CN105770348A

CN105770348A - Traditional Chinese medicine for treating neonatal hyperbilirubinemia and preparation method thereof

Info

Publication number: CN105770348A
Application number: CN201610284987.3A
Authority: CN
Inventors: 于连玲; 张焕英
Original assignee: Individual
Current assignee: Individual
Priority date: 2016-04-30
Filing date: 2016-04-30
Publication date: 2016-07-20

Abstract

The invention provides traditional Chinese medicine for treating neonatal hyperbilirubinemia and a preparation method thereof. The traditional Chinese medicine comprises following active pharmaceutical ingredients: Elsholtzia blanda, Hypericum kouytchouense, Lamium amplexicaule, jequirity root, Sophora moorcroftiana, Armillaria tabescens, Ficus formosana, fern root, Patrinia rupestris, Rheum pumilum, root of Berberis wilsonae, Japanese tripterospermum herb, Ainsliaea pertyoides, Phyllanthus virgatus, Semen sojae germinatum, twisted-stalk, longan root, Erysimum bungei, Incarvillea mairei and Galium vernum. The traditional Chinese medicine has the advantages that the traditional Chinese medicine is combined with a conventional method of Western medicine to treat neonatal hyperbilirubinemia, and is convenient to use, better in treatment effect, free of toxic and side effect and adverse reaction, quick in action and simple to prepare.

Description

A kind of Chinese medicine treating hyperbilirubinemia of newborn and preparation method thereof

Technical field

The present invention relates to engineering of traditional Chinese medicine technical field, particularly relate to a kind of Chinese medicine treating hyperbilirubinemia of newborn and preparation method thereof.

Background technology

The disease that hyperbilirubinemia of newborn is neonate because abnormal level of serum total bilirubin that many reasons causes increases, this diagnosis is symptomatic diagnosis.Owing to neonate is common with Pathological jaundice disease, therefore refer mainly to unconjugated hyperbilirubinemia (unconjugatedhyperbilirubinemia).Its cause of disease includes bilirubin and generates too much, hepatocyte picked-up and conjugated bilirubin inferior capabilities, abnormal, the intestinal-liver circulation increase of bilirubin excretion etc..Pressing bilirubin character, hyperbilirubinemia of newborn can be divided into unconjugated hyperbilirubinemia and the big class of conjugated hyperbilirubinemia two.Its pathogeny is particularly as follows: unconjugated hyperbilirubinemia: when increasing of unconjugated bilirubin exceedes albumin carrying capacity, or exceed liver metabolism load, the unconjugated bilirubin combined without liver disperse can enter the tissue containing phospholipid composition by blood brain barrier, by containing lipocyte film, particularly neuronal cell film and enter neuron, make mitochondrion be subject to barrier, brain cell energy are suppressed and to cause brain cell impaired, cause bilirubin encephalopathy or the xanthochromia because of nucleus to form bilirubin encephalopathy.Conjugated hyperbilirubinemia: hepatic necrosis causes bile capillary block and break；Swelling of liver cell is oppressed, hepatocyte bile secretion dysfunction, and the permeability of bile capillary increases all can cause the minimizing of bile secretion flow, and bile concentration, stasis promote bile sedimentation and gallbladder bolt to be formed, and cause bile capillary obturation；Inflammatory cell chip blocks tip biliary ductuli.In blood, the degree of unconjugated bilirubin increases the acatharsia being likely due to conjugated bilirubin, it is suppressed that Glucuronosyltransferase activity and hepatocyte are to caused by the picked-up of unconjugated bilirubin.

Hyperbilirubinemia of newborn belongs to jaundice due to fright or traumatic injury or the fetal jaundice of the traditional Chinese medical science, accumulates damp and hot, pass in fetus during because of gestation in parent.Owing to children's's internal organs are tender and lovely, shape gas does not fill, dysfunction of the spleen, damp and hot fails catharsis, interior strongly fragrant in liver and gall, excessive in flesh table be jaundice.Owing to children's's internal organs are tender and lovely, shape gas does not fill, dysfunction of the spleen, damp and hot fails catharsis, interior strongly fragrant in liver and gall, excessive sends out as jaundice in flesh table.Among damp and hot or cold-damp, the most common with damp and hot pregnant jaundice, if excessive noxious heat, evil fall into the moon of fainting, be also shown in the critical performance of coma, tic.

Summary of the invention

The technical problem to be solved is in that, utilizes the theory of Chinese medical science that China is traditional, it is provided that a kind of determined curative effect and the Chinese medicine for the treatment of hyperbilirubinemia of newborn free of toxic effects and preparation method thereof.

In order to solve above-mentioned technical problem, the invention provides a kind of Chinese medicine treating hyperbilirubinemia of newborn, described Chinese medicine includes following raw medicinal material: Herba Elsholtziae Blandae, water perfume (or spice) bavin, Herba Lamii Amplexicaulis, Radix Abri, Sophora moocroftiana(Wall．) Benth. Ex Bak., Armillaria mella tabescens (Scop.ex Fr.) Sing., Taiwan banyan, Rhizoma pteridii latiusculi, Herba Patriniae Rupestris, Radix et Rhizoma Rhei, Radix Berberidis wilsonae, Herba Tripterospermi japonici, Herba Ainsliaea Albotomentosae, Phyllanthus simplex Retz．, Semen Glycine Germinatum, Streptopus simplex D. Don, Radix Longan, Herba Erysimi Cheiranthoidis, Radix Incarvilleae Delavayi and Herba galii veri.

