CN1256124C - Blood-supplementing medicine composition - Google Patents
Blood-supplementing medicine composition Download PDFInfo
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- CN1256124C CN1256124C CNB031092810A CN03109281A CN1256124C CN 1256124 C CN1256124 C CN 1256124C CN B031092810 A CNB031092810 A CN B031092810A CN 03109281 A CN03109281 A CN 03109281A CN 1256124 C CN1256124 C CN 1256124C
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Abstract
The present invention relates to a blood-supplementing medicament composition and a preparation method thereof. The medicament composition comprises the components of donkey-hide gelatin, red dates, wolfberry fruit, radices paeoniae alba, prepared rehmannia root, Codonopsis pilosula, milk vetch, haw and crystal sugar. The present invention has the preparation method that the red date, the wolfberry fruit, the radix paeoniae alba, the prepared rehmannia root, the codonopsis pilosula, the milk vetch and the haw are taken and are decocted and manufactured with water for 2 to 5 hours; the donkey-hide gelatin and/or the crystal sugar are added to be decocted and prepared; filtering is carried out, and then, the filtering liquid is concentrated; and afterwards, the filtering liquid is made into various dosage forms by a conventional preparation method. The present invention has no poison and side effects, and has the efficiencies of supplementing blood and nourishing Yin, moistening and stopping bleeding, warming and supplementing liver and kidney, and replenishing vital essence and cultivating blood. The present invention has obvious curative effects on the treatment of symptoms of lung dryness and cough, blood deficiency and chlorosis, dizziness and vertigo, dysphoria and insomnia, poor appetite, impotence and spermatorrhea, soreness of waists and knees, asthenic diseases, thinness, etc.
Description
Technical field
The present invention relates to a kind of hematonic compositions and preparation method thereof.
Background technology
At present, that sell on the market or common treatment because the blood deficiency and yellow complexion, the xeropulmonary cough that cause of deficiency of the kidney yin table, have a dizzy spell, dysphoria and insomnia, inappetence, sexual impotence spermatorrhea, the acid of waist knee joint are cold, asthenia is won disease such as thin medicine, medicines such as whip ball class are arranged, but the curative effect of these medicines is very indefinite, therapeutic effect is not good yet, or mouthfeel is poor, the cost height, price is also more expensive, and the inventor has proposed the present invention at the shortcoming of these medicines just.
Summary of the invention
The purpose of this invention is to provide a kind of hematonic compositions and preparation method thereof, overcome present Drug therapy blood deficiency and yellow complexion, xeropulmonary cough, had a dizzy spell, that dysphoria and insomnia, inappetence, sexual impotence spermatorrhea, the acid of waist knee joint are cold, asthenia is won disease curative effect such as thin is very indefinite, therapeutic effect is not good, or mouthfeel is poor, the cost height, the shortcoming that price is more expensive.
The objective of the invention is to finish by the following technical programs:
Hematonic compositions of the present invention comprises donkey glue, Fructus Jujubae, Fructus Lycii, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Radix Codonopsis, the Radix Astragali, Fructus Crataegi component.
Described component is following parts by weight of component: donkey glue 30-70, Fructus Jujubae 10-30, Fructus Lycii 2-7, Radix Paeoniae Alba 1-3, Radix Rehmanniae Preparata 1-3, Radix Codonopsis 1-3, Radix Astragali 1-3, Fructus Crataegi 1-3.
Described component is preferably following parts by weight of component: donkey glue 60, Fructus Jujubae 20, Fructus Lycii 5, the Radix Paeoniae Alba 2, Radix Rehmanniae Preparata 2, Radix Codonopsis 2, the Radix Astragali 1, Fructus Crataegi 2.
For reaching the better purpose of lung moistening and mouthfeel, described compositions also contains following parts by weight of component: crystal sugar 2-6.
Described pharmaceutical composition is a said dosage form on any pharmaceutics.
Described pharmaceutical composition is preferably oral liquid, piece agent, electuary.
The preparation method of hematonic compositions of the present invention may further comprise the steps: get Fructus Jujubae, Fructus Lycii, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Radix Codonopsis, the Radix Astragali, Fructus Crataegi adds water and boiled 2-5 hour, add donkey glue and/or crystal sugar and boil, filter, filtrate concentrates, and the preparation method is made various dosage forms routinely again.
The described water that adds boils, and behind 100 ℃ of the initial Wen Huozhi, vigorous fire boiled 2 hours again, and boiling pressure is 1-2 atmospheric pressure.
