CN101683437B - Traditional Chinese medicine composition for soothing liver and strengthening spleen and nourishing qi and promoting blood circulation and preparation method thereof - Google Patents
Traditional Chinese medicine composition for soothing liver and strengthening spleen and nourishing qi and promoting blood circulation and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for soothing the liver and strengthening the spleen and nourishing qi and promoting blood circulation and a preparation method thereof. The composition is prepared from the following raw material medicines in parts by weight: lyophiled royal jelly powder, camellia powder, rabdosia amethystoides and endothelium corneum gigeriae galli. The traditional Chinese medicine composition of the invention has obvious functions of improving symptoms of liver diseases, recovering liver functions, promoting protein synthesis and inhibiting liver fibrosis indexes, and has better effect on treating chronic active hepatitis B and early cirrhosis.
Description
Technical field
The present invention relates to a kind of the liver soothing and the spleen invigorating, Chinese medicine composition of benefiting QI for activating blood circulation and preparation method thereof belongs to technical field of Chinese medicines.
Background technology
Liver cirrhosis (comprising hepatic ascites, splenomegaly, portal hypertension, esophageal varix) is the common difficulty property hepatopathy of internal medicine, is to damage for a long time or repeatedly due to the liver by one or more paathogenic factors, and be main paathogenic factor with hepatitis B at present.Both at home and abroad the research of this sick medicine is attached great importance to, but the reliable medicine of inefficacy still so far.
The traditional Chinese medical science thinks that this disease is that insufficiency of the spleen, blood stasis finally causes the kidney yang deficiency of kidney-YIN, the disease of a kind of general immunologic hypofunction of spleen, liver, kidney, stomach, the deficient initiation of the many internal organs of intestine and small intestine owing to long-term stagnation of liver-QI.
Summary of the invention
First purpose of the present invention is to provide a kind of the liver soothing and the spleen invigorating, the Chinese medicine composition of benefiting QI for activating blood circulation.
The present invention also aims to provide a kind of the liver soothing and the spleen invigorating, Chinese medicine composition of benefiting QI for activating blood circulation and preparation method thereof.
First purpose of the present invention realizes through following technical scheme:
A kind of the liver soothing and the spleen invigorating, the Chinese medicine composition of benefiting QI for activating blood circulation, said composition is processed by following raw medicaments in portion by weight:
Freeze-dried royal jelly powder 3-20 weight portions, Flos Camelliae Japonicae powder 3-20 weight portions, Herba Rabdosiae glaucocalycis 5-25 weight portions, Endothelium Corneum Gigeriae Galli 10-40 weight portions.
Said composition is preferably processed by following raw medicaments in portion by weight:
Freeze-dried royal jelly powder 5-15 weight portion Flos Camelliae Japonicae powder 3-10 weight portion Herba Rabdosiae glaucocalycis 5-15 weight portion Endothelium Corneum Gigeriae Galli 10-30 weight portion.
The method for preparing of said composition may further comprise the steps:
A. earlier with Flos Camelliae Japonicae powder, Endothelium Corneum Gigeriae Galli drying, pulverize, it is for use to get fine powder A;
B. with the Herba Rabdosiae glaucocalycis pulverizing, cross 24 mesh sieves, decocte with water 1-3 hours filters, and relative density was the thick paste of 1.25-1.30 when filtrating was concentrated into 60 ℃, and drying is pulverized, and sieves, and it is for use to get fine powder B;
C. with freeze-dried royal jelly powder fine powder A, B mix homogeneously, add adjuvant by common process and process clinical acceptable forms such as tablet, capsule, oral liquid, soft capsule, granule; Said adjuvant comprises solvent, disintegrating agent, correctives, antiseptic, coloring agent, binding agent, lubricant, substrate etc.
Preferably, the baking temperature among the above-mentioned steps a is 60 ℃, and grinding particle size is 100 orders.
Preferably, decocting amount of water among the above-mentioned steps b is 8 times of amounts, and decocting time is 2 hours, and the thick paste baking temperature is 60 ℃, and grinding particle size is 100 orders.
Pharmaceutical composition of the present invention has significance to improve to treatment chronic active hepatitis, early stage liver cirrhosis and positive control medicine QINGGAN FUZHENG JIAONANG comparison curative effect; Medicine of the present invention has the obvious hepatopathy symptom of improving; Recovering liver function, promotion albumen synthesize, suppress the effect of hepatic fibrosis index, and treatment chronic active hepatitis B early stage liver cirrhosis is had better curative effect.