The ratio of weight and number of the various raw medicinal materials in described Chinese medicine can be preferably: Herba Elsholtziae Blandae 20～30 parts, water perfume (or spice) bavin 5～15 parts, Herba Lamii Amplexicaulis 15～25 parts, Radix Abri 20～35 parts, Sophora moocroftiana(Wall．) Benth. Ex Bak. 5～15 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 25～35 parts, Taiwan banyan 20～30 parts, Rhizoma pteridii latiusculi 15～25 parts, Herba Patriniae Rupestris 30～40 parts, Radix et Rhizoma Rhei 15～30 parts, Radix Berberidis wilsonae 25～35 parts, Herba Tripterospermi japonici 20～30 parts, Herba Ainsliaea Albotomentosae 15～25 parts, Phyllanthus simplex Retz． 10～20 parts, Semen Glycine Germinatum 25～35 parts, Streptopus simplex D. Don 5～15 parts, Radix Longan 20～30 parts, Herba Erysimi Cheiranthoidis 25～40 parts, Radix Incarvilleae Delavayi 10～20 parts and Herba galii veri 15～25 parts.

The ratio of weight and number of the various raw medicinal materials in described Chinese medicine can also be more preferably: Herba Elsholtziae Blandae 20～25 parts, water perfume (or spice) bavin 10～15 parts, Herba Lamii Amplexicaulis 15～20 parts, Radix Abri 25～30 parts, Sophora moocroftiana(Wall．) Benth. Ex Bak. 5～10 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 30～35 parts, Taiwan banyan 25～30 parts, Rhizoma pteridii latiusculi 15～20 parts, Herba Patriniae Rupestris 30～35 parts, Radix et Rhizoma Rhei 20～25 parts, Radix Berberidis wilsonae 30～35 parts, Herba Tripterospermi japonici 20～25 parts, Herba Ainsliaea Albotomentosae 15～20 parts, Phyllanthus simplex Retz． 10～15 parts, Semen Glycine Germinatum 25～30 parts, Streptopus simplex D. Don 10～15 parts, Radix Longan 20～25 parts, Herba Erysimi Cheiranthoidis 30～35 parts, Radix Incarvilleae Delavayi 10～15 parts and Herba galii veri 20～25 parts.

The ratio of weight and number of the various raw medicinal materials in described Chinese medicine can also be more preferably: Herba Elsholtziae Blandae 21 parts, water perfume (or spice) bavin 15 parts, Herba Lamii Amplexicaulis 17 parts, Radix Abri 26 parts, Sophora moocroftiana(Wall．) Benth. Ex Bak. 9 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 32 parts, Taiwan banyan 28 parts, Rhizoma pteridii latiusculi 16 parts, Herba Patriniae Rupestris 35 parts, Radix et Rhizoma Rhei 21 parts, Radix Berberidis wilsonae 35 parts, Herba Tripterospermi japonici 22 parts, Herba Ainsliaea Albotomentosae 19 parts, Phyllanthus simplex Retz． 12 parts, Semen Glycine Germinatum 28 parts, Streptopus simplex D. Don 12 parts, Radix Longan 25 parts, Herba Erysimi Cheiranthoidis 31 parts, Radix Incarvilleae Delavayi 15 parts and Herba galii veri 21 parts.

When the dosage form of described Chinese medicine is oral liquid, its preparation method comprises the following steps:

The first step, Herba Elsholtziae Blandae, water perfume (or spice) bavin, Herba Lamii Amplexicaulis, Radix Abri, Sophora moocroftiana(Wall．) Benth. Ex Bak., Armillaria mella tabescens (Scop.ex Fr.) Sing., Taiwan banyan, Rhizoma pteridii latiusculi, Herba Patriniae Rupestris, Radix et Rhizoma Rhei and Radix Berberidis wilsonae are mixed in proportion, add relative to the alcohol reflux that mixture 3 times～5 times amount determining alcohol is 55%～65% 2 times～4 times, each 2 hours～3 hours, filtering, filtrate merges, and reclaims ethanol, being concentrated into 70 DEG C of relative densities is the mastic of 1.30～1.32, standby；

Second step, is mixed in proportion surplus stock medical material, adds relative to mixture 3～5 times amount water, boils 2～4 hours, filters, and being concentrated into 70 DEG C of relative densities is the mastic of 1.27～1.29；

3rd step, the described mastic mixing first step, second step obtained, 55 DEG C～65 DEG C reduced vacuum dry, and get dry extract powder；

4th step, added ethanol in the described dried cream powder the 3rd step obtained, obtains containing alcohol mastic, and the alcohol content of described containing alcohol mastic is 65%～70%；Described containing alcohol mastic being sequentially carried out chilling treatment, precipitation process, filtration treatment, recovery Ethanol Treatment, obtains dealcoholysis mastic, wherein, the chilling treatment time is 30～40 hours, and refrigerated storage temperature is 0 DEG C～6 DEG C；

5th step, will add cane sugar powder, activated carbon in described dealcoholysis mastic, be sequentially carried out heat treated, filtration treatment, dilution process, obtain semi-finished product；The weight ratio of described dealcoholysis mastic and described cane sugar powder is 1: 0.1～0.3；The weight ratio of described dealcoholysis mastic and described activated carbon is 1: 0.001～0.002；The time of described heat treated is 20～40 minutes, and temperature is 100 DEG C～110 DEG C；

6th step, the more described semi-finished product that the 5th step obtains are sequentially carried out filtration treatment, embedding process, sterilization treatment, obtain described Chinese medicine oral liquid finished product.

When the dosage form of described Chinese medicine is syrup, its preparation method comprises the following steps:

The first step, by Herba Elsholtziae Blandae, water perfume (or spice) bavin, Herba Lamii Amplexicaulis, Radix Abri, Sophora moocroftiana(Wall．) Benth. Ex Bak., Radix et Rhizoma Rhei and Radix Berberidis wilsonae are mixed in proportion, add the ethanol that determining alcohol is 80%～90% relative to 4～6 times of mixture, heating and refluxing extraction 2～4 times, each reflux, extract, 2 hours～3 hours, united extraction liquid, with the centrifugal remove impurity of tube centrifuge, when extracting solution after remove impurity is evaporated to 60 DEG C in 60 DEG C～70 DEG C when, relative density is the medicinal liquid of 1.05～1.10, concentrated solution spray dryer after concentration is dried, it is ground into 100～200 orders subsequently, obtain dry powder；

