CN102836389B - Traditional Chinese medicine composition for improving postpartum hypogalactia and preparation method thereof - Google Patents
Traditional Chinese medicine composition for improving postpartum hypogalactia and preparation method thereof Download PDFInfo
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- Medicines Containing Plant Substances (AREA)
Abstract
The invention provides a traditional Chinese medicine composition for improving postpartum hypogalactia, which comprises semen vaccariae, fructus liquidambaris, radix astragali, rhizoma polygonati, rhizoma atractylodis macrocephalae, cortex albiziae, radix achyranthis bidentatae, rhizoma kaempferiae, radix rehmanniae praeparata, caulis polygoni multiflori, dianthus superbus, herba plantaginis, folium pyrrosiae, semen coicis, platycodon grandiflorum, folium apocyni veneti, rhizoma gastrodiae, panax notoginseng, radix curcumae longae, Japanese ardisia herb, pericarpium citri reticulatae viride and citrus chirocarpus. The traditional Chinese medicine composition can obviously promote lactescence, increase lactation yield and reduce milk supply; compared with the Western medicine, the traditional Chinese medicine composition takes effect quickly and reduces the efficacy of the toxic and side effects, so that the symptom of postpartum hypogalactia can be treated well, the breast feeding is conductive to implementation, and the growth and development of infants can be promoted.
Description
Technical field
The present invention relates to Chinese medicine technical field, relate in particular to a kind of for improving the Chinese medicine composition of puerperal hypogalactia.
Background technology
Breast milk is the optimal wholefood of baby, and nutrient substance is abundant, is easy to digest and assimilate, and has the highest bioavailability.In breast milk, containing rich in protein, also have more S-IgA, lactoferrin, and contain more leukocyte, lysozyme and antimicrobial factors, these materials are defendd to infect extremely important for baby, and can Polyglucan.Breast feeding is the important means that promotes prenatal and postnatal care.
Puerpera in the time of suckling milk very less or completely without, enough even can feeding infant person, be called puerperal hypogalactia, puerperal hypogalactia mostly occurred 2 days ~ 15 days puerperal.Galactopoiesis and wet nurse's spirit, emotion, nutriture, rest and work have relation.Any spiritual stimulation, as worried, terrified, worried, sad, all can reduce galactopoiesis.Hypogalactia may be poor by development of breast, too much or the emotion of postpartum hemorrhage is not good enough etc., and factor causes, infect, diarrhoea, loose stools etc. also can make hypogalactia, or because of milk can not Channel Group due to, in addition, along with cuing open the rising of palace productive rate, the phenomenon of puerperal hypogalactia is increasing, sickness rate is about puerpera's 20% ~ 30%, doctor trained in Western medicine think part puerpera produce time or run out of space puerperal, hemorrhage relatively many, feed to neonate again, psychology is difficult to adapt to for the moment, add spirit, overtired in muscle power, nerve and hormonal system are affected, cause oligogalactia, there is no at present targeted treatment schemes.
Theory of Chinese medical science thinks, the reason of puerperal hypogalactia is that milk derives from the raw essence of water and grain of tasteization, with QI and blood homology, relies Ru Mai, newborn network to carry, and secretes through nipple.As said in Cheng Ruo water: " tire both produced, and the gas of pure body fluid in stomach, is attributed to lung, towards in arteries and veins, flowed into breast, bleached as breast ".Therefore insufficiency of vital energy and blood or depression and stagnation of QI, affect the biochemical and circulation of milk, is the main cause that causes hypogalactia.Puerpera's body insufficiency of vital energy and blood is many by the consumption gas of losing blood puerperal, or emptiness of spleen and stomach, or puerperal, work and rest was not normal, so that deficient qi and blood, the deficient and performance milk in newborn source very less or completely without; Liver controlling conveyance and dispersion ", nipple belongs to the cloudy liver of fainting to be led ", if disposition is depressed or while producing, puerperal feelings will do not relax, liver mistake bar reaches, depression and stagnation of QI; Or puerperal throw off restraint food greasy and surfeit flavour, pungent stimulation, impairing the spleen and stomach, essential resistance of turbid phlegm; Or postnatal blood stasis retardance; Or exopathogen invasion and attack in puerperal be detained wait all can cause Ru Mai, newborn network is obstructed, milk operation is lost freely, so overflow hypogalactia very at least.
The traditional Chinese medical science thinks, puerpera shows as stagnation of QI due to depression of the liver puerperal more, and deficient qi and blood easily makes milk stagnate.Therefore need dispersing the stagnated live-QI to relieve the stagnation of QI acupuncture-stimulating treatment, due to puerperal asthenia, bad, the lying on bed for a long time of having a rest etc., easily cause depression and stagnation of QI, QI-blood circulation is not smooth, blood stasis Zu Yuluo road, hematogenous blockage; Mental disorder is condensed, and expectorant stasis causes mammary swelling in breast; Stagnation of QI due to depression of the liver, stagnation of liver-QI is suffered from a deficiency of the kidney, and causes disorder of QI and blood, and punching is appointed deficient.
Based on this, the invention provides a kind ofly for improving the Chinese medicine composition of puerperal hypogalactia, taking dredging collateral for promoting lactation, benefiting qi and nourishing blood, dispersing the stagnated live-QI to relieve the stagnation of QI as Therapeutic Principle, can obviously promote galactopoiesis, increase lactation amount, reduce and mend lactication amount, with respect to Western medicine, there is instant effect, reduce effect of toxic and side effects, thereby well treat the symptom of puerperal hypogalactia, contribute to breastfeeding enforcement, promote baby's growth promoter.
Summary of the invention
Technical problem to be solved by this invention is, provide a kind of for improving the Chinese medicine composition of puerperal hypogalactia, it can obviously promote galactopoiesis, increases lactation amount, reduces the lactication amount of mending, with respect to Western medicine, there is instant effect, reduce effect of toxic and side effects, thereby well treat the symptom of puerperal hypogalactia, contribute to breastfeeding enforcement, promote baby's growth promoter.
In order to solve the problems of the technologies described above, the invention provides a kind of novelly for improving the Chinese medicine composition of puerperal hypogalactia, it comprises Semen Vaccariae, Fructus Liquidambaris, the Radix Astragali, Rhizoma Polygonati, the Rhizoma Atractylodis Macrocephalae, Cortex Albiziae, Radix Achyranthis Bidentatae, Rhizoma Kaempferiae, Radix Rehmanniae Preparata, Caulis Polygoni Multiflori, Herba Dianthi, Herba Plantaginis, Folium Pyrrosiae, Semen Coicis, Radix Platycodonis, Folium Apocyni Veneti, Rhizoma Gastrodiae, Radix Notoginseng, Rhizoma Curcumae Longae, Herba Ardisiae Japonicae, Pericarpium Citri Reticulatae Viride and Fructus Citri Sarcodactylis.
Wherein, in described Chinese medicine composition, each constituent content is Semen Vaccariae 50 ~ 60 weight portions, Fructus Liquidambaris 37 ~ 47 weight portions, the Radix Astragali 71 ~ 81 weight portions, Rhizoma Polygonati 22 ~ 32 weight portions, the Rhizoma Atractylodis Macrocephalae 19 ~ 29 weight portions, Cortex Albiziae 16 ~ 26 weight portions, Radix Achyranthis Bidentatae 25 ~ 35 weight portions, Rhizoma Kaempferiae 13 ~ 23 weight portions, Radix Rehmanniae Preparata 17 ~ 27 weight portions, Caulis Polygoni Multiflori 43 ~ 53 weight portions, Herba Dianthi 21 ~ 31 weight portions, Herba Plantaginis 12 ~ 22 weight portions, Folium Pyrrosiae 15 ~ 25 weight portions, Semen Coicis 20 ~ 30 weight portions, Radix Platycodonis 14 ~ 24 weight portions, Folium Apocyni Veneti 26 ~ 36 weight portions, Rhizoma Gastrodiae 19 ~ 29 weight portions, Radix Notoginseng 26 ~ 36 weight portions, Rhizoma Curcumae Longae 29 ~ 39 weight portions, Herba Ardisiae Japonicae 23 ~ 33 weight portions, Pericarpium Citri Reticulatae Viride 16 ~ 26 weight portions and Fructus Citri Sarcodactylis 11 ~ 21 weight portions.
Wherein, in described Chinese medicine composition, each constituent content is Semen Vaccariae 55 ~ 60 weight portions, Fructus Liquidambaris 42 ~ 47 weight portions, the Radix Astragali 76 ~ 81 weight portions, Rhizoma Polygonati 27 ~ 32 weight portions, the Rhizoma Atractylodis Macrocephalae 24 ~ 29 weight portions, Cortex Albiziae 21 ~ 26 weight portions, Radix Achyranthis Bidentatae 30 ~ 35 weight portions, Rhizoma Kaempferiae 18 ~ 23 weight portions, Radix Rehmanniae Preparata 22 ~ 27 weight portions, Caulis Polygoni Multiflori 48 ~ 53 weight portions, Herba Dianthi 26 ~ 31 weight portions, Herba Plantaginis 17 ~ 22 weight portions, Folium Pyrrosiae 20 ~ 25 weight portions, Semen Coicis 25 ~ 30 weight portions, Radix Platycodonis 19 ~ 24 weight portions, Folium Apocyni Veneti 31 ~ 36 weight portions, Rhizoma Gastrodiae 24 ~ 29 weight portions, Radix Notoginseng 31 ~ 36 weight portions, Rhizoma Curcumae Longae 34 ~ 39 weight portions, Herba Ardisiae Japonicae 28 ~ 33 weight portions, Pericarpium Citri Reticulatae Viride 21 ~ 26 weight portions and Fructus Citri Sarcodactylis 16 ~ 21 weight portions.
Wherein, in described Chinese medicine composition, each constituent content is Semen Vaccariae 55 weight portions, Fructus Liquidambaris 42 weight portions, the Radix Astragali 76 weight portions, Rhizoma Polygonati 27 weight portions, the Rhizoma Atractylodis Macrocephalae 24 weight portions, Cortex Albiziae 21 weight portions, Radix Achyranthis Bidentatae 30 weight portions, Rhizoma Kaempferiae 18 weight portions, Radix Rehmanniae Preparata 22 weight portions, Caulis Polygoni Multiflori 48 weight portions, Herba Dianthi 26 weight portions, Herba Plantaginis 17 weight portions, Folium Pyrrosiae 20 weight portions, Semen Coicis 25 weight portions, Radix Platycodonis 19 weight portions, Folium Apocyni Veneti 31 weight portions, Rhizoma Gastrodiae 24 weight portions, Radix Notoginseng 31 weight portions, Rhizoma Curcumae Longae 34 weight portions, Herba Ardisiae Japonicae 28 weight portions, Pericarpium Citri Reticulatae Viride 21 weight portions and Fructus Citri Sarcodactylis 16 weight portions.
Wherein, can in described Chinese medicine composition, add Herba Taraxaci, Spica Prunellae, described Herba Taraxaci and the Spica Prunellae content in described Chinese medicine composition is Herba Taraxaci 17 ~ 27 weight portions, Spica Prunellae 12 ~ 22 weight portions, more preferably Herba Taraxaci 22 ~ 27 weight portions, Spica Prunellae 17 ~ 22 weight portions.
Wherein, can in described Chinese medicine composition, add Retinervus Luffae Fructus and Rhizoma Sparganii, described Retinervus Luffae Fructus and the Rhizoma Sparganii content in described Chinese medicine composition is Retinervus Luffae Fructus 24 ~ 34 weight portions, Rhizoma Sparganii 15 ~ 25 weight portions, more preferably Retinervus Luffae Fructus 29 ~ 34 weight portions, Rhizoma Sparganii 20 ~ 25 weight portions.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, and in the time that the dosage form of described Chinese medicine composition is oral liquid, it comprises the following steps,
The first step, described component is mixed in proportion, be placed in super micron mill and pulverize 20 minutes～40 minutes, in the ethanol that is 85%～95% in determining alcohol by the powder dissolution after pulverizing, flood 12 hours～18 hours, adopt the speed slowly percolation of percolation with 1～2ml per minute, collect percolate, the quality of the ethanol adding is 2～4 times of mixed-powder quality, is evaporated to 1/10 left and right of original volume, 15000rpm pipeline is centrifugal, obtains supernatant;
Second step, the supernatant that the first step is obtained is crossed macroporous resin column absorption, first use the water elution of 2～4 times of mixture qualities that obtain with respect to the first step to discard, then gradient ethanol elution, use for the first time 3～5 times of determining alcohol 70%～80% ethanol elutions of mixture quality that obtain with respect to the first step, use again 3～5 times of determining alcohol 85%～95% ethanol elutions of mixture quality that obtain with respect to the first step, merge gradient ethanol elution, 200 ~ 400 object powder are pulverized and be screened into decompression recycling ethanol, to most, lyophilization, subsequently;
The 3rd step, the powder that second step is obtained mixes with saccharin sodium and is dissolved in water, and sodium carboxymethyl cellulose is dispersed in hot water, cooling, then mix with the aqueous suspension that contains saccharin sodium, preparing solution is become to volume required and mix homogeneously, concentrated, subpackage after sterilizing, obtain oral liquid, with respect to the powder of 100 weight portions, the weight fraction of described saccharin sodium is 2～4 weight portions, the weight fraction of described sodium carboxymethyl cellulose is 3～5 weight portions, water 1000～10000 weight portions.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, and in the time that the dosage form of described Chinese medicine composition is powder, it comprises the following steps,
The first step, described component is mixed in proportion, be placed in super micron mill and pulverize 20 minutes～40 minutes, in the ethanol that is 85%～95% in determining alcohol by the powder dissolution after pulverizing, flood 12 hours～18 hours, adopt the speed slowly percolation of percolation with 1～2ml per minute, collect percolate, the quality of the ethanol adding is 2～4 times of mixed-powder quality, is evaporated to 1/10 left and right of original volume, 15000rpm pipeline is centrifugal, obtains supernatant;
Second step, the supernatant that the first step is obtained is crossed macroporous resin column absorption, first use the water elution of 2～4 times of mixture qualities that obtain with respect to the first step to discard, then gradient ethanol elution, use for the first time 3～5 times of determining alcohol 70%～80% ethanol elutions of mixture quality that obtain with respect to the first step, use again 3～5 times of determining alcohol 85%～95% ethanol elutions of mixture quality that obtain with respect to the first step, merge gradient ethanol elution, 200 ~ 400 object powder are pulverized and be screened into decompression recycling ethanol, to most, lyophilization, subsequently;
The 3rd step, by the powder of second step acquisition, with respect to the protein sugar of 0.01～0.05 times of its quality, the dextrin of 0.1～0.2 times, the starch of 1～2 times is put into blender and is stirred 30 minutes～1 hour, makes powder, with racking machine subpackage.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, and in the time that the dosage form of described Chinese medicine composition is granule, it comprises the following steps,
The first step, described component is mixed in proportion, be placed in super micron mill and pulverize 20 minutes～40 minutes, in the ethanol that is 85%～95% in determining alcohol by the powder dissolution after pulverizing, flood 12 hours～18 hours, adopt the speed slowly percolation of percolation with 1～2ml per minute, collect percolate, the quality of the ethanol adding is 2～4 times of mixed-powder quality, is evaporated to 1/10 left and right of original volume, 15000rpm pipeline is centrifugal, obtains supernatant;
Second step, the supernatant that the first step is obtained is crossed macroporous resin column absorption, first use the water elution of 2～4 times of mixture qualities that obtain with respect to the first step to discard, then gradient ethanol elution, use for the first time 3～5 times of determining alcohol 70%～80% ethanol elutions of mixture quality that obtain with respect to the first step, use again 3～5 times of determining alcohol 85%～95% ethanol elutions of mixture quality that obtain with respect to the first step, merge gradient ethanol elution, 200 ~ 400 object powder are pulverized and be screened into decompression recycling ethanol, to most, lyophilization, subsequently;
The 3rd step, above-mentioned fine powder and starch are mixed, the ratio of the quality sum of the quality of described starch and the fine powder obtaining is 0.1:1～0.3:1, carry out subsequently pelletization treatment, dried, obtain compound particles, more further in compound particles, add magnesium stearate, described magnesium stearate and described compound particles mass ratio are 0.15～100:0.5～100, obtain capsule 's content, described capsule 's content is incapsulated and in housing, obtains capsule.
The present invention also provides above-mentioned Chinese medicine composition in the application for the preparation of improving in the medicine of puerperal hypogalactia symptom.
Beneficial effect of the present invention:
Chinese medicine composition provided by the invention can obviously promote galactopoiesis, increases lactation amount, reduces the lactication amount of mending, with respect to Western medicine, there is instant effect, reduce effect of toxic and side effects, thereby well treat the symptom of puerperal hypogalactia, contribute to breastfeeding enforcement, promote baby's growth promoter.
Detailed description of the invention
The invention provides a kind of novelly for improving the Chinese medicine composition of puerperal hypogalactia, it comprises Semen Vaccariae, Fructus Liquidambaris, the Radix Astragali, Rhizoma Polygonati, the Rhizoma Atractylodis Macrocephalae, Cortex Albiziae, Radix Achyranthis Bidentatae, Rhizoma Kaempferiae, Radix Rehmanniae Preparata, Caulis Polygoni Multiflori, Herba Dianthi, Herba Plantaginis, Folium Pyrrosiae, Semen Coicis, Radix Platycodonis, Folium Apocyni Veneti, Rhizoma Gastrodiae, Radix Notoginseng, Rhizoma Curcumae Longae, Herba Ardisiae Japonicae, Pericarpium Citri Reticulatae Viride and Fructus Citri Sarcodactylis.
Fang Zhong, the Radix Astragali, Rhizoma Polygonati, Rhizoma Atractylodis Macrocephalae replenishing QI to invigorate the spleen nourish blood, Radix Rehmanniae Preparata, the promoting the circulation of blood of Caulis Polygoni Multiflori blood-supplementing blood-nourishing, Herba Dianthi, Herba Plantaginis, Folium Pyrrosiae, Semen Coicis, Radix Platycodonis promoting the circulation of QI a surname network, Folium Apocyni Veneti, Rhizoma Gastrodiae is soothing the liver eliminating stagnation, Semen Vaccariae, the Radix Astragali, Caulis Polygoni Multiflori, Fructus Liquidambaris dredging collateral for promoting lactation, Radix Achyranthis Bidentatae, Radix Notoginseng, Rhizoma Curcumae Longae, Herba Ardisiae Japonicae, Cortex Albiziae promoting blood circulation to restore menstrual flow, circulation of qi promoting that Rhizoma Kaempferiae, Pericarpium Citri Reticulatae Viride and Fructus Citri Sarcodactylis are soothing the liver, all medicines share, and play altogether effect of dispersing the stagnated live-QI to relieve the stagnation of QI, benefiting qi and nourishing blood, dredging collateral for promoting lactation.
In described Chinese medicine composition, each constituent content can be Semen Vaccariae 50 ~ 60 weight portions, Fructus Liquidambaris 37 ~ 47 weight portions, the Radix Astragali 71 ~ 81 weight portions, Rhizoma Polygonati 22 ~ 32 weight portions, the Rhizoma Atractylodis Macrocephalae 19 ~ 29 weight portions, Cortex Albiziae 16 ~ 26 weight portions, Radix Achyranthis Bidentatae 25 ~ 35 weight portions, Rhizoma Kaempferiae 13 ~ 23 weight portions, Radix Rehmanniae Preparata 17 ~ 27 weight portions, Caulis Polygoni Multiflori 43 ~ 53 weight portions, Herba Dianthi 21 ~ 31 weight portions, Herba Plantaginis 12 ~ 22 weight portions, Folium Pyrrosiae 15 ~ 25 weight portions, Semen Coicis 20 ~ 30 weight portions, Radix Platycodonis 14 ~ 24 weight portions, Folium Apocyni Veneti 26 ~ 36 weight portions, Rhizoma Gastrodiae 19 ~ 29 weight portions, Radix Notoginseng 26 ~ 36 weight portions, Rhizoma Curcumae Longae 29 ~ 39 weight portions, Herba Ardisiae Japonicae 23 ~ 33 weight portions, Pericarpium Citri Reticulatae Viride 16 ~ 26 weight portions and Fructus Citri Sarcodactylis 11 ~ 21 weight portions.
In described Chinese medicine composition, each constituent content can be also Semen Vaccariae 55 ~ 60 weight portions, Fructus Liquidambaris 42 ~ 47 weight portions, the Radix Astragali 76 ~ 81 weight portions, Rhizoma Polygonati 27 ~ 32 weight portions, the Rhizoma Atractylodis Macrocephalae 24 ~ 29 weight portions, Cortex Albiziae 21 ~ 26 weight portions, Radix Achyranthis Bidentatae 30 ~ 35 weight portions, Rhizoma Kaempferiae 18 ~ 23 weight portions, Radix Rehmanniae Preparata 22 ~ 27 weight portions, Caulis Polygoni Multiflori 48 ~ 53 weight portions, Herba Dianthi 26 ~ 31 weight portions, Herba Plantaginis 17 ~ 22 weight portions, Folium Pyrrosiae 20 ~ 25 weight portions, Semen Coicis 25 ~ 30 weight portions, Radix Platycodonis 19 ~ 24 weight portions, Folium Apocyni Veneti 31 ~ 36 weight portions, Rhizoma Gastrodiae 24 ~ 29 weight portions, Radix Notoginseng 31 ~ 36 weight portions, Rhizoma Curcumae Longae 34 ~ 39 weight portions, Herba Ardisiae Japonicae 28 ~ 33 weight portions, Pericarpium Citri Reticulatae Viride 21 ~ 26 weight portions and Fructus Citri Sarcodactylis 16 ~ 21 weight portions.
In described Chinese medicine composition, each constituent content most preferably is Semen Vaccariae 55 weight portions, Fructus Liquidambaris 42 weight portions, the Radix Astragali 76 weight portions, Rhizoma Polygonati 27 weight portions, the Rhizoma Atractylodis Macrocephalae 24 weight portions, Cortex Albiziae 21 weight portions, Radix Achyranthis Bidentatae 30 weight portions, Rhizoma Kaempferiae 18 weight portions, Radix Rehmanniae Preparata 22 weight portions, Caulis Polygoni Multiflori 48 weight portions, Herba Dianthi 26 weight portions, Herba Plantaginis 17 weight portions, Folium Pyrrosiae 20 weight portions, Semen Coicis 25 weight portions, Radix Platycodonis 19 weight portions, Folium Apocyni Veneti 31 weight portions, Rhizoma Gastrodiae 24 weight portions, Radix Notoginseng 31 weight portions, Rhizoma Curcumae Longae 34 weight portions, Herba Ardisiae Japonicae 28 weight portions, Pericarpium Citri Reticulatae Viride 21 weight portions and Fructus Citri Sarcodactylis 16 weight portions.
For the serious patient of distending pain of the breast, can in described Chinese medicine composition, add Herba Taraxaci, Spica Prunellae, described Herba Taraxaci and the Spica Prunellae content in described Chinese medicine composition is Herba Taraxaci 17 ~ 27 weight portions, Spica Prunellae 12 ~ 22 weight portions, more preferably Herba Taraxaci 22 ~ 27 weight portions, Spica Prunellae 17 ~ 22 weight portions.
There is the patient of lump around for breast, can in described Chinese medicine composition, add Retinervus Luffae Fructus and Rhizoma Sparganii, described Retinervus Luffae Fructus and the Rhizoma Sparganii content in described Chinese medicine composition is Retinervus Luffae Fructus 24 ~ 34 weight portions, Rhizoma Sparganii 15 ~ 25 weight portions, more preferably Retinervus Luffae Fructus 29 ~ 34 weight portions, Rhizoma Sparganii 20 ~ 25 weight portions.
In described Chinese medicine composition, each component pharmacology is as follows:
Semen Vaccariae: bitter in the mouth, property are flat, return stomach warp, have effect of promoting blood circulation to restore menstrual flow stimulating milk secretion, are good at promoting blood circulation, row and not walking, walks and does not keep, upper can promoting lactation, lower energy leads to amenorrhea,
Fructus Liquidambaris: bitter in the mouth, property are put down, and return liver, kidney channel, have dispelling, collateral-activating, and diuretic stimulates the menstrual flow, and cures mainly arthralgia, numbness contracture, edema distension, breast is few, the cards such as amenorrhea.
The Radix Astragali: bitter in the mouth, cold in nature, GUIXIN, lung, stomach, gallbladder, large intestine channel, have heat clearing and damp drying, and eliminating fire and detoxication is antiabortive, and the effect of hemostasis cures mainly diarrhoea, dysentery, jaundice, pyretic stranguria due to damp and hot; Cough due to lung-heat, thirsty pharyngalgia, also can be used for excessive fetal movement due to heat in pregnancy, pyretic toxicity pathogenic fire is invaded the swollen card of carbuncle sore poison of excessive skin, the Radix Astragali can air making-up and spleen enlivening hemopoietic to change breast, again can QI invigorating circulation of qi promoting with lactogenesis, Radix Astragali Endocrine system has certain regulating action.
Cortex Albiziae: sweet in the mouth, hardship, property is flat, and GUIXIN, Liver Channel, have resolving stagnation for tranquilization, and effect of promoting blood circulation and detumescence cures mainly melancholy insomnia, irritability, inside and outside carbuncle and ulcer, the cards such as injury from falling down.
Radix Achyranthis Bidentatae: bitter in the mouth, acid; Property is put down, and returns liver; Kidney channel, has invigorating the liver and kidney; Bone and muscle strengthening; Promoting blood circulation to restore menstrual flow; Ignite (blood) descending; Effect of inducing diuresis for treating stranguria syndrome, cures mainly soreness of waist and knee joint; Flaccidity and weakness of the lower limbs; Amenorrhea due to stagnation of blood; Dysmenorrhea; Puerperal abdominal pain due to blood stasis; Lump in the abdomen; Retention of placenta; Pyretic stranguria; Stranguria with blood; Traumatic injury; Carbuncle malignant boil; The cards such as laryngopharynx swelling and pain.
Rhizoma Kaempferiae: acrid in the mouth, warm in nature, return stomach warp, there is circulation of qi promoting warming middle-JIAO, effect of the pain relieving that helps digestion, cures mainly chest and diaphragm distension, coldness and pain in the epigastrium, the diet card such as do not disappear.
Radix Rehmanniae Preparata: sweet in the mouth, slightly warm in nature, enters liver, kidney channel, has the YIN nourishing of enriching blood, and beneficial essence is filled out effect of marrow, cures mainly blood deficiency and yellow complexion; Dizzy, cardiopalmus, insomnia, menoxenia, collapses more than; Hepatic and renal YIN deficiency, night sweat, sufficient knee joint pain, soreness of the waist and knees, Hiccough and deaf, the head is dim-sighted; Seminal emission sexual impotence; Infertility; Menoxenia; Metrostaxis; Early whitening of beard and hair; Quench one's thirst; Constipation; The cards such as dyspnea with rapid and short breath of suffering from a deficiency of the kidney.
Caulis Polygoni Multiflori: sweet in the mouth, property is flat, and GUIXIN, Liver Channel, have nourishing blood to tranquillize the mind, and effect of dispelling wind and removing obstruction in the collateral, cures mainly insomnia and dreamful sleep, blood deficiency general pain, rheumatic arthralgia; The cards such as skin pruritus, Caulis Polygoni Multiflori can be invigorated blood circulation, stimulated the menstrual flow, blood vessel dilating, blood circulation promoting, stimulating milk secretion detumescence.
Herba Dianthi: bitter in the mouth, cold in nature, GUIXIN, small intestine meridian, have inducing diuresis for treating stranguria syndrome, effect that removing blood stasis stimulates the menstrual flow, cure mainly pyretic stranguria, stranguria with blood, stranguria caused by urinary stone, urinary obstruction, the puckery pain of pouring drop, increase through etc. card, Herba Dianthi has excitation to cental system.
Herba Plantaginis: sweet in the mouth, cold in nature, return liver, kidney, lung, small intestine meridian, there is clearing away heat and promoting diuresis treating stranguria, effect of the removing pathogenic heat from blood and toxic substance from the body of eliminating the phlegm, cures mainly the puckery pain of pyretic stranguria, edema oliguria, diarrhea due to summer heat and dampness, phlegm-heat cough, the cards such as carbuncle sore tumefacting virus.
Folium Pyrrosiae: sweet in the mouth, hardship, cold nature, returns lung, urinary bladder channel, has relieving stranguria by diuresis, and effect that lung heat clearing expels the heat-evil cures mainly and drenches pain, hematuria, lithangiuria, nephritis, metrorrhagia, dysentery, cough due to lung-heat, chronic tracheitis, incised wound, the cards such as carbuncle.
Semen Coicis: cool in nature, sweet in the mouth, light, returns spleen, stomach, lung meridian.There is the function of spleen invigorating eliminating dampness by diuresis, clearing away heat and discharging pus, eliminating impediment, diuretic, for weakness of the spleen and stomach, loose stool diarrhoea, or vaginal discharge diseases of women, insufficiency of the spleen leading to overabundance of dampness edema, dysuria, or beriberi swells and ache; Damp and hot arthralgia pain, contracture of the limbs, miserable pain; Lung abscess cough and spit purulent sputum, or enterodynia contracture stomachache.
Radix Platycodonis: bitter in the mouth, pungent, property is flat, returns lung meridian, has lung qi dispersing, sore-throat relieving, eliminates the phlegm, effect of evacuation of pus, cures mainly cough with copious phlegm, uncomfortable in chest not smooth, pharyngalgia hoarseness, the cards such as lung abscess vomiting pus.
Folium Apocyni Veneti: sweet in the mouth, hardship, cool in nature, enter Liver Channel, there is suppressing the hyperactive liver and calm the nerves, the effect of clearing away heat and promoting diuresis, for dizziness due to hyperactivity of liver-YANG, palpitation and insomnia, edema oliguria; Hypertension, neurasthenia, the cards such as nephritis edema.
Rhizoma Gastrodiae: sweet in the mouth, property are flat, enter Liver Channel, have suppressing the hyperactive liver to relieve the wind syndrome, spasmolytic, the effect of removing obstruction in the collateral to relieve pain, is mainly used in the dizzy headache of flaming up of liver-fire, the card such as strong wind tic, epilepsy due to excessive rising of liver-YANG, liver-wind stirring up internally.
Radix Notoginseng: warm in nature, sweet in the mouth, micro-hardship, return liver, stomach warp, has hemostasis; dissipating blood stasis, detumescence, the effect of pain relieving, cures mainly: control haematemesis; hemoptysis, epistaxis, has blood in stool, dysentery; metrorrhagia, lump in the abdomen, puerperal blood faints, retention of lochia; fall and flutter blood stasis, traumatic hemorrhage, the cards such as carbuncle pain; modern pharmacology proves, Radix Notoginseng can hemostasis, antithrombotic, promotion hemopoietic, antiinflammatory, protect the liver, antitumor, analgesia, cardiovascular is had to good effect, and myocardial damage is had to protective effect.
Rhizoma Curcumae Longae: bitter in the mouth, pungent, warm in nature, enter Liver Channel, there is removing blood stasis circulation of qi promoting, effect of inducing menstruation to relieve menalgia, twinges for the breast side of body, amenorrhea, lump in the abdomen, rheumatism shoulder arm pain, the cards such as tumbling and swelling.
Herba Ardisiae Japonicae: property is flat, acrid in the mouth, micro-hardship.Return lung, Liver Channel, there is preventing phlegm from forming and stopping coughing, dampness removing, the effect of invigorating blood circulation, cures mainly the cards such as cough, sputum mixed with blood, chronic bronchitis, jaundice due to damp-heat, injury from falling down.
Pericarpium Citri Reticulatae Viride: bitter in the mouth, pungent, warm in nature, enter liver, gallbladder, stomach warp, there is easypro gallbladder dispelling the stagnated QI, the stagnant effect of removing food stagnancyization, for stagnation of QI due to dyspepsia, abdominal distention, infantile malnutrition, old man's abdominal distention of stopping eating, gastrointestinal tract is had to gentle stimulation, can facilitating digestion liquid secretion and get rid of gas in body, again can diastole gastrointestinal smooth muscle, main manifestations is the effect of adjusting gastrointestinal function.
Fructus Citri Sarcodactylis: acrid in the mouth, hardship, warm in nature, return liver, stomach, lung meridian, there is soothing the liver circulation of qi promoting, and in the effect of reducing phlegm, for the distending pain in the chest and hypochondrium of stagnation of QI due to depression of the liver, incoordination between the liver and stomach, stagnation of QI in spleen and stomach, the cards such as vomiting and nausea lack of appetite.
Herba Taraxaci: sweet in the mouth, hardship, cold in nature, enter liver, stomach warp, there is the effect of heat-clearing and toxic substances removing, eliminating carbuncle eliminating stagnation, liver heat removing and eyesight improving, inducing diuresis for treating stranguria syndrome, be mainly used in the treatment of sore swollen toxin, especially remarkable to acute mastitis effect, also can be used for the cards such as the conjunctival congestion and swelling pain of flaming up of liver-fire.
Spica Prunellae: bitter in the mouth, pungent, cold in nature, enter liver, gallbladder meridian, have and relieve inflammation or internal heat, improving eyesight, eliminating stagnation, effect of detumescence, cures mainly conjunctival congestion and swelling pain, and order pearl nyctalgia, has a headache dizzy, scrofula, goiter, swells and ache; Thyromegaly, tuberculous lymphadenitis, cyclomastopathy, the cards such as hypertension, hyperglycemia, hyperlipidemia and high blood viscosity.
Retinervus Luffae Fructus: cool in nature, sweet in the mouth.Enter lung, stomach, Liver Channel, have dredging collateral, invigorate blood circulation, the effect of dispeling the wind, cures mainly the cards such as arthralgia pain contracture, distending pain in the chest and hypochondrium, galactostasis.
Rhizoma Sparganii: bitter in the mouth, pungent, property is flat, enters liver, spleen channel, has removing blood stasis circulation of qi promoting, effect of removing food stagnancy pain relieving, for blood stasis amenorrhea, dysmenorrhea, the stagnant stomachache of the stasis of blood in puerperal, lump in the abdomen mass in the abdomen in abdomen, stagnation of QI due to dyspepsia, the cards such as abdominal distention.
Chinese medicine composition of the present invention is preferably prepared into powder, capsule and oral liquid.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, and in the time that the dosage form of described Chinese medicine composition is oral liquid, it comprises the following steps,
The first step, described component is mixed in proportion, be placed in super micron mill and pulverize 20 minutes～40 minutes, in the ethanol that is 85%～95% in determining alcohol by the powder dissolution after pulverizing, flood 12 hours～18 hours, adopt the speed slowly percolation of percolation with 1～2ml per minute, collect percolate, the quality of the ethanol adding is 2～4 times of mixed-powder quality, is evaporated to 1/10 left and right of original volume, 15000rpm pipeline is centrifugal, obtains supernatant;
Second step, the supernatant that the first step is obtained is crossed macroporous resin column absorption, first use the water elution of 2～4 times of mixture qualities that obtain with respect to the first step to discard, then gradient ethanol elution, use for the first time 3～5 times of determining alcohol 70%～80% ethanol elutions of mixture quality that obtain with respect to the first step, use again 3～5 times of determining alcohol 85%～95% ethanol elutions of mixture quality that obtain with respect to the first step, merge gradient ethanol elution, 200 ~ 400 object powder are pulverized and be screened into decompression recycling ethanol, to most, lyophilization, subsequently;
The 3rd step, the powder that second step is obtained mixes with saccharin sodium and is dissolved in water, and sodium carboxymethyl cellulose is dispersed in hot water, cooling, then mix with the aqueous suspension that contains saccharin sodium, preparing solution is become to volume required and mix homogeneously, concentrated, subpackage after sterilizing, obtain oral liquid, with respect to the powder of 100 weight portions, the weight fraction of described saccharin sodium is 2～4 weight portions, the weight fraction of described sodium carboxymethyl cellulose is 3～5 weight portions, water 1000～10000 weight portions.