Described adding donkey glue and/or the crystal sugar time of boiling are 1-2 hour.
Described 120 mesh sieves that are filtered into filter.
Described filtrate simmer down to temperature fire concentrates, and the concentrated solution water content is 50%, can be made into oral liquid.
Described filtrate simmer down to temperature fire concentrates, and the simmer down to water content is 15% wet piece, can be made into the piece agent.
Solution of the present invention is based on understanding and the Therapeutic Principle of motherland's medical science to treatment deficiency of the kidney yin surface diseases and comprehensive regulating body function mechanism, achieve with reference to modern pharmacological research, from motherland's medicine treasure-house, filter out nourishing kidney-yin, QI invigorating void, change congestion, pure and impurely stagnate, the body resistance strengthening and constitution consolidating, the homologous natural edible-plant medicine of medicated diet, monarch prescription by theory of Chinese medical science, skim the cream off milk, the effect that makes its performance enrich blood YIN nourishing, moisturize hemostasis, temperature compensation Liver and kidney, beneficial intensive culture blood increases biological activity and immunity of organisms.
Donkey glue has another name called Colla Corii Asini, and the medicine for nourishing blood thing boils the blob of viscose that forms for donkey skin.Sweet in the mouth, property is flat.Go into lung, liver, kidney channel.Can enrich blood, YIN nourishing, lung moistening, and anastalsis is arranged.
Fructus Jujubae, the medicine for nourishing blood thing, sweet in the mouth, warm in nature.Go into lung, liver, kidney channel.Can enrich blood, YIN nourishing.
Fructus Lycii, yin nourishing class medicine is the dry mature fruit of matrimony vine of solanaceae plant.Sweet in the mouth, property is flat.Go into liver, kidney channel.Can nourishing the liver and kidney.
The Radix Paeoniae Alba, yin nourishing class medicine is the dry root of ranunculaceae plant Radix Paeoniae.Bitter in the mouth, acid, cold nature.Go into Liver Channel.Can yin fluid astringing enrich blood, and effect such as suppressing the hyperactive liver Shu Jing is arranged.
Radix Rehmanniae Preparata, the medicine for nourishing blood thing steams the product that steam of solarization repeatedly with wine for Radix Rehmanniae.Sweet in the mouth, slightly warm in nature.Go into the heart, liver, kidney channel.Can enrich blood, YIN nourishing, promoting the production of body fluid to quench thirst.
Radix Codonopsis, QI invigorating class medicine is the dry root of campanulaceae plant Radix Codonopsis.Sweet in the mouth, property is flat.Go into spleen, lung meridian.Energy strongly invigorating primordial QI, promoting the production of body fluid to quench thirst.Be the main medicine in the deficiency tonifying kind medicine.
The Radix Astragali, QI invigorating class medicine is the dry root of the leguminous plant Radix Astragali.Sweet in the mouth, warm in nature.Go into spleen, lung meridian.Energy QI invigorating, consolidating superficial resistance, and effects such as poison holding, granulation promoting and diuresis are arranged.
Fructus Crataegi, digestion class medicine is the dry mature fruit of rosaceous plant Fructus Crataegi or Crataegi cuneatae.Sour in the mouth, sweet, slightly warm in nature.Go into spleen, stomach, Liver Channel.Energy promoting digestion and removing stagnation, and the effect of stimulating the menstrual flow of becoming silted up of dispelling.
Medicine material of the present invention all can be buied from market, selects the top grade raw material for use.
Effect of the present invention and indication: have the YIN nourishing of enriching blood, moisturize hemostasis, the effect of temperature compensation Liver and kidney, beneficial intensive culture blood, be used for the treatment of xeropulmonary cough, blood deficiency and yellow complexion, have a dizzy spell, dysphoria and insomnia, inappetence, sexual impotence spermatorrhea, the acid of waist knee joint are cold, asthenia is won diseases such as thin.
The present invention has the following advantages:
1, determined curative effect, therapeutic effect is good.
2, mouthfeel is good, at the bottom of the cost.
3, select the homologous natural edible-plant medicine of medicated diet for use, have no side effect.
For proving blood tonification effect of the present invention, the inventor has done following test: to the influence of " void " card animal model
1. mice loses blood and causes " blood deficiency " model test
1.1 test objective
Causing " blood deficiency " animal model with the method for losing blood, is index with Hb, RBC, observes to be subjected to the reagent thing that this model is had or not blood tonification effect.