Second step, Herba Tripterospermi japonici, Herba Ainsliaea Albotomentosae, Phyllanthus simplex Retz．, Semen Glycine Germinatum, Streptopus simplex D. Don and Radix Longan are mixed in described ratio, it is ground into powder, with the ethanol that determining alcohol is 85%～95% as solvent, impregnate 48 hours～72 hours, adopt percolation with the speed slowly percolation of 1～2ml per minute, collect percolate, being concentrated into relative density when 60 DEG C is the mastic of 1.25～1.27, dry with spray dryer, being ground into 100～200 orders subsequently, it is thus achieved that dry powder, the quality of affiliated ethanol is 3～5 times of second step mixture quality；

3rd step, surplus stock medical material is mixed in described ratio, add relative to the alcohol reflux that mixture 4～6 times amount determining alcohol is 70%～80% 2～4 times, each 1 hour～3 hours, filtering, filtrate merges, reclaim ethanol, being concentrated into relative density when 60 DEG C is the mastic of 1.20～1.22, dries in 55 DEG C～65 DEG C reduced vacuum, obtains dry powder；

4th step, the dry powder blend that the first step is obtained to the 3rd step, add the water dissolution relative to mixture quality 3～5 times, pH value is regulated to 7.0 with 40% sodium hydroxide solution, it is subsequently added correctives sucrose, preservative mix homogeneously, obtain syrup, the correctives of addition, preservative and the content in medicine thereof: sucrose 15～40%, Pyrusussuriensis acids preservative such as potassium sorbate 0.1～0.3%, paraben preservative such as ethyl hydroxybenzoate 0.01～0.05%.

Beneficial effects of the present invention: the Chinese medicine associating doctor trained in Western medicine conventional treatment hyperbilirubinemia of newborn of the present invention, easy to use, therapeutic effect is better, has no side effect and untoward reaction, and instant effect, preparation technology is simple.

Detailed description of the invention

The invention provides a kind of Chinese medicine treating hyperbilirubinemia of newborn, Chinese medicine includes following raw medicinal material: Herba Elsholtziae Blandae, water perfume (or spice) bavin, Herba Lamii Amplexicaulis, Radix Abri, Sophora moocroftiana(Wall．) Benth. Ex Bak., Armillaria mella tabescens (Scop.ex Fr.) Sing., Taiwan banyan, Rhizoma pteridii latiusculi, Herba Patriniae Rupestris, Radix et Rhizoma Rhei, Radix Berberidis wilsonae, Herba Tripterospermi japonici, Herba Ainsliaea Albotomentosae, Phyllanthus simplex Retz．, Semen Glycine Germinatum, Streptopus simplex D. Don, Radix Longan, Herba Erysimi Cheiranthoidis, Radix Incarvilleae Delavayi and Herba galii veri.

The pharmacology of various raw medicinal materials is as follows:

Herba Elsholtziae Blandae: [another name] white Herba Moslae, Herba Elsholtziae penduliforare, four rib Artemisias, Kochia scoparia, wild Soviet Union, climing dam, wild mint.[source] medical material Ji Yuan: for the herb of labiate Elsholtzia blanda.[nature and flavor] bitter in the mouth；Pungent；Property is put down.[function cures mainly] heat clearing away；Dampness removing；Removing toxic substances.Main cold, fever；Sensible heat dysentery；Jaundice；Dysuria；Foot a word used for translation is rotten itches；Burn.[each discussion] " Yunnan Chinese herbal medicine ": invigorating spleen to remove dampness, anti-inflammatory analgetic, controls nyctalopia, and dysentery is suffered from abdominal pain, bromhidrosis, fire burn.[extracts] " China's book on Chinese herbal medicine "

Water perfume (or spice) bavin: [another name] Radix Cynanchi Paniculati, Herba Artemisiae Anomalae, Lysimachia christinae Hance.[source] medical material Ji Yuan: for the root of Garcinia maingayii Guizhou Radix Hyperici Monogyni (Herba Hyperici Monogyni), seed.[nature and flavor] are pungent；Sweet；Cold.[function cures mainly] clearing away heat-damp and promoting diuresis；Promoting blood circulation and stopping pain.Main jaundice；Dysentery；Menoxenia；Infantile malnutrition；Traumatic injury.[extracts] " China's book on Chinese herbal medicine "

Herba Lamii Amplexicaulis: [another name] Rhizoma seu Herba Elatostematis stewardii, lotus throne summer be withered, the imperial grass of lamp, Radix Thalictri Trichopi, Buddhist seat, wind small cup, wax candle skewer grass.[source] medical material Ji Yuan: for the herb of labiate Herba Lamii Amplexicaulis.[nature and flavor] acrid in the mouth；Bitter；Slightly warm in nature.[function cures mainly] promoting blood circulation to remove obstruction in the collateral；Removing toxic substances and promoting subsidence of swelling.Main traumatic injury；Bones and muscles pain；Numb limbs and tense tendons；Hemiplegia；Face is completed；Jaundice；Nasal sinusitis；Scrofula；Toxic swelling；Impetigo.[extracts] " China's book on Chinese herbal medicine "

Radix Abri: [source] medical material Ji Yuan: for the root of leguminous plant Semen Abri Precatorii.[nature and flavor] are sweet；Cool.[return through] lung；Gallbladder；Bladder warp.[function cures mainly] heat-clearing and toxic substances removing, diuresis.Main laryngopharynx swelling and pain, bronchitis, jaundice, hepatitis.[each discussion] 1, " Nanning City's medicine will ": cellulitis of harnessing the Yellow River.2, " Guangxi Chinese herbal medicine ": clearing away heat and promoting diuresis.Control laryngopharynx swelling and pain, hepatitis, bronchitis.[extracts] " China's book on Chinese herbal medicine "

Sophora moocroftiana(Wall．) Benth. Ex Bak.: [another name] Ji watt.[source] medical material Ji Yuan: for the seed of leguminous plant Sophora moocroftiana(Wall．) Benth. Ex Bak..[nature and flavor] bitter in the mouth；Cold in nature.[return through] Liver Channel.[function cures mainly] heat clearing and damp drying；Removing toxic substances.Main jaundice due to damp-heat；Diphtheria；Tonsillitis.[extracts] " China's book on Chinese herbal medicine "

Armillaria mella tabescens (Scop.ex Fr.) Sing.: [another name] armillariella tabescens, easily die a glass umbrella, blue or green car bit, light bacterium, luminous Armillariella.[source] medical material Ji Yuan: for Bai Mo section fungus luminescence armillariella tabescens filament.[nature and flavor] are bitter；Cold in nature.[return through] liver；Gallbladder meridian.[function cures mainly] heat-clearing and toxic substances removing.Main acute and chronic cholecystitis；Biliary tract infection；Hepatitis；Appendicitis；Otitis media.[extracts] " China's book on Chinese herbal medicine "

Taiwan banyan: [another name] comes into leaves Fici hispidae, Folium seu Cortex Osmanthi Matsumurani, the Lac Bovis seu Bubali tree that comes into leaves, milk fruit, TianXing wood, water Semen Arecae, Xian Rentao.[source] medical material Ji Yuan: for the Herb of moraceae plants Taiwan banyan.[nature and flavor] are sweet；Micro-puckery；Property is put down.[function cures mainly] blood circulation promoting and enriching；Lactogenic；Cough-relieving；Expelling wind and removing dampness；Heat-clearing and toxic substances removing.Main menoxenia；Puerperal or weak after being ill；Agalactia；Cough；Rheumatic arthralgia；Traumatic injury；Carbuncle on the back；Acute mastitis；Venom；Jaundice due to damp-heat；Acute nephritis；Urinary tract infection.[extracts] " China's book on Chinese herbal medicine "

Rhizoma pteridii latiusculi: [another name] Herba pteridii latiusculi Radix polygalae arillatae, Wu Jiao, little Jiao, Herba pteridii latiusculi powder.[source] medical material Ji Yuan: for the rhizome of Pteridiaceae plant Herba pteridii latiusculi.[nature and flavor] are sweet；Cold；Nontoxic.[return through] lung；Liver；Spleen；Large intestine channel.[function cures mainly] heat clearing away；Dampness removing；Suppressing the hyperactive liver is calmed the nerves；Removing toxic substances and promoting subsidence of swelling.Main heating；Laryngopharynx swelling and pain；Diarrhoea；Dysentery；Jaundice；Leucorrhea；Hypertension；Dizzy insomnia；Rheumatic arthralgia；Hemorrhoid；Proctoptosis；Eczema；Scald；Snake bite and insect sting.[each discussion] 1, " south of the Five Ridges gather medicinal herbs record ": for antipyretic.Harness the Yellow River subcutaneous ulcer, treat carbuncle wind pain, ophthalmalgia, control throat heat symptom-complex, typhoid fever epidemic febrile disease.2, " conventional glossary of Herbs and Drugs among the people ": strengthening the spleen and stomach, relieving restlessness is hot-tempered, settling five organs, controls leucorrhea.3, " Jilin Chinese herbal medicine ": antipyretic, diuresis, QI invigorating, yin nourishing.Control unconsciousness due to high fever, deficient five internal organs, stagnation of QI meridians, bones and muscles pain.[extracts] " China's book on Chinese herbal medicine " " Chinese medicine voluminous dictionary "

Herba Patriniae Rupestris: [source] medical material Ji Yuan: for the herb of Valerianaceae plant Herba Patriniae Rupestris.[nature and flavor] acrid in the mouth；Bitter；Cold in nature.[function cures mainly] heat-clearing and toxic substances removing；Invigorate blood circulation；Evacuation of pus.Main dysentery；Have loose bowels；Jaundice；Enterodynia.[extracts] " China's book on Chinese herbal medicine "

Radix et Rhizoma Rhei: [another name] Radix Et Rhizoma Rhei, secondary Radix Et Rhizoma Rhei, white Radix Et Rhizoma Rhei.[source] medical material Ji Yuan: for the herb of polygonaceae plant Radix et Rhizoma Rhei.[nature and flavor] are bitter；Cold in nature.[function cures mainly] removing the relative excess heat；Removing mass is stagnant；Lower blood stasis；Subduing inflammation.Staple food is long-pending to be stagnated；Abdominal distention；Constipation with heat retention；Jaundice；Amenorrhea；Lump in the abdomen；Carbuncle erysipelas；Traumatic injury；Burn due to hot liquid or fire.[each discussion] " Huatuo's Zhongzang classic opinion edema arteries and veins card life and death is waited ": yellow fluid person, its root arises from spleen, its shape first from abdomen also.By this product energy profit two just, removing food stagnancy heat, the water that disappears, relieving constipation, like Radix Et Rhizoma Rhei, but power is delayed.[extracts] " China's book on Chinese herbal medicine "

Radix Berberidis wilsonae: [another name] little Rhizoma Coptidis, three-jaw Rhizoma Coptidis, little Rhizoma Coptidis thorn, CIHUANQIN, Radix seu caulis Berberidis Gagnepainii (Radix Berberidis Virgetori), little chicken foot Huang thorn.[source] medical material Ji Yuan: for the root of Berberidaceae plant JINHUA Radix Berberidis Amurensis.[nature and flavor] bitter in the mouth；Cold in nature.[return through] heart, lung, large intestine channel.[function cures mainly] heat clearing and damp drying；Eliminating fire and detoxication.Main damp-heat dysentery；Jaundice；Cough due to lung-heat；Conjunctival congestion and swelling pain；Oral aphthae in children；Pyretic toxicity carbuncle.[each discussion] " choosing of Yunnan Chinese herbal medicine ": controlling enteritis, pneumonia, upper respiratory tract infection, acute binding film is scorching, mastitis, acute icterohepatitis, furuncle.[extracts] " China's book on Chinese herbal medicine "

Herba Tripterospermi japonici: [another name] climing Radix Gentianae, Herba Swertiae davidi, Herba Ceropegiae Pubescentis, cramp grass spray seven, fish loach rattan.[source] medical material Ji Yuan: for the herb of gentianaceae plant Tripterospermum cordatum.[nature and flavor] are pungent；Bitter；Cool in nature.[return through] lung；Liver；Spleen channel.[function cures mainly] wind and heat dispersing；Invigorating spleen to remove dampness；Parasite killing.Main air heat cough；Jaundice；Rheumatic arthralgia；Ascariasis.[extracts] " China's book on Chinese herbal medicine "

Herba Ainsliaea Albotomentosae: [another name] wind catching arrow, Ainsliaea fragrans Champ., Herba Munroniae henryi.[source] medical material Ji Yuan: carry on the back herb or the root of Ainsliaea fragrans Champ. for feverfew in vain.[nature and flavor] bitter in the mouth；Warm in nature.[function cures mainly] expelling wind and removing dampness；Dissipating blood stasis stops blooding；Dispersing swelling and dissipating binds.Main air pain of dampness syndrome；Blood stasis amenorrhea；Traumatic injury；Fracture swells and ache；Traumatic hemorrhage；Scrofula tuberculosis；Wind and cold；Breath with cough.[each discussion] " Yunnan Chinese herbal medicine ": promoting flow of QI and blood, removing damp and stopping pain, connects muscles and bones.Dispelling the wind and dampness pathogens arthralgia, traumatic injury, fracture, amenorrhea, allergic dermatitis.[extracts] " China's book on Chinese herbal medicine "

Phyllanthus simplex Retz．: [another name] Herba Phyllanthi Urinariae, fishbone grass, open day close night, sound leaf Cacumen Securinegae Suffruticosae, Acronychi apedunculata (L.) Miq..[source] medical material Ji Yuan: for the herb of euphorbia plant Phyllanthus simplex Retz．.[nature and flavor] sweetness and bitterness；Flat.[return through] spleen channel.[function cures mainly] spleen invigorating removing food stagnancy；Inducing diuresis for treating stranguria syndrome；Heat-clearing and toxic substances removing.Main infantile malnutrition；Dysentery；Gonorrhea；Acute mastitis；Ulcerative gingivitis；Venom.[each discussion] " register planted by Guangxi medicine ": herb: tonifying the spleen and stomach, controls gonorrhea, and bone is choked larynx, infantile malnutrition.Root: control galactapostema.[extracts] " China's book on Chinese herbal medicine "

Semen Glycine Germinatum: [another name] sojae germinatum,semen, yellow volume, yellow volume skin, Glycine max (L.) Merr. volume, bean tiller.[source] medical material Ji Yuan: form for drying after the germination of legume soybean.[nature and flavor] are sweet；Flat.[return through] spleen；Liver；Stomach warp.[function cures mainly] heat clearing away expelling pathogenic factors from the exterior；Dehumidifying promoting the circulation of QI.Main hygropyrexia from the beginning of；Heat-damp in summer is generated heat；Dyspepsia gastral cavity painful abdominal mass；Arthralgia chiefly caused by damp pathogen；Clonic spasm of the muscle；Arthralgia with restlessness；Edema distension；Dysuria.[extracts] " China's book on Chinese herbal medicine "

Streptopus simplex D. Don: [another name] Radix Streptopi Simplicis, female's short, bristly hair or beard.[source] medical material Ji Yuan: for the root of liliaceous plant Streptopus simplex.[nature and flavor] are sweet；It is slightly cold.[function cures mainly] clearing away lung-heat to relieve cough；Invigorating the spleen and regulating the stomach.Main cough due to lung-heat；Deficiency of YIN chronic cough；Few food of incoordination between the spleen and stomach；Nausea.[extracts] " China's book on Chinese herbal medicine "

Radix Longan: [source] medical material Ji Yuan: for root or the root bark of sapindaceous plant Arillus Longan.[nature and flavor] are bitter；Puckery；Flat.[return through] large intestine channel.[function cures mainly] eliminating damp-heat；Change and turbid exempt from numbness.Main chyluria；Leucorrhea；Erysipelas；Damp and hot arthralgia pain.[extracts] " China's book on Chinese herbal medicine "

Herba Erysimi Cheiranthoidis: [another name] Gang Tuoba.[source] medical material Ji Yuan: for herb and the seed of crucifer Herba Erysimi Cheiranthoidis.[nature and flavor] are bitter；Pungent；Cold.[return through] lung；Stomach warp.[function cures mainly] invigorating the spleen and regulating the stomach；Diuresis heart tonifying.Main incoordination between the spleen and stomach；Accumulation of food in the stomach and intes tine due to indigestion；And the edema of heart failure.[each discussion] " Chinese herbal medicine is commonly used in Tibet ": clearing away heat from blood, antitussive, heart tonifying.Being in harmony the heating of empty infections, pulmonary tuberculosis is coughed, and prolonged illness cardianeuria can solve meat poisoning.[extracts] " China's book on Chinese herbal medicine "

Radix Incarvilleae Delavayi: [source] medical material Ji Yuan: for the root of Bignoniaceae plant Radix Incarvilleae Delavayi and river POLO flower.[nature and flavor] sweet in the mouth；Light；Warm in nature.[return through] liver；Spleen；Kidney channel.[function cures mainly] invigorating qi and benefiting blood.Main insufficiency of blood of making angry after being ill；Dizziness and fatigue；Puerperal, breast was few.[extracts] " China's book on Chinese herbal medicine "

Herba galii veri: [another name] cattle clothing, ferrum chi grass, menstruation grass, Semen setariae flower, willow husband floss Artemisia, furunculosis Artemisia, Tu Miaocao, white Radix Rubiae.[source] medical material Ji Yuan: for the herb of Maguireothamnus speciosus Herba galii veri.[nature and flavor] are micro-pungent；Bitter；It is slightly cold.[function cures mainly] heat-clearing and toxic substances removing；Promoting blood circulation to restore menstrual flow；Dispelling wind for relieving itching.Main hepatitis；Ascites；Laryngopharynx swelling and pain；Furuncle toxic swelling；Traumatic injury；Women's amenorrhea；Leukorrhagia；Venom；Honor measles；Paddy field dermatitis.[extracts] " China's book on Chinese herbal medicine "

When the dosage form of described Chinese medicine is syrup, it comprises the following steps:

Hereinafter adopting embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the process that realizes reaching technique effect can fully understand and implement according to this.