The specific embodiment
Following experimental example and embodiment further specify but are not limited to the present invention.
The write out a prescription research of disintegrating process of experimental example 1 the present invention
Because capsule content of the present invention contains more medicated powder, its mobile quality is relevant with the accuracy of capsule loading amount, turnover rate commonly used and representing angle of repose on the pharmaceutics.Angle of repose is littler, and flowability better.
Get 3 parts of crude drug respectively by following prescription: Flos Camelliae Japonicae powder 200g, Endothelium Corneum Gigeriae Galli 400g, every part of operation as follows:
Confirming of table 1 prescription Chinese crude drug grinding particle size
| The prescription number | Processing method |
| 1 | With Flos Camelliae Japonicae powder, Endothelium Corneum Gigeriae Galli cold drying, pulverize earlier, cross 80 mesh sieves, collect fine powder through 80 mesh sieves |
| 2 | With Flos Camelliae Japonicae powder, Endothelium Corneum Gigeriae Galli cold drying, pulverize earlier, cross 100 mesh sieves, collect fine powder through 100 mesh sieves |
| 3 | With Flos Camelliae Japonicae powder, Endothelium Corneum Gigeriae Galli cold drying, pulverize earlier, cross 120 mesh sieves, collect fine powder through 120 mesh sieves |
Adopt the fixed funnel method; With the series connection of 3 funnels and be fixed in the height place of 1cm on the graph paper of horizontal positioned; Carefully medicated powder is poured into along hopper walls in the funnel of going up most till the medicated powder cone tip that forms on the graph paper touches bell mouth; Measure the diameter (2R) of conical base by graph paper, calculate angle of repose tga=H/R. and do calculating mean value 5 times.The result sees table 2.
The mensuration result of table 2 angle of repose
Draw through above mensuration result, this prescription gained medicated powder is crushed to 100 orders, and is mobile best, is suitable for encapsulated.
Experimental example 2 the present invention Study on extraction process of writing out a prescription
Selective extraction time, extraction time, three factors of extraction amount of water, each factor is established 3 levels, and factor level is seen table 3, and EXPERIMENTAL DESIGN result sees table 4, and table 5 is seen in variance analysis.
Take by weighing Herba Rabdosiae glaucocalycis 300g, be ground into coarse powder, coarse powder is dropped into multi-function extractor carry out reflux, extract, by the design of table 2, filter while hot, merge extractive liquid, concentrates, and measures content of ursolic acid in the concentrated solution, calculates.
The preferred factor level table of table 3
| Level | A extraction time (min) | The B extraction time | C extracts amount of water |
| 1 | 60 | 2 | 6 |
| ?2 | 120 | ?1 | ?8 |
| 3 | 180 | 3 | 10 |
Table 4 factor screening orthogonal experiment data table
Table 5 analysis of variance table
| Soruces of variation | Sum of deviation square | Degree of freedom | Mean square with | The F ratio | Significance |
| ?A | 1.68 | 2 | 4.749733 | 82.70 | ?* |
| ?B | 7.07 | 2 | 4.822533 | 83.97 | ?* |
| ?C | 19.48 | 2 | 12.883900 | 224.33 | ** |
| D (error) | 0.62 | 2 | 0.057433 |
F
1-0.1(2，2)＝9.00?F
1-0.05(2，2)＝19.00?F
1-0.01(2，2)＝99.00
With the ursolic acid content is that the orthogonal test intuitive analysis of investigation index and the result of variance analysis show that factor C has the greatest impact to result of the test, is followed successively by B, A later on.Wherein the C2 extraction effect is best, should select C2; Optimum extraction concentration technology condition is A3B2C2.Be extracting in water 1 time, each 3 hours, amount of water was 8 times of amounts.
According to this result and the executory practical situation of technology, method for optimizing is following: get crude drug and add 8 times of water gagings decoctions 1 time, extracted 2 hours.
The research of experimental example 3 pharmacodynamics tests
1 experiment material
1.1 medicine
Positive control drug: YANGGAN JIAONANG, Hangzhou miracle king pharmaceutcal corporation, Ltd produces, authentication code: the accurate word B20040002 of traditional Chinese medicines.
1.2 animal Wistar rat, Kunming mouse, ♀ ♂ all uses.
The influence of ALT content in the 2 pairs of hepatic injury mice serums
2.1 divide into groups: get 90 kunming mices and be divided into 6 groups at random, 15 every group, the A group is the normal control group; The B group is model control group; C organizes positive matched group; The medicine of D1 group for making according to embodiment 5 said methods, the D2 group is embodiment 3 medicines, the D3 group is the medicine of embodiment 4;
2.2 modeling method: adopt the method for bacillus calmette-guerin vaccine and lipopolysaccharide associating to set up the immunologic liver injury mouse model.After each treated animal adaptability is fed 3d, except that the normal control group, 1 tail vein injection bacillus calmette-guerin vaccine 5 * 10 of every mice
7Individual viable bacteria, 12d intravenous injection lipopolysaccharide 7.5 μ g/ Mus are put to death behind 16h and draw materials after injection of BCG, and the normal control group is all injected the equivalent normal saline with same procedure 2 times.
2.3 administration and processing: played the beginning gastric infusion, 1 time/d in first day of the intravenous injection bacillus calmette-guerin vaccine.Normal control group and model control group: normal saline is irritated stomach, irritates the medication capacity of stomach amount with medication therapy groups; Positive control medicine treatment group: QINGGAN FUZHENG JIAONANG, 3.9g/kg dosed administration; Medication therapy groups of the present invention, the 3.9g/kg dosed administration.Normal control group 16h behind the 12d injecting normal saline, the eyeball rear vein beard is got blood, and puts to death animal and get the hepatic tissue censorship; All the other organize 16h behind the intravenous injection lipopolysaccharide, and the eyeball rear vein beard is got blood, and put to death animal and get the hepatic tissue censorship.
2.4 observation index and detection method: 1. detect paddy-pyruvic transaminase (ALT): adopt chemical colorimetry to measure.2. endogenous nitric oxide (NO) is measured: adopt radioimmunology, cut open and get the 0.5g liver and process 10% liver tissue homogenate, and under 4 ℃ of conditions, 3000 commentaries on classics/min, centrifugal 10min gets supernatant.3. Endothelin (ET) detects: adopt radiation to exempt from method and directly measure blood plasma ET concentration.The result sees table 6.
The situation of change that table 6 is respectively organized Serum ALT, ET, NO compares
| Group | n | Dosage | ATL(nmol*s -1/L) | ET(ng/L) | NO(μmol/L) |
| A | 15 | \ | 837.58±384.45 | 49.65±16.75 | 37.14±8.25 |
| B | 15 | \ | 3621.56±874.64 | 97.24±42.65 | 69.31±20.48 |
| C | 15 | 2.2g/kg | 1884.64±643.74** | 58.91±22.32* | 45.54±10.32* |
| D1 | 15 | 2.2g/kg | 1322.31±488.88**△ | 52.57±21.82* | 39.54±9.39*△ |
| ·D2 | 15 | 2.2g/kg | 1723.28±426.36** | ·54.19±19.64* | 42.22±9.05* |
| D3 | 15 | 2.2g/kg | 1810.96±430.57** | 55.22±19.85* | 43.71±9.12* |
* with model group relatively, * P 0.05, * * P < 0.01; △ and positive controls compare, △ P < 0.05.
Can find out that from above result detecting qualified medicine of the present invention has significance to improve to ALT, ET, NO content in the hepatic injury mice serum, with the positive control medicine significant difference is arranged relatively.
3, to the protective effect of chronic hepatic injury
Rat skin lower injection 10%5ml/kg carbon tetrachloride oil solution, 2 times weekly, injected continuously 3 months, cause carbon tetrachloride chronic hepatic injury animal model, observe the protective effect of medicine of the present invention to the damage liver.
Normal control group and model control group: normal saline is irritated stomach, irritates the medication capacity of stomach amount with medication therapy groups; Positive control medicine treatment group: YANGGAN JIAONANG, 1.8g/kg dosed administration; Medication therapy groups of the present invention, the 1.8g/kg dosed administration.Normal control group 16h behind the 12d injecting normal saline, the eyeball rear vein beard is got blood, and puts to death animal and get the hepatic tissue censorship; All the other organize 16h behind the intravenous injection lipopolysaccharide, and the eyeball rear vein beard is got blood, and put to death animal and get the hepatic tissue censorship.The result sees table 7.
Table 7 medicine of the present invention is to the protective effect of chronic hepatic injury rat (X ± SD)
| Group | ?n | Dosage | SGPT (Ka Menshi unit) | SGOT (Ka Menshi unit) | Hydroxyproline content |
| A | 10 | \ | 42.36±20.12 | 108.12±14.07 | 1.62±0.24 |
| B | 10 | \ | 277.75±99.38 | 364.14±72.47 | 2.08±0.28 |
| C | 10 | 1.8g/kg | 48.52±29.25** | 119.53±19.18** | 1.85±0.68 |
| D1 | 10 | 1.8g/kg | 37.32±14.87** | 67.17±16.26**△ | 1.53±0.26 |
| D2 | 10 | 1.8g/kg | 42.25±15.88** | 98.20±18.57** | 1.65±0.48 |
| D3 | 10 | 1.8g/kg | 44.04±15.63** | 105.41±18.68** | 1.70±0.50 |
* with model group relatively, * P 0.05, * * P < 0.01; △ and positive controls compare, △ P < 0.05.
Can find out that from above result detecting qualified medicine of the present invention has significance to improve to ALT, ET, NO content in the hepatic injury mice serum, and chronic hepatic injury is had tangible protective effect, with the positive control medicine significant difference is arranged relatively.
Test Example 4 clinical trials and result
1 material and method
1.1 ordinary circumstance: patient's 155 examples of selecting over nearly 5 years to confirm as chronic active hepatitis B, drought period liver cirrhosis in outpatient service.Observation group's 79 examples., male 55 examples, women 24 examples, 24～69 years old age, average 38.5 years old, 3～28 years courses of treatment, average 5.4 years.Matched group 76 examples, male 54 examples., women 22 examples, 27～71 years old age, average 32.6 years old, the course of disease 2～26 years, average 5.6 years.
1.2 case is selected: all patients who meets following several, as observing case.It is chronic active hepatitis and HBSAg positive person that " viral hepatitis is prevented and treated scheme " /> of 1. revising according to the 6th the national viral hepatitis meeting in nineteen ninety Shanghai meets clinical diagnosis; 2. platelet count<80,000mm
33. protein electrophoresis r>23%; 4. splenomegaly, B ultrasonic show spleen Hou>4.0cm or touch spleen under the rib.
1.3 Therapeutic Method: two groups of patients give sub-western medicine simultaneously, 30 μ g intramuscular injection January of Hepatitis B virus vaccine once, vitamin C 3 times on the 0.2%th 1. persantin 25mg, 3 times on the one, levamisole 25mg 3 times on the one.Observation group gives pharmaceutical composition of the present invention (according to the capsule of embodiment 5 preparation) 3 times on the one, one time 5.Matched group gives commercially available QINGGAN FUZHENG JIAONANG, 3 times on the one, one time 5.Took 3 months.
1.4 detection index: biochemistry detection (comprising ALT, AST, platelet, protein electrophoresis), hepatic fibrosis detect and (comprise HA, PIIIP, LN).
1.5 curative effect determinate standard: with reference to " viral hepatitis curative effect determinate standard (trying) " chronic active hepatitis curative effect determinate standard of internal medicine hepatopathy Professional Committee of All-China Association of Traditional Chinese Medicine Tianjin in 1991 meeting formulation.
2 efficacy results
2.1 medicine is to the influence of biochemistry detection index: see table 8
Change conditions (x scholar s) before and after the treatment of table 8 biochemical indicator
Annotate: compare with matched group: < 0.05**P < 0.01 for * P
Can find out influencing of biochemical indicator medicine of the present invention and positive control medicine are relatively had significant difference in clinical from last table, medicine of the present invention is superior to the positive control medicine.
2.2 hepatic fibrosis is detected the influence of index: see table 9
Table 9 hepatic fibrosis detects index change conditions (x scholar s)
Annotate: compare with matched group: < 0.05**P < 0.01 for * P
Can find out from last table, medicine of the present invention to hepatic fibrosis index influence be significantly higher than positive control medicine group, medicine of the present invention is in the better effects if of improving to hepatic fibrosis.
2.3 condition of illness sign situation of change:
Compare before and after the treatment of table 10 symptom and sign
2.4 curative effect synthetic determination:
Table 11 clinical efficacy synthetic determination
| Clinical cure | Produce effects | Take a turn for the better | Invalid | Total effective rate | |
| The n=79 of observation group | 6(7.6) | 32(41.5) | 32(40.5) | 9(11.4) | 88.6* |
| Matched group n=76 | 5(6.6) | 27(35.5) | 27(35.5) | 17(23.4) | 76.6 |
Annotate: compare with matched group: * P < 0.05
Can find out from table 10 and table 11 result; Pharmaceutical composition of the present invention has significance to improve to treatment chronic active hepatitis, early stage liver cirrhosis and positive control medicine QINGGAN FUZHENG JIAONANG comparison curative effect; Medicine of the present invention has the obvious hepatopathy symptom of improving; Recovering liver function, promotion albumen synthesize, suppress the effect of hepatic fibrosis index, and treatment chronic active hepatitis B early stage liver cirrhosis is had better curative effect.
Embodiment 1
Take by weighing the crude drug of following weight portion (kg):
Freeze-dried royal jelly powder 7, Flos Camelliae Japonicae powder 8, Herba Rabdosiae glaucocalycis 8, Endothelium Corneum Gigeriae Galli 15
Method of making preparation is:
A. earlier with Flos Camelliae Japonicae powder, 60 ℃ of dryings of Endothelium Corneum Gigeriae Galli, pulverize, cross 100 mesh sieves, it is for use to get fine powder A;
B. Herba Rabdosiae glaucocalycis is pulverized, crossed 24 mesh sieves, add 8 times of water gagings decoctions 1 hour, filter, relative density was 1.25 thick paste when filtrating was concentrated into 60 ℃, and 60 ℃ of dryings are pulverized, and cross 100 mesh sieves, and it is for use to get fine powder B;
C. with freeze-dried royal jelly powder and fine powder A, B mix homogeneously, add dextrin 5kg, stevioside 0.2kg, granulate granule 25kg.
Embodiment 2.
Take by weighing the crude drug of following weight portion (kg):
Freeze-dried royal jelly powder 10, Flos Camelliae Japonicae powder 5, Herba Rabdosiae glaucocalycis 13, Endothelium Corneum Gigeriae Galli 20
Method of making preparation is:
A. earlier with Flos Camelliae Japonicae powder, 60 ℃ of dryings of Endothelium Corneum Gigeriae Galli, pulverize, cross 100 mesh sieves, it is for use to get fine powder A;
B. Herba Rabdosiae glaucocalycis is pulverized, crossed 24 mesh sieves, add 8 times of water gagings and decocted 3 hours, filter, relative when filtrating is concentrated into 60 ℃
Density is 1.25 thick paste, and 60 ℃ of dryings are pulverized, and cross 100 mesh sieves, and it is for use to get fine powder B;
C. with freeze-dried royal jelly powder fine powder A, B mix homogeneously, press medicated powder: PEG600: the weight ratio mix homogeneously of glycerol (6:6:1), be pressed into soft capsule, promptly get.Soft capsule shell is with gelatin: glycerol: the preparation of water (3:1:2) ratio.
Embodiment 3
Take by weighing the crude drug of following weight portion (kg):
Freeze-dried royal jelly powder 3, Flos Camelliae Japonicae powder 20, Herba Rabdosiae glaucocalycis 35, Endothelium Corneum Gigeriae Galli 45
Method of making preparation is:
A. earlier with Flos Camelliae Japonicae powder, 60 ℃ of dryings of Endothelium Corneum Gigeriae Galli, pulverize, cross 100 mesh sieves, it is for use to get fine powder A;
B. Herba Rabdosiae glaucocalycis is pulverized, crossed 24 mesh sieves, add 8 times of water gagings decoctions 1 hour, filter, relative density was 1.30 thick paste when filtrating was concentrated into 60 ℃, and 60 ℃ of dryings are pulverized, and cross 100 mesh sieves, and it is for use to get fine powder B;
C. with freeze-dried royal jelly powder fine powder A, B mix homogeneously, add the magnesium stearate mixing of 0.01 times of amount, granulate, drying, granulate, tabletting gets 10000, promptly gets.
Embodiment 4
Take by weighing the crude drug of following weight portion (kg):
Freeze-dried royal jelly powder 30, Flos Camelliae Japonicae powder 4, Herba Rabdosiae glaucocalycis 5, Endothelium Corneum Gigeriae Galli 5
Method of making preparation is:
A. earlier with Flos Camelliae Japonicae powder, 60 ℃ of dryings of Endothelium Corneum Gigeriae Galli, pulverize, cross 100 mesh sieves, it is for use to get fine powder A;
B. Herba Rabdosiae glaucocalycis is pulverized, crossed 24 mesh sieves, add 8 times of water gagings decoctions 2 hours, filter, relative density was 1.28 thick paste when filtrating was concentrated into 60 ℃, and 60 ℃ of dryings are pulverized, and cross 100 mesh sieves, and it is for use to get fine powder B;
C. with freeze-dried royal jelly powder fine powder A, B mix homogeneously, add sucrose 3kg, potassium sorbate 0.1kg, add water adjustment total amount to 10L, stir, fill promptly gets.
Embodiment 5
Take by weighing the crude drug of following weight portion (kg):
Freeze-dried royal jelly powder 10 Flos Camelliae Japonicae powder 6 Herba Rabdosiae glaucocalycis 10 Endothelium Corneum Gigeriae Galli 20
Method of making preparation is:
A. earlier with Flos Camelliae Japonicae powder, 60 ℃ of dryings of Endothelium Corneum Gigeriae Galli, pulverize, cross 100 mesh sieves, it is for use to get fine powder A;
B. Herba Rabdosiae glaucocalycis is pulverized, crossed 24 mesh sieves, add 8 times of water gagings decoctions 2 hours, filter, relative density was 1.252 thick paste when filtrating was concentrated into 60 ℃, and 60 ℃ of dryings are pulverized, and cross 100 mesh sieves, and it is for use to get fine powder B;
C. with freeze-dried royal jelly powder fine powder A, B mix homogeneously, encapsulated, promptly get.
Claims (4)
1. the Chinese medicine composition of the liver soothing and the spleen invigorating, benefiting QI for activating blood circulation is characterized in that said composition processed by following raw medicaments in portion by weight:
Freeze-dried royal jelly powder 10 weight portions, Flos Camelliae Japonicae powder 6 weight portions, Herba Rabdosiae glaucocalycis 10 weight portions, Endothelium Corneum Gigeriae Galli 20 weight portions.
2. the method for preparing of Chinese medicine composition as claimed in claim 1 is characterized in that this method may further comprise the steps:
A. earlier with Flos Camelliae Japonicae powder, 60 ℃ of cold drying of Endothelium Corneum Gigeriae Galli, pulverize, it is for use to get fine powder A;
B. with the Herba Rabdosiae glaucocalycis pulverizing, cross 24 mesh sieves, decocte with water 1-3 hour, filter, relative density was the thick paste of 1.25-1.30 when filtrating was concentrated into 60 ℃, and drying is pulverized, and sieves, and it is for use to get fine powder B;
C. with freeze-dried royal jelly powder and fine powder A, B mix homogeneously, add adjuvant by common process and process tablet, capsule, oral liquid, granule; Said adjuvant is selected from solvent, disintegrating agent, correctives, antiseptic, coloring agent, binding agent, lubricant.
3. method for preparing as claimed in claim 2 is characterized in that the baking temperature among the step a is 60 ℃, and grinding particle size is 100 orders.
4. method for preparing as claimed in claim 2 is characterized in that decocting amount of water among the step b is 8 times of amounts, and decocting time is 2 hours, and the thick paste baking temperature is 60 ℃, and grinding particle size is 100 orders.
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| CN1315195A (en) * | 2000-03-24 | 2001-10-03 | 黄亚平 | Jingan shierkang capsule and its preparing process |
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| CN1315195A (en) * | 2000-03-24 | 2001-10-03 | 黄亚平 | Jingan shierkang capsule and its preparing process |
Non-Patent Citations (1)
| Title |
|---|
| 黄亚平等.灵丹王养肝胶囊对小鼠NK细胞活性的影响.《中西医结合肝病杂志》.2001,第11卷(第3期),第157-158页. * |
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