1.2 be subjected to the reagent thing: oral liquid of the present invention, every 100ml contains crude drug in whole 160g.Positive control drug: celestial being side's element (YXS) that nourishes blood, form by Radix Ginseng, the Radix Astragali, Cornu Cervi Pantotrichum, Colla Corii Asini etc., can benefiting qi and nourishing blood, be used for all cards of blood deficiency such as anemia that a variety of causes causes, deficiency of vital energy and physically weak.Specification and consumption: capsule, every box 0.28g * 12, every day 3 times, each 1.The sharp Pharma Inc. of Jilin Province ginseng industry group state produces.Proportionately 60 kilograms of calculating of body weight for humans, said preparation dosage every day are 0.014g (capsule 's content)/kg body weight.Join method: get capsule 's content 1.5g adding distil water to 100ml, promptly get experimental drug.
1.3 animal: Kunming mouse, closed colony＞30 generations, body weight 20-22g is provided by the institute of Chinese materia medica, Anhui Province.
1.4 reagent, instrument
Reagent: the hemoglobin conversional solution is that Hefei medical science detects the institute product; The injection normal saline, the 500ml/ bottle is a Hefei Pharmaceutical limited company product.
Instrument: day island proper Tianjin UV-730 automatic biochemical colour comparatour; Day island proper Tianjin EB-3200D type precise electronic balance.
1.5 test method
Get 54 of female mices, get blood 0.5ml through the socket of the eye vein, survey RBC and Hb simultaneously, survey RBC and Hb behind the 48h again, by RBC after losing blood and Hb number, mice is divided into 5 groups at random, i.e. 1. matched group, 2. 4g of the present invention (crude drug amount)/kg group, 3. 8g of the present invention (crude drug amount)/kg group, 4. 16g of the present invention (crude drug amount)/kg group, 5. YXS0.15g (capsule 's content)/kg group (be equivalent to clinical daily dose 10.7 times).Every day is ig the present invention according to dosage and YXS respectively, the 0.1ml/10g body weight, and matched group ig respective volume distilled water, continuous 6d, 1h after the administration in the 6th day gets blood and surveys RBC and Hb, observes being subjected to the influence of reagent thing to RBC and Hb.
1.6 result of the test (see Table 1, table 2)
Table 1 the present invention to the influence of mice " blood deficiency " model Hb (+± SD)
| Group | Number of animals (only) | Dosage (g/kg * d) | Preceding Hb (g/L) loses blood | The preceding Hb (g/L) of the back administration of losing blood | Hb (g/L) after the administration after losing blood |
| Normal group model group YXS of the present invention of the present invention | 10 8 12 12 12 10 | / / 4×6 8×6 16×6 0.15×6 | 12.9±0.8 13.1±0.9 12.8±0.5 12.7±1.2 12.9±0.9 15.1±0.6 | 13.1±0.8 11.4±1.9##△ 11.3±2.1△ 11.2±1.4△ 11.5±1.3△ 11.2±2.3△ | 12.5±0.8 8.8±0.9## 12.0±2.1* 9.8±0.5* 11.0±0.7** 11.0±0.5** |
Compare with normal group: # represents P＜0.05; ## represents P＜0.01.
Compare with matched group: * represents P＜0.05; * represents P＜0.01.
With the preceding comparison (paired t-test) of losing blood on the same group, △ P＜0.01.
Table 2 the present invention to the influence of mice " blood deficiency " model RBC (+± SD)
| Group | Number of animals (only) | Dosage (g/kg * d) | Preceding RBC (10 loses blood 12/L) | The preceding RBC (10 of the back administration of losing blood 12/L) | RBC (10 after the administration after losing blood 12/L) |
| Normal group model group YXS of the present invention of the present invention | 10 8 12 12 12 10 | / / 4×6 8×6 16×6 0.15×6 | 8.1±0.2 7.8±0.7 7.6±0.8 7.6±0.2 7.8±0.6 7.1±0.3 | 6.0±0.3 3.4±1.0##△ 2.8±1.0△ 3.3±0.7△ 2.9±0.5△ 3.1±0.8△ | 6.1±0.3 5.0±0.7## 5.5±0.3* 5.7±0.3* 5.6±0.4* 5.6±0.3* |
Compare with the normal control group: # represents P＜0.05; ## represents P＜0.01.
Compare with model control group: * represents P＜0.05; * represents P＜0.01.
With the preceding comparison (paired t-test) of losing blood on the same group, △ P＜0.01.
1.7 conclusion (of pressure testing)
Result of the test shows that " blood deficiency " model RBC and Hb that the present invention causes losing blood all improve significantly.
2. mice hunger causes " deficiency of vital energy " model test
2.1 test objective
Causing " deficiency of vital energy " animal model with starvation method, is index with Hb, RBC and immune organ organ coefficient, observes to be subjected to the reagent thing that this model is had or not " QI invigorating " effect.
2.2. be subjected to the reagent thing: oral liquid of the present invention is the same.Positive control drug: BUZHONG YIQI WAN (BZYQW), an oral 6g, 3 times on the one.The Hefei pharmaceutical factory of traditional Chinese medicine produces.Calculate by adult's 60 kg body weight, said preparation dosage every day is 0.3g (pill)/kg body weight.Join method: the ball 32g porphyrize of getting it filled, adding distil water promptly gets experimental drug to 100ml.
2.3 animal: Kunming mouse, closed colony＞30 generations, body weight 20-22g is provided by the institute of Chinese materia medica, Anhui Province.
2.4 reagent, instrument
Reagent: the hemoglobin conversional solution is that Hefei medical science detects the institute product; The injection normal saline, the 500ml/ bottle is a Hefei Pharmaceutical limited company product.
Instrument: day island proper Tianjin UV-730 automatic biochemical colour comparatour; Day island proper Tianjin EB-3200D type precise electronic balance.
2.5 test method
Get 66 of female mices, be divided into 6 groups at random, every group 11, i.e. 1. normal control group, 2. model of qi-asthenia group, 3. 4g of the present invention (crude drug amount)/kg group, 4. 8g of the present invention (crude drug amount)/kg group, 5. 16g of the present invention (crude drug amount)/kg group, 6. BZYQW3.2/kg group (be equivalent to clinical daily dose 10.7 times).Except that 1. organizing, other organizes equal limiting feed amount (forage volume is 100g/kg/d), 3. 4. 5. 6. organize simultaneously difference ig the present invention according to dosage every day and BZYQW, 1. 2. organize ig respective volume distilled water, continuous 7d, 1h after the last administration, eye socket is got blood and is surveyed RBC and Hb, and dissect title thymus, spleen, liver, adrenal gland's organ weights, and calculate organ coefficient (mg/10g), observe the influence of the present invention to above-mentioned organ weight and RBC and Hb.
2.6 result of the test (see Table 3, table 4)
Table 3 the present invention to the influence of mice model of qi-asthenia thymus, spleen, liver, adrenal gland's coefficient (+± SD)
| Group | Number of animals (only) | Dosage (g/kg * d) | Thymus (mg/10g) | Spleen (mg/0g) | Liver (mg/10g) | Adrenal gland (mg/10g) |
| Normal group model group BZYQW of the present invention of the present invention | 11 11 11 11 11 11 | - - 4×7 8×7 16×7 3.2×7 | 45.7±18.0 35.8±7.7 32.5±15.2 41.6±14.7 33.9±17.9 36.7±12.5 | 56.5±12.8 38.3±11.8## 37.8±12.8 42.9±10.8 40.8±8.7 40.2±12.9 | 567.5±37.6 568.3±52.1 578.9±48.4 579.6±56.9 568.2±41.8 557.5±52.6 | 4.8±0.7 3.5±0.4## 4.0±0.8 4.7±0.7** 4.8±0.8** 4.5±0.4** |
Compare with the normal control group: # represents P＜0.05; ## represents P＜0.01.
Compare with model control group: * represents P＜0.05; * represents P＜0.01.
Table 4 the present invention to the influence of mice model of qi-asthenia RBC and Hb (+± SD)
| Group | Number of animals (only) | Dosage (g/kg * d) | Hb (g/L) | RBC (1012/L) |
| Normal control group model of qi-asthenia group BZYQW of the present invention of the present invention | 11 11 11 11 11 11 | / / 4×7 8×7 16×7 3.2×7 | 14.1±1.3 11.1±0.8## 13.3±1.2** 12.6±1.0** 11.9±1.2 12.7×1.0** | 5.0±0.4 4.0±0.3## 4.4±0.4** 4.8±0.4** 4.1±0.4 4.6±0.8** |
Compare with the normal control group: # represents P＜0.05; ## represents P＜0.01.
Compare with model control group: * represents P＜0.05; * represents P＜0.01.
2.7 conclusion (of pressure testing)
Result of the test shows that " deficiency of vital energy " mice RBC number and Hb content that 3 dosage groups of the present invention cause hunger all improve significantly, and obviously increase adrenal gland's weight.
For the proof present composition has no side effect, the inventor has done following test:
One, phase I test
Pharmaceutical composition of the present invention has been carried out the oral acute toxicity (LD of mice
50) mensuration.
1, animal Kunming outbreeding system mice (male and female half and half) is 40, and body weight 180-220g is provided by institute of oncology, Anhui Experimental Animal Center.Animal Lab. is 24 ± 1 ℃ of constant temperature, and relative humidity is 50-70%, and artificial lighting's (time phase: 12 hours bright, and 12 hours dark) divides cylinder to raise, and 5 in every cylinder is fed with common mice piece material, freely drinks water.
2, experimental technique
Sample is a medicine concentrated solution of the present invention, and is as follows.
Mice is pressed the horn method random assortment, establishes four groups, and 10 every group, male and female half and half, each is organized dosage and is respectively 10580mg/kg, 5010mg/kg, 2140mg/kg, 1000mg/kg.Preceding jejunitas 14 hours of administration, drinking-water is not limit.Gastric infusion according to dosage, per 10 gram body weight are irritated stomach 0.3ml, and 2 hours feedings after the administration were observed 14 days.Performance and death condition that every day, the observed and recorded animal poisoned.Dead animal performs an autopsy on sb, and weighs once in per 7 days.
Mice is pressed the horn method random assortment, establishes four groups, and 10 every group, male and female half and half, each is organized dosage and is respectively 22000mg/kg, 10580mg/kg, 5010mg/kg, 2140mg/kg, medication is the same.
3, computational methods
Calculate following parameters, animal half lethal dose (LD with simplifying probit's general formula
50).
4, experimental result
Medicine of the present invention is to the oral LD of mice
50＞10580mg/kg, true border innocuous substance, the LD of male and female mice
50No significant difference (table 1).
Table 1 medicine of the present invention is to chmice acute toxicity (LD
50) measurement result
| Dosage (mg/kg) | Number of animals (only) | Death toll (only) | ||
| Male | Female | Male | Female | |
| 1000 | 5 | 5 | 0 | 0 |
| 2140 | 5 | 5 | 0 | 0 |
| 5010 | 5 | 5 | 0 | 0 |
| 10580 | 5 | 5 | 0 | 0 |
Medicine of the present invention is to chmice acute toxicity (LD
50) measurement result
| Dosage (mg/kg) | Number of animals (only) | Death toll (only) | ||
| Male | Female | Male | Female | |
| 2140 | 5 | 5 | 0 | 0 |
| 5010 | 5 | 5 | 0 | 0 |
| 10580 | 5 | 5 | 0 | 0 |
| 22000 | 5 | 5 | 0 | 0 |
5, judge: can carry out the second stage test
Two, second stage test
In view of this product rat oral LD50＞10580mg/kg, the cumulative toxicity experiment in the second stage is omitted, and does following three mutagenicity tests in accordance with regulations.
(1) Salmonella reversion test
1, test method: by the unified approach test of domestic regulation.Treated before the sample test.
2, strain: by the salmonella typhimurium strain of California, USA university Ames Lab introduction, TA98, TA100, TA97, TA102 four strains through five CHARACTERISTICS IDENTIFICATION, show that enzymatic activity is good recently.
3, S-9 liver particle enzyme is prepared recently by this chamber, through identifying with known mutagen, shows that enzymatic activity is good.
4, dosage and contrast:, done following various dose test simultaneously, various triplicates by above-mentioned condition and method.Employing standard plate mixes method, and each plate adds and tried thing 0.1ml.
1. this medicine 1mg/ ware
2. this medicine 2.5mg/ ware
3. this medicine 5mg/ ware
4. this medicine 10mg/ ware
Negative control: do not add S-9 activation system mitomycin 0.5 μ g/10 μ l,
Positive control: add S-9 activation system Hydrazoic acid,sodium salt 5 μ g/10 μ l.