Described macroporous resin column is preferably D101 type macroporous resin column.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, and in the time that the dosage form of described Chinese medicine composition is powder, it comprises the following steps,
The first step, described component is mixed in proportion, be placed in super micron mill and pulverize 20 minutes～40 minutes, in the ethanol that is 85%～95% in determining alcohol by the powder dissolution after pulverizing, flood 12 hours～18 hours, adopt the speed slowly percolation of percolation with 1～2ml per minute, collect percolate, the quality of the ethanol adding is 2～4 times of mixed-powder quality, is evaporated to 1/10 left and right of original volume, 15000rpm pipeline is centrifugal, obtains supernatant;
Second step, the supernatant that the first step is obtained is crossed macroporous resin column absorption, first use the water elution of 2～4 times of mixture qualities that obtain with respect to the first step to discard, then gradient ethanol elution, use for the first time 3～5 times of determining alcohol 70%～80% ethanol elutions of mixture quality that obtain with respect to the first step, use again 3～5 times of determining alcohol 85%～95% ethanol elutions of mixture quality that obtain with respect to the first step, merge gradient ethanol elution, 200 ~ 400 object powder are pulverized and be screened into decompression recycling ethanol, to most, lyophilization, subsequently;
The 3rd step, by the powder of second step acquisition, with respect to the protein sugar of 0.01～0.05 times of its quality, the dextrin of 0.1～0.2 times, the starch of 1～2 times is put into blender and is stirred 30 minutes～1 hour, makes powder, with racking machine subpackage.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, and in the time that the dosage form of described Chinese medicine composition is capsule, it comprises the following steps,
The first step, described component is mixed in proportion, be placed in super micron mill and pulverize 20 minutes～40 minutes, in the ethanol that is 85%～95% in determining alcohol by the powder dissolution after pulverizing, flood 12 hours～18 hours, adopt the speed slowly percolation of percolation with 1～2ml per minute, collect percolate, the quality of the ethanol adding is 2～4 times of mixed-powder quality, is evaporated to 1/10 left and right of original volume, 15000rpm pipeline is centrifugal, obtains supernatant;
Second step, the supernatant that the first step is obtained is crossed macroporous resin column absorption, first use the water elution of 2～4 times of mixture qualities that obtain with respect to the first step to discard, then gradient ethanol elution, use for the first time 3～5 times of determining alcohol 70%～80% ethanol elutions of mixture quality that obtain with respect to the first step, use again 3～5 times of determining alcohol 85%～95% ethanol elutions of mixture quality that obtain with respect to the first step, merge gradient ethanol elution, 200 ~ 400 object powder are pulverized and be screened into decompression recycling ethanol, to most, lyophilization, subsequently;
The 3rd step, above-mentioned fine powder and starch are mixed, the ratio of the quality sum of the quality of described starch and the fine powder obtaining is 0.1:1～0.3:1, carry out subsequently pelletization treatment, dried, obtain compound particles, more further in compound particles, add magnesium stearate, described magnesium stearate and described compound particles mass ratio are 0.15～100:0.5～100, obtain capsule 's content, described capsule 's content is incapsulated and in housing, obtains capsule.
The present invention also provides above-mentioned Chinese medicine composition in the application for the preparation of improving in the medicine of puerperal hypogalactia symptom.
Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure of reaching technique effect can fully understand and implement according to this.
Powder 1 prepared by embodiment 1 the present invention
By Semen Vaccariae 55g, Fructus Liquidambaris 42g, Radix Astragali 76g, Rhizoma Polygonati 27g, Rhizoma Atractylodis Macrocephalae 24g, Cortex Albiziae 21g, Radix Achyranthis Bidentatae 30g, Rhizoma Kaempferiae 18g, Radix Rehmanniae Preparata 22g, Caulis Polygoni Multiflori 48g, Herba Dianthi 26g, Herba Plantaginis 17g, Folium Pyrrosiae 20g, Semen Coicis 25g, Radix Platycodonis 19g, Folium Apocyni Veneti 31g, Rhizoma Gastrodiae 24g, Radix Notoginseng 31g, Rhizoma Curcumae Longae 34g, Herba Ardisiae Japonicae 28g, Pericarpium Citri Reticulatae Viride 21g and Fructus Citri Sarcodactylis 16g mix, be placed in super micron mill and pulverize 40 minutes, in the ethanol that is 95% in 2000g determining alcohol by the powder dissolution after pulverizing, flood 18 hours, adopt the speed slowly percolation of percolation with 2ml per minute, collect percolate, be evaporated to 1/10 left and right of original volume, 15000rpm pipeline is centrifugal, obtain supernatant, the supernatant of acquisition is crossed to the absorption of D101 type macroporous resin column, first discard with the water elution of 2000g, then gradient ethanol elution, use for the first time 2700g determining alcohol 80% ethanol elution, use 2700g determining alcohol 95% ethanol elution again, merge gradient ethanol elution, decompression recycling ethanol is to most, lyophilization, pulverizes and is screened into 300 object powder subsequently, by the protein sugar of this powder of 655g and 13g, the dextrin of 66g, the starch of 700g is put into blender and is stirred 1 hour, makes powder 1.
Embodiment 2 acute toxicity testings:
Get 40 of ICR mices (Beijing Vital River Experimental Animals Technology Co., Ltd. provides), body weight is at 25～30 grams, and powder 1 prepared by embodiment 1 is dissolved in water, to mouse stomach, to the median lethal dose(LD 50) (LD of administration
50) carry out test determination, but do not measure LD
50, therefore carried out mtd test.Result: with Cmax (60%), maximum administration, crude drug amount 60g/kg, 300 times (by 75kg) of the daily dosage of clinical plan are equivalent to be grown up, none death of mice in seven days, put to death the each internal organs of mice anatomic observation and do not find toxic reaction, administration group and control group mice are without any difference.
Embodiment 3 long term toxicity tests:
Experimental agents is set as high, medium and low three dosage by application Wistar rat (Beijing Vital River Experimental Animals Technology Co., Ltd. provides), is respectively powder 8g/kg, 4g/kg, 2g/kg prepared by embodiment 1.Calculate by people's use dosage 0.1g/kg/ sky-backing, be 80 times, 40 times and 20 times of people's use effective dose; Separately establish a matched group, gastric infusion 90 days, 180 days and Some Animals drug withdrawal, after 10 days, are observed the impact on the every physiology of rat, biochemical indicator continuously.Experimental result shows: by various dose, to rat continuous oral 180 days, the food-intake on rat and body weight gain were all without impact.Hepatic and renal function is not all found to overt toxicity effect.Routine blood test, blood biochemistry, urine biochemistry and bone marrow sheet etc. are showed no to obvious impact, between each group, compare no significant difference with matched group.
Powder 2 prepared by embodiment 4 the present invention
By Semen Vaccariae 58g, Fructus Liquidambaris 44g, Radix Astragali 80g, Rhizoma Polygonati 29g, Rhizoma Atractylodis Macrocephalae 26g, Cortex Albiziae 23g, Radix Achyranthis Bidentatae 33g, Rhizoma Kaempferiae 21g, Radix Rehmanniae Preparata 26g, Caulis Polygoni Multiflori 50g, Herba Dianthi 29g, Herba Plantaginis 18g, Folium Pyrrosiae 22g, Semen Coicis 26g, Radix Platycodonis 22g, Folium Apocyni Veneti 34g, Rhizoma Gastrodiae 28g, Radix Notoginseng 35g, Rhizoma Curcumae Longae 37g, Herba Ardisiae Japonicae 31g, Pericarpium Citri Reticulatae Viride 25g and Fructus Citri Sarcodactylis 17g mix, be placed in super micron mill and pulverize 40 minutes, in the ethanol that is 95% in 2200g determining alcohol by the powder dissolution after pulverizing, flood 18 hours, adopt the speed slowly percolation of percolation with 2ml per minute, collect percolate, be evaporated to 1/10 left and right of original volume, 15000rpm pipeline is centrifugal, obtain supernatant, the supernatant of acquisition is crossed to the absorption of D101 type macroporous resin column, first discard with the water elution of 2000g, then gradient ethanol elution, use for the first time 2700g determining alcohol 80% ethanol elution, use 2700g determining alcohol 95% ethanol elution again, merge gradient ethanol elution, decompression recycling ethanol is to most, lyophilization, pulverizes and is screened into 300 object powder subsequently, by the protein sugar of this powder of 655g and 13g, the dextrin of 66g, the starch of 700g is put into blender and is stirred 1 hour, makes powder 2.
Oral liquid prepared by embodiment 5 the present invention
By Semen Vaccariae 55g, Fructus Liquidambaris 42g, Radix Astragali 76g, Rhizoma Polygonati 27g, Rhizoma Atractylodis Macrocephalae 24g, Cortex Albiziae 21g, Radix Achyranthis Bidentatae 30g, Rhizoma Kaempferiae 18g, Radix Rehmanniae Preparata 22g, Caulis Polygoni Multiflori 48g, Herba Dianthi 26g, Herba Plantaginis 17g, Folium Pyrrosiae 20g, Semen Coicis 25g, Radix Platycodonis 19g, Folium Apocyni Veneti 31g, Rhizoma Gastrodiae 24g, Radix Notoginseng 31g, Rhizoma Curcumae Longae 34g, Herba Ardisiae Japonicae 28g, Pericarpium Citri Reticulatae Viride 21g and Fructus Citri Sarcodactylis 16g mix, be placed in super micron mill and pulverize 40 minutes, in the ethanol that is 95% in 2000g determining alcohol by the powder dissolution after pulverizing, flood 18 hours, adopt the speed slowly percolation of percolation with 2ml per minute, collect percolate, be evaporated to 1/10 left and right of original volume, 15000rpm pipeline is centrifugal, obtain supernatant, the supernatant of acquisition is crossed to the absorption of D101 type macroporous resin column, first discard with the water elution of 2000g, then gradient ethanol elution, use for the first time 2700g determining alcohol 80% ethanol elution, use 2700g determining alcohol 95% ethanol elution again, merge gradient ethanol elution, decompression recycling ethanol is to most, lyophilization, pulverize subsequently and be screened into 300 object powder, this powder of 655g mixed with 20g saccharin sodium and antiseptic and be dissolved in the water of 6000g, 26g sodium carboxymethyl cellulose being dispersed in the hot water of 600g, cooling, then mix with the aqueous suspension that contains saccharin sodium, preparing solution is become to volume required and mix homogeneously, concentrated, subpackage after sterilizing, obtain oral liquid, every bottle of 100ml.
Capsule prepared by embodiment 6 the present invention
By Semen Vaccariae 55g, Fructus Liquidambaris 42g, Radix Astragali 76g, Rhizoma Polygonati 27g, Rhizoma Atractylodis Macrocephalae 24g, Cortex Albiziae 21g, Radix Achyranthis Bidentatae 30g, Rhizoma Kaempferiae 18g, Radix Rehmanniae Preparata 22g, Caulis Polygoni Multiflori 48g, Herba Dianthi 26g, Herba Plantaginis 17g, Folium Pyrrosiae 20g, Semen Coicis 25g, Radix Platycodonis 19g, Folium Apocyni Veneti 31g, Rhizoma Gastrodiae 24g, Radix Notoginseng 31g, Rhizoma Curcumae Longae 34g, Herba Ardisiae Japonicae 28g, Pericarpium Citri Reticulatae Viride 21g and Fructus Citri Sarcodactylis 16g mix, be placed in super micron mill and pulverize 40 minutes, in the ethanol that is 95% in 2000g determining alcohol by the powder dissolution after pulverizing, flood 18 hours, adopt the speed slowly percolation of percolation with 2ml per minute, collect percolate, be evaporated to 1/10 left and right of original volume, 15000rpm pipeline is centrifugal, obtain supernatant, the supernatant of acquisition is crossed to the absorption of D101 type macroporous resin column, first discard with the water elution of 2000g, then gradient ethanol elution, use for the first time 2700g determining alcohol 80% ethanol elution, use 2700g determining alcohol 95% ethanol elution again, merge gradient ethanol elution, decompression recycling ethanol is to most, lyophilization, pulverizes and is screened into 300 object powder subsequently, and 655g powder and 120g starch are mixed, and carries out subsequently pelletization treatment, dried, obtains compound particles, more further in compound particles, adds 2.4g magnesium stearate, obtains capsule 's content, and described capsule 's content is incapsulated and in housing, obtains capsule, each capsule 1g.
Embodiment 7 cases
Zhang, female, 28 years old, be expert at and cut open palace product on August 23rd, 2010, give birth to a 3850g boy baby, suckling after 2 days, without milk, then please the department of Chinese medicine consultation of doctors.Examine quarter: the two hard pain of mammary swelling of patient, milk yellow thick not under, the breast side of body is swollen stagnant, inappetence, thin white fur of tongue, stringy pulse.Western medicine diagnose: puerperal hypogalactia, tcm diagnosis: lack of lactation after delivery, by the powder of taking the embodiment of the present invention 1 and preparing, every day, 150g, took with water dissolution, every day 3 times, and with manipulation of massage auxiliary it, advise its lover to suck to help lactogenesis more.After 3 days, two examine, and patient's private prosecution mammary swelling takes a turn for the better, under milk and amount is few, and slightly lochia, lower abdominal pain, then three examine after 2 days, milk is logical, can meet baby's demand, and good appetite easily starves.
Embodiment 8 clinical experiments
Case selection
Object of study: in July, 2010-2011 year December obstetrics cut open palace and produce puerpera's 213 examples, and patient's random assortment is treatment group 110 examples and matched group 103 examples.Treatment group signature informed consent postscript starts.213 examples are included in this test altogether in, treatment group 110 examples, 21 ~ 34 years old age, average (27.5 ± 4.2) year, hypogalactia degree: slight 42 examples, moderate 47 examples, severe 21 examples; Matched group 103 examples, 22 ~ 35 years old age, average (26.3 ± 4.5) year, hypogalactia degree: slight 49 examples, moderate 37 examples, severe 17 examples.Two groups of ages while entering to organize, severity extent, lactation amount, prolactin antagonist (PRL) level determinations there are no significant difference (P>0.05).
Inclusive criteria and exclusion standard: with reference to the diagnostic criteria of " new Chinese medicine guideline of clinical investigations " " guideline of clinical investigations of new Chinese medicine treatment hypogalactia " and " Gynecology of Chinese Medicine " formulation galactopoiesis deficiency.Hypogalactia grading: 1) slight: to meet 2/3 of baby's requirement.2) moderate: meet 1/3 of baby's requirement.3) severe: almost there is no milk, can not feeding infant.Inclusive criteria: 1) meet tcm diagnosis standard and dialectical, and the person that signs Informed Consent Form.2) do not merge severe cardiac, cerebrovascular, without the serious primary disease such as liver and hemopoietic system.3) mammary gland is without dissecting abnormal development.Exclusion standard: 1) age person below 20 years old or more than 40 years old.2) allergic constitution or to cloth hypersensitivity person.3) the be born neonate of low weight and asphyxia.4) milk that extremely causes in the defect in mammary gland anatomy and function is discharged impassable patient.5) acute mastitis is discharged impassable patient from the beginning of, milk.
Therapeutic Method
Matched group: the skilled nurse of assigned operation carries out traditional wet towel hot compress breast 10～15 minutes to puerpera, then massaging breasts, milk, every day 2 times, continuous 5 days, and estimate breast feeding, every day, breast milk number of times was no less than 8 times, 5 days 1 courses for the treatment of, statistical result after one week.
Treatment group: on the basis for the treatment of of control group, take powder 1 prepared by the embodiment of the present invention 1, every day, 150g, used warm boiled water, every day 3 times, 5 days 1 courses for the treatment of, statistical result after one week.Statistical analysis
Adopt SPSS 15.0 statistical softwares to carry out data analysis.Measurement data is with mean ± standard deviation
represent the relatively employing t inspection of measurement data; Enumeration data adopts X 2 test, and ranked data are checked with Ridit, have statistical significance taking P<0.05 as difference.
Observation index
1) observation of curative effect
Observe breast filling degree before and after each group for the treatment of, milk quality, lactation amount and also need to mend breast amount, measures levels of serum PRL content.Syndrome integration scale has 8 syndromes, and main symptom comprises lactation amount: meet baby's requirement completely, count 0 point; Meet 2/3 of baby's requirement, count 1 point; Meet 1/3 of baby's requirement, count 2 points; Almost there is no milk, can not feeding infant, count 3 points.The filling degree of breast: breast is full, has slight distending pain sense, and milk, from overflowing, is counted 0 point; Breast is obviously full, and milk gently firmly pushes to go out, and counts 1 point; Full but the distension not of breast, the milk firmly side of extruding goes out, and counts 2 points; Breast is without obviously full, pushes excessively without milk, counts 3 points.Milk quality: matter is thick, counts 0 point; Matter is thick clearly, counts 1 point; Matter is rare clearly, counts 2 points.Inferior card comprises lustreless complexion, spiritlessness and weakness, inappetence, counts respectively 0 point, 1 point, 2 points, 3 points according to the weight of symptom.Picture of the tongue, pulse condition: not classification, appear as (+), do not appear as (-), be not counted in total score.Above scale respectively at treatment before and treatment evaluate record after finishing.
2) lactation amount is measured
Two groups of puerpera's nursing time a daies every day are no less than 8 times, are instructed and are breast-feeded, and with milk in maneuver crowded empty breast before treatment, after treatment by special messenger, measure to feed after volume newbornly, measure thus cesarean lactation amount.
3) mend lactication amount: after breast milk has been fed, need add the breast amount of feeding.
4) PRL measures: respectively at the forward and backward detection for the treatment of.Because human serum PRL level fluctuation is large, have property round the clock to change, and with baby suck directly relevant, therefore each blood sampling is fixed on before suckling in morning.Centrifugal in 1h after collection of specimens, get serum, be placed in-20 DEG C of Refrigerator stores, time to be determined, take out and thaw.Detect and adopt semi-automatic chemical luminescence method, instrument is MPC-1 type single photon counting meter of micropore plate, and Beijing Yuande Biology Medicine Engineering Co., Ltd produces, and medicine box is produced by the said firm, operates by medicine box illustration method.
5) safety is observed: comprise the general health check-up project of puerpera, blood, urine, feces routine, glutamate pyruvate transaminase (ALT), blood urea nitrogen (BUN), creatinine (Cr), electrocardiogram.
Therapeutic evaluation
With reference to the curative effect determinate standard in " new Chinese medicine guideline of clinical investigations " " new Chinese medicine treatment hypogalactia guideline of clinical investigations " with subtract a point rate (nimodipine method) and evaluate the curative effect of galactopoiesis deficiency.Subtract a point rate computing formula: subtract a point rate=[integration before (the rear integration of integration-treatment before treatment) ÷ treatment] × 100%.
Comprehensive therapeutic effect criterion: clinical recovery: galactopoiesis meets baby's needs completely, other symptoms disappear completely, subtract point rate >=95%.Effective: galactopoiesis meets baby's requirement 2/3 and (or) severity extent transfers slightly (improving more than 2 grades) to by severe, and symptom is obviously improved, and subtracts point rate >=70%, < 95%.Effective: galactopoiesis increases, 1/3 and (or) the severity extent that can meet baby's requirement improve 1 grade, and symptom take a favorable turn, and subtracts point rate >=30%, <70%.Invalid: hypogalactia is without improvement, and symptom, without improvement, subtracts a point rate <30%.
Result
The comparison of two groups of patient's comprehensive therapeutic effects, the results are shown in Table 1.
Table 1 liang group patient's comprehensive therapeutic effect comparison (%)
| Group | Number of cases | Recovery from illness (%) | Effective (%) | Effectively (%) | Invalid (%) |
| Treatment group | 110 | 73(66.4) | 35(31.8) | 2(1.8) | 0(0) |
| Matched group | 103 | 26(25.2) | 29(22.2) | 12(11.7) | 36(35.0) |
Before and after two groups of patient treatments, tcm syndrome integral contrast, the results are shown in Table 2.
Tcm syndrome integral contrast before and after table 2 liang group patient treatment
| Group | Number of cases | Before treatment | After treatment | Difference |
| Treatment group | 110 | 12.92±1.21 | 2.00±1.15 | 10.92±1.20 |
| Matched group | 103 | 12.59±1.23 | 7.21±1.19 | 5.38±1.21 |
Two groups of patient's lactation amounts and mend the comparison of lactication amount situation, the results are shown in Table 3.
Table 3 liang group patient's lactation amount and the comparison of benefit lactication amount situation
| Group | Number of cases | Before treatment | After treatment | Lift-off value | Mend lactication amount |
| Treatment group | 110 | 5.3±2.5 | 712.2±17.4 | 706.9±13.9 | 46.0±9.1 |
| Matched group | 103 | 5.8±2.6 | 258.7±10.9 | 252.9±11.6 | 238.0±11.4 |
Before and after two groups of patient treatments, prolactin level comparison, the results are shown in Table 4.
Prolactin level comparison before and after table 4 liang group patient treatment
| Group | Number of cases | Before treatment | After treatment | Lift-off value |
| Treatment group | 110 | 1011.4±20.2 | 2008.6±34.4 | 997.2±33.6 |
| Matched group | 103 | 1013.1±19.4 | 1233.2±22.3 | 220.1±20.2 |
Can find out from the result of above-mentioned table, adopt the traditional Chinese medicine composition for treating puerperal hypogalactia prepared of the present invention, can significantly improve puerpera's prolactin level, increase lactation amount, reduce and mend lactication amount, puerperal hypogalactia is had to significant curative effect.
All above-mentioned these intellectual properties of primary enforcement, do not set restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing amendment, 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 preferred embodiment of the present invention, is not the restriction of the present invention being made to other form, and any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the equivalent embodiment of equivalent variations.But every technical solