CN105456995A - Traditional Chinese medicine composition for treating neonatal jaundice - Google Patents
Traditional Chinese medicine composition for treating neonatal jaundice Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9068—Zingiber, e.g. garden ginger
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/282—Artemisia, e.g. wormwood or sagebrush
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/344—Codonopsis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/35—Caprifoliaceae (Honeysuckle family)
- A61K36/355—Lonicera (honeysuckle)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/481—Astragalus (milkvetch)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/51—Gentianaceae (Gentian family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/68—Plantaginaceae (Plantain Family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/704—Polygonum, e.g. knotweed
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
Abstract
The invention discloses a traditional Chinese medicine composition for treating neonatal jaundice, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following Chinese herbal medicines of capillary wormwood herb, large-leaved gentian, astragalus root, giant knot weed, rhizome of Chinese atractylodes, plantain seed, honeysuckle, dried ginger, root of hairy asiabell and licorice root. The traditional Chinese medicine composition has the advantages that by utilizing all Chinese herbal medicines according to the prescription, the effects of clearing heat and detoxifying, and removing dampness and relieving jaundice are realized, and the neonatal pathologic jaundice can be treated; the symptoms of a neonatal patient, such as skin yellow staining, sclera yellowing and yellow urine, can be effectively relieved, the bilirubin level of the neonatal patient is obviously decreased, the neonatal jaundice is quickly eliminated, and the function of treating the neonatal jaundice is realized; after clinical proofing, compared with prior art, the traditional Chinese medicine composition has the advantages that the compatibility is concise, the treatment process is short, the treatment effect is good, the curative rate is obviously better than the curative rate of the traditional Chinese medicine at existing market, and the traditional Chinese medicine composition is suitable for being popularized and applied.
Description
Technical field
The invention belongs to technical field of Chinese medicines, relate to a kind of Chinese medicine composition for the treatment of neonatal jaundice.
Background technology
Neonatal jaundice is the common disease of neonatal period, and about 60%-70% FTNB has transient jaundice, and premature infant almost 100% has jaundice.Neonatal jaundice is divided into physiologic jaundice and pathological jaundice, and the former can transform to pathological jaundice again under certain condition, and pathological jaundice of newborn incidence rate is higher, and part bilirubin encephalopathy can occur.
The sickness rate of neonatal jaundice is higher, pathological jaundice hazardness is comparatively large, can obviously reduce and alleviate its incidence rate and the extent of injury thereof by active intervention.
Western medicine thinks that the factors such as hematoclasis increases, liver enzyme activity low, the excretion defect of conjugated bilirubin are the pathologic basis causing pathological jaundice, property after property before liver, Hepatocellular regulating liver-QI can be divided into according to jaundice genesis mechanism, traditional doctor trained in Western medicine uses intravenous drug to coordinate blue-light treatment, not only treats expensive but also phototherapy and can produce the adverse consequencess such as erythra, diarrhoea, retinal damage.
The traditional Chinese medical science thinks that neonate forms pathological jaundice and belongs to " pregnant jaundice " category, and its cause of disease is a lot, is mainly tire and reports wet accumulateing, due to pregnant female element accumulate wet contain or in accumulate damp and hot poison, lose in fetus, or because of when tire produces, after birth, baby experiences caused by toxic dampness and heat.If pregnant mother is weak and sickly, QI and blood element loses, and can cause fetus natural endowment not enough, deficiency of spleen-YANG is weak, endogenous damp formation; Or by damp is invaded after life, conversion of dampness into cold, stagnation of cold-damp.Traditional prescription such as dampness removing jaundice eliminating Chinese medicine such as " Herba Artemisiae Scopariae punt-pole soup ", " Yinzhihuang" granula " for " pregnant jaundice " achieves significant curative effect in treatment neonatal jaundice.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of Chinese medicine composition for the treatment of neonatal jaundice and preparation method thereof.
The Chinese medicine composition that the present invention treats neonatal jaundice is achieved through the following technical solutions:
Treat a Chinese medicine composition for neonatal jaundice, be prepared from by the Chinese crude drug of following weight portion: Herba Artemisiae Scopariae 6-24 part, Radix Gentianae Macrophyllae 6-24 part, Radix Astragali 3-12 part, Rhizoma Polygoni Cuspidati 3-12 part, Rhizoma Atractylodis 3-12 part, Semen Plantaginis 3-9 part, Flos Lonicerae 3-9 part, Rhizoma Zingiberis 3-9 part, Radix Codonopsis 3-9 part, Radix Glycyrrhizae 3-9 part.
Preferably, treat a Chinese medicine composition for neonatal jaundice, be prepared from by the Chinese crude drug of following weight portion: Herba Artemisiae Scopariae 18 parts, Radix Gentianae Macrophyllae 18 parts, the Radix Astragali 9 parts, Rhizoma Polygoni Cuspidati 9 parts, Rhizoma Atractylodis 9 parts, Semen Plantaginis 6 parts, Flos Lonicerae 6 parts, Rhizoma Zingiberis 3 parts, Radix Codonopsis 3 parts, 6 parts, Radix Glycyrrhizae.
Preferably, treat a Chinese medicine composition for neonatal jaundice, be prepared from by the Chinese crude drug of following weight portion: Herba Artemisiae Scopariae 15 parts, Radix Gentianae Macrophyllae 15 parts, the Radix Astragali 10 parts, Rhizoma Polygoni Cuspidati 10 parts, Rhizoma Atractylodis 6 parts, Semen Plantaginis 6 parts, Flos Lonicerae 6 parts, Rhizoma Zingiberis 6 parts, Radix Codonopsis 6 parts, 9 parts, Radix Glycyrrhizae.
The Chinese crude drug that the present invention is all recorded by pharmacopeia is prepared from, and its wide material sources, are easy to get, and cheap.Effect of its each taste Chinese crude drug is as follows:
Herba Artemisiae Scopariae: nature and flavor: bitter, pungent, is slightly cold.Gui Jing: return spleen, stomach, liver, gallbladder meridian.Function cures mainly: clearing away damp-heat, jaundice eliminating subcutaneous ulcer.For jaundice oliguria, eczema pruritus; Infectious jaundice type hepatitis.
Radix Gentianae Macrophyllae: nature and flavor: pungent, bitter is flat.Gui Jing: return stomach, liver, gallbladder meridian.Function cures mainly: wind-damp dispelling, clearing away damp-heat, stopping numbness pain.For rheumatic arthralgia, the contracture of muscle arteries and veins, joint is ached, afternoon fever, and infantile malnutrition generates heat.
The Radix Astragali: nature and flavor: sweet, temperature.Gui Jing: return lung, spleen channel.Function cures mainly: invigorating QI to consolidate the body surface resistance, diuresis poison holding, evacuation of pus, expelling pus and promoting granulation.
Rhizoma Polygoni Cuspidati: nature and flavor: micro-hardship, is slightly cold.Gui Jing: return liver, gallbladder, lung meridian.Function cures mainly: expelling wind and removing dampness, dissipating blood stasis analgesic therapy, relieving cough and resolving phlegm.For arthralgia, jaundice due to damp-heat, amenorrhea, lump in the abdomen, burn due to hot liquid or fire, injury from falling down, carbuncle sore tumefacting virus, cough with copious phlegm.
Rhizoma Atractylodis: nature and flavor: pungent, bitter, temperature.Gui Jing: return spleen, stomach, Liver Channel.Function cures mainly: drying damp and strengthening spleen, expelling wind and cold, improving eyesight.For distension and fullness in the abdomen, have loose bowels, edema, beriberi flaccidity of feet with lamenness, rheumatic arthralgia, anemofrigid cold, nyctalopia.
Semen Plantaginis: nature and flavor: sweet, is slightly cold.Gui Jing: return liver, kidney, lung, small intestine meridian.Function cures mainly: clearing away heat and promoting diuresis, and eliminating dampness by diuresis is treating stranguria, and improving eyesight is eliminated the phlegm.For edema distension, the puckery pain of pyretic stranguria, diarrhea due to summer heat and dampness, conjunctival congestion and swelling pain, phlegm-heat cough.
Flos Lonicerae: nature and flavor: sweet, cold.Gui Jing: return lung, the heart, stomach warp.Function cures mainly: heat-clearing and toxic substances removing, wind-heat dissipating.For carbuncle furuncle, sore throat, erysipelas, toxic-heat and blood stasis, anemopyretic cold, epidemic febrile disease is generated heat.
Rhizoma Zingiberis: nature and flavor: pungent, hot.Gui Jing: return spleen, stomach, kidney, the heart, lung meridian.Function cures mainly: Rhizoma Zingiberis warming spleen and stomach for dispelling cold, and recuperating depleted YANG is promoted blood circulation, dampness expectorant.For coldness and pain in the epigastrium, vomiting is had loose bowels, and cold extremities faint pulse, phlegm retention is breathed with cough.
Radix Codonopsis: nature and flavor: sweet is flat.Gui Jing: return spleen, lung meridian.Function cures mainly: invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.For deficiency of the spleen and lung, cardiopalmus of breathing hard, anorexia and loose stool, dyspnea due to deficiency is coughed, and interior-heat is quenched one's thirst.
Radix Glycyrrhizae: nature and flavor: sweet, flat.Gui Jing: GUIXIN, lung, spleen, stomach warp.Function cures mainly: invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, the anxious pain of gastral cavity abdomen, extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.
The bitter diarrhea of Herba Artemisiae Scopariae falls, and be slightly cold heat clearing away, its gas delicate fragrance, and the special germinating and sprouting of merit causes newly, heat-clearing and dampness-resolving, is control the damp and hot special medicine of taste two, kind clear sharp taste dampness-heat in the liver and gallbladder, and make it to go out from urine, join Radix Gentianae Macrophyllae: Radix Gentianae Macrophyllae heat-clearing and dampness-resolving, stimulate the menstrual flow outward tunnel, inside leads two just; Herba Artemisiae Scopariae removing damp and turbid jaundice eliminating, kind subcutaneous ulcer of harnessing the Yellow River.Two medicines match, and the effect of dampness removing jaundice eliminating is more outstanding.So the two is altogether for the present invention harnesses the Yellow River the monarch drug of subcutaneous ulcer.
Semen Plantaginis clearing away heat and promoting diuresis, eliminating dampness by diuresis is treating stranguria; Radix Astragali tonifying Qi and lifting yang, hemopoietic is capable stagnant, and benefit defends consolidating superficial resistance, holder skin ulcer granulation promoting, inducing diuresis to remove edema, promoting the production of body fluid to quench thirst; Rhizoma Polygoni Cuspidati bitter cold, kind to let out the middle burnt stasis of blood stagnant, and fall and rush down dampness-heat in the liver and gallbladder, can rush down damp and hot, sharp liver and gall, blood stasis removing is tied, waterway, promoting the function of the gallbladder to alleviate jaundice.The dampness removing of this three medicine altogether principal drug assistance is yellow, diuretic merit.So three is ministerial drug.
Rhizoma Atractylodis are apt to dry spleen and are wet, and wet go, and taste be good for fortune, have that dry spleen wets, the merit of spleen invigorating gas.Flos Lonicerae sweet in the mouth is cold in nature, returns lung, the heart, stomach warp.Be longer than clearing heat in QI system heresy, thoroughly battalion to reach gas, separate fire-toxin, subduing inflammation, heat-clearing and toxic substances removing.Rhizoma Zingiberis is hot dry strong, and master enters spleen, stomach warp, is strong activating the spleen sun, the key medicine of warming spleen and stomach for dispelling cold.Radix Codonopsis is sweet flat, and strengthening the spleen stomach, changes precise and tiny, and raw cloudy blood, has the effect of qi-supplementing, blood-engendering.In the sweet mitigation of Radix Glycyrrhizae, removing toxic substances heat clearing away.All medicines are altogether for assistant makes above.
Full side shares, heat-clearing and toxic substances removing, dampness removing jaundice eliminating, can be used for treating pathological jaundice of newborn.Chinese medicine composition of the present invention both effectively can alleviate the symptoms such as infant xanthochromia, sclera jaundice, yellowish urine, significantly can reduce again the bilirubin level of infant, thus make the rapid regression of neonatal jaundice, played the effect for the treatment of neonate jaundice.Through clinical verification, Chinese medicine of the present invention compared with prior art, has following advantage: compatibility is simplified, short treating period, good effect, and its cure rate is significantly better than existing commercially available Chinese medicine.Therefore, the present invention also will protect the application of above-mentioned Chinese medicine composition in the medicine of preparation treatment neonatal jaundice.
Present invention also offers a kind of preparation method for the treatment of the Chinese medicine composition of neonatal jaundice, particularly, it comprises following preparation process:
(1), take Herba Artemisiae Scopariae, Radix Gentianae Macrophyllae, the Radix Astragali, Rhizoma Polygoni Cuspidati, Rhizoma Atractylodis, Semen Plantaginis, Flos Lonicerae, Rhizoma Zingiberis, Radix Codonopsis and Radix Glycyrrhizae, pulverize, mix for subsequent use;
(2), add the water of 6-10 times of weight, soak 1-12 hour, backflow decoction 2 times, each 1-2 hour, filter, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.15-1.25;
(3) concentration, by step (2) gained filtering residue adding 4-8 times of weight is the ethanol of 85%, reflux, extract, 2 times, each 1-2 hour, and filter, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.15-1.25;
(4), the thick paste of combining step (2) and (3) gained, make pharmaceutical preparation.
Described pharmaceutical preparation can be the multiple dosage forms such as granule, oral liquid, capsule, tablet, is preferably granule.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, but the present invention is not limited only to following specific embodiment.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.
Embodiment 1
Prescription (weight portion): Herba Artemisiae Scopariae 24 parts, Radix Gentianae Macrophyllae 24 parts, the Radix Astragali 12 parts, Rhizoma Polygoni Cuspidati 12 parts, Rhizoma Atractylodis 12 parts, Semen Plantaginis 9 parts, Flos Lonicerae 9 parts, Rhizoma Zingiberis 9 parts, Radix Codonopsis 9 parts, Radix Glycyrrhizae 9.
Preparation method:
(1), take Herba Artemisiae Scopariae, Radix Gentianae Macrophyllae, the Radix Astragali, Rhizoma Polygoni Cuspidati, Rhizoma Atractylodis, Semen Plantaginis, Flos Lonicerae, Rhizoma Zingiberis, Radix Codonopsis and Radix Glycyrrhizae, pulverize, mix for subsequent use;
(2), add the water of 8 times of weight, soak 6 hours, backflow decoction 2 times, each 1.5 hours, filter, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities was the thick paste of 1.20;
(3) concentration, by step (2) gained filtering residue adding 8 times of weight is the ethanol of 85%, reflux, extract, 2 times, each 1.5 hours, and filter, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.20;
(4), the thick paste of combining step (2) and (3) gained, drying under reduced pressure, pulverizes, and add appropriate amount of starch, sucrose, is prepared into granule, and pack, every bag of 2g, containing crude drug 0.4g.
Embodiment 2
Prescription (weight portion): Herba Artemisiae Scopariae 6 parts, Radix Gentianae Macrophyllae 6 parts, the Radix Astragali 3 parts, Rhizoma Polygoni Cuspidati 3 parts, Rhizoma Atractylodis 3 parts, Semen Plantaginis 3 parts, Flos Lonicerae 3 parts, Rhizoma Zingiberis 3 parts, Radix Codonopsis 3 parts, 3 parts, Radix Glycyrrhizae.
Preparation method is with embodiment 1.
Embodiment 3
Prescription (weight portion): Herba Artemisiae Scopariae 20 parts, Radix Gentianae Macrophyllae 20 parts, the Radix Astragali 10 parts, Rhizoma Polygoni Cuspidati 10 parts, Rhizoma Atractylodis 10 parts, Semen Plantaginis 5 parts, Flos Lonicerae 3 parts, Rhizoma Zingiberis 3 parts, Radix Codonopsis 3 parts, 6 parts, Radix Glycyrrhizae.
Preparation method is with embodiment 1.
Embodiment 4
Prescription (weight portion): Herba Artemisiae Scopariae 18 parts, Radix Gentianae Macrophyllae 18 parts, the Radix Astragali 9 parts, Rhizoma Polygoni Cuspidati 9 parts, Rhizoma Atractylodis 9 parts, Semen Plantaginis 6 parts, Flos Lonicerae 6 parts, Rhizoma Zingiberis 3 parts, Radix Codonopsis 3 parts, 6 parts, Radix Glycyrrhizae.
Preparation method is with embodiment 1.
Embodiment 5
Prescription (weight portion): Herba Artemisiae Scopariae 15 parts, Radix Gentianae Macrophyllae 15 parts, the Radix Astragali 10 parts, Rhizoma Polygoni Cuspidati 10 parts, Rhizoma Atractylodis 6 parts, Semen Plantaginis 6 parts, Flos Lonicerae 6 parts, Rhizoma Zingiberis 6 parts, Radix Codonopsis 6 parts, 9 parts, Radix Glycyrrhizae.
Preparation method is with embodiment 1.
pharmacodynamics test
The granule that inventor utilizes embodiment 1-5 to produce has carried out toxicity test, with security verified.
Laboratory animal: SPF level KM mice, body weight 25 ± 4g, 110, male and female half and half, are provided by Fudan University in Shanghai Experimental Animal Center.
The granule that trial drug: embodiment 1-5 produces.
Acute toxicity test:
With the granule that embodiment of the present invention 1-5 makes, to mice by each maximum dosage-feeding 0.15g crude drug/10g body weight, administration every day 3 times, prerun is done with 10 mices (male and female half and half), after observing, none example of result mice is dead, does not also occur any intoxicating phenomenon.So dosage is safe dose, can obtain as calculated, this dosage is 100 times of neonate (body weight calculates by 4kg) consumption per day.According to above trial test, the toxicity of known medicine is less.
Slow toxicity test:
Get SPF level mice, male and female half and half, be divided into 2 groups at random, be divided into administration group and blank group.Before gavage, water 16h is can't help in fasting, and administration group gastric infusion 3 times in 1 day, carries out administration by each maximum dosage-feeding 0.15g crude drug/10g body weight at every turn, is equivalent to 100 times of neonate consumption per day (body weight is calculated by 4Kg).The same gavage of blank group gives the distilled water of same dose.Continuous gavage 90 days, observes 7 days after stopping gavage, normal diet, observes the death of mice, poisoning and outward appearance, behavior, secretions and excremental situation, and record the body weight change of mice.
Not there is death condition in test small mouse.Mice is movable normal, and general state is good, does not occur obvious intoxicating phenomenon.Its heart of anatomic observation, liver, spleen, lung, kidney after putting to death, all without special change.The delta data no difference of science of statistics of body weight before mouse stomach and after gavage.
Visible Chinese medicine preparation of the present invention is safe and reliable, has no side effect.
clinical trial:
1.1 physical data
Select neonate 240 example that in March ,-2009 in March, 2007, my section went to a doctor, 2.5kg< body weight <4kg, man 130 example, female 110 example.
1.2 diagnostic criterias:
(1) neonate ordinary circumstance is good, spirit and diet good, growth promoter is normal, and liver without enlargement, and gets rid of the factors such as other pathological jaundices, infection of newborn, hemolytic disease;
(2) simple breast-feeding infant is;
(3) jaundice is based on light, moderate;
(4) xanthochromia time of occurrence is 4-7d, and deepens gradually, persistent >2 week;
(5) after stopping breast milk, 48-72h jaundice obviously disappears, then suckling is deepened again.
1.3 observational techniques:
Adopt the NT-33 percutaneous bilirubin detector of Shanghai Instrument Research Institute's development, by measuring forehead glabella 1cm, horizontal line two positions, breastbone the 2nd intercostal center, observing percutaneous bilirubin (TCB) index before and after treatment, carrying out comparitive study.
1.4 groupings:
At random infant is divided into three groups at random, treats 1 group of 80 example, Transcutaneous bilirubin value 12.5-19.2mg/dl before treatment; Treat 2 group of 80 example, Transcutaneous bilirubin value 12.5-19.2mg/dl before treatment; Matched group 80 example, Transcutaneous bilirubin value 12.4-18.8mg/dl before treatment.The physical data data such as three groups of children age, sex, gestational age, weight, consultation time and the front Transcutaneous bilirubin values for the treatment of, through statistical procedures, are all learned Yi Yi ﹙ P>0.05 ﹚ without Tong meter, are had comparability.
1.5 Therapeutic Method
Matched group: oral Yinzhihuang" granula 1g/ time, every day 3 times, serve on 5d;
Treat 1 group: granule prepared by the embodiment of the present invention 4,0.4g/ time, every day 2 times, serve on 5d;
Treat 2 groups: granule prepared by the embodiment of the present invention 5,0.4g/ time, every day 2 times, serve on 5d.
Three groups of equal normal breast feedings.With percutaneous bilirubin detector check bilirubin value after medication 5d.
1.6 curative effect judging standard
Effective: after treatment 5d, jaundice obviously disappears, Transcutaneous bilirubin value <7mg/dl;
Effective: treatment 5d xanthochromia major part disappears, Transcutaneous bilirubin value 7-10mg/dl;
Invalid: treatment 5d xanthochromia disappears not obvious, Transcutaneous bilirubin value >10mg/dl.
1.7 statistical method
Adopt χ
2inspection carries out statistical analysis to data.P<0.05 difference has statistical significance.
2 experimental results
2.1 3 groups of comparitive study are in table 1.
Table 1 three groups of comparitive study results
Compare with matched group,
*p<0.05.
Before and after 2.2 3 groups of treatments, percutaneous survey bilirubin level compares in table 2.
Transcutaneous bilirubin before and after the treatment of three groups, table 2
± S, mg/L
Note: compare with after treatment of control group,
*p<0.05.
In therapeutic process all there is not obvious adverse reaction in three groups of infants, surveys before bilirubin level is comparatively treated and obviously reduce, the reduction degree aobvious outstanding ﹙ P<0.05 ﹚ different from matched group phase ratio of two treatment groups after three groups of treatments through skin; The total effective rate for the treatment of group compares with the total effective rate of matched group, difference You Xian Zhu ﹙ P<0.05 ﹚; The obvious effective rate for the treatment of group compares with the obvious effective rate of matched group, difference You Xian Zhu ﹙ P<0.05 ﹚.Visible Chinese medicine of the present invention can be accelerated jaundice and disappear, and significantly alleviates jaundice degree, shortens the jaundice persistent period, and non-evident effect, clinic is promoted.
Claims (4)
1. treat the Chinese medicine composition of neonatal jaundice for one kind, it is characterized in that, described Chinese medicine composition is prepared from by the Chinese crude drug of following weight portion: Herba Artemisiae Scopariae 6-24 part, Radix Gentianae Macrophyllae 6-24 part, Radix Astragali 3-12 part, Rhizoma Polygoni Cuspidati 3-12 part, Rhizoma Atractylodis 3-12 part, Semen Plantaginis 3-9 part, Flos Lonicerae 3-9 part, Rhizoma Zingiberis 3-9 part, Radix Codonopsis 3-9 part, Radix Glycyrrhizae 3-9 part.
2. the Chinese medicine composition for the treatment of neonatal jaundice as claimed in claim 1, it is characterized in that, described Chinese medicine composition is prepared from by the Chinese crude drug of following weight portion: Herba Artemisiae Scopariae 18 parts, Radix Gentianae Macrophyllae 18 parts, the Radix Astragali 9 parts, Rhizoma Polygoni Cuspidati 9 parts, Rhizoma Atractylodis 9 parts, Semen Plantaginis 6 parts, Flos Lonicerae 6 parts, Rhizoma Zingiberis 3 parts, Radix Codonopsis 3 parts, 6 parts, Radix Glycyrrhizae.
3. the Chinese medicine composition for the treatment of neonatal jaundice as claimed in claim 1, it is characterized in that, described Chinese medicine composition is prepared from by the Chinese crude drug of following weight portion: Herba Artemisiae Scopariae 15 parts, Radix Gentianae Macrophyllae 15 parts, the Radix Astragali 10 parts, Rhizoma Polygoni Cuspidati 10 parts, Rhizoma Atractylodis 6 parts, Semen Plantaginis 6 parts, Flos Lonicerae 6 parts, Rhizoma Zingiberis 6 parts, Radix Codonopsis 6 parts, 9 parts, Radix Glycyrrhizae.
4. the Chinese medicine composition of the treatment neonatal jaundice as described in any one of claim 1-3, is characterized in that, described Chinese medicine composition is made into granule, oral liquid, capsule or tablet.
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| CN111388577A (en) * | 2020-05-25 | 2020-07-10 | 自贡市妇幼保健院 | Traditional Chinese medicine composition and preparation for treating neonatal hyperbilirubinemia, and preparation method and application thereof |
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