol B monoacetate peak area, which is 240477, RSD, is shown for examination
Product solution is good in internal stability for 24 hours.
Repetitive test：Precision weighs the glad recovering particles of fat of the present invention and each 6 parts of the glad recovering particles of existing fat respectively, according to " 2.2 "
Legal system available test sample solution 1 and test solution 2 below are measured by above-mentioned chromatographic condition sample introduction.As a result RSD=1.05%
And RSD=1.08%, show that this method repeatability is good.
Recovery test：Each 6 parts, every part of the glad recovering particles of fat of the present invention and the glad recovering particles of existing fat of known content are taken respectively
About 1.5g, precise weighing is accurate respectively that a certain amount of Alisol B monoacetate reference substance is added, and prepares test sample as stated above
Solution is measured by 10 μ l of above-mentioned chromatographic condition sample introduction, calculates the rate of recovery.As a result average recovery rate is 98.67% and 98.55%,
RSD=0.99% and RSD=0.10%.
2.4 sample sizes measure
The glad recovering particles of fat of the present invention and each 6 parts of the glad recovering particles of existing fat are taken respectively, it is finely ground, 3g is taken, it is accurately weighed, every part point
An not be after prepare by test solution 1 and 2 method of test solution, precision weighs test solution 1 and test solution 2, every part
Each 10 μ l measure Alisol B monoacetate content in the glad recovering particles of fat and the glad recovering particles of existing fat of the present invention in accordance with the law.It the results are shown in Table
1。
The assay result of 1 Alisol B monoacetate of table
As known from Table 1, the average content of Alisol B monoacetate is 0.036mg/g in the glad recovering particles of fat of the present invention, existing
The average content of Alisol B monoacetate is 0.025mg/g in the glad recovering particles of fat.
Conclusion：Compared with the glad recovering particles of existing fat, the active ingredient 23- acetyl rhizoma alismatis of rhizoma alismatis in the glad recovering particles of fat of the present invention
The content higher of alcohol B.Similarly, according to the preparation of other dosage forms made of extracting method of the present invention, the active constituent content of rhizoma alismatis
Also should increase.
Experimental example 2：Effect tests
1 experiment material
1.1 drug
1.1.1 the glad recovering particles of fat of the present invention, with embodiment 1.
1.1.2 the glad recovering particles of existing fat, with experimental example 1.
1.2 animal health female W istar rats 45, weight (200 ± 20) g, by the western school animal of Shandong University
The heart provides.
2 methods
2.1 animal model
After rat conventinal breeding 1 week, fasting 8h cuts blood fat before tail blood sampling test experience.Then give high lipid food (yolk
Powder 10g, lard 10g, cholesterol 2g, Pig cholate 0.5g, add basal feed to 100g) 15g/d, drinks water unlimited；；After 6 weeks, on an empty stomach
8h cuts blood fat after tail blood sampling detection high fat diet.45 rats are randomly divided into model group with hyperlipemia (model group) 15 later
Only, high lipid food 15g/d is given, unlimited, 0.9% sodium chloride injection 2.5mL/d gavages of drinking water；Of the present invention group l5, in mould
On the basis of type group, the glad recovering particles of fat of the present invention (daily 10 times of amounts that adult human dose is converted by weight) are added water to
2.5m L gavages；The existing glad recovering particles group 15 of fat, it is on the basis of model group, the glad recovering particles of existing fat are (daily
10 times of amounts of adult human dose are converted by weight), add water to 2.5mL gavages.3 groups after 6,15 weeks, empty stomach 8h, blood sampling inspection
Survey blood fat after treating.
2.2 detection method
3 groups of rat blood serums are taken in the different experiments stage, its serum TC, TG and HDL-C are detected with enzyme process.After treating 15 weeks, 3
Group rat limosis 8h removes vena cave blood system I, II liang of equal portions, it is low that oxidized form is added in serum I with urethane 1g/kg intraperitoneal anesthesias
Density lipoprotein (OX-LD L) protective agent, serum II are not added with protective agent, detach serum after 3500r/min, 1min, set -20 DEG C
Preserve standby inspection.Serum II is taken, detects serum N O with enzyme process respectively, xanthine oxidase detects serum superoxide dismutases
(SOD) and malonaldehyde (MDA).Serum I is taken, is provided with E LISA double antibody sandwich methods, Nanjing biomedical engineering research institute
Kit detects serum ox-LDL.
2.3 statistical method
Using SAS statistical softwares, measurement data compares to be examined with t, and comparison among groups are examined with F.P≤0.05, which is difference, system
Meter learns meaning.
3 results
3.1 3 groups of rat different tests stage blood fat compare, and are shown in Table 2.
2 different tests stage of table, 3 groups of rat fats compare (mmol/L)
Note：Compared with before same group of experiment,*P<0.05；Compared with after same group of high fat diet,+P<0.05,++P<0.05；
Compared with model group,#P<0.05；
Compared with the glad recovering particles group of existing fat,&P<0.05。
As seen from table, compared with model group, when the glad recovering particles group of fat of the present invention, the glad recovering particles group of existing fat are treated 6 weeks, height
Pionemia rat TC, TG are substantially reduced, and HDL-C is significantly raised.Illustrate that the glad recovering particles of fat of the present invention and the glad recovering particles of existing fat are equal
There is notable regulating blood lipid action, and extend with administration time, lipid-lowering effect becomes apparent from.And the effect of the glad recovering particles of fat of the present invention is excellent
In the glad recovering particles of existing fat (&P<0.05)。
3.2 3 groups of rats pretherapy and post-treatment serum N O, ox-LD L, SOD, MDA are relatively shown in Table 3.
33 groups of rats of table pretherapy and post-treatment serum N O, ox-LD L, SOD, MDA compare (mmol/L)
Note：Compared with before same treatment,*P<0.05；
Compared with after model group treatment,#P<0.05,##P<0.01；
Compared with the glad recovering particles group of existing fat,&P<0.05。
As seen from table, compared with model group, the glad recovering particles group of fat of the present invention, the glad recovering particles group of existing fat can be substantially reduced
The serum ox-LD L of hyperlipidemia rats illustrate that it has and inhibit lipoprotein oxidation effect, caused by prevention hyperlipidemia
A S are significant.And the effect of the glad recovering particles of fat of the present invention better than the glad recovering particles of existing fat (&P<0.05)。
Meanwhile compared with model group, the glad recovering particles group of fat of the present invention, the glad recovering particles group of existing fat can significantly improve blood
Clear SOD vigor, reduces MDA.Energy anti-lipid peroxidation object generates, and improves itself activities of antioxidant enzymes.And the glad health of fat of the present invention
The effect of particle better than the glad recovering particles of existing fat (&P<0.05)。
Compared with prior art, in the Zhixinkang preparation that the method for the invention makes, the active ingredient 23- second in rhizoma alismatis
Acyl alisol B is easy to measure, and the content for the Alisol B monoacetate measured is high.The medicine of Zhixinkang preparation can effectively be improved
Effect.
Specific implementation mode：
Embodiment 1：
Formula：Cassia seed 30g, lotus leaf 40g, gynostemma pentaphylla 30g, rhizoma alismatis 20g, honeysuckle 10g, Ilex Latifolia Thunb 10g, ginkgo leaf
10g, dextrin 85g and Steviosin 4.5g.
Technique：Include the following steps：
(1) it after rhizoma alismatis impregnates 5h with soak, is cleaned with clear water, then with 85 DEG C of hot water ultrasonic extractions 3 times, every time
35min, solid-liquid ratio 1：45；Ultrasonic extraction power is 750W, and extracting solution merges, filtering, relative density when being condensed into 50-60 DEG C
For the thick paste of 1.12-1.13, rhizoma alismatis thick paste is obtained；The soak is prepared：Take fermented glutinous wine 30g and green tea slag 80g, mixing,
Be sealed by fermentation 6 days, filtering, filter residue discards, collect filtrate to get；
(2) lotus leaf adds 10 times of amount water to decoct 3 times, and 2 hours every time, filtration, merging filtrate was concentrated under reduced pressure into opposite at 50 DEG C
Density is the medicinal extract of 1.05-1.10, adds ethyl alcohol to make alcohol content up to 60%, is stirred continuously, and when standing 24, filtering, filtrate decompression is returned
The medicinal extract that relative density is 1.05-1.10 when receiving ethyl alcohol and being concentrated into 50 DEG C keeps the temperature 5 hours with hydrochloric acid tune pH for 2,40-60 DEG C,
Tipping supernatant, filtering, it is 3-4 that precipitation, which is washed with water to pH, and relative density is the medicinal extract of 1.05-1.10 when being condensed into 60-70 DEG C,
Obtain lotus leaf medicinal extract；
(3) remaining cassia seed, gynostemma pentaphylla, honeysuckle, Ilex Latifolia Thunb and ginkgo leaf add 7 times of water amount water to decoct secondary, and every time 2
Hour, collecting decoction, filtration, when filtrate is concentrated into 80~85 DEG C relative density be 1.30~1.38 thick paste, thick paste with it is above-mentioned
Dextrin, Steviosin is added in rhizoma alismatis thick paste, lotus leaf medicinal extract mixing, and mixing is made particle, it is dry to get.
Usage and dosage：Oral, boiling water is taken after mixing it with water, a 5~10g, 3 times a day.
Specification：5g/ bags.
Embodiment 2：
Formula：Cassia seed 30g, lotus leaf 40g, gynostemma pentaphylla 30g, rhizoma alismatis 20g, honeysuckle 10g, Ilex Latifolia Thunb 10g, ginkgo leaf
10g。
Technique：Include the following steps：
(1) it after rhizoma alismatis impregnates 6h with soak, is cleaned with clear water, then with 90 DEG C of hot water ultrasonic extractions 3 times, each 30-
40min, solid-liquid ratio 1：40；Ultrasonic extraction power is 800W, and extracting solution merges, filtering, relative density when being condensed into 50-60 DEG C
For the thick paste of 1.12-1.13, rhizoma alismatis thick paste is obtained；The soak is prepared：Take fermented glutinous wine 30g and green tea slag 80g, mixing,
Be sealed by fermentation 7 days, filtering, filter residue discards, collect filtrate to get；
(2) lotus leaf adds 7-12 times to measure water and decocts 4 times, and 3 hours every time, filtration, merging filtrate was concentrated under reduced pressure into 50 DEG C of phases
To the medicinal extract that density is 1.05-1.10, add ethyl alcohol to make alcohol content up to 75%, be stirred continuously, stand 48 hours, filtering, filtrate subtracts
The medicinal extract that relative density when receiving ethyl alcohol and being concentrated into 50 DEG C is 1.05-1.10 is pushed back, is 2,40-60 DEG C of heat preservation 8 with hydrochloric acid tune pH
Hour, tipping supernatant, filtering, it is 3-4 that precipitation, which is washed with water to pH, and relative density is 1.05-1.10's when being condensed into 60-70 DEG C
Medicinal extract obtains lotus leaf medicinal extract；(3) remaining cassia seed, gynostemma pentaphylla, honeysuckle, Ilex Latifolia Thunb and ginkgo leaf add 7 times of amount water of water to decoct two
Secondary, 2 hours every time, collecting decoction filtered, and the thick paste that relative density is 1.30~1.38 when filtrate is concentrated into 80~85 DEG C is thick
Cream and above-mentioned rhizoma alismatis thick paste, lotus leaf medicinal extract mixing, pill, dry, polishing is to get pill.
Usage and dosage：It is oral, a 1-2 ball, 3 times a day.
Specification：3g/ balls.
Embodiment 3：
Formula：Cassia seed 30g, lotus leaf 40g, gynostemma pentaphylla 30g, rhizoma alismatis 20g, honeysuckle 10g, Ilex Latifolia Thunb 10g, ginkgo leaf
10g。
Technique：Include the following steps：
(1) it after rhizoma alismatis impregnates 4h with soak, is cleaned with clear water, then uses 80-90 DEG C of hot water ultrasonic extraction 2-3 times, often
Secondary 30-40min, solid-liquid ratio 1：50；Ultrasonic extraction power is 700W, and extracting solution merges, and filtering is condensed into 50-60 DEG C of phase
To the thick paste that density is 1.12-1.13, rhizoma alismatis thick paste is obtained；The soak is prepared：Fermented glutinous wine 30g and green tea slag 80g are taken,
Mixing is sealed by fermentation 5 days, and filtering, filter residue discards, collect filtrate to get；
(2) lotus leaf adds 7 times of amount water to decoct 2 times, and 1 hour every time, filtration, merging filtrate was concentrated under reduced pressure into opposite at 50 DEG C
Density is the medicinal extract of 1.05-1.10, adds ethyl alcohol to make alcohol content up to 50%, is stirred continuously, and stands 12 hours, filtering, filtrate decompression
The medicinal extract that relative density is 1.05-1.10 when recycling ethyl alcohol and being concentrated into 50 DEG C is that 2,40-60 DEG C of heat preservation 3 is small with hydrochloric acid tune pH
When, tipping supernatant, filtering, it is 3-4 that precipitation, which is washed with water to pH, and relative density is the leaching of 1.05-1.10 when being condensed into 60-70 DEG C
Cream obtains lotus leaf medicinal extract；
(3) remaining cassia seed, gynostemma pentaphylla, honeysuckle, Ilex Latifolia Thunb and ginkgo leaf add 7 times of water amount water to decoct secondary, and every time 2
Hour, collecting decoction, filtration, when filtrate is concentrated into 80~85 DEG C relative density be 1.30~1.38 thick paste, thick paste with it is above-mentioned
The starch of rhizoma alismatis thick paste, lotus leaf medicinal extract and the amount of being made 10-20%, mixing are pelletized, dry, are packed into capsule to get capsule.
Usage and dosage：It is oral, one time 2-3,3 times a day.
Specification：0.5g/.
Claims (10)
1. a kind of manufacture craft of Zhixinkang preparation, it is characterised in that：The Zhixinkang preparation calculates by weight, mainly by certainly
30 parts of pine torch, 40 parts of lotus leaf, 30 parts of gynostemma pentaphylla, 20 parts of rhizoma alismatis, 10 parts of honeysuckle, 10 parts of Ilex Latifolia Thunb, 10 parts of ginkgo leaf and auxiliary material
It is made；The production method of the Zhixinkang preparation is：After rhizoma alismatis is impregnated with soak, clear water is cleaned, with hot water ultrasonic extraction 2-3
Secondary, extracting solution merges, and filtering, relative density is the thick paste of 1.12-1.13 when being condensed into 50-60 DEG C, obtains rhizoma alismatis thick paste；Lotus leaf adds
Water decocts, filtration, and filtrate decompression is condensed into medicinal extract, then adds ethyl alcohol that alcohol content is made to reach 50%-75%, is stirred continuously, and stands, filtering,
Decompression filtrate recycling ethanol is simultaneously condensed into medicinal extract, and with hydrochloric acid tune pH, heat preservation, tipping supernatant, filtering, precipitation, which is washed with water to pH, is
3-4 is condensed into medicinal extract, obtains lotus leaf medicinal extract；Remaining cassia seed, gynostemma pentaphylla, honeysuckle, Ilex Latifolia Thunb and ginkgo leaf, add water to cook two
Secondary, 2 hours every time, collecting decoction filtered, and the thick paste that relative density is 1.30~1.38 when filtrate is concentrated into 80~85 DEG C is thick
Cream and above-mentioned rhizoma alismatis thick paste, lotus leaf medicinal extract mixing, are added auxiliary material, pharmaceutical preparation are made.
2. the manufacture craft of Zhixinkang preparation as described in claim 1, it is characterised in that：The rhizoma alismatis thick paste is made in this way
It is standby：It after rhizoma alismatis impregnates 4-6h with soak, is cleaned with clear water, then uses 80-90 DEG C of hot water ultrasonic extraction 2-3 times, each 30-
40min, solid-liquid ratio 1：（40-50）；Ultrasonic extraction power is 700-800W, and extracting solution merges, and filtering is condensed into 50-60 DEG C
When relative density be 1.12-1.13 thick paste, obtain rhizoma alismatis thick paste.
3. the manufacture craft of Zhixinkang preparation as claimed in claim 1 or 2, it is characterised in that：The soak is prepared：
It is 3 by the weight ratio of fermented glutinous wine and green tea slag：8, by fermented glutinour rice slag and green tea slag mixing, are sealed by fermentation 5-7 days, and filtering, filter residue is abandoned
Go, collect filtrate to get.
4. the manufacture craft of Zhixinkang preparation as described in claim 1, it is characterised in that：The lotus leaf medicinal extract is prepared：
Lotus leaf adds 7-12 times to measure water decoction 2-4 times, 1-3 hours each, filtration, merging filtrate, relative density when being concentrated under reduced pressure into 50 DEG C
For the medicinal extract of 1.05-1.10, add ethyl alcohol that alcohol content is made to reach 50%-75%, be stirred continuously, stand 12-48 hours, filtering, filtrate subtracts
The medicinal extract that relative density when receiving ethyl alcohol and being concentrated into 50 DEG C is 1.05-1.10 is pushed back, is 2,40-60 DEG C of heat preservation 3- with hydrochloric acid tune pH
8 hours, tipping supernatant, filtering, it was 3-4 that precipitation, which is washed with water to pH, and relative density is 1.05-1.10 when being condensed into 60-70 DEG C
Medicinal extract to get.
5. the manufacture craft of Zhixinkang preparation as described in claim 1, it is characterised in that：The pharmaceutical preparation is oral system
Agent.
6. the manufacture craft of Zhixinkang preparation as claimed in claim 6, it is characterised in that：The oral preparation be granule,
Pill, tablet, capsule or granule.
7. the manufacture craft of Zhixinkang preparation as claimed in claim 6, it is characterised in that：The granule makes in this way：Pool
It rushes down after being impregnated with soak, clear water is cleaned, and with hot water ultrasonic extraction 2-3 time, extracting solution merges, and filters, when being condensed into 50-60 DEG C
Relative density is the thick paste of 1.12-1.13, obtains rhizoma alismatis thick paste；Lotus leaf adds water to cook, and filtration, filtrate decompression is condensed into medicinal extract, then
Add ethyl alcohol that alcohol content is made to reach 50%-75%, be stirred continuously, stand, filtering, decompression filtrate recycling ethanol is simultaneously condensed into medicinal extract, uses salt
Acid adjusts pH, and heat preservation, tipping supernatant, filtering, it is 3-4 that precipitation, which is washed with water to pH, is condensed into medicinal extract, obtains lotus leaf medicinal extract；Remaining is determined
Pine torch, gynostemma pentaphylla, honeysuckle, Ilex Latifolia Thunb and ginkgo leaf, add water to cook secondary, and 2 hours every time, collecting decoction, filtration, filtrate was dense
The thick paste that relative density is 1.30~1.38 when being reduced to 80~85 DEG C, thick paste and above-mentioned rhizoma alismatis thick paste, lotus leaf medicinal extract mixing, are added
Dextrin, Steviosin, mixing are made particle, it is dry to get.
8. the manufacture craft of Zhixinkang preparation as claimed in claim 6, it is characterised in that：The pill makes in this way：Rhizoma alismatis
After being impregnated with soak, clear water is cleaned, and with hot water ultrasonic extraction 2-3 time, extracting solution merges, and filters, is condensed into 50-60 DEG C of phase
To the thick paste that density is 1.12-1.13, rhizoma alismatis thick paste is obtained；Lotus leaf adds water to cook, filtration, and filtrate decompression is condensed into medicinal extract, then adds
Ethyl alcohol makes alcohol content reach 50%-75%, is stirred continuously, and stands, and filtering, decompression filtrate recycling ethanol is simultaneously condensed into medicinal extract, uses hydrochloric acid
PH is adjusted, heat preservation, tipping supernatant, filtering, it is 3-4 that precipitation, which is washed with water to pH, is condensed into medicinal extract, obtains lotus leaf medicinal extract；Remaining Cassia
Son, gynostemma pentaphylla, honeysuckle, Ilex Latifolia Thunb and ginkgo leaf, add water to cook it is secondary, 2 hours every time, collecting decoction, filtration, filtrate concentration
To the thick paste that relative density at 80~85 DEG C is 1.30~1.38, thick paste and above-mentioned rhizoma alismatis thick paste, lotus leaf medicinal extract mixing, pill,
It is dry, polishing to get.
9. the manufacture craft of Zhixinkang preparation as claimed in claim 6, it is characterised in that：The tablet makes in this way：Rhizoma alismatis
After being impregnated with soak, clear water is cleaned, and with hot water ultrasonic extraction 2-3 time, extracting solution merges, and filters, is condensed into 50-60 DEG C of phase
To the thick paste that density is 1.12-1.13, rhizoma alismatis thick paste is obtained；Lotus leaf adds water to cook, filtration, and filtrate decompression is condensed into medicinal extract, then adds
Ethyl alcohol makes alcohol content reach 50%-75%, is stirred continuously, and stands, and filtering, decompression filtrate recycling ethanol is simultaneously condensed into medicinal extract, uses hydrochloric acid
PH is adjusted, heat preservation, tipping supernatant, filtering, it is 3-4 that precipitation, which is washed with water to pH, is condensed into medicinal extract, obtains lotus leaf medicinal extract；Remaining Cassia
Son, gynostemma pentaphylla, honeysuckle, Ilex Latifolia Thunb and ginkgo leaf, add water to cook it is secondary, 2 hours every time, collecting decoction, filtration, filtrate concentration
To the thick paste that relative density at 80~85 DEG C is 1.30~1.38, thick paste and above-mentioned rhizoma alismatis thick paste, lotus leaf medicinal extract and the amount of being made 10-
20% starch mixing, tabletting, it is dry to get.
10. the manufacture craft of Zhixinkang preparation as claimed in claim 6, it is characterised in that：The capsule makes in this way：Pool
It rushes down after being impregnated with soak, clear water is cleaned, and with hot water ultrasonic extraction 2-3 time, extracting solution merges, and filters, when being condensed into 50-60 DEG C
Relative density is the thick paste of 1.12-1.13, obtains rhizoma alismatis thick paste；Lotus leaf adds water to cook, and filtration, filtrate decompression is condensed into medicinal extract, then
Add ethyl alcohol that alcohol content is made to reach 50%-75%, be stirred continuously, stand, filtering, decompression filtrate recycling ethanol is simultaneously condensed into medicinal extract, uses salt
Acid adjusts pH, and heat preservation, tipping supernatant, filtering, it is 3-4 that precipitation, which is washed with water to pH, is condensed into medicinal extract, obtains lotus leaf medicinal extract；Remaining is determined
Pine torch, gynostemma pentaphylla, honeysuckle, Ilex Latifolia Thunb and ginkgo leaf, add water to cook secondary, and 2 hours every time, collecting decoction, filtration, filtrate was dense
The thick paste that relative density is 1.30~1.38 when being reduced to 80~85 DEG C, thick paste and above-mentioned rhizoma alismatis thick paste, lotus leaf medicinal extract and the amount of being made
The starch of 10-20%, mixing are pelletized, dry, be packed into capsule to get.
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