CN103961582B - Treat the Chinese medicine composition and its preparation and preparation method of ephritis - Google Patents
Treat the Chinese medicine composition and its preparation and preparation method of ephritis Download PDFInfo
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Abstract
The present invention relates to a kind of Chinese medicine composition for treating ephritis, Chinese medicine composition mainly processed is prepared from by the bulk drug of following parts by weight：The dried rhizome of rehmannia, the Radix Astragali, radix pseudostellariae, Poria cocos, the bighead atractylodes rhizome, rhizoma imperatae, the fruit of glossy privet, Eclipta prostrata, radix bupleuri, oldenlandia diffusa, wrinkled giant hyssop, rheum officinale, dried orange peel, Radix Rhapontici seu Radix Echinopsis, the shell of areca nut, umbellate pore furgus, radix glycyrrhizae and Alectoria asiatica Du Rietz；The Chinese medicine composition also provides oral formulations, including but not limited to oral liquid, granule, tablet, pill or capsule.The Chinese medicine composition and its preparation of the treatment ephritis of the present invention, cure mainly compensatory phase and the Decompensated stage of renal insufficiency, and the traditional Chinese medicine composition for treating effect is obvious, convenient to take, Small side effects.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, more particularly to a kind of Chinese medicine composition and its preparation for treating ephritis and preparation
Method.
Background technology
Renal insufficiency is the glomerulus heavy damage as caused by many reasons, makes body in excretion metabolism waste and tune
The clinical syndrome later stage group got muddled in terms of water saving electrolyte, acid-base balance.The compensatory phase renal function of renal insufficiency
Decline, but its excretion metabolism product and regulation fluid and electrolyte balance ability can still meet normal need, not go out clinically
Existing symptom, renal function chemical examination also has slightly higher phenomenon in normal range (NR) or occasionally.The Decompensated stage of renal insufficiency, glomerulus it is existing compared with
There is anaemia in many infringements, existing certain obstacle during kidney excretion metabolic waste, patient, and fatigue and weak, weight loss, spirit is difficult
Collection is medium.Effectively treated between compensatory stage of renal insufficiency and Decompensated stage, cure rate is high.Chinese medicine often take warm kidney,
The means such as QI invigorating and promoting blood circulation are treated to renal insufficiency, and evident in efficacy, and toxic side effect is small, has broad prospects.But
In practice, because many Chinese medicines slow, curative effect that has the shortcomings that to work is long, its clinical practice is had a strong impact on.
Patent application publication number discloses one kind for CN102552729A application documents and treats mesangial matrix * glomerulus
The medicine of ephritis, the pharmaceutical formulation includes the Radix Astragali, pseudo-ginseng, Eclipta prostrata, the dried rhizome of rehmannia, Radix Angelicae Sinensis, donkey-hide gelatin, oldenlandia diffusa, rhizoma imperatae, benefit
Brittle Falsepimpernel Herb, madder rheum officinale, Poria cocos, rhizoma alismatis, cultivated land, the fruit of glossy privet and Semen Cuscutae.Pure Chinese medicinal preparation, drug effect is made in above-mentioned raw materials medicine
Good, effect is obvious and is difficult to trigger other lesions, reaches the effect for the treatment of mesangial proliferative glomerulonephritis.Though the Chinese medicine preparation
Ephritis caused by so being destroyed to glomerulus has certain curative effect, but its effect is not notable, and matching somebody with somebody due to its pure Chinese medicine
Side, the shortcomings of there is low disintegration time length, bioavilability and inherent quality whard to control, absorption of the influence human body to medicine.
The content of the invention
In order to solve the above-mentioned technical problem, the present invention provides a kind of Chinese medicine composition and its preparation for treating ephritis, cures mainly
The compensatory phase of renal insufficiency and Decompensated stage, the traditional Chinese medicine composition for treating effect are obvious, convenient to take, Small side effects.
Concrete technical scheme of the present invention is as follows：
The present invention provides a kind of Chinese medicine composition for treating ephritis, the main raw material by following parts by weight of the Chinese medicine composition
Medicine is processed to be prepared from：
Compensatory phase of the composition provided by the present invention to renal insufficiency, Decompensated stage, it is evident in efficacy；Cure rate is high,
And few side effects, cost is low.
It is used as the preferred scheme of above-mentioned technical characteristic, the Chinese medicine composition of present invention treatment ephritis, by following parts by weight
Bulk drug processed be prepared from：
Further, in order that with and it is easy to carry, the present invention by treat ephritis Chinese medicine composition oral formulations are made,
The oral formulations include but is not limited to oral liquid, granule, tablet, pill or capsule, the weight of the Chinese medicine composition and auxiliary material
It is 1 to measure score ratio:1.5-1:3.
Further, the oral formulations that the Chinese medicine composition and auxiliary material for treating ephritis by the present invention are made are granule, auxiliary
Material includes the lactose, 30-40 parts of beta-schardinger dextrin, 3-5 parts of xylitan monostearate and 3-5 that parts by weight are 30-40 parts
The carbomer of part.
Lactose and beta-schardinger dextrin are used as excipient, granule is preferably molded, while improving the stability of tablet；
Xylitan monostearate contributes to the scattered of Chinese medicine composition, further improves the bioavilability of Chinese medicine composition, together
When also act as the effect for promoting the mixing of each composition；Carbomer plays a part of adhesive and flavouring.
Being used in mixed way for above-mentioned auxiliary material, to effect synergy of main ingredient, significantly improves shaping and the stability of granule.
Further, the oral formulations that the Chinese medicine composition and auxiliary material for treating ephritis by the present invention are made are tablet, auxiliary material
Be 25-35 parts of dextrin including parts by weight, 25-35 parts of sodium starch glycol, 3-5 parts of magnesium laurylsulfate, 10-15 parts
Xanthans and 3-5 parts of sodium alginate.
Dextrin and sodium starch glycol improve bioavilability and stability as filler；While sodium starch glycol
Play a part of disintegrant, make tablet Fast Stripping；Magnesium laurylsulfate has preferable lubrication, can increase particle flow
Property, in favor of tablet is released into nib, and its influence to tablet hardness is smaller.
Xanthans has good bio-compatibility and bioadhesive, with the supplementary product compatibility such as sodium starch glycol, dextrin
The sustained release tablets with certain viscosity, hardness and dissolution rate are prepared, extends action time of the medicine in privileged site, slows down
Insoluble drug release, reduces administration number of times；The synergy of the use of xanthans combination sodium alginate, raising stability, and xanthans
Extend action time, extend curative effect.Tabletting properties that the present invention is provided are stable, efficacy time length and evident in efficacy.
Further, the oral formulations that the Chinese medicine composition and auxiliary material for treating ephritis by the present invention are made are pill, described
Auxiliary material includes lactitol, 3-5 part of western tragacanth and 5-8 part of pregelatinized starch of the parts by weight for 50-60 parts.
The western tragacanth of the lactitol combination plasticity matrix auxiliary material of low melting point matrix auxiliary material, prepares simple, obtained ball
Agent property is stable, and its interior coherency and plasticity are high, and hardness is moderate；Pregelatinized starch has pill as the disintegrant of pill
Good dissolving out capability, simultaneously because pregelatinized starch is shoes low, can improve mixture of powders and machine in production process
The viscose glue effect of metal part.Auxiliary material is used in conjunction with, and effect to main ingredient plays synergy, significantly improve pill shaping and
The stabilization of property；While drug action is lasting, the dissolution of medicine and absorption rate are fast.
, can be by taking the direct water of medicine of the parts by weight to extract the invention provides the preparation method of Chinese medicine composition
Obtain, or extracted by water, alcohol extracting and ethyl acetate extraction are mixed to get.
Further, preparation method of the invention comprises the following steps：
A) Eclipta prostratas of the parts by weight, the bighead atractylodes rhizome, the dried rhizome of rehmannia, radix pseudostellariae, Poria cocos, rhizoma imperatae, the fruit of glossy privet, the shell of areca nut are taken first
Decocting is boiled twice, is added water for the first time as 10 times of medicinal material weight, decocts 2h, is added water for the second time as 8 times of amounts of medicinal material weight, decoction
1.5h, collecting decoction, plus 95% ethanol make alcohol content up to 75%, and stirring stands overnight filtering, filtrate is in 0.08MPa, 65 DEG C of bars
Relative density is 1.15g/ml when 65 DEG C are concentrated under reduced pressure under part, and medicinal powder 1 is made in spray drying；
B) Radixs Astragali of the parts by weight, oldenlandia diffusa, wrinkled giant hyssop, dried orange peel, umbellate pore furgus, radix glycyrrhizae alcohol reflux 3 times are taken, every time
Plus the 80%-85% ethanol of 10 times of amounts, 65 DEG C of backflow 4h, reclaim ethanol and concentrate, medicinal powder 2 is made in 65 DEG C of spray drying；
C) take the radix bupleuri of the parts by weight, rheum officinale, Radix Rhapontici seu Radix Echinopsis, Alectoria asiatica Du Rietz decocting to boil twice, add water for the first time as medicinal material weight
10 times, decoct 2h, add water for the second time as 8 times of medicinal material weight amounts, decoct 1.5h, collecting decoction, plus ethyl acetate extraction, water layer
Relative density is 1.15g/ml when liquid is concentrated under reduced pressure into 65 DEG C under the conditions of 0.08MPa, 65 DEG C, and medicinal powder 3 is made in spray drying；
D) medicinal powder 1, medicinal powder 2 and medicinal powder 3 of above-mentioned gained are well mixed, obtain the medicinal powder of Chinese medicine composition.
The invention provides the preparation method of the tablet of the Chinese medicine composition for the treatment of ephritis, comprise the following steps：
A) medicinal powder of Chinese medicine composition and the sodium starch glycol of parts by weight, dextrin are well mixed, obtain mixture；
C) xanthans, sodium alginate are dissolved in 75% ethanol, add the mixture that step b) is obtained, mixed, cross 24 mesh sieves
Granulation, under conditions of temperature is 60 °, is dried under reduced pressure, whole grain；
D) dry particl after whole grain is added into magnesium laurylsulfate, be well mixed, tabletting, packaging is produced.
Present invention also offers the preparation method of the pill of the Chinese medicine composition for the treatment of ephritis, comprise the following steps：
A) lactitol, western tragacanth, pregelatinized starch are placed in heating water bath, fused mass is made, add Chinese medicine composition
Medicinal powder, stir, it is dispersed in fused mass, dripping liquid is made；
B) hopper that dripping liquid is moved into pill dripping machine is incubated 80-90 DEG C, and condensate liquid is atoleine, condensate temperature
20-25 DEG C, condensation cured is carried out, pill is made；
C) pill is taken out, attachment condensate liquid is removed, dried, packaging produces pill finished product.
The source of bulk drug of the present invention is as follows：
The dried rhizome of rehmannia：Alias radix rehmanniae recen, this product is new for scrophulariaceae rehmannia glutinosa plant Rehmannia glutinosa Libosch.'s
Fresh or dried root.
The Radix Astragali：This product is legume astragalus mongolicus Astragalus membranaceus (Fisch.)
Bge.var.mongholicus (Bge.) Hsiao or Astragalus membranacus Astragalus membranaceus (Fisch.) Bge.'s
Dry root.
Radix pseudostellariae：This product is pinkwort caryophyllaceous ginseng Pseudostellaria heterophylla (Miq.) Pax ex
Pax et Hoffm. dried root.
Poria cocos：This product is On Polyporaceae Poria cocos Poria cocos (Schw.) Wolf dry sclerotia.
The bighead atractylodes rhizome：This product is feverfew bighead atractylodes rhizome Atractylodes macrocephala Koidz. dry rhizome.
Rhizoma imperatae：This product is grass cogongrass Imperata cylindrica Beauv.var.major (Nees)
C.E.Hubb. dry rhizome.
The fruit of glossy privet：This product is Oleaceae plants glossy privet Ligustrum lucidum Ait. dry mature fruit.Have
It is nourishing liver and kidney, improving eyesight black hair effect.
Eclipta prostrata：This product is feverfew Eclipta prostrata Eclipta prostrata L. dry aerial parts.Adopted when the flowers are in blossom
Cut, dry.
Radix bupleuri：This product is umbelliferae bupleurum Bupleurum chinense DC. or radix bupleuri scorzoneraefolii Bupleurum
Scorzonerifolium Willd. dry root.
Oldenlandia diffusa:This product is Rubiaceae plants of Hedyotis oldenlandia diffusa Hedyotis diffusa Willd.
The herb of [Oldenlandia diffusa (Willd.) Roxb.].Nature and flavor are sweet, light, cool.
Wrinkled giant hyssop:For labiate Pogostemon cablin or the herb of wrinkled giant hyssop.Harvested when Pogostemon cablin grows in great numbers between 6~July, sea
Southern area is annual to receive 2 times.
Rheum officinale:This product is polygonum rheum palmatum Rheum palmatum L., Rheum tanguticum Maxim Rheum
Tanguticum Maxim.ex Balf. or Rheum officinale Rheum officinale Baill. drying root and rhizome.
Dried orange peel:This product is rutaceae orange Citrus reticulata Blanco and its drying and ripening of variety
Pericarp.
Radix Rhapontici seu Radix Echinopsis:This product is feverfew centaurea monanthos Georgi Rhaponticum uniflorum (L.) DC. dry root.Spring, autumn
Two seasons excavated, and removed fibrous root and silt, dried.
The shell of areca nut:This product is babassu betel nut Areca catechu L. drying pericarp.
Umbellate pore furgus:This product is On Polyporaceae umbellate pore furgus Polyporus umbellatus (Pers.) Fries dry sclerotia.
Radix glycyrrhizae:This product is glycyrrhizic legume Glycyrrhiza uralensis Fisch., swollen fruit Radix
Glycyrrhiza inflata Bat. or glycyrrhiza glabra Glycyrrhiza glabra L. dry root.
Alectoria asiatica Du Rietz:The filamentous of Usneaceae plant Asia tree hair.Whole year can adopt, and remove impurity, dry.
The formula of the important composition of the treatment ephritis of the present invention, it is non-stimulated, have no toxic side effect；By clinical repetition test
Obtain, cure mainly renal insufficiency, compensatory phase, Decompensated stage, with good curative effect；Property is stable, instant effect, and cure rate is high.
It is made after the peroral dosage forms such as granule, tablet, pill, uses and carry more convenient, further increase Chinese medicine
The bioavilability and curative effect of composition；And it is low to prepare cost, it is adapted to industrialized production.
Brief description of the drawings
The vitro release result of the test of tablet described in Fig. 1 embodiments 11-12.
Embodiment
Embodiment 1
A kind of Chinese medicine composition for treating ephritis, the main processed system of bulk drug by following parts by weight of the Chinese medicine composition
It is standby to form：
Preparation method：
A) Eclipta prostratas of the parts by weight, the bighead atractylodes rhizome, radix rehmanniae recen, radix pseudostellariae, Poria cocos, rhizoma imperatae, the fruit of glossy privet, big abdomen are taken first
The severe edema due to hypofunction of the spleen is decocted twice, is added water for the first time as 10 times of medicinal material weight, decocts 2h, is added water as 8 times of medicinal material weight amounts, is decocted for the second time
Boiling 1.5h, collecting decoction, plus 95% ethanol makes alcohol content up to 75%, stirring, stands overnight filtering, filtrate 0.08MPa, 65 DEG C
Under the conditions of when being concentrated under reduced pressure into 65 DEG C relative density be 1.15g/ml, medicinal powder 1 is made in spray drying；
B) Radixs Astragali of the parts by weight, oldenlandia diffusa, wrinkled giant hyssop, dried orange peel, umbellate pore furgus, radix glycyrrhizae alcohol reflux 3 times are taken, every time
Plus the 80%-85% ethanol of 10 times of amounts, 65 DEG C of backflow 4h, reclaim ethanol and concentrate, medicinal powder 2 is made in 65 DEG C of spray drying；
C) take the radix bupleuri of the parts by weight, rheum officinale, Radix Rhapontici seu Radix Echinopsis, Alectoria asiatica Du Rietz decocting to boil twice, add water for the first time as medicinal material weight
10 times, decoct 2h, add water for the second time as 8 times of medicinal material weight amounts, decoct 1.5h, collecting decoction, plus ethyl acetate extraction, water layer
Relative density is 1.15g/ml when liquid is concentrated under reduced pressure into 65 DEG C under the conditions of 0.08MPa, 65 DEG C, and medicinal powder 3 is made in spray drying；
D) medicinal powder 1, medicinal powder 2 and medicinal powder 3 of above-mentioned gained are well mixed, obtain the medicinal powder of Chinese medicine composition.
Embodiment 2
A kind of Chinese medicine composition for treating ephritis, the Chinese medicine composition processed is prepared from by the bulk drug of following parts by weight：
Preparation method：Prepared by the methods described of embodiment 1.
Embodiment 3
A kind of Chinese medicine composition for treating ephritis, the main processed system of bulk drug by following parts by weight of the Chinese medicine composition
It is standby to form：
Preparation method：Prepared by the methods described of embodiment 1.
Embodiment 4
A kind of Chinese medicine composition for treating ephritis, the Chinese medicine composition processed is prepared from by the bulk drug of following parts by weight：
Preparation method：Prepared by the methods described of embodiment 1.
Embodiment 5
A kind of Chinese medicine composition for treating ephritis, the main processed system of bulk drug by following parts by weight of the Chinese medicine composition
It is standby to form：
Preparation method：Prepared by the methods described of embodiment 1.
Embodiment 6
A kind of Chinese medicine composition for treating ephritis, the Chinese medicine composition processed is prepared from by the bulk drug of following parts by weight：
Preparation method：Prepared by the methods described of embodiment 1.
Embodiment 7
A kind of Chinese medicine composition for treating ephritis, the main processed system of bulk drug by following parts by weight of the Chinese medicine composition
It is standby to form：
Preparation method：Prepared by the methods described of embodiment 1.
Embodiment 8
A kind of Chinese medicine composition for treating ephritis, the Chinese medicine composition processed is prepared from by the bulk drug of following parts by weight：
Preparation method：Prepared by the methods described of embodiment 1.
The granule of embodiment 9
Preparation method：
A) take lactose, beta-schardinger dextrin, xylitan monostearate and the carbomer of parts by weight to be well mixed, add Chinese medicine
The medicinal powder of composition, is stirred and evenly mixed, and softwood is made；
B) softwood a) obtained is put into granulator and extruded 40 mesh sieves, granule is made.
The granule of embodiment 10
Preparation method：Prepared by the methods described of embodiment 9.
The tablet of embodiment 11
Preparation method：
A) medicinal powder of Chinese medicine composition and the sodium starch glycol of parts by weight, dextrin are well mixed, obtain mixture；
B) xanthans, sodium alginate are dissolved in 75% ethanol, add the mixture that step a) is obtained, mixed, cross 24 mesh sieves
Granulation, under conditions of temperature is 60 °, is dried under reduced pressure, whole grain；
C) dry particl after whole grain is added into magnesium laurylsulfate, be well mixed, tabletting, 200 tablets, every weight are made
About 0.48g.
The tablet of embodiment 12
Preparation method：130 tablets are prepared by the methods described of embodiment 11, every weighs about 0.9g.
The pill of embodiment 13
Preparation method：
A) lactitol, western tragacanth, pregelatinized starch are placed in heating water bath, fused mass is made, add Chinese medicine composition
Medicinal powder, stir, it is dispersed in fused mass, dripping liquid is made；
B) hopper that dripping liquid is moved into pill dripping machine is incubated 80-90 DEG C, and condensate liquid is atoleine, condensate temperature
20-25 DEG C, condensation cured is carried out, pill is made；
C) pill is taken out, attachment condensate liquid is removed, dries, dripping pill 400 is made, every nearly weighs 0.2g.
The pill of embodiment 14
Preparation method：Dripping pill 150 is prepared into by the methods described of embodiment 13, every nearly weighs 0.6g.
Comparative examples 15
Preparation method：
A) medicinal powder of Chinese medicine composition and the starch of parts by weight, dextrin are well mixed, obtain mixture；
B) sodium alginate is dissolved in 75% ethanol, adds the mixture that step a) is obtained, mixed, cross the granulation of 24 mesh sieves,
Temperature be 60 ° under conditions of, be dried under reduced pressure, whole grain；
C) by the dry particl tabletting after whole grain, 200 tablets are made, every weighs about 0.48g.
The stability test of test example 1
1. accelerated test
The tablet described in the embodiment of the present invention 11 is taken, is divided into 3 batches, numbering is sample 1, sample 2 and sample 3 respectively, is taken pair
According to embodiment 15 tablet as reference substance, by sample and reference substance at 40 DEG C ± 2 DEG C, relative humidity be 75% ± 5%
Under conditions of place 6 months, 1 month during testing, 2 months, 3 months, 6 the end of month it is separately sampled once, by Chinese Pharmacopoeia
In regulation, detect character, the amount (labelled amount %) containing acteoside and the disintegration time limited of tablet, result of the test is shown in Table 1；
The three batches of samples and the accelerated test result of reference substance of the embodiment of table 1
Result above shows：The tablet of the present embodiment detects after 6 months accelerated tests, its character, containing acteoside
The testing index such as amount, disintegration time limited compared with 0 month substantially without obvious change；And the tablet of comparative examples 15 is placed
After 6 months, tablet surface is roughening, and part tablet has sliver phenomenon, and the content of acteoside is remarkably decreased, during disintegration
Limit extension；Show the tablet of the present invention compared with the tablet of comparative examples 15, stability is improved.
2. long term test
The tablet of the embodiment of the present invention 11 is taken, is divided into 3 batches, numbering is sample 1, sample 2 and sample 3 respectively, is taken to according to the facts
The tablet for applying example 15 is reference substance, and by sample and reference substance at 20 DEG C ± 2 DEG C of temperature, relative humidity is 60% ± 10%
Under the conditions of place 24 months, every 3 months sampling once, respectively at 0 month, 3 months, 6 months, 9 months, 12 months, 18 months,
24 months sample, detect tablet character, the amount (labelled amount %) containing acteoside and disintegration time limited, and by testing result with
Compare within 0 month, result of the test is shown in Table 2；
The three batches of samples and the long-term test results of reference substance of the embodiment of table 2
Result above shows, the sample of the present embodiment 11 is detected for 24 months through long term test, its character, contains verbascose
Testing index was compared with 0 month substantially without significantly changing when the amount of glycosides, disintegration etc.；And the tablet of comparative examples 15 is placed
After 9 months, there is spot in tablet surface, and sliver phenomenon occurs for part tablet surface；And the content of acteoside shows in tablet
Write and decline, disintegration time limited significantly extends；Show that the tablet of the invention stability compared with the tablet of comparative examples 15 is significantly carried
It is high；And the holding time is long.
3. conclusion
The tablet of the present embodiment was investigated through accelerated test, long-time stability experiment in 24 months in 6 months, when its character, disintegration
The project indicators such as limit, acteoside assay were compared with 0 month substantially without significant change, met its treatment standard, product
Steady quality.
The vitro release determination test of test example 2
The drug release rate detection of tablet:With reference to 2010 editions《Chinese Pharmacopoeia》Annex XIXD vitro drug releases degree is checked.
Above example 11-12 tablet is taken respectively, is put in medicament dissolution instrument, in 1h, 2h, 4h, 6h, 12h, 16h, 24h
It is separately sampled, dissolution percentage is detected with high performance liquid chromatography, and the cumulative release percentage of tablet is calculated, as a result see Fig. 1.
As can be seen from the figure embodiment 11-12 tablet, slowly discharges in 24h.
Clinical test
1. diagnostic criteria
According to《Chinese and western medical science diagnostics》It is described, renal insufficiency, including compensatory phase and Decompensated stage.
2. test case
Accept patient totally 62 for medical treatment, the age is between 30-50 Sui；Compensatory phase patient 32, decompensation are made a definite diagnosis on inspection
Phase patient 30.
3. packet and administration
32 compensatory phase patients are randomly divided into treatment group 20, control group 12；30 Decompensated stage patients are random
It is divided into treatment group 20, control group 10；The Chinese medicine group for the treatment ephritis that the embodiment of the present invention 1 is made is given by above treatment group
Compound, a 4g, 3 times a day, one week is a course for the treatment of, takes 6 courses for the treatment of；Control group gives oral shenyankangfu tablet, per chip base
Weight 0.48g, one time 8,3 times a day, one week be a course for the treatment of, take 6 courses for the treatment of.
4. observational technique
Each patient all records medical history, sign, diagnosis, painful area and property and relevant physics, physiology inspection.
5. efficacy assessment standard
Recovery from illness：Illness all disappears after treatment, reaches clinical cure standard；
It is effective：State of an illness sign is obviously improved after treatment；
Effectively：State of an illness sign makes moderate progress after treatment；
It is invalid：It is unchanged before and after treatment.
6. Treatment analysis
By the collated analysis of patient clinical data, by treatment group and control group in recovery from illness, effective, effective and invalid four marks
It is compared in standard, the difference between treatment group and control group is verified by examining.
7. result
The curative effect for the treatment of group and control group such as table 1~2.
The treatment group of table 1 and control group compare compensatory phase nephritis treatment effect
Treatment group is compared with control group with significant difference (Pa<0.01)；
The treatment group of table 2 and control group compare Decompensated stage nephritis treatment effect
Treatment group is compared with control group with significant difference (Pa<0.01)。
8. conclusion
The Chinese medicine composition and its oral formulations for the treatment ephritis that the present invention is provided are to compensatory phase, the renal function of Decompensated stage
There is no significant curative effect entirely, the compensatory phase treats cure rate up to 90%, and effective percentage reaches more than 100%；Decompensated stage treatment is fullyed recover from an illness
More rate is up to 85%, and effective percentage reaches 95%, and uneasy to recur；Its therapeutic effect is substantially better than control group.Verifying its curative effect
During, any adverse reaction and toxic side effect are not found.
Model case
Lee, female, 25 years old, Jixian Tianjin student suffered from renal insufficiency (Decompensated stage) 2 years, failed to control through multi-treatment
More, tablet made from the rear Chinese medicine composition with the present invention, takes 3 times, 13 every time, takes 16 weeks, the state of an illness is steadily controlled so far day
System does not develop so far.
Still certain, 29 years old, man, the plump people in Tangshan is renal insufficiency (Decompensated stage) 1.5 years, takes the Chinese medicine of the present invention
Tablet made from composition, takes 3 times, 12 every time, all state of an illness of medication 5-8 have been taken a turn for the better, and 19 weeks state of an illness are taken altogether and are steadily controlled day
System does not develop so far.
Sun, man, 32 years old, people from Yutian County suffered from renal insufficiency (compensatory phase) 0.5 year, failed to cure through multi-treatment, after
Pill made from taking the Chinese medicine composition of the present invention, takes 3 times, 10 every time, takes healing in 13 weeks, do not recur so far day.
Claims (7)
1. a kind of Chinese medicine composition for treating ephritis, it is characterised in that described for treating the renal insufficiency as caused by ephritis
Chinese medicine composition processed is prepared from by the bulk drug of following parts by weight：
A) Eclipta prostratas of the parts by weight, the bighead atractylodes rhizome, the dried rhizome of rehmannia, radix pseudostellariae, Poria cocos, rhizoma imperatae, the fruit of glossy privet, shell of areca nut decocting are taken first
Boil twice, add water for the first time as 10 times of medicinal material weight, decoct 2h, add water for the second time as 8 times of amounts of medicinal material weight, decoction
1.5h, collecting decoction, plus 95% ethanol make alcohol content up to 75%, and stirring stands overnight filtering, filtrate is in 0.08MPa, 65 DEG C of bars
Relative density is 1.15 when 65 DEG C are concentrated under reduced pressure under part, and medicinal powder 1 is made in spray drying；
B) Radixs Astragali of the parts by weight, oldenlandia diffusa, wrinkled giant hyssop, dried orange peel, umbellate pore furgus, radix glycyrrhizae alcohol reflux 3 times are taken, Jia 10 every time
The 80%-85% ethanol of amount, 65 DEG C of backflow 4h, reclaim ethanol and simultaneously concentrate again, and medicinal powder 2 is made in 65 DEG C of spray drying；
C) take the radix bupleuri of the parts by weight, rheum officinale, Radix Rhapontici seu Radix Echinopsis, Alectoria asiatica Du Rietz decocting to boil twice, add water for the first time as the 10 of medicinal material weight
Times, 2h is decocted, is added water for the second time as 8 times of amounts of medicinal material weight, decoction 1.5h, collecting decoction, plus ethyl acetate extraction, water layer liquid
Relative density is 1.15 when being concentrated under reduced pressure into 65 DEG C under the conditions of 0.08MPa, 65 DEG C, and medicinal powder 3 is made in spray drying；
D) medicinal powder 1, medicinal powder 2 and medicinal powder 3 of above-mentioned gained are well mixed, obtain Chinese medicine composition.
2. the oral formulations being made up of the Chinese medicine composition and auxiliary material of the treatment ephritis described in claim 1, it is characterised in that institute
Stating oral formulations includes oral liquid, granule, tablet, pill or capsule, the weight fraction of the Chinese medicine composition and auxiliary material
Than for 1:1.5-1:3.
3. the oral formulations of the Chinese medicine composition of ephritis are treated as claimed in claim 2, it is characterised in that the oral formulations
For granule, the auxiliary material is the lactose that parts by weight are 30-40 parts, 30-40 parts of beta-schardinger dextrin, 3-5 parts of xylitol acid anhydride list
Stearate and 3-5 parts of carbomer.
4. the oral formulations of the Chinese medicine composition of ephritis are treated as claimed in claim 2, it is characterised in that the oral formulations
For tablet, the auxiliary material is the dextrin that parts by weight are 25-35 parts, 25-35 parts of sodium starch glycol, 3-5 parts of laruyl alcohol sulphur
Sour magnesium, 10-15 parts of xanthans and 3-5 parts of sodium alginate.
5. the oral formulations of the Chinese medicine composition of ephritis are treated as claimed in claim 2, it is characterised in that the oral formulations
For pill, the auxiliary material is the lactitol that parts by weight are 50-60 parts, 3-5 parts of western tragacanth and 5-8 parts of pregelatinized starch.
6. a kind of preparation method of the oral formulations of the Chinese medicine composition of the treatment ephritis described in claim 4, it is characterised in that
The preparation method of the tablet comprises the following steps：
A) Chinese medicine composition and the sodium starch glycol of parts by weight, dextrin are well mixed, obtain mixture；
B) xanthans, sodium alginate are dissolved in 75% ethanol, add the mixture that step a) is obtained, mixed, cross the granulation of 24 mesh sieves,
Under conditions of temperature is 60 °, it is dried under reduced pressure, whole grain；
C) dry particl after whole grain is added into magnesium laurylsulfate, be well mixed, tabletting, packaging is produced.
7. a kind of preparation method of the oral formulations of the Chinese medicine composition of the treatment ephritis described in claim 5, it is characterised in that
Prepared by the pill comprises the following steps：
A) lactitol, western tragacanth and pregelatinized starch are placed in heating water bath, fused mass is made, added Chinese medicine composition, stir
Mix uniform, it is dispersed in fused mass, dripping liquid is made；
B) hopper that dripping liquid is moved into pill dripping machine is incubated 80-90 DEG C, and condensate liquid is atoleine, condensate temperature 20-25
DEG C, condensation cured is carried out, pill is made；
C) pill is taken out, attachment condensate liquid is removed, dried, packaging produces pill finished product.
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| CN105998936A (en) * | 2016-05-18 | 2016-10-12 | 孙福强 | Traditional Chinese medicine composition for treating chronic nephritis and renal insufficiency |
| WO2018163192A1 (en) * | 2017-03-06 | 2018-09-13 | Jagannathan V T | Herbal extract for promoting and managing benign prostatic hypertrophy (bph) and related ageing symptoms using extract from ageratum spp. |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102366588A (en) * | 2011-08-26 | 2012-03-07 | 赵守基 | Traditional Chinese medicine for treating nephritis |
| CN102552729A (en) * | 2012-02-16 | 2012-07-11 | 王建国 | Medicament for treating mesangial proliferative glomerulonephritis |
| CN103656538A (en) * | 2013-12-31 | 2014-03-26 | 青岛市市立医院 | Chinese medicinal preparation for treating hematuresis of latent glomerulonephritis |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102366588A (en) * | 2011-08-26 | 2012-03-07 | 赵守基 | Traditional Chinese medicine for treating nephritis |
| CN102552729A (en) * | 2012-02-16 | 2012-07-11 | 王建国 | Medicament for treating mesangial proliferative glomerulonephritis |
| CN103656538A (en) * | 2013-12-31 | 2014-03-26 | 青岛市市立医院 | Chinese medicinal preparation for treating hematuresis of latent glomerulonephritis |
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