CN108126025A - The preparation process of pure and impure kidney-tonifying capsule - Google Patents
The preparation process of pure and impure kidney-tonifying capsule Download PDFInfo
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Abstract
The invention belongs to drug extraction and preparing technical fields, disclose the preparation process of pure and impure kidney-tonifying capsule, include the following steps:Step 1)Weigh raw material, step 2)It crushes, step 3)Alcohol extracting, microwave and enzymolysis, step 4)Water carries, step 5)Alcohol extracting and ultrasound, step 6)Decoction and alcohol extracting, step 7)It decocts, step 8)Mixing, drying crush and prepare capsule.Pure and impure kidney-tonifying capsule preparation effect prepared by the present invention is better than existing preparation, and dosage also accordingly reduces.
Description
Technical field
The invention belongs to drug extraction and preparing technical field, specifically, being related to the preparation process of pure and impure kidney-tonifying capsule.
Background technology
Nephrosis has become at present endangers one of publilc health principal disease.And due to it is lack of standardization treatment, drug abuse with
And undesirable life style causes the nephropathy in China also to rise year after year.Nephrotic syndrome (nephrotic syndrome,
NS) abbreviation kidney is comprehensive, refers to as caused by Different types of etiopathogenises, is increased with glomerular basement membrane permeability with kidneys such as glomerular filtration rate reductions
One group of syndrome based on bead lesion.Nephrotic syndrome is not a kind of independence disease, but one group in renal glomerular disease
Syndrome.Its typical Symptoms is High-grade Proteinuria, hypoalbuminemia, treating serious edema caused, hyperlipidemia.It can be by many kinds
Renal lesions cause to cause, and present medical field, which generally believes, belongs to cellular immunity disease.At present, routine clinical therapeutic scheme
To carry out hormone therapy, antiplatelet accumulation treatment and applying immunity inhibitor.
Pure and impure kidney-tonifying capsule is a kind of drug of effective treatment nephrotic syndrome, and material composition is relatively easy, Er Qiexiao
Fruit is good, and toxic side effect is small, receives patient's favor.Applicant has found that the medicine material extracting method is relatively single in pharmacy procedure
One, to plurality of raw materials using identical extraction process, there are the defects of effective ingredients from lossing, and nephrotic syndrome needs to take every time
With 4, three times a day, dosage is excessive, and some patients are beyond affordability, is susceptible to resentful attitudes.And to known drug into
Row improves, the R&D costs that can save enterprise's early period, is the hot spot of business research in recent years.How by modified technique, come
To greatest extent using raw material, drug effect is improved, is the problem of we need research.
Invention content
The defects of in order to overcome the prior art, the present invention propose a kind of new preparation process of pure and impure kidney-tonifying capsule, the technique
Simple possible, the active ingredient for being extracted raw material to greatest extent, improve drug effect, reduce drug administration amount.
The present invention is achieved by the following technical solution:
The preparation process of pure and impure kidney-tonifying capsule, includes the following steps:Step 1)Weigh raw material, step 2)It crushes, step 3)Alcohol
It carries, microwave and enzymolysis, step 4)Water carries, step 5)Alcohol extracting and ultrasound, step 6)Decoction and alcohol extracting, step 7)It decocts, step
8)Mixing, drying crush and prepare capsule.
Specifically, the step 1)Weigh raw material:Weigh each raw material for standby:Cordyceps sinensis 100g, Radix Astragali 1400g, pellet
Join 280g, safflower 280g, spina date seed 280g, Semen Cuscutae 500g, rheum officinale 100g.
Specifically, the step 2)It crushes:Cordyceps sinensis is taken, is ground into fine powder.
Specifically, the step 3)Alcohol extracting, microwave and enzymolysis:Radix Astragali is crushed, 200 mesh sieve is crossed, is placed in container, adds
Add the 85% of double weight(v/v)Ethyl alcohol, 300rpm stirring extractions, control microwave power is 500W in extraction process, during extraction
Between be 60-90min;4 DEG C of placement 12h are subsequently placed in, are filtered, filter residue is spare;Filtrate decompression evaporation recycling ethyl alcohol, and concentrate filtrate
To the extractum A that density is 1.3g/ml;
It by filter residue plus the water of double weight, stirs evenly, the neutral proteinase (200,000 U/g) of 0.5wt% is then added in, at 37 DEG C
120min is digested, then boils 5min, then adds in the absolute ethyl alcohol for accounting for filter residue double weight, 300rpm stirs 5min, then
12h is stood, removes supernatant, precipitation is collected, is dissolved in water, -20 DEG C are placed 12h, and then 3000rpm is centrifuged, and filtering removal is heavy
It forms sediment, concentrates filtrate to the medicinal extract B that density is 1.3g/ml;Merge extractum A and medicinal extract B obtains Astragalus Root P.E.
Specifically, the step 4)Water carries:Radix Salviae Miltiorrhizae is crushed, 200 mesh sieve is crossed, is then paved into the flat bed of 3mm thickness, is placed in
15min is irradiated under ultraviolet light, powder is collected and is placed in container, adds the water of double weight, 300rpm stirring extractions, extraction process
Middle control microwave power is 700W, extraction time 20min;Filtering collects filtrate, is condensed into the medicinal extract of 1.3g/ml to get pellet
Conopsea extraction.
Specifically, the step 5)Alcohol extracting and ultrasound:Safflower is put into ultrasonic extraction tank, adds in the 75% of three times weight(Body
Product number)Ethyl alcohol, control Extracting temperature is 50 DEG C, and with frequency 50KHz ultrasonic extraction 30min, filtrate, concentration are collected in filtering
Into 1.3g/ml medicinal extract to get safflower extract.
Specifically, the step 6)Decoction and alcohol extracting:Spina date seed is taken, is added water to cook twice, for the first time plus 8 times of weight
Water decocts 2 hours, filtrate and the dregs of a decoction is obtained after filtering;Rheum officinale is added into the dregs of a decoction, then adds again and accounts for 5 times of weight of spina date seed
Water, decoct 1.5 hours, filter to get filtrate;Merge above-mentioned filtrate twice, be condensed into the clear cream that density is 1.1g/ml, it is cold
But, addition ethyl alcohol makes alcohol content up to 70%(Volume fraction), 24 hours are stood, filtration takes supernatant, ethyl alcohol is recovered under reduced pressure, dense
Be reduced to density be 1.3g/ml medicinal extract to get spina date seed Chinese rhubarb extract;
Specifically, the step 7)It decocts:Semen Cuscutae is added water to cook twice, for the first time plus 10 times are measured water, are decocted 1.5 hours,
Filtering obtains filtrate and the dregs of a decoction, and slag of getting it filled adds 8 times of amount water to decoct 1 hour, merges filtrate twice, is concentrated into density as 1.3g/ml
Medicinal extract to get Semen Cuscutae extract;
Specifically, the step 8)Mixing, drying crush and prepare capsule:By step 3)Gained Astragalus Root P.E, step 4)
Gained Salvia root P.E, step 5)Gained safflower extract, step 6)Gained spina date seed Chinese rhubarb extract, step 7)Gained Tu
Seed extract and step 2)Gained cordyceps sinensis fine powder mixing, dry, pulverize, and addition starch is appropriate, mixing, be packed into capsule,
Be made 1000 to get.
The present invention is had the following advantages relative to the prior art and effect:
Pure and impure kidney-tonifying capsule preparation effect prepared by the present invention is better than existing preparation, and dosage also accordingly reduces;This hair
Bright preparation process simple possible handles different traditional Chinese medicine ingredients using different technologies, improve each raw material it is effective into
Point, drug effect is increased, reduces wastage of material;Present invention process can improve the leaching of astragalus root active ingredient using smaller grain size
Extracting rate, the mode of cooperation microwave alcohol extracting can obtain glycosides compound and polysaccharide, avoid the loss of ingredient;Radix Salviae Miltiorrhizae extracts
When, by the way of decoction, the decomposition of phenolic acid and letones is easy to cause, Radix Salviae Miltiorrhizae extraction process of the present invention is using suitable strong
The ultraviolet light of degree is improved the dissolution rate of active ingredient, while is carried using microwave assisted aqueous extraction, and the time is short, improves extraction efficiency,
Reduce energy consumption;The acids such as the chlorogenic acid in safflower, phenols active principle are not easy by the way of decocting, and the present invention uses
Alcohol extracting remains active ingredient.
Specific embodiment
In order to make those skilled in the art better understand the technical solutions in the application, have below in conjunction with the application
Body embodiment more clearly and completely describes the present invention, it is clear that described embodiment is only the application one
Divide embodiment, instead of all the embodiments.Based on the embodiment in the application, those of ordinary skill in the art are not making
All other embodiments obtained under the premise of creative work should all belong to the scope of protection of the invention.
Embodiment 1
The preparation process of pure and impure kidney-tonifying capsule, includes the following steps:
1)Weigh each raw material for standby:Cordyceps sinensis 100g, Radix Astragali 1400g, Radix Salviae Miltiorrhizae 280g, safflower 280g, spina date seed
280g, Semen Cuscutae 500g, rheum officinale 100g;
2)Cordyceps sinensis is taken, is ground into fine powder;
3)Radix Astragali is crushed, 200 mesh sieve is crossed, is placed in container, adds the 85% of double weight(v/v)Ethyl alcohol, 300rpm stirring
It extracts, control microwave power is 500W, extraction time 60-90min in extraction process;4 DEG C of placement 12h are subsequently placed in, are filtered,
Filter residue is spare;Filtrate decompression evaporation recycling ethyl alcohol, and filtrate is concentrated to the extractum A that density is 1.3g/ml;Using high-efficient liquid phase color
Astragaloside content is more than 1.2mg/ml in spectrometry Test extraction liquid;
It by filter residue plus the water of double weight, stirs evenly, the neutral proteinase (200,000 U/g) of 0.5wt% is then added in, at 37 DEG C
120min is digested, then boils 5min, then adds in the absolute ethyl alcohol for accounting for filter residue double weight, 300rpm stirs 5min, then
12h is stood, removes supernatant, precipitation is collected, is dissolved in water, -20 DEG C are placed 12h, and then 3000rpm is centrifuged, and filtering removal is heavy
It forms sediment, concentrates filtrate to the medicinal extract B that density is 1.3g/ml;Merge extractum A and medicinal extract B obtains Astragalus Root P.E;Using solidifying
Glue coefficients data measured by chromatography obtains astragalus polyose molecular weight in medicinal extract B and is distributed in 20000~40000 more, accounts for more than the 70% of total reducing sugar;
4)Radix Salviae Miltiorrhizae is crushed, 200 mesh sieve is crossed, is then paved into the flat bed of 3mm thickness, is placed under ultraviolet light and irradiates 15min, collect powder
End is placed in container, adds the water of double weight, and 300rpm stirrings are extracted, and control microwave power is 700W in extraction process, is carried
It is 20min to take the time;Filtering collects filtrate, is condensed into the medicinal extract of 1.3g/ml to get Salvia root P.E;The uitraviolet intensity
For 3000uW/cm2;
5)Safflower is put into ultrasonic extraction tank, adds in the 75% of three times weight(Volume parts)Ethyl alcohol, control Extracting temperature be
50 DEG C, with frequency 50KHz ultrasonic extraction 30min, filtrate is collected in filtering, is condensed into the medicinal extract of 1.3g/ml and is extracted to get safflower
Object;
6)Spina date seed is taken, is added water to cook twice, for the first time plus the water of 8 times of weight, decoction 2 hours obtain filtrate and medicine after filtering
Slag;Rheum officinale is added into the dregs of a decoction, then adds the water for accounting for 5 times of weight of spina date seed again, decocts 1.5 hours, filters to get filtrate;Merge
Above-mentioned filtrate twice, is condensed into the clear cream that density is 1.1g/ml, cooling, and addition ethyl alcohol makes alcohol content up to 70%(Volume point
Number), stand 24 hours, filtration, take supernatant, ethyl alcohol be recovered under reduced pressure, be concentrated into density be 1.3g/ml medicinal extract to get wild jujube
Benevolence Chinese rhubarb extract;
7)Semen Cuscutae adds water to cook twice, and for the first time plus 10 times of amount water, decoction 1.5 hours, filtering obtain filtrate and the dregs of a decoction, get it filled
Slag adds 8 times of amount water to decoct 1 hour, merges filtrate twice, is concentrated into medicinal extract that density is 1.3g/ml to get Semen Cuscutae extract;
8)By step 3)Gained Astragalus Root P.E, step 4)Gained Salvia root P.E, step 5)Gained safflower extract, step 6)
Gained spina date seed Chinese rhubarb extract, step 7)Gained Semen Cuscutae extract and step 2)Gained cordyceps sinensis fine powder mixing is done
It is dry, crush, add in starch it is appropriate, mixing, be packed into capsule, be made 1000 to get.
Usage and dosage:It is oral, one time 3,0.45g/, 3 times a day.
Comparative example 1
A kind of pure and impure kidney-tonifying capsule for being used to treat nephrotic syndrome, is prepared by the raw material of following weight:Cordyceps sinensis
100g, Radix Astragali 1400g, Radix Salviae Miltiorrhizae 280g, safflower 280g, spina date seed 280g, Semen Cuscutae 500g, rheum officinale 100g.
The preparation method of the pure and impure kidney-tonifying capsule is:It is spare that bulk pharmaceutical chemicals are weighed according to weight
(1)Cordyceps sinensis is taken to be ground into fine powder;
(2)Radix Astragali, Radix Salviae Miltiorrhizae, safflower, spina date seed is taken to add water to cook twice, for the first time plus 10 times of amount water, decoction 1.5 hours are filtered
After obtain filtrate and the dregs of a decoction;
(3)In step(2)In obtained dregs of a decoction addition rheum officinale and add 8 times of amount water of water, decoct 1 hour, filter to get filtrate
(4)Merge step(2)And step(3)Filtrate, be condensed into relative density as 1.14-1.16(80-85℃)Clear cream, it is cold
But, addition ethyl alcohol makes alcohol content up to 70%(Volume fraction), 24 hours are stood, filtration takes supernatant, recycles ethyl alcohol.
(5)Semen Cuscutae adds water to cook twice, and for the first time plus 10 times of amount water, decoction 1.5 hours, filtering obtain filtrate and medicine
Slag, slag of getting it filled add 8 times of amount water to decoct 1 hour, merge filtrate twice.
(6)By step(5)The filtrate of acquisition and step(4)The supernatant of acquisition merges, and is concentrated into relative density as 1.30-
The thick paste of 1.35 (80-85 DEG C) adds in step(1)The fine powder mixing of preparation, dry, pulverize, and addition starch is appropriate, mixing, dress
Enter capsule, be made 1000 to get.
Usage and dosage:It is oral, one time 4,0.45g/, 3 times a day.
Embodiment 2
The quality standard and inspection method of finished product prepared by embodiment 1, are shown in Table 1:
Table 1
Embodiment 3
Animal safety is tested
Healthy Kunming Strains of Mouse 40, half male and half female, weight are 18.6 ± 2.7g, 40 mouse are randomly divided into two groups, often
Group half male and half female, wherein 20 as control group, fills with ordinary water;Other 20 mouse give the drug of 1 technique of embodiment preparation,
For 2mg/ only, three times a day, Application mouse carries out acute toxicity testing and shows dosage:Compared with the control group, mouse is not after administration
See notable difference, experiment is observed continuously two weeks, mouse systemic situation, ingest, drink water, body weight increase it is normal.Two weeks after administration
It is interior, it has no animal dead, prompts the medicine acute toxicity low, clinical application safety.
Embodiment 4
Clinical data
Selection 122 patients that in July, -2016 in December, 2014, institute of traditional Chinese medicine of city accepted for medical treatment, wherein male 71, women 51, year
Age 28-71 Sui, average age 41.6 years old;Patient is randomly divided into 2 groups by the course of disease 1 month to 36 months, and 1 group of 61 people of embodiment is right
1 group of 61 people as usual.
Inclusion criteria and criterion of therapeutical effect refer to CN103638135A:
Therapy:
1 group of embodiment:Take embodiment 1 preparation drug, one time 3,3 times a day, 4 weeks are as a treatment course, treatment 2 treat
Journey.
2 groups of embodiment:Take the drug of 1 group of preparation of reference examples, one time 4,3 times a day, 4 weeks are as a treatment course, treatment 2
A course for the treatment of.
Therapeutic effect such as the following table 2:
Table 2
Group | It cures | It improves | It is not cured | Cure rate |
1 group of embodiment | 47 | 11 | 3 | 77.05% |
1 group of reference examples | 35 | 20 | 6 | 57.38% |
Conclusion:The cure rate of embodiment 1 is apparently higher than 1 group of reference examples, and dosage is reduced.
Claims (9)
1. the preparation process of pure and impure kidney-tonifying capsule, includes the following steps:Step 1)Weigh raw material, step 2)It crushes, step 3)
Alcohol extracting, microwave and enzymolysis, step 4)Water carries, step 5)Alcohol extracting and ultrasound, step 6)Decoction and alcohol extracting, step 7)It decocts, step
Rapid 8)Mixing, drying crush and prepare capsule.
2. preparation process according to claim 1, which is characterized in that the step 1)Weigh raw material:It is standby to weigh each raw material
With:Cordyceps sinensis 100g, Radix Astragali 1400g, Radix Salviae Miltiorrhizae 280g, safflower 280g, spina date seed 280g, Semen Cuscutae 500g, rheum officinale
100g。
3. preparation process according to claim 1, which is characterized in that the step 2)It crushes:Cordyceps sinensis is taken, is ground into
Fine powder.
4. preparation process according to claim 1, which is characterized in that the step 3)Alcohol extracting, microwave and enzymolysis:
(1)Radix Astragali is crushed, 200 mesh sieve is crossed, is placed in container, adds the 85% of double weight(v/v)Ethyl alcohol, 300rpm stirs
Extraction is mixed, control microwave power is 500W, extraction time 60-90min in extraction process;It is subsequently placed in 4 DEG C of placement 12h, mistake
Filter, filter residue are spare;Filtrate decompression evaporation recycling ethyl alcohol, and filtrate is concentrated to the extractum A that density is 1.3g/ml;
(2)Add the water of double weight into filter residue, stir evenly, then add in the neutral proteinase (200,000 U/g) of 0.5wt%,
120min is digested at 37 DEG C, then boils 5min, then adds in the absolute ethyl alcohol for accounting for filter residue double weight, 300rpm stirrings
Then 5min stands 12h, remove supernatant, collects precipitation, is dissolved in water, -20 DEG C of placement 12h, and then 3000rpm is centrifuged, mistake
Filter off the medicinal extract B for except precipitation, concentrating filtrate to that density is 1.3g/ml;Merge extractum A and medicinal extract B obtains astragalus extraction
Object.
5. preparation process according to claim 1, which is characterized in that the step 4)Water carries:Radix Salviae Miltiorrhizae is crushed, crosses 200
Mesh sieves, and is then paved into the flat bed of 3mm thickness, is placed under ultraviolet light and irradiates 15min, collects powder and is placed in container, adds twice
The water of weight, 300rpm stirrings are extracted, and control microwave power is 700W, extraction time 20min in extraction process;Filtering is received
Collect filtrate, be condensed into the medicinal extract of 1.3g/ml to get Salvia root P.E.
6. preparation process according to claim 1, which is characterized in that the step 5)Alcohol extracting and ultrasound:Safflower is put into
Ultrasonic extraction tank adds in the 75% of three times weight(Volume parts)Ethyl alcohol, control Extracting temperature be 50 DEG C, surpassed with frequency 50KHz
Sound extracts 30min, and filtering collects filtrate, is condensed into the medicinal extract of 1.3g/ml to get safflower extract.
7. preparation process according to claim 1, which is characterized in that the step 6)Decoction and alcohol extracting:Spina date seed is taken, is added
Water decocts twice, and for the first time plus the water of 8 times of weight, decoction 2 hours obtain filtrate and the dregs of a decoction after filtering;It is added into the dregs of a decoction big
Then Huang adds the water for accounting for 5 times of weight of spina date seed again, decoct 1.5 hours, filter to get filtrate;Merge above-mentioned filtrate twice, it is dense
Shorten the clear cream that density is 1.1g/ml, cooling into, addition ethyl alcohol makes alcohol content up to 70%(Volume fraction), 24 hours are stood, filter
Cross, take supernatant, ethyl alcohol is recovered under reduced pressure, be concentrated into density be 1.3g/ml medicinal extract to get spina date seed Chinese rhubarb extract;
8. preparation process according to claim 1, which is characterized in that the step 7)It decocts:Semen Cuscutae is added water to cook
Twice, first time plus 10 times of amount water, decoct 1.5 hours, filtering acquisition filtrate and the dregs of a decoction, and it is small that slag of getting it filled adds 8 times of amount water to decoct 1
When, merge filtrate twice, be concentrated into medicinal extract that density is 1.3g/ml to get Semen Cuscutae extract;
9. according to the preparation process described in claim 1-8, which is characterized in that the step 8)Mixing, drying, crushing and system
Standby capsule:By step 3)Gained Astragalus Root P.E, step 4)Gained Salvia root P.E, step 5)Gained safflower extract, step
6)Gained spina date seed Chinese rhubarb extract, step 7)Gained Semen Cuscutae extract and step 2)Gained cordyceps sinensis fine powder mixing,
Dry, pulverize, add in starch it is appropriate, mixing, be packed into capsule, be made 1000 to get.
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN112168804A (en) * | 2020-11-04 | 2021-01-05 | 翔宇药业股份有限公司 | Preparation of kidney-tonifying capsule and quality standard test method |
CN114158728A (en) * | 2021-11-23 | 2022-03-11 | 成都华西康健生物工程有限公司 | Food for improving diabetes and fatty liver and preparation method thereof |
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2016
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112168804A (en) * | 2020-11-04 | 2021-01-05 | 翔宇药业股份有限公司 | Preparation of kidney-tonifying capsule and quality standard test method |
CN114158728A (en) * | 2021-11-23 | 2022-03-11 | 成都华西康健生物工程有限公司 | Food for improving diabetes and fatty liver and preparation method thereof |
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