5, calculate returning of growing on the culture medium and become bacterium colony
The results are shown in Table 2
Table 2 medicine Salmonella reversion test of the present invention result
| Sample title and dosage (μ g/m) | Every flat board returns the change clump count | |||||||
| TA96 | TA100 | TA97 | TA102 | |||||
| -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | |
| From beaming back change | 27 | 36 | 14 | 165 | 126 | 108 | 216 | 222 |
| Medicine 1000 of the present invention | 25 | 32 | 37 | 158 | 120 | 115 | 196 | 212 |
| Medicine 2140 of the present invention | 28 | 33 | 140 | 158 | 126 | 113 | 190 | 208 |
| Medicine 5010 of the present invention | 27 | 30 | 148 | 157 | 122 | 121 | 188 | 208 |
| Medicine 10580 of the present invention | 23 | 34 | 140 | 163 | 115 | 114 | 201 | 204 |
| Negative control | 26 | 38 | 47 | 148 | 116 | 113 | 201 | 206 |
| Positive control | ＞2000＞2000＞2000＞2000＞2000＞2000＞2000＞2000 | |||||||
Result of the test as seen, under each experimental concentration, each ware returns and becomes bacterium bacterium colony number average end and surpass from 2 times that beam back parameter, and each positive controls has shown strong mutagenesis.
According to Salmonella reversion test criterion as a result, think under the dosage of the every ware 10580ug/ of medicine ware of this test, show to cause unexpected change positive effect.
Conclusion:
The medicine of the present invention of this test is not the mutagenesis positive effect.
(2) PCEMNR micronucleus test
1, method
(1) sample: the same
(2) animal
By the Kunming kind healthy mice that the institute of oncology, Anhui Province provides, totally 50 of male and female, body weight 240-260 gram; Be divided into into five groups, 10 every group, male and female half and half.
(3) dosage grouping and method:
I organizes negative control group (distilled water), V organizes positive controls (cyclophosphamide 50mg/kg), other experimental group is respectively II group 1300mg/kg, III organizes 2610mg/kg, this medicine of IV group 5010mg/kg, press the 0.1ml/10g capacity and irritate stomach, adopt dose regimen twice, be 24 hours twice blanking time, after the last administration 6 hours, the mice cervical vertebra takes off white execution, takes out the both sides femur, with calf serum flushing medullary cavity content, through centrifugal, smear, fixing, dyeing, the cell aberration rate of micronucleus occurs in 1000 polychromatic erythrocytes of every Mus microscopy counting and represent with permillage.
2 results
The test of mouse Bone marrow cells micronucleus: the results are shown in Table 3, by table 3 as seen, give and mice 1300,2610, the present invention of 5010mg/kg body weight, male mice bone marrow polychromatic erythrocyte micronuclear rates is respectively 1.2 ‰, 1.4 ‰ ‰, 1.6 ‰; The female mice micronuclear rates is respectively 1.2 ‰, 1.4 ‰.1.4 ‰ with negative control group (distilled water) micronuclear rates, male mice is 1.0%, female mice is 1.0%, learn by statistics and handle P＞0.05, there was no significant difference, positive controls (cyclophosphamide) micronuclear rates male mice is 18.8%, female mice is 25.2%, learn by statistics and handle relatively, there is significant difference P＜0.05.Result of the test shows that medicine of the present invention finds no tangible mutagenic action to the PCEMNR micronucleus test.
Table 3 medicine PCEMNR of the present invention micronucleus detects
| Dosage mg/kg | Number of animals (only) | Observe polychromatic erythrocyte number (individual/group) | Male | Female | |||||
| Male | Female | Contain micronucleated cell (‰) | Micronuclear rates born of the same parents number | Contain micronucleated cell (‰) | Micronuclear rates | ||||
| Male | Female | Born of the same parents' number | |||||||
| 0 1,300 2,610 5010 cyclophosphamide | 5 5 5 5 5 | 5 5 5 5 5 | 5000 5000 5000 5000 5000 | 5000 5000 5000 5000 5000 | 5 6 7 8 108 | 1.0 1.2 1.4 1.6 21.6 | 5 6 7 7 13.3 | 1.0 1.2 1.4 1.4 26.6 | |
Conclusion:
Can think that medicine of the present invention does not have influence to the mouse Bone marrow cells micronucleus occurrence rate.
(3) mouse testis chromosome aberration analysis
1, method:
(1) sample: the same
(2) animal
Be the Kunming mouse that the institute of oncology, Anhui Province provides, male 25, body weight 320-350 gram.
(3) dosage grouping and method
Distinguish component at random by body weight and become 5 groups, I organizes negative matched group (distilled water), and II organizes 1300mg/kg, and III organizes 2610mg/kg, IV group 5010mg/kg medicine of the present invention, and V organizes positive matched group (cyclophosphamide 50mg/kg).Mice is pressed the 0.2mL/10g body weight and irritates stomach, once a day, continuous 5 days, observe 100 in counting first metaphase cell, record statistics distortion cell number is calculated aberration rate.
Table 4 mouse testis chromosome aberration assay test result
| Dosage mg/kg | Number of animals (only) | Analysis of cells number (individual) | Single autosome | Valency body aberration rate % | Part | |||
| Sex chromosome | Aberration rate % | Quantity | Aberration rate % | |||||
| I 0 II 1300 III2610 IV 5000 V cyclophosphamide 50 | 5 5 5 5 5 | 500 500 500 500 500 | 6 7 7 8 34 | 1.2 1.4 1.4 1.6 6.8 | 14 16 18 16 76 | 2.8 3.2 3.6 3.2 15.2 | 0 1 1 1 36 | 0 0.2 0.2 0.2 7.2 * |
*P＜0.01
Positive controls is compared with negative control group and each test group as seen from the table all has significant differences (P＜0.01), and the aberration rate of each group of negative control group and Flos Ginseng is all in range of normal value.
Conclusion:
Medicine of the present invention does not show the damaging effect to sexual cell in the mouse testis chromosome aberration assay test.
Three, to the comprehensive conclusion of first and second step-by-step test of this product drug safety toxicological evaluation
1, the mice of drug sample of the present invention, its mouse oral LD50＞100g/kg, true border innocuous substance.
2, the Ames of drug sample of the present invention experiment, PCEMNR micronucleus test, three mutagenicity tests of mouse testis chromosome aberration assay test, all negative, the same with the contrast distilled water, show that sample does not have mutagenicity.
Comprehensive above each point thinks that the present invention has the good effect of enriching blood, and does not have toxic and side effects.
The specific embodiment
Embodiment 1
Take by weighing each component (kg) by following proportioning: donkey glue 60, Fructus Jujubae 20, Fructus Lycii 5, the Radix Paeoniae Alba 2, Radix Rehmanniae Preparata 2, Radix Codonopsis 2, the Radix Astragali 1, Fructus Crataegi 2, crystal sugar 5 is made oral liquid.
Preparation method may further comprise the steps: get above-mentioned Fructus Jujubae, and Fructus Lycii, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Radix Codonopsis, the Radix Astragali, Fructus Crataegi adds water and boils, and behind 100 ℃ of the initial Wen Huozhi, vigorous fire boiled 2 hours again, and boiling pressure is 1.5 atmospheric pressure.Add donkey glue and crystal sugar and boil, the time of boiling is 1 hour.120 mesh sieve filters filter, and filtrate concentrates through the temperature fire, and the concentrated solution water content is 50%, and embedding is in 300ml or 10ml oral liquid bottle, with 115 ℃ of 30 minutes flowing steam sterilizations, promptly.
Embodiment 2
Take by weighing each component (kg) by following proportioning: donkey glue 30, Fructus Jujubae 10, Fructus Lycii 2, the Radix Paeoniae Alba 1, Radix Rehmanniae Preparata 1, Radix Codonopsis 1, the Radix Astragali 1, Fructus Crataegi 1 is made the piece agent.
Preparation method may further comprise the steps: get above-mentioned Fructus Jujubae, and Fructus Lycii, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Radix Codonopsis, the Radix Astragali, Fructus Crataegi adds water and boils, and behind 100 ℃ of the initial Wen Huozhi, vigorous fire boiled 1.5 hours again, and boiling pressure is 1 atmospheric pressure.Add donkey glue and boil, the time of boiling is 1.5 hours.120 mesh sieve filters filter, and filtrate concentrates through the temperature fire, and the simmer down to water content is 15% wet piece, drying, and ultraviolet sterilization 30 minutes, promptly.
Embodiment 3
Take by weighing each component (kg) by following proportioning: donkey glue 70, Fructus Jujubae 30, Fructus Lycii 7, the Radix Paeoniae Alba 3, Radix Rehmanniae Preparata 3, Radix Codonopsis 3, the Radix Astragali 3, Fructus Crataegi 3, crystal sugar 2 is made electuary.
Preparation method may further comprise the steps: get above-mentioned Fructus Jujubae, and Fructus Lycii, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Radix Codonopsis, the Radix Astragali, Fructus Crataegi adds water and boils, and behind 100 ℃ of the initial Wen Huozhi, vigorous fire boiled 3 hours again, and boiling pressure is 2 atmospheric pressure.Add donkey glue and crystal sugar and boil, the time of boiling is 1.5 hours.120 mesh sieve filters filter, and filtrate concentrates through the temperature fire, the simmer down to piece that wet, and it is dry to granulate with 60% concentration ethanol, and 20 orders sieve, pack, 2.5 gram/bags, 1000 bags, ultraviolet was sterilized 30 minutes, promptly.
Claims (8)
1. hematonic compositions, it is characterized in that the effective ingredient of making this pharmaceutical composition is mainly: donkey glue 30-70 weight portion, Fructus Jujubae 10-30 weight portion, Fructus Lycii 2-7 weight portion, Radix Paeoniae Alba 1-3 weight portion, Radix Rehmanniae Preparata 1-3 weight portion, Radix Codonopsis 1-3 weight portion, Radix Astragali 1-3 weight portion, Fructus Crataegi 1-3 weight portion.
2. according to the hematonic compositions of claim 1, it is characterized in that the weight portion of described each effective ingredient is: 60 parts in donkey glue, 20 parts of Fructus Jujubaes, 5 parts of Fructus Lycii, 2 parts of the Radix Paeoniae Albas, 2 parts of Radix Rehmanniae Preparata, 2 parts of Radix Codonopsis, 1 part of the Radix Astragali, 2 parts of Fructus Crataegis.
3. according to the hematonic compositions of claim 1 or 2, it is characterized in that the effective ingredient of making this pharmaceutical composition also contains: crystal sugar 2-6 weight portion.
4. according to the hematonic compositions of claim 1, described pharmaceutical composition is oral liquid, piece agent or electuary.
5. the preparation method of a hematonic compositions may further comprise the steps: take by weighing each raw material by following weight portion: Fructus Jujubae 10-30 part, Fructus Lycii 2-7 part, Radix Paeoniae Alba 1-3 part, Radix Rehmanniae Preparata 1-3 part, Radix Codonopsis 1-3 part, Radix Astragali 1-3 part, Fructus Crataegi 1-3 part; Above-mentioned raw materials is added water boiled 2-5 hour, the donkey glue that adds the 30-70 weight portion boils, and filters, and filtrate concentrates, and the preparation method is made various dosage forms routinely again.
6. according to the preparation method of the hematonic compositions of claim 5, the described water that adds boils, and behind 100 ℃ of the initial Wen Huozhi, vigorous fire boiled 2 hours again, and boiling pressure is 1-2 atmospheric pressure; The described adding donkey glue time of boiling is 1-2 hour, and described 120 mesh sieves that are filtered into filter.
7. according to the preparation method of the hematonic compositions of claim 5, described filtrate simmer down to temperature fire concentrates, and the concentrated solution water content is 50%, makes oral liquid.
8. according to the preparation method of the hematonic compositions of claim 5, described filtrate simmer down to temperature fire concentrates, and the simmer down to water content is 15% wet piece, makes the piece agent.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB031092810A CN1256124C (en) | 2003-04-08 | 2003-04-08 | Blood-supplementing medicine composition |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB031092810A CN1256124C (en) | 2003-04-08 | 2003-04-08 | Blood-supplementing medicine composition |
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| CN1256124C true CN1256124C (en) | 2006-05-17 |
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| CNB031092810A Expired - Fee Related CN1256124C (en) | 2003-04-08 | 2003-04-08 | Blood-supplementing medicine composition |
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Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102160663B (en) * | 2011-04-01 | 2012-09-26 | 郑州朴素堂食品股份有限公司 | Date junket composite beverage and preparation method thereof |
| CN103301245B (en) * | 2013-06-03 | 2015-08-05 | 安徽华佗国药股份有限公司 | The medicine of a kind of benefiting QI and nourishing blood, nourishing the liver and kidney |
| CN103549068A (en) * | 2013-11-23 | 2014-02-05 | 王芬 | Qi-tonifying and blood-nourishing bagged tea |
| CN104544425B (en) * | 2014-05-09 | 2016-08-24 | 徐强 | A kind of plant health-care drink |
| CN104172176A (en) * | 2014-09-20 | 2014-12-03 | 张永胜 | Health-care food for promoting postpartum recovery |
| CN104435360A (en) * | 2014-12-10 | 2015-03-25 | 广东聚智诚科技有限公司 | Pharmaceutical composition for treating anemia |
| CN105687486A (en) * | 2016-03-15 | 2016-06-22 | 曹康 | Blood-replenishing oral solution |
| CN105748824A (en) * | 2016-04-01 | 2016-07-13 | 王琰 | Origin preserving and blood replenishing paste and preparation technology thereof |
| CN106138439A (en) * | 2016-08-31 | 2016-11-23 | 张彦 | A kind of blood tonic |
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2003
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