CN103961582A - Traditional Chinese medicine composition for treating nephritis, and preparation and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating nephritis, and preparation and preparation method thereof Download PDFInfo
- Publication number
- CN103961582A CN103961582A CN201410221641.XA CN201410221641A CN103961582A CN 103961582 A CN103961582 A CN 103961582A CN 201410221641 A CN201410221641 A CN 201410221641A CN 103961582 A CN103961582 A CN 103961582A
- Authority
- CN
- China
- Prior art keywords
- chinese medicine
- medicine composition
- preparation
- nephritis
- treatment
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
The invention relates to a traditional Chinese medicine composition for treating nephritis. The traditional Chinese medicine composition is mainly prepared from the following medicinal raw materials in parts by weight: dried radix rehmanniae, astragalus membranaceus, radix pseudostellariae, poria cocos, rhizoma atractylodis macrocephalae, lalang grass rhizome, glossy privet fruit, eclipta alba, bupleurum, oldenlandia diffusa, agastache rugosa, rhubarb, pericarpium citri reticulatae, uniflower swisscentaury root, pericarpium arecae, polyporus umbellatus, liquorice and asiatic alectoria filament. The traditional Chinese medicine composition also provides an oral preparation, which comprises but not limited to oral liquid, granules, tablets, pills or capsules. The traditional Chinese medicine composition for treating nephritis and the preparation thereof disclosed by the invention are mainly used for treating renal insufficiency at a compensated stage and a decompensated stage, and the traditional Chinese medicine composition is significant in treatment effect, convenient to take and small in side effect.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, particularly a kind of Chinese medicine composition and preparation and preparation method for the treatment of nephritis.
Background technology
Renal insufficiency is caused by many reasons, glomerule heavy damage, the clinical syndrome later stage group that health is got muddled at aspects such as excretion metabolism refuse and adjusting Water-Electrolyte, acid-base balances.The compensatory phase renal hypofunction of renal insufficiency, but its excretion metabolism product and adjusting fluid and electrolyte balance ability still can meet normal need, do not occur clinically symptom, and renal function chemical examination also has slightly high phenomenon in normal range or idol.The compensatory phase of mistake of renal insufficiency, glomerule has more infringement, existing certain obstacle when renal excretion metabolic waste, and there is anemia in patient, and fatigue and weak loses weight, and spirit is difficult for concentrating etc.During compensatory stage of renal insufficiency and mistake are compensatory, effectively treat, cure rate is high.Chinese medicine is often taked the kidney warming, QI invigorating and the means such as invigorate blood circulation are treated renal insufficiency, and evident in efficacy, and toxic and side effects is little, has broad prospects.But in practice, because much Chinese medicine has the shortcomings such as onset is slow, curative effect is long, have a strong impact on its clinical practice.
Public announcement of a patent application number is that the application documents of CN102552729A disclose a kind of medicine for the treatment of mesangial proliferative glomerulonephritis, and this pharmaceutical formulation comprises the Radix Astragali, Radix Notoginseng, Herba Ecliptae, the Radix Rehmanniae, Radix Angelicae Sinensis, Colla Corii Asini, Herba Hedyotidis Diffusae, Rhizoma Imperatae, Herba Leonuri, Radix Rubiae Radix Et Rhizoma Rhei, Poria, Rhizoma Alismatis, Radix Rehmanniae Preparata, Fructus Ligustri Lucidi and Semen Cuscutae.Above-mentioned raw materials medicine is made to pure Chinese medicinal preparation, good drug efficacy, effect is obvious and be difficult for other pathological changes of initiation, reaches the effect for the treatment of mesangial proliferative glomerulonephritis.Although destroying to glomerule the nephritis causing, this Chinese medicine formula there is certain curative effect, but its effect is not remarkable, and due to the formula of its pure Chinese medicine, have that disintegration time is long, bioavailability is low and the shortcoming such as inherent quality is wayward, affect the absorption of human body to medicine.
Summary of the invention
In order to solve the problems of the technologies described above, the invention provides a kind of Chinese medicine composition and preparation thereof for the treatment of nephritis, cure mainly the compensatory phase of renal insufficiency and lose the compensatory phase, this traditional Chinese medicine composition for treating successful, taking convenience, side effect is little.
The concrete technical scheme of the present invention is as follows:
The invention provides a kind of Chinese medicine composition for the treatment of nephritis, this Chinese medicine composition is mainly prepared from through processing by the crude drug of following weight portion:
The compensatory phase of compositions provided by the present invention to renal insufficiency, lose the compensatory phase, evident in efficacy; Cure rate is high, and few side effects, and cost is low.
As the preferred version of above-mentioned technical characterictic, the present invention treat nephritis Chinese medicine composition, be prepared from through processing by the crude drug of following weight portion:
Further, in order to use and easy to carry, the Chinese medicine composition for the treatment of nephritis is made oral formulations by the present invention, and this oral formulations includes but not limited to oral liquid, granule, tablet, pill or capsule, and this Chinese medicine composition is 1:1.5-1:3 with the weight fraction ratio of adjuvant.
Further, treat the Chinese medicine composition of nephritis and oral formulations that adjuvant is made is granule by the present invention, adjuvant comprises that weight portion is the lactose of 30-40 part, beta-schardinger dextrin-, the xylitan monostearate of 3-5 part and the carbomer of 3-5 part of 30-40 part.
Lactose and beta-schardinger dextrin-use as excipient, make the better molding of granule, improve the stability of tablet simultaneously; Xylitan monostearate contributes to the dispersion of Chinese medicine composition, further improves the bioavailability of Chinese medicine composition, also plays the effect that promotes that each composition mixes simultaneously; Carbomer plays the effect of binding agent and correctives.
The mixing of above-mentioned adjuvant is used, and effect of principal agent is played to synergism, significantly improves molding and the stability of granule.
Further, treat the Chinese medicine composition of nephritis and oral formulations that adjuvant is made is tablet by the present invention, adjuvant comprises that weight portion is the dextrin of 25-35 part, the sodium starch glycol of 25-35 part, magnesium laurylsulfate, the xanthan gum of 10-15 part and the sodium alginate of 3-5 part of 3-5 part.
Dextrin and sodium starch glycol, as filler, improve bioavailability and stability; Sodium starch glycol plays the effect of disintegrating agent simultaneously, makes tablet Fast Stripping; Magnesium laurylsulfate has good lubrication, can increase mobility of particle, be beneficial to tablet to release nib, and its impact on tablet hardness is less.
Xanthan gum has good bio-compatibility and bioadhesive, prepare with the supplementary product compatibility such as sodium starch glycol, dextrin there is certain viscosity, the slow releasing tablet of hardness and dissolution rate, extend the action time of this medicine at specific part, slow down drug release, reduce administration number of times; Xanthan gum, in conjunction with the use of sodium alginate, improves stability, and the synergism of xanthan gum extends action time, prolongation curative effect.Tablet stable in properties provided by the invention, effective drug duration is long and evident in efficacy.
Further, treat the Chinese medicine composition of nephritis and oral formulations that adjuvant is made is pill by the present invention, described adjuvant comprises that weight portion is lactose, the tragacanth of 3-5 part and the pregelatinized Starch of 5-8 part of 50-60 part.
The lactose of low melting point substrate adjuvant is in conjunction with the tragacanth of plasticity substrate adjuvant, and preparation is simple, the pill stable in properties making, and in it, coherency and plasticity are high, and hardness is moderate; Pregelatinized Starch, as the disintegrating agent of pill, makes pill have good dissolving out capability, simultaneously because the viscose glue of pregelatinized Starch is low, can improve the viscose glue effect of mixture of powders and machine metal part in production process.The common use of adjuvant, plays synergism to effect of principal agent, significantly improves the molding of pill and stablizing of character; When drug action is lasting, stripping and the absorption rate of medicine are fast.
The invention provides the preparation method of Chinese medicine composition, can obtain by the direct water extraction of medicine of getting described weight portion, or be mixed to get by water extraction, alcohol extraction and ethyl acetate extraction.
Further, preparation method of the present invention comprises the steps:
A) Herba Ecliptae, the Rhizoma Atractylodis Macrocephalae, the Radix Rehmanniae, Radix Pseudostellariae, Poria, Rhizoma Imperatae, Fructus Ligustri Lucidi, the Pericarpium Arecae decocting of first getting described weight portion boil twice, add water for the first time as medical material weight 10 times, decoct 2h, add water for the second time as 8 times of amounts of medical material weight, decoct 1.5h, collecting decoction, adds 95% ethanol and makes to reach 75% containing alcohol amount, stirs, hold over night is filtered, filtrate when under 0.08MPa, 65 DEG C of conditions, concentrating under reduced pressure becomes 65 DEG C relative density be 1.15g/ml, spraying is dry, makes medicated powder 1;
B) get the Radix Astragali, Herba Hedyotidis Diffusae, Herba Pogostemonis, Pericarpium Citri Reticulatae, Polyporus, the Radix Glycyrrhizae alcohol reflux 3 times of described weight portion, add the 80%-85% ethanol of 10 times of amounts at every turn, 65 DEG C of backflow 4h, reclaim ethanol concentrated, and 65 DEG C of sprayings are dry, make medicated powder 2;
C) Radix Bupleuri, Radix Et Rhizoma Rhei, Radix Rhapontici, the Alectoria asiatica Du Rietz decocting of getting described weight portion boil twice, add water for the first time as medical material weight 10 times, decoct 2h, add water for the second time as 8 times of amounts of medical material weight, decoct 1.5h, collecting decoction, add ethyl acetate extraction, water layer liquid when under 0.08MPa, 65 DEG C of conditions, concentrating under reduced pressure becomes 65 DEG C relative density be 1.15g/ml, spraying is dry, makes medicated powder 3;
D), by the medicated powder of above-mentioned gained 1, medicated powder 2 and medicated powder 3 mix homogeneously, obtain the medicated powder of Chinese medicine composition.
The preparation method that the invention provides the tablet of the Chinese medicine composition for the treatment of nephritis, comprises the following steps:
A) by the sodium starch glycol of the medicated powder of Chinese medicine composition and weight portion, dextrin mix homogeneously, obtain mixture;
C) xanthan gum, sodium alginate are dissolved in to 75% ethanol, the mixture that adds step b) to obtain, mixes, and cross 24 mesh sieves and granulate, be under the condition of 60 ° in temperature, drying under reduced pressure, granulate;
D) the dry granule after granulate is added to magnesium laurylsulfate, mix homogeneously, tabletting, packs and get final product.
The present invention also provides the preparation method of the pill of the Chinese medicine composition for the treatment of nephritis, comprises the following steps:
A) lactose, tragacanth, pregelatinized Starch are placed in to heating in water bath, make fused mass, add the medicated powder of Chinese medicine composition, stir, it is dispersed in fused mass, make dripping liquid;
B) by the hopper insulation 80-90 DEG C of dripping liquid immigration pill dripping machine, condensed fluid is liquid paraffin, and condensate temperature 20-25 DEG C carries out condensation cured, makes pill;
C) take out pill, remove and adhere to condensed fluid, be dried, pack and obtain pill finished product.
The source of crude drug of the present invention is as follows:
The Radix Rehmanniae: another name Radix Rehmanniae, this product is the fresh or dried root of scrophulariaceae rehmannia glutinosa plant Rehmannia glutinosaLibosch..
The Radix Astragali: this product is the dry root of leguminous plant Radix Astagali Astragalus membranaceus (Fisch.) Bge.var.mongholicus (Bge.) Hsiao or Radix Astragali Astragalusmembranaceus (Fisch.) Bge..
Radix Pseudostellariae: this product is the dried root of pinkwort Radix Ginseng Pseudostellaria heterophylla (Miq.) Pax ex Pax et Hoffm..
Poria: this product is the dry sclerotia of On Polyporaceae Poria Poria cocos (Schw.) Wolf.
The Rhizoma Atractylodis Macrocephalae: this product is the dry rhizome of feverfew Rhizoma Atractylodis Macrocephalae Atractylodes macrocephala Koidz..
Rhizoma Imperatae: this product is the dry rhizome of grass Herba Imperatae Imperata cylindrica Beauv.var.major (Nees) C.E.Hubb..
Fructus Ligustri Lucidi: this product is the dry mature fruit of Oleaceae plants Fructus Ligustri Lucidi Ligustrum lucidum Ait..There is nourishing the liver and kidney, improving eyesight black hair effect.
Herba Ecliptae: this product is the dry aerial parts of feverfew Eclipta prostrata Eclipta prostrata L..When the flowers are in blossom, tap, dry.
Radix Bupleuri: this product is the dry root of umbelliferae bupleurum Bupleurum chinense DC. or Radix Bupeuri Scorzonerfolii. Bupleurum scorzonerifolium Willd..
Herba Hedyotidis Diffusae: this product is Rubiaceae plants of Hedyotis Herba Hedyotidis Diffusae Hedyotisdiffusa Willd.[Oldenlandia diffusa (Willd.) Roxb.] herb.Nature and flavor are sweet, light, cool.
Herba Pogostemonis: be the herb of labiate Herba Pogostemonis or Herba Pogostemonis.Herba Pogostemonis is gathered when grow prolifically between 6～July, and receive 2 times every year Hainan Region.
Radix Et Rhizoma Rhei: this product is the dry root and rhizome of polygonum rheum palmatum Rheum palmatum L., Rheum tanguticum Rheum tanguticum Maxim.ex Balf. or Rheum officinale Rheum officinale Baill..
Pericarpium Citri Reticulatae: this product is the dry mature skin of rutaceae orange Citrus reticulata Blanco and variety thereof.
Radix Rhapontici: this product is the dry root of feverfew centaurea monanthos Georgi Rhaponticum uniflorum (L.) DC..Spring, Qiu Erji excavate, and remove fibrous root and silt, dry.
Pericarpium Arecae: this product is the dry peel of babassu Semen Arecae Areca catechu L..
Polyporus: this product is the dry sclerotia of On Polyporaceae Polyporus Polyporus umbellatus (Pers.) Fries.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. Glycyrrhiza glabra L..
Alectoria asiatica Du Rietz: the filamentous that Usneaceae plant Asia tree sends out.Can adopt the whole year, removes impurity, dries.
The formula of the important composition for the treatment of nephritis of the present invention, non-stimulated, have no side effect; Obtain through clinical repetition test, cure mainly renal insufficiency, the compensatory phase, lose the compensatory phase, there is good curative effect; Stable in properties, instant effect, cure rate is high.
After the peroral dosage forms such as granulation agent, tablet, pill, use and carry conveniently, further having improved bioavailability and the curative effect of Chinese medicine composition; And preparation cost is low, be applicable to suitability for industrialized production.
Brief description of the drawings
The vitro release result of the test of tablet described in Fig. 1 embodiment 11-12.
Detailed description of the invention
Embodiment 1
Treat a Chinese medicine composition for nephritis, this Chinese medicine composition is mainly prepared from through processing by the crude drug of following weight portion:
Preparation method:
A) Herba Ecliptae, the Rhizoma Atractylodis Macrocephalae, Radix Rehmanniae, Radix Pseudostellariae, Poria, Rhizoma Imperatae, Fructus Ligustri Lucidi, the Pericarpium Arecae decocting of first getting described weight portion boil twice, add water for the first time as medical material weight 10 times, decoct 2h, add water for the second time as 8 times of amounts of medical material weight, decoct 1.5h, collecting decoction, adds 95% ethanol and makes to reach 75% containing alcohol amount, stirs, hold over night is filtered, filtrate when under 0.08MPa, 65 DEG C of conditions, concentrating under reduced pressure becomes 65 DEG C relative density be 1.15g/ml, spraying is dry, makes medicated powder 1;
B) get the Radix Astragali, Herba Hedyotidis Diffusae, Herba Pogostemonis, Pericarpium Citri Reticulatae, Polyporus, the Radix Glycyrrhizae alcohol reflux 3 times of described weight portion, add the 80%-85% ethanol of 10 times of amounts at every turn, 65 DEG C of backflow 4h, reclaim ethanol concentrated, and 65 DEG C of sprayings are dry, make medicated powder 2;
C) Radix Bupleuri, Radix Et Rhizoma Rhei, Radix Rhapontici, the Alectoria asiatica Du Rietz decocting of getting described weight portion boil twice, add water for the first time as medical material weight 10 times, decoct 2h, add water for the second time as 8 times of amounts of medical material weight, decoct 1.5h, collecting decoction, add ethyl acetate extraction, water layer liquid when under 0.08MPa, 65 DEG C of conditions, concentrating under reduced pressure becomes 65 DEG C relative density be 1.15g/ml, spraying is dry, makes medicated powder 3;
D), by the medicated powder of above-mentioned gained 1, medicated powder 2 and medicated powder 3 mix homogeneously, obtain the medicated powder of Chinese medicine composition.
Embodiment 2
Treat a Chinese medicine composition for nephritis, this Chinese medicine composition is prepared from through processing by the crude drug of following weight portion:
Preparation method: press method preparation described in embodiment 1.
Embodiment 3
Treat a Chinese medicine composition for nephritis, this Chinese medicine composition is mainly prepared from through processing by the crude drug of following weight portion:
Preparation method: press method preparation described in embodiment 1.
Embodiment 4
Treat a Chinese medicine composition for nephritis, this Chinese medicine composition is prepared from through processing by the crude drug of following weight portion:
Preparation method: press method preparation described in embodiment 1.
Embodiment 5
Treat a Chinese medicine composition for nephritis, this Chinese medicine composition is mainly prepared from through processing by the crude drug of following weight portion:
Preparation method: press method preparation described in embodiment 1.
Embodiment 6
Treat a Chinese medicine composition for nephritis, this Chinese medicine composition is prepared from through processing by the crude drug of following weight portion:
Preparation method: press method preparation described in embodiment 1.
Embodiment 7
Treat a Chinese medicine composition for nephritis, this Chinese medicine composition is mainly prepared from through processing by the crude drug of following weight portion:
Preparation method: press method preparation described in embodiment 1.
Embodiment 8
Treat a Chinese medicine composition for nephritis, this Chinese medicine composition is prepared from through processing by the crude drug of following weight portion:
Preparation method: press method preparation described in embodiment 1.
Embodiment 9 granules
Preparation method:
A) get lactose, beta-schardinger dextrin-, xylitan monostearate and the carbomer mix homogeneously of weight portion, add the medicated powder of Chinese medicine composition, stirring and evenly mixing, makes soft material;
B) soft material a) obtaining is put into granulator and pushed 40 mesh sieves, granulation agent.
Embodiment 10 granules
Preparation method: press method preparation described in embodiment 9.
Embodiment 11 tablets
Preparation method:
A) by the sodium starch glycol of the medicated powder of Chinese medicine composition and weight portion, dextrin mix homogeneously, obtain mixture;
B) xanthan gum, sodium alginate are dissolved in to 75% ethanol, the mixture that adds step a) to obtain, mixes, and cross 24 mesh sieves and granulate, be under the condition of 60 ° in temperature, drying under reduced pressure, granulate;
C) the dry granule after granulate is added to magnesium laurylsulfate, mix homogeneously, tabletting, makes 200 tablets of tablets, every heavily about 0.48g.
Embodiment 12 tablets
Preparation method: prepare 130 tablets of tablets by method described in embodiment 11, every heavily about 0.9g.
Embodiment 13 pills
Preparation method:
A) lactose, tragacanth, pregelatinized Starch are placed in to heating in water bath, make fused mass, add the medicated powder of Chinese medicine composition, stir, it is dispersed in fused mass, make dripping liquid;
B) by the hopper insulation 80-90 DEG C of dripping liquid immigration pill dripping machine, condensed fluid is liquid paraffin, and condensate temperature 20-25 DEG C carries out condensation cured, makes pill;
C) take out pill, remove and adhere to condensed fluid, dry, make 400 of drop pill, every nearly weighs 0.2g.
Embodiment 14 pills
Preparation method: be prepared into 150 of drop pill by method described in embodiment 13, every nearly weighs 0.6g.
Control Example 15
Preparation method:
A) by the starch of the medicated powder of Chinese medicine composition and weight portion, dextrin mix homogeneously, obtain mixture;
B) sodium alginate is dissolved in to 75% ethanol, the mixture that adds step a) to obtain, mixes, and cross 24 mesh sieves and granulate, be under the condition of 60 ° in temperature, drying under reduced pressure, granulate;
C), by the dry granule tabletting after granulate, make 200 tablets of tablets, every heavily about 0.48g.
Test example 1 stability test
1. accelerated test
Get the tablet described in the embodiment of the present invention 11, be divided into 3 batches, be numbered respectively sample 1, sample 2 and sample 3, get the tablet product in contrast of control Example 15, by sample and reference substance all at 40 DEG C ± 2 DEG C, relative humidity is to place 6 months under 75% ± 5% condition, sample respectively once 1 month, 2 months, 3 months, 6 the end of month at duration of test, by the regulation in Chinese Pharmacopoeia, detect the character of tablet, containing amount (labelled amount %) and disintegration of verbascoside, result of the test is in table 1;
Three batch samples of table 1 embodiment and the accelerated test result of reference substance
Above result shows: the tablet of the present embodiment detected after accelerated test through 6 months, its character, containing the testing index and more essentially no obvious variations in 0 month such as amount, disintegration of verbascoside; And the tablet of control Example 15 was placed after 6 months, tablet surface roughening, part tablet has sliver phenomenon, and the content of verbascoside significantly declines, and extend disintegration; Show that compared with the tablet of tablet of the present invention and control Example 15, stability improves.
2. long term test
Get the tablet of the embodiment of the present invention 11, be divided into 3 batches, be numbered respectively sample 1, sample 2 and sample 3, the tablet of getting control Example 15 is reference substance, by sample and reference substance all at 20 DEG C ± 2 DEG C of temperature, relative humidity is to place 24 months under 60% ± 10% condition, sampling in every 3 months once, respectively at sampling in 0 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, detect the character of tablet, containing amount (labelled amount %) and disintegration of verbascoside, and by testing result and comparison in 0 month, result of the test is in table 2;
Three batch samples of table 2 embodiment and the long-term test results of reference substance
Above result shows, the sample of the present embodiment 11 detects through long term test for 24 months, testing index and more essentially no obvious variations in 0 month such as when its character, the amount that contains verbascoside, disintegrate; And the tablet of control Example 15 was placed after 9 months, there is speckle in tablet surface, part tablet surface generation sliver phenomenon; And the content of verbascoside significantly declines in tablet, disintegration significant prolongation; Show compared with the tablet of tablet of the present invention and control Example 15 that stability significantly improves; And the holding time is long.
3. conclusion
The tablet of the present embodiment is through 6 months accelerated tests, 24 months long-time stability the effects, and the project indicators such as its character, disintegration, verbascoside assay and 0 month, more substantially without significant change, meet its treatment standard, constant product quality.
Test example 2 vitro release determination tests
The drug release rate of tablet detects: check with reference to 2010 editions " Chinese Pharmacopoeia " annex XIXD vitro drug release degree.
Get respectively the tablet of above embodiment 11-12, put in medicament dissolution instrument, sample respectively in 1h, 2h, 4h, 6h, 12h, 16h, 24h, detect stripping percentage rate by high performance liquid chromatography, and calculate the cumulative release percentage rate of tablet, the results are shown in Figure 1.
As can be seen from the figure the tablet of embodiment 11-12 slowly discharges in 24h.
Clinical trial
1. diagnostic criteria
Record according to " Chinese and western medical science diagnostics ", renal insufficiency, comprises the compensatory phase and loses the compensatory phase.
2. test case
Accept patient's totally 62 examples for medical treatment, the age is all between 30-50 year; All make a definite diagnosis on inspection compensatory phase patient 32 examples, lose compensatory phase patient 30 examples.
3. grouping and administration
32 routine compensatory phase patients are divided into treatment group 20 examples, matched group 12 examples at random; 30 examples are lost to compensatory phase patient and be divided at random treatment group 20 examples, matched group 10 examples; Above treatment group all gives the Chinese medicine composition of the treatment nephritis that the embodiment of the present invention 1 makes, a 4g, and 3 times on the one, one week is a course for the treatment of, takes 6 courses for the treatment of; Matched group gives oral shenyankangfu tablet, every basic weight 0.48g, one time 8,3 times on the one, one week is a course for the treatment of, takes 6 courses for the treatment of.
4. observational technique
Each patient all records medical history, sign, diagnosis, painful area and character and relevant physics, physiology inspection.
5. efficacy assessment standard
Recovery from illness: after treatment, disease all disappears, and reaches clinical cure standard;
Effective: after treatment, state of an illness sign is obviously improved;
Effective: after treatment, state of an illness sign makes moderate progress;
Invalid: unchanged before and after treatment.
6. treatment is analyzed
Patient clinical data, through finishing analysis, is compared treatment group and matched group in recovery from illness, effective, effective and invalid four standards, verify the difference between treatment group and matched group by inspection.
7. result
The curative effect for the treatment of group and matched group is as table 1～2.
Table 1 treatment group and matched group are to compensatory phase nephritis treatment effect comparison
Treatment group is compared with matched group and is had significant difference (P
a<0.01);
Table 2 treatment group and matched group are to losing compensatory phase nephritis treatment effect comparison
Treatment group is compared with matched group and is had significant difference (P
a<0.01).
8. conclusion
The Chinese medicine composition for the treatment of nephritis provided by the invention and oral formulations thereof to the compensatory phase, lose the renal insufficiency of compensatory phase and there is significant curative effect, compensatory phase treatment cure rate reaches 90%, effective percentage reaches more than 100%; Lose compensatory phase treatment cure rate and reach 85%, effective percentage reaches 95%, and is difficult for recurrence; Its therapeutic effect is obviously better than matched group.In its curative effect process of checking, do not find any untoward reaction and toxic and side effects.
Model case
Lee, female, 25 years old, Jixian Tianjin student, suffer from renal insufficiency (losing the compensatory phase) 2 years, fail to cure through multi-treatment, the tablet that rear use Chinese medicine composition of the present invention makes, day takes 3 times, each 13, to take 16 weeks, the state of an illness is steadily controlled so far not development so far.
Still certain, 29 years old, man, the plump people in Tangshan, be renal insufficiency (losing the compensatory phase) 1.5 years, take the tablet that Chinese medicine composition of the present invention makes, day takes 3 times, each 12,5-8 all state of an illness of taking medicine take a turn for the better to some extent, take altogether 19 weeks state of an illness and steadily control so far not development.
Grandson, man, 32 years old, people from Yutian County, suffered from renal insufficiency (compensatory phase) 0.5 year, fail to cure through multi-treatment, after take the pill that Chinese medicine composition of the present invention makes, day take 3 times, each 10, take healing in 13 weeks, do not recur so far.
Claims (10)
1. a Chinese medicine composition for the treatment of nephritis, is characterized in that, described Chinese medicine composition is mainly prepared from through processing by the crude drug of following weight portion:
2. the Chinese medicine composition for the treatment of nephritis as claimed in claim 1, is characterized in that, described Chinese medicine composition is prepared from through processing by the crude drug of following weight portion:
3. by the Chinese medicine composition of the treatment nephritis described in any one in claim 1-2 and the oral formulations that adjuvant is made, it is characterized in that, described oral formulations includes but not limited to oral liquid, granule, tablet, pill or capsule, and described Chinese medicine composition is 1:1.5-1:3 with the weight fraction ratio of adjuvant.
4. the oral formulations of the Chinese medicine composition for the treatment of nephritis as claimed in claim 3, it is characterized in that, described oral formulations is granule, and described adjuvant comprises that weight portion is the lactose of 30-40 part, beta-schardinger dextrin-, the xylitan monostearate of 3-5 part and the carbomer of 3-5 part of 30-40 part.
5. the oral formulations of the Chinese medicine composition for the treatment of nephritis as claimed in claim 3, it is characterized in that, described oral formulations is tablet, and described adjuvant comprises that weight portion is the dextrin of 25-35 part, the sodium starch glycol of 25-35 part, magnesium laurylsulfate, the xanthan gum of 10-15 part and the sodium alginate of 3-5 part of 3-5 part.
6. the oral formulations of the Chinese medicine composition for the treatment of nephritis as claimed in claim 3, is characterized in that, described oral formulations is pill, and described adjuvant comprises that weight portion is lactose, the tragacanth of 3-5 part and the pregelatinized Starch of 5-8 part of 50-60 part.
7. the preparation method of the Chinese medicine composition of the treatment nephritis as described in any one in claim 1-2, is characterized in that, can obtain by the direct water extraction of medicine of getting described weight portion, or be mixed to get by water extraction, alcohol extraction and ethyl acetate extraction.
8. a preparation method for the Chinese medicine composition for the treatment of nephritis claimed in claim 6, is characterized in that, described preparation method comprises the steps:
A) Herba Ecliptae, the Rhizoma Atractylodis Macrocephalae, the Radix Rehmanniae, Radix Pseudostellariae, Poria, Rhizoma Imperatae, Fructus Ligustri Lucidi, the Pericarpium Arecae decocting of first getting described weight portion boil twice, add water for the first time as medical material weight 10 times, decoct 2h, add water for the second time as 8 times of amounts of medical material weight, decoct 1.5h, collecting decoction, adds 95% ethanol and makes to reach 75% containing alcohol amount, stirs, hold over night is filtered, filtrate when under 0.08MPa, 65 DEG C of conditions, concentrating under reduced pressure becomes 65 DEG C relative density be 1.15g/ml, spraying is dry, makes medicated powder 1;
B) get the Radix Astragali, Herba Hedyotidis Diffusae, Herba Pogostemonis, Pericarpium Citri Reticulatae, Polyporus, the Radix Glycyrrhizae alcohol reflux 3 times of described weight portion, add the 80%-85% ethanol of 10 times of amounts at every turn, 65 DEG C of backflow 4h, reclaim ethanol concentrated, and 65 DEG C of sprayings are dry, make medicated powder 2;
C) Radix Bupleuri, Radix Et Rhizoma Rhei, Radix Rhapontici, the Alectoria asiatica Du Rietz decocting of getting described weight portion boil twice, add water for the first time as medical material weight 10 times, decoct 2h, add water for the second time as 8 times of amounts of medical material weight, decoct 1.5h, collecting decoction, add ethyl acetate extraction, water layer liquid when under 0.08MPa, 65 DEG C of conditions, concentrating under reduced pressure becomes 65 DEG C relative density be 1.15g/ml, spraying is dry, makes medicated powder 3;
D), by the medicated powder of above-mentioned gained 1, medicated powder 2 and medicated powder 3 mix homogeneously, obtain the medicated powder of Chinese medicine composition.
9. a preparation method for the oral formulations of the Chinese medicine composition for the treatment of nephritis claimed in claim 5, is characterized in that, the preparation method of described tablet comprises the following steps:
A) by the sodium starch glycol of the medicated powder of Chinese medicine composition and weight portion, dextrin mix homogeneously, obtain mixture;
B) xanthan gum, sodium alginate are dissolved in to 75% ethanol, the mixture that adds step a) to obtain, mixes, and cross 24 mesh sieves and granulate, be under the condition of 60 ° in temperature, drying under reduced pressure, granulate;
C) the dry granule after granulate is added to magnesium laurylsulfate, mix homogeneously, tabletting, packs and get final product.
10. a preparation method for the oral formulations of the Chinese medicine composition for the treatment of nephritis claimed in claim 6, is characterized in that, described pill preparation comprises the following steps:
A) lactose, tragacanth and pregelatinized Starch are placed in to heating in water bath, make fused mass, add the medicated powder of Chinese medicine composition, stir, it is dispersed in fused mass, make dripping liquid;
B) by the hopper insulation 80-90 DEG C of dripping liquid immigration pill dripping machine, condensed fluid is liquid paraffin, and condensate temperature 20-25 DEG C carries out condensation cured, makes pill;
C) take out pill, remove and adhere to condensed fluid, be dried, pack and obtain pill finished product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410221641.XA CN103961582B (en) | 2014-05-23 | 2014-05-23 | Treat the Chinese medicine composition and its preparation and preparation method of ephritis |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410221641.XA CN103961582B (en) | 2014-05-23 | 2014-05-23 | Treat the Chinese medicine composition and its preparation and preparation method of ephritis |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN103961582A true CN103961582A (en) | 2014-08-06 |
| CN103961582B CN103961582B (en) | 2017-10-13 |
Family
ID=51231902
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410221641.XA Active CN103961582B (en) | 2014-05-23 | 2014-05-23 | Treat the Chinese medicine composition and its preparation and preparation method of ephritis |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103961582B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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. |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
-
2014
- 2014-05-23 CN CN201410221641.XA patent/CN103961582B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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. |
Also Published As
| Publication number | Publication date |
|---|---|
| CN103961582B (en) | 2017-10-13 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101254247B (en) | Pharmaceutical combination with depression resistance and angst resistance effect and method of preparing the same | |
| CN102416139B (en) | Chinese medicine composition for treating breast diseases | |
| CN106324174A (en) | Quality standard for traditional Chinese medicine formula granules | |
| CN101254261B (en) | Pharmaceutical combination with hypnogenesis, depression resistance and angst resistance effect and method of preparing the same | |
| CN104771563A (en) | Kidney tonifying Chinese herbal medicine compound preparation and preparation method thereof | |
| CN106110143B (en) | Preparation process of gynecological reconstitution preparation | |
| CN103285207B (en) | Miao medicine for treating dysfunctional uterine bleeding and preparation method thereof | |
| CN102343026B (en) | Traditional Chinese medicine composition for treating diabetes and preparation method thereof | |
| CN103961582A (en) | Traditional Chinese medicine composition for treating nephritis, and preparation and preparation method thereof | |
| CN101129448A (en) | Compositions for preventing and controlling climacteric syndrome and osteoporosis, and processes for producing the same | |
| CN100488544C (en) | Improved Chinese medicinal capsule for treating climacteric syndrome | |
| CN105267559A (en) | Diabetic peripheral neuropathy treatment medicine and manufacturing method thereof | |
| CN105853759B (en) | Traditional Chinese medicine composition, extract thereof, preparation method thereof and application thereof | |
| CN103156976A (en) | Traditional Chinese medicine dispersible tablet used for regulating menstruation and tonifying blood and preparation method thereof | |
| CN103386106B (en) | Drug for curing allergic rhinitis and preparation method thereof | |
| CN102178891B (en) | Chinese medicinal dispersible tablets for treating gastritis and preparation method thereof | |
| CN101474332A (en) | Danxiang capsule and preparation method thereof | |
| CN103961602B (en) | The treatment Chinese medicine composition of chronic gastritis and tablet thereof and preparation method | |
| CN101380437B (en) | Medicine for treating hysteromyoma | |
| CN101991760A (en) | Chinese patent medicine for treating climacteric syndrome and preparation method thereof | |
| CN101375989B (en) | Anti-inflammation formulation for treating hyperplastic prostate gland and preparation method thereof | |
| CN106729408B (en) | Traditional Chinese medicine preparation for treating hysteromyoma and preparation method thereof | |
| CN110585387A (en) | Bone-strengthening and tendon-relaxing medicine and preparation method thereof | |
| CN105232912A (en) | Compound rhubarb capsules for treating acne | |
| CN106309636B (en) | Pharmaceutical composition for uterine bleeding |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |