CN102068669B - Medicament for treating infant hepatitis syndrome, and preparation method and quality control method thereof - Google Patents
Medicament for treating infant hepatitis syndrome, and preparation method and quality control method thereof Download PDFInfo
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- CN102068669B CN102068669B CN2011100041262A CN201110004126A CN102068669B CN 102068669 B CN102068669 B CN 102068669B CN 2011100041262 A CN2011100041262 A CN 2011100041262A CN 201110004126 A CN201110004126 A CN 201110004126A CN 102068669 B CN102068669 B CN 102068669B
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Abstract
The invention belongs to the field of traditional Chinese medicines, and discloses a medicament for treating infant hepatitis syndrome, and a preparation method and a quality control method thereof. In the medicament, according to the theory of traditional Chinese medical science, a compound preparation is prepared from medicinal materials such as virgate wormwood herb, white poria, southern curcuma root, green tangerine peel, longhairy antenoron herb, white paeony root, szechuan tangshen root, largehead atractylodes rhizome, root of red-rooted salvia, coral ardisia root, grassleaf sweelflag rhizome, hawthorn and the like. The medicament has the effects of clearing heat and damp, removing jaundice, inducing diuresis and excreting dampness and invigorating spleen and tranquilizing mental, and is used for treating the infant hepatitis syndrome.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition for the treatment of infant hepatitis syndrome and preparation method thereof and quality determining method, belong to the field of Chinese medicines.
Background technology
The infantile hepatitis syndrome refers to betide infancy stage (comprising neonatal period) with jaundice, hepatosplenomegaly, and liver function injury is one group of syndrome of main performance.Sickness rate increases year by year, and pathological characters is multinucleated giant cell to occur in the liver parenchyma, so the title of " giant cell hepatitis " is arranged.Lab testing is that serum total bilirubin and bilirubin direct raise.Medically belong to " jaundice " category in motherland.
This disease symptoms sees that all the jaundice of body order is main, or yellow skin is dark and gloomy as gold or color and luster; Often with constipation with dry stool, or the loose stool, the crissum flushing; Urine yellow skin band is red.Infant is not thought the breast food, abdominal distention, and health heating is sometimes cryed endlessly, pale tongue, yellow and greasy fur, fingerprint is blue or green to stagnate.Pathogenesis mostly is dampness-heat in the liver and gallbladder and accumulates Yu Yuli, on must not get over, must not let out down, the stifling stasis of blood is held back, and immerses lung, sends out in skin, then the whole body is all yellow; Or because the damp internal resistance, hypoactivity of spleen-YANG, bile are stranded resistance by wetting, and contamination muscle overflows in skin, sends out to be jaundice.Infantile hepatitis syndrome cause of disease complexity does not still have the specific treatment method at present.
Mattress four Siberian cocklebur mixture are the classical preparations of my institute, adopt medical materials such as Herba Artemisiae Scopariae, Poria, RADIX CURCUMAE, Pericarpium Citri Reticulatae Viride, Herba Lysimachiae, the Radix Paeoniae Alba, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Radix Salviae Miltiorrhizae, PINGDIMU, Rhizoma Acori Graminei, Fructus Crataegi to make compound preparation, Herba Artemisiae Scopariae is monarch drug in the side, effect with clearing away heat-damp and promoting diuresis, jaundice eliminating has the effect of significant promotion bile secretion.Mattress four Siberian cocklebur mixture have the function of clearing away damp-heat, jaundice eliminating subcutaneous ulcer, promoting diuresis to eliminate damp pathogen, spleen invigorating mind calming.Be used for the treatment of infant hepatitis syndrome.
Summary of the invention
The object of the invention is to provide a kind of Chinese medicine composition and preparation method thereof and quality determining method.
The present invention seeks to be achieved through the following technical solutions:
The raw material of Chinese medicine composition of the present invention is composed as follows:
Herba Artemisiae Scopariae 3-18 part, Poria 3-18 part, RADIX CURCUMAE 3-18 part,
Pericarpium Citri Reticulatae Viride 1-6 part, Herba Lysimachiae 1-6 part, Radix Paeoniae Alba 3-18 part,
Radix Codonopsis 3-18 part, Rhizoma Atractylodis Macrocephalae 1-6 part, Radix Salviae Miltiorrhizae 3-18 part,
PINGDIMU 3-18 part, Rhizoma Acori Graminei 1.5-9 part, Fructus Crataegi 3-18 part.
The preferred weight proportioning of above-mentioned raw materials is as follows:
6 parts of Herba Artemisiae Scopariaes, 6 parts of Porias, 6 parts of RADIX CURCUMAEs,
2 parts on Pericarpium Citri Reticulatae Viride, 2 parts of Herba Lysimachiaes, 6 parts of the Radix Paeoniae Albas,
6 parts of Radix Codonopsis, 2 parts of the Rhizoma Atractylodis Macrocephalaes, 6 parts of Radix Salviae Miltiorrhizaes,
6 parts of PINGDIMU, 3 parts of Rhizoma Acori Graminei, 6 parts of Fructus Crataegis.
The preferred weight proportioning of above-mentioned raw materials is as follows:
9 parts of Herba Artemisiae Scopariaes, 6 parts of Porias, 9 parts of RADIX CURCUMAEs,
3 parts on Pericarpium Citri Reticulatae Viride, 3 parts of Herba Lysimachiaes, 6 parts of the Radix Paeoniae Albas,
9 parts of Radix Codonopsis, 3 parts of the Rhizoma Atractylodis Macrocephalaes, 9 parts of Radix Salviae Miltiorrhizaes,
6 parts of PINGDIMU, 4.5 parts of Rhizoma Acori Graminei, 9 parts of Fructus Crataegis.
The preferred weight proportioning of above-mentioned raw materials is as follows:
15 parts of Herba Artemisiae Scopariaes, 15 parts of Porias, 15 parts of RADIX CURCUMAEs,
5 parts on Pericarpium Citri Reticulatae Viride, 5 parts of Herba Lysimachiaes, 15 parts of the Radix Paeoniae Albas,
15 parts of Radix Codonopsis, 5 parts of the Rhizoma Atractylodis Macrocephalaes, 15 parts of Radix Salviae Miltiorrhizaes,
15 parts of PINGDIMU, 7.5 parts of Rhizoma Acori Graminei, 15 parts of Fructus Crataegis.
Chinese medicine composition raw material of the present invention according to common process, is made clinical acceptable oral administration solution.
The concrete preparation technology of Chinese medicine composition of the present invention is as follows:
Get 12 flavor Chinese medicines of weight proportion in the prescription, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae and Herba Artemisiae Scopariae decoct with water 15 minutes, filter, and filtrate for later use, nine flavors such as medicinal residues and all the other Poria merge, and add water to cross powder 2-4 centimetre, decoct twice, and 1.5 hours for the first time, 1 hour for the second time.Decocting liquid filters, and merges, and leaves standstill more than 12 hours, gets supernatant concentration to about 850ml, merges with above-mentioned reserve liquid, adds sucrose 200g, and sodium benzoate 2g stirs evenly.
Chinese medicine composition quality determining method of the present invention comprises following discrimination method:
A: get Chinese medicine composition 20ml, extract 2 times with the ethyl acetate jolting, each 20ml merges ethyl acetate liquid, and evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets the Hesperidin reference substance, adds methanol and makes saturated solution, in contrast product solution.Drawing each 1 μ l of above-mentioned two kinds of solution, put respectively on same silica gel G F lamellae, is developing solvent with chloroform-acetone-methanol (5:1:1); Launch, take out, dry, spray is put under the ultraviolet light (365nm) and is inspected with 2% aluminum chloride alcoholic solution; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
The specific embodiment
Following experiment and example are used for further specifying but are not limited to the present invention
Embodiment 1:The preparation of Chinese medicine composition.
6 parts of Herba Artemisiae Scopariaes, 6 parts of Porias, 6 parts of RADIX CURCUMAEs,
2 parts on Pericarpium Citri Reticulatae Viride, 2 parts of Herba Lysimachiaes, 6 parts of the Radix Paeoniae Albas,
6 parts of Radix Codonopsis, 2 parts of the Rhizoma Atractylodis Macrocephalaes, 6 parts of Radix Salviae Miltiorrhizaes,
6 parts of PINGDIMU, 3 parts of Rhizoma Acori Graminei, 6 parts of Fructus Crataegis.
Get 12 flavor Chinese medicines of weight proportion in the prescription, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae and Herba Artemisiae Scopariae decoct with water 15 minutes, filter, and filtrate for later use, nine flavors such as medicinal residues and all the other Poria merge, and add water to cross powder 2-4 centimetre, decoct twice, and 1.5 hours for the first time, 1 hour for the second time.Decocting liquid filters, and merges, and leaves standstill more than 12 hours, gets supernatant concentration to about 850ml, merges with above-mentioned reserve liquid, adds sucrose 200g, and sodium benzoate 2g stirs evenly.
Embodiment 2:The preparation of Chinese medicine composition
9 parts of Herba Artemisiae Scopariaes, 6 parts of Porias, 9 parts of RADIX CURCUMAEs,
3 parts on Pericarpium Citri Reticulatae Viride, 3 parts of Herba Lysimachiaes, 6 parts of the Radix Paeoniae Albas,
9 parts of Radix Codonopsis, 3 parts of the Rhizoma Atractylodis Macrocephalaes, 9 parts of Radix Salviae Miltiorrhizaes,
6 parts of PINGDIMU, 4.5 parts of Rhizoma Acori Graminei, 9 parts of Fructus Crataegis.
Get 12 flavor Chinese medicines of weight proportion in the prescription, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae and Herba Artemisiae Scopariae decoct with water 15 minutes, filter, and filtrate for later use, nine flavors such as medicinal residues and all the other Poria merge, and add water to cross powder 2-4 centimetre, decoct twice, and 1.5 hours for the first time, 1 hour for the second time.Decocting liquid filters, and merges, and leaves standstill more than 12 hours, gets supernatant concentration to about 850ml, merges with above-mentioned reserve liquid, adds sucrose 200g, and sodium benzoate 2g stirs evenly.
Embodiment 3:
The preparation of Chinese medicine composition
15 parts of Herba Artemisiae Scopariaes, 15 parts of Porias, 15 parts of RADIX CURCUMAEs,
5 parts on Pericarpium Citri Reticulatae Viride, 5 parts of Herba Lysimachiaes, 15 parts of the Radix Paeoniae Albas,
15 parts of Radix Codonopsis, 5 parts of the Rhizoma Atractylodis Macrocephalaes, 15 parts of Radix Salviae Miltiorrhizaes,
15 parts of PINGDIMU, 7.5 parts of Rhizoma Acori Graminei, 15 parts of Fructus Crataegis.
Get 12 flavor Chinese medicines of weight proportion in the prescription, Pericarpium Citri Reticulatae Viride, Pericarpium Citri Reticulatae and Herba Artemisiae Scopariae decoct with water 15 minutes, filter, and filtrate for later use, nine flavors such as medicinal residues and all the other Poria merge, and add water to cross powder 2-4 centimetre, decoct twice, and 1.5 hours for the first time, 1 hour for the second time.Decocting liquid filters, and merges, and leaves standstill more than 12 hours, gets supernatant concentration to about 850ml, merges with above-mentioned reserve liquid, adds sucrose 200g, and sodium benzoate 2g stirs evenly.
Embodiment 4:
Discrimination method in the quality testing
A: get embodiment 3 Chinese medicine composition 20ml, extract 2 times with the ethyl acetate jolting, each 20ml merges ethyl acetate liquid, and evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets the Hesperidin reference substance, adds methanol and makes saturated solution, in contrast product solution.Drawing each 1 μ l of above-mentioned two kinds of solution, put respectively on same silica gel G F lamellae, is developing solvent with chloroform-acetone-methanol (5:1:1).Launch, take out, dry, spray is put under the ultraviolet light (365nm) and is inspected with 2% aluminum chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
Embodiment 5:
Clinical and experimental study
1 physical data: 46 examples all meet the infantile hepatitis syndrome diagnostic criteria that national child virus hepatitis control forum is worked out.
Inpatient's 21 examples wherein, clinic case 25 examples, male 28 examples, women 18 examples. men and women's ratio 1.6:1, the oldest is 6.5 months, the age minimum is 22 days, is 10 days-2 months from morbidity to diagnostic interval.
2 clinical datas: 46 examples are all with skin, and the mucosa xanthochromia is cardinal symptom.Companion low grade fever, vomiting, abdominal distention person's 21 examples, 37 examples have the enlargement in various degree of liver spleen, and the shallow or white pottery soil sample of stool color changes 24 examples.
3 lab testings:
3.1 hemogram: HB 〉=110g/l, WBC10 * 10
9Below/the l.
3.2 serum bilirubin determination: 46 routine serum total bilirubins all increase.
3.3 liver function test: 46 examples are all done liver function test, and wherein 25 examples serum glutamic pyruvic transminase value in various degree raises.
3.4 it is positive that the ELISA method detects the anti-CMV-IGM of the anti-CMV – of serum IGM:28 example serum, accounts for 61%, male 17 examples, women 11 examples.
4 Therapeutic Method
4.1 general treatment: strengthen nursing, instruct breast feeding, guarantee enough nutrition and additional appropriate vitamin.
4.2 medicine of the present invention is made mattress four Siberian cocklebur mixture, produced by Shanghai City Children Hospital, and every day 3 times, each 5-10ml, 2 weeks of taking medicine continuously are 1 course for the treatment of.
5 results
5.1 treatment standard
Cure: the jaundice complete obiteration, the check liver function, bilirubin is normal.
Take a turn for the better: jaundice obviously goes down, the more preceding decline of bilirubin.
5.2 therapeutic outcome
Cure 23 examples, 15 examples that take a turn for the better, 8 examples are invalid, total effective rate 82.6%.
5.3 untoward reaction: in this experiment, do not see that obvious adverse reaction takes place.
Claims (5)
1. Chinese medicine composition for the treatment of infant hepatitis syndrome is characterized in that said composition is made up of the raw material of following weight portion: Herba Artemisiae Scopariae 3-18 part, Poria 3-18 part, RADIX CURCUMAE 3-18 part, Pericarpium Citri Reticulatae Viride 1-6 part, Herba Lysimachiae 1-6 part, Radix Paeoniae Alba 3-18 part, Radix Codonopsis 3-18 part, Rhizoma Atractylodis Macrocephalae 1-6 part, Radix Salviae Miltiorrhizae 3-18 part, PINGDIMU 3-18 part, Rhizoma Acori Graminei 1.5-9 part, Fructus Crataegi 3-18 part.
2. Chinese medicine composition according to claim 1 is characterized in that the preferred weight proportioning of above-mentioned raw materials is as follows: 6 parts of Herba Artemisiae Scopariaes, 6 parts of Porias, 6 parts of RADIX CURCUMAEs, 2 parts on Pericarpium Citri Reticulatae Viride, 2 parts of Herba Lysimachiaes, 6 parts of the Radix Paeoniae Albas, 6 parts of Radix Codonopsis, 2 parts of the Rhizoma Atractylodis Macrocephalaes, 6 parts of Radix Salviae Miltiorrhizaes, 6 parts of PINGDIMU, 3 parts of Rhizoma Acori Graminei, 6 parts of Fructus Crataegis.
3. Chinese medicine composition according to claim 1 is characterized in that the preferred weight proportioning of above-mentioned raw materials is as follows: 9 parts of Herba Artemisiae Scopariaes, 6 parts of Porias, 9 parts of RADIX CURCUMAEs, 3 parts on Pericarpium Citri Reticulatae Viride, 3 parts of Herba Lysimachiaes, 6 parts of the Radix Paeoniae Albas, 9 parts of Radix Codonopsis, 3 parts of the Rhizoma Atractylodis Macrocephalaes, 9 parts of Radix Salviae Miltiorrhizaes, 6 parts of PINGDIMU, 4.5 parts of Rhizoma Acori Graminei, 9 parts of Fructus Crataegis.
4. Chinese medicine composition according to claim 1 is characterized in that the preferred weight proportioning of above-mentioned raw materials is as follows: 15 parts of Herba Artemisiae Scopariaes, 15 parts of Porias, 15 parts of RADIX CURCUMAEs, 5 parts on Pericarpium Citri Reticulatae Viride, 5 parts of Herba Lysimachiaes, 15 parts of the Radix Paeoniae Albas, 15 parts of Radix Codonopsis, 5 parts of the Rhizoma Atractylodis Macrocephalaes, 15 parts of Radix Salviae Miltiorrhizaes, 15 parts of PINGDIMU, 7.5 parts of Rhizoma Acori Graminei, 15 parts of Fructus Crataegis.
5. as the detection method of Chinese medicine composition as described in the claim 1,2,3,4, it is characterized in that this method comprises following discriminating:
A: get Chinese medicine composition 20ml, extract 2 times with the ethyl acetate jolting, each 20ml merges ethyl acetate liquid, and evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets the Hesperidin reference substance, adds methanol and makes saturated solution, in contrast product solution; Draw each 1 μ l of above-mentioned two kinds of solution, put respectively on same silica gel G F lamellae, with chloroform: acetone: methanol=5:1:1 is developing solvent; Launch, take out, dry, spray is with 2% aluminum chloride alcoholic solution, puts under the ultraviolet light of λ=365nm and inspects; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
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| Title |
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| 汤锡华.菌陈四苓合剂治疗婴儿肝炎综合征(附342例分析).《上海中医药杂志》.1987,第1987卷(第3期),全文. * |
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