Embodiment 1: oral solutions prepared by the present invention

Take Herba Elsholtziae Blandae 210g, water perfume (or spice) bavin 150g, Herba Lamii Amplexicaulis 170g, Radix Abri 260g, Sophora moocroftiana(Wall．) Benth. Ex Bak. 90g, Armillaria mella tabescens (Scop.ex Fr.) Sing. 320g, Taiwan banyan 280g, Rhizoma pteridii latiusculi 160g, Herba Patriniae Rupestris 350g, Radix et Rhizoma Rhei 210g, Radix Berberidis wilsonae 350g, Herba Tripterospermi japonici 220g, Herba Ainsliaea Albotomentosae 190g, Phyllanthus simplex Retz． 120g, Semen Glycine Germinatum 280g, Streptopus simplex D. Don 120g, Radix Longan 250g, Herba Erysimi Cheiranthoidis 310g, Radix Incarvilleae Delavayi 150g and Herba galii veri 210g.

Its preparation method comprises the following steps:

The first step, Herba Elsholtziae Blandae, water perfume (or spice) bavin, Herba Lamii Amplexicaulis, Radix Abri, Sophora moocroftiana(Wall．) Benth. Ex Bak., Armillaria mella tabescens (Scop.ex Fr.) Sing., Taiwan banyan, Rhizoma pteridii latiusculi, Herba Patriniae Rupestris, Radix et Rhizoma Rhei and Radix Berberidis wilsonae are mixed in proportion, add relative to the alcohol reflux that mixture 4 times amount determining alcohol is 60% 3 times, each 2.5 hours, filtering, filtrate merges, and reclaims ethanol, being concentrated into 70 DEG C of relative densities is the mastic of 1.31, standby；

Second step, is mixed in proportion surplus stock medical material, adds relative to mixture 4 times amount water, boils 3 hours, filters, and being concentrated into 70 DEG C of relative densities is the mastic of 1.28；

3rd step, the described mastic mixing first step, second step obtained, 60 DEG C of reduced vacuum dry, and get dry extract powder；

4th step, added ethanol in the described dried cream powder the 3rd step obtained, obtains containing alcohol mastic, and the alcohol content of described containing alcohol mastic is 65%；Described containing alcohol mastic being sequentially carried out chilling treatment, precipitation process, filtration treatment, recovery Ethanol Treatment, obtains dealcoholysis mastic, wherein, the chilling treatment time is 35 hours, and refrigerated storage temperature is 2 DEG C；

5th step, will add cane sugar powder, activated carbon in described dealcoholysis mastic, be sequentially carried out heat treated, filtration treatment, dilution process, obtain semi-finished product；The weight ratio of described dealcoholysis mastic and described cane sugar powder is 1: 0.15；The weight ratio of described dealcoholysis mastic and described activated carbon is 1: 0.001；The time of described heat treated is 30 minutes, and temperature is 105 DEG C；

Embodiment 2: syrup prepared by the present invention

Take Herba Elsholtziae Blandae 230g, water perfume (or spice) bavin 130g, Herba Lamii Amplexicaulis 190g, Radix Abri 280g, Sophora moocroftiana(Wall．) Benth. Ex Bak. 70g, Armillaria mella tabescens (Scop.ex Fr.) Sing. 340g, Taiwan banyan 260g, Rhizoma pteridii latiusculi 180g, Herba Patriniae Rupestris 320g, Radix et Rhizoma Rhei 250g, Radix Berberidis wilsonae 320g, Herba Tripterospermi japonici 250g, Herba Ainsliaea Albotomentosae 170g, Phyllanthus simplex Retz． 150g, Semen Glycine Germinatum 260g, Streptopus simplex D. Don 140g, Radix Longan 220g, Herba Erysimi Cheiranthoidis 350g, Radix Incarvilleae Delavayi 120g and Herba galii veri 250g.

Its preparation method comprises the following steps:

The first step, Herba Elsholtziae Blandae, water perfume (or spice) bavin, Herba Lamii Amplexicaulis, Radix Abri, Sophora moocroftiana(Wall．) Benth. Ex Bak., Radix et Rhizoma Rhei and Radix Berberidis wilsonae are mixed in proportion, add the ethanol that determining alcohol is 85% relative to 6 times of mixture, heating and refluxing extraction 3 times, each reflux, extract, 3 hours, united extraction liquid, with the centrifugal remove impurity of tube centrifuge, when extracting solution after remove impurity is evaporated to 60 DEG C in 65 DEG C when, relative density is the medicinal liquid of 1.06, concentrated solution spray dryer after concentration is dried, it is ground into 150 orders subsequently, it is thus achieved that dry powder；

Second step, Herba Tripterospermi japonici, Herba Ainsliaea Albotomentosae, Phyllanthus simplex Retz．, Semen Glycine Germinatum, Streptopus simplex D. Don and Radix Longan are mixed in described ratio, is ground into powder, with the ethanol that determining alcohol is 85% as solvent, impregnate 60 hours, adopting percolation with the speed slowly percolation of 2ml per minute, collect percolate, being concentrated into relative density when 60 DEG C is the mastic of 1.26, dry with spray dryer, being ground into 150 orders subsequently, it is thus achieved that dry powder, the quality of affiliated ethanol is 4 times of second step mixture quality；

3rd step, mixes surplus stock medical material in described ratio, adds relative to the alcohol reflux that mixture 5 times amount determining alcohol is 75% 3 times, each 2 hours, filtering, filtrate merges, and reclaims ethanol, being concentrated into relative density when 60 DEG C is the mastic of 1.20, dries in 65 DEG C of reduced vacuum, obtains dry powder；

4th step, the dry powder blend that the first step is obtained to the 3rd step, add the water dissolution relative to mixture quality 4 times, pH value is regulated to 7.0 with 40% sodium hydroxide solution, it is subsequently added correctives sucrose, preservative mix homogeneously, obtain syrup, the correctives of addition, preservative and the content in medicine thereof: sucrose 20%, ethyl hydroxybenzoate 0.03%.

Toxicity test:

Acute toxicity testing: application mice 60, male and female half and half, body weight 22-32g, carries out acute toxicity test.Mice is randomly divided into two groups, i.e. matched group and administration group, fasting 12 hours before experiment, the extract oral liquor prepared by embodiments of the invention 1 is dissolved in water, (concentration is 8.91g crude drug/ml, maximum concentration) gavage, gavage volume is 5ml/kg (namely unit dosage form is 44.55 crude drugs/kg), and matched group gives normal saline, within one day, it is administered 2 times, delivery time 6 hours, Continuous Observation 14 days after administration, and record mice toxic reaction and death toll.Test result indicate that: compare with matched group, after administration, mice has no notable difference, and experiment Continuous Observation 14 days, mouse systemic situation, diet, drinking-water, body weight increase all normal.Oral solutions LD50 > 44.55 crude drugs/the kg of the Mouse oral gavage present invention, every day, maximum dosage-feeding was 89.1 crude drugs/kg/ day.The Chinese medicine clinical application amount of the present invention be 8.29g crude drug/day/people, adult body weight in 60KG, average dosage is 0.138g crude drug/kg/ day.By weighing machine: 646 times that the dosis tolerata of the Chinese medicine of mice (average weight with 27g) the oral administration gavage present invention is quantity.Therefore the Chinese medicine acute toxicity of the present invention is extremely low, clinical drug safety.

Long term toxicity test: Chinese medicine embodiment 1 oral solutions of the present invention to three groups of mices (often group 20) by 13.47,25.38 and 49.52g crude drug/kg continuous use 15 weeks (1.0ml/100g body weight, every day 2 times) and drug withdrawal 3 weeks after, result shows: the indexs such as the hair of mice, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat are all had no significant effect by Chinese medicine of the present invention, internal organs naked eyes do not find that difference change and histological indications show, after medication 15 weeks and drug withdrawal 3 weeks, Organs of Mice is all without substantially changing.Illustrate that Chinese medicine of the present invention is little to toxicity after mice long-term prescription, react also without difference after drug withdrawal, application safety.

Clinical data:

Case selection: all 168 selected example cases derive from this Out-patient Department and the hyperbilirubinemia of newborn patient being in hospital, boy 93 example, girl 75 example, are born 1～26 day, term infant 105 example, premature infant 63 example；It is randomly divided into two groups, often organizes 84 examples.Wherein, treatment group 84 example, boy 47 example, girl 37 example, it is born 1～26 day, term infant 52 example, premature infant 32 example.Matched group 84 example, boy 46 example, girl 38 example, it is born 1～24 day, term infant 53 example, premature infant 31 example.Two groups of infants compare no difference of science of statistics in sex, date of birth and clinical symptoms etc., have comparability.

Diagnostic criteria: with reference to " clinical disease diagnosis and the curative effect judging standard " of Wang Weiwen chief editor.In raw latter 24 hours, jaundice and serum total bilirubin occurring > 102 μm of mol/L or FTNB total serum bilirubin be higher than 220.6 μm of mol/L (premature infant > 255 μm mol/L).

Therapeutic Method:

Matched group: while Cure the Primary Disease, to (1g/kg adds Glucose Liquid 10-20ml intravenous drip with albumin, every day 1 time) or blood plasma (25ml/ time, intravenous drip, every day 1-2 time), Liver enzyme inducer (phenobarbital 5mg/ (kg d), point 2-3 time)), mend alkali correction acidosis and phototherapy (intermittent irradiation 8-12h every day) etc.；7 days 1 courses for the treatment of.

Treatment group: on matched group western medicine routine treatment basis, simultaneously oral Chinese medicine embodiment 1 oral solutions of the present invention, each 10ml, every day 3 times；7 days 1 courses for the treatment of.

Curative effect judging standard: cure: jaundice disappears completely, serum bilirubin recovers normal.Taking a turn for the better: jaundice disappears or partial remission substantially, serum bilirubin declines.Invalid: jaundice does not disappear, serum bilirubin is without decline.

Therapeutic outcome: two groups treat 7 days respectively after, statistical result is referring to table 1 and table 2.

Clinical efficacy comparison (unit: example) after treating 7 days respectively organized by 1 liang of table

Group	Number of cases	Cure	Take a turn for the better	Invalid	Total effective rate
						Treatment group	84	72	12	0	84 (100%)
Matched group	84	57	20	7	77 (91.67%)

As it can be seen from table 1 treatment group adopts the Chinese medicine of the present invention, coordinate western medical treatment hyperbilirubinemia of newborn, relative to matched group, on therapeutic effect, have and be markedly improved.

2 liang of table is organized healing number and time after treating 7 days respectively and is compared (unit: example/%)

Group	Number of cases	Medication 3 days	Medication 5 days	Medication 7 days
					Treatment group	72	29 (34.52%)	54 (64.29%)	72 (85.71%)
Matched group	57	17 (20.24%)	35 (41.67%)	57 (67.86%)

From table 2 it can be seen that treatment group adopts the Chinese medicine of the present invention, coordinate western medical treatment hyperbilirubinemia of newborn, relative to matched group, not only better efficacy, takes effect also faster.

Untoward reaction: hepatic and renal function injure or other untoward reaction all do not occur during two groups of patient treatments.

Concrete case: infant Zhao, man, term infant, without household heredity factors, without congenital medical history.Within 5th, occurring that skin sclera turn to be yellow after infant is raw, yellow is distinct, oliguria and yellow, be not intended to inhale newborn, suck unable, survey body temperature 37.6 DEG C, the heart, lung, liver, spleen are had a medical check-up no abnormality seen, bowel sounds active.Lab testing: 387.6 μm of ol/L of total bilirubin, 374.5 μm of ol/L of unconjugated bilirubin.Hemoculture, without bacterial growth, is diagnosed as hyperbilirubinemia of newborn.On western medicine routine treatment basis, oral Chinese medicine embodiment 1 oral solutions of the present invention, each 10ml, every day 3 times simultaneously；After treating 3 days, jaundice disappears completely, and serum bilirubin recovers normal, cures, and follows up a case by regular visits to 1 month without recurrence.

All above-mentioned primary these intellectual properties of enforcement, do not set this new product of enforcement or the new method that limit other forms.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But, all modifications or transformation belong to the right of reservation based on new product of the present invention.

The above, be only presently preferred embodiments of the present invention, is not the restriction that the present invention makees other form, and any those skilled in the art are changed or be modified as the Equivalent embodiments of equivalent variations possibly also with the technology contents of the disclosure above.But every without departing from technical solution of the present invention content, according to any simple modification, equivalent variations and remodeling that above example is made by the technical spirit of the present invention, still fall within the protection domain of technical solution of the present invention.

Claims

1. the Chinese medicine treating hyperbilirubinemia of newborn, it is characterized in that, described Chinese medicine includes following raw medicinal material: Herba Elsholtziae Blandae, water perfume (or spice) bavin, Herba Lamii Amplexicaulis, Radix Abri, Sophora moocroftiana(Wall．) Benth. Ex Bak., Armillaria mella tabescens (Scop.ex Fr.) Sing., Taiwan banyan, Rhizoma pteridii latiusculi, Herba Patriniae Rupestris, Radix et Rhizoma Rhei, Radix Berberidis wilsonae, Herba Tripterospermi japonici, Herba Ainsliaea Albotomentosae, Phyllanthus simplex Retz．, Semen Glycine Germinatum, Streptopus simplex D. Don, Radix Longan, Herba Erysimi Cheiranthoidis, Radix Incarvilleae Delavayi and Herba galii veri.

2. Chinese medicine as claimed in claim 1, it is characterized in that, the ratio of weight and number of described raw medicinal material is: Herba Elsholtziae Blandae 20～30 parts, water perfume (or spice) bavin 5～15 parts, Herba Lamii Amplexicaulis 15～25 parts, Radix Abri 20～35 parts, Sophora moocroftiana(Wall．) Benth. Ex Bak. 5～15 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 25～35 parts, Taiwan banyan 20～30 parts, Rhizoma pteridii latiusculi 15～25 parts, Herba Patriniae Rupestris 30～40 parts, Radix et Rhizoma Rhei 15～30 parts, Radix Berberidis wilsonae 25～35 parts, Herba Tripterospermi japonici 20～30 parts, Herba Ainsliaea Albotomentosae 15～25 parts, Phyllanthus simplex Retz． 10～20 parts, Semen Glycine Germinatum 25～35 parts, Streptopus simplex D. Don 5～15 parts, Radix Longan 20～30 parts, Herba Erysimi Cheiranthoidis 25～40 parts, Radix Incarvilleae Delavayi 10～20 parts and Herba galii veri 15～25 parts.

3. Chinese medicine as claimed in claim 1 or 2, it is characterized in that, the ratio of weight and number of described raw medicinal material is: Herba Elsholtziae Blandae 20～25 parts, water perfume (or spice) bavin 10～15 parts, Herba Lamii Amplexicaulis 15～20 parts, Radix Abri 25～30 parts, Sophora moocroftiana(Wall．) Benth. Ex Bak. 5～10 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 30～35 parts, Taiwan banyan 25～30 parts, Rhizoma pteridii latiusculi 15～20 parts, Herba Patriniae Rupestris 30～35 parts, Radix et Rhizoma Rhei 20～25 parts, Radix Berberidis wilsonae 30～35 parts, Herba Tripterospermi japonici 20～25 parts, Herba Ainsliaea Albotomentosae 15～20 parts, Phyllanthus simplex Retz． 10～15 parts, Semen Glycine Germinatum 25～30 parts, Streptopus simplex D. Don 10～15 parts, Radix Longan 20～25 parts, Herba Erysimi Cheiranthoidis 30～35 parts, Radix Incarvilleae Delavayi 10～15 parts and Herba galii veri 20～25 parts.

4. the Chinese medicine as described in claims 1 to 3, it is characterized in that, the ratio of weight and number of described raw medicinal material is: Herba Elsholtziae Blandae 21 parts, water perfume (or spice) bavin 15 parts, Herba Lamii Amplexicaulis 17 parts, Radix Abri 26 parts, Sophora moocroftiana(Wall．) Benth. Ex Bak. 9 parts, Armillaria mella tabescens (Scop.ex Fr.) Sing. 32 parts, Taiwan banyan 28 parts, Rhizoma pteridii latiusculi 16 parts, Herba Patriniae Rupestris 35 parts, Radix et Rhizoma Rhei 21 parts, Radix Berberidis wilsonae 35 parts, Herba Tripterospermi japonici 22 parts, Herba Ainsliaea Albotomentosae 19 parts, Phyllanthus simplex Retz． 12 parts, Semen Glycine Germinatum 28 parts, Streptopus simplex D. Don 12 parts, Radix Longan 25 parts, Herba Erysimi Cheiranthoidis 31 parts, Radix Incarvilleae Delavayi 15 parts and Herba galii veri 21 parts.

5. the Chinese medicine as described in Claims 1-4, it is characterised in that the dosage form of described Chinese medicine is oral solutions, and its preparation method comprises the following steps:

6. the Chinese medicine as described in Claims 1-4, it is characterised in that the dosage form of described Chinese medicine is syrup, and its preparation method comprises the following steps:

7. the preparation method of the Chinese medicine described in a Claims 1-4, it is characterised in that the dosage form of described Chinese medicine is oral solutions, and it comprises the following steps:

8. the preparation method of the Chinese medicine described in a Claims 1-4, it is characterised in that the dosage form of described Chinese medicine is syrup, and its preparation method comprises the following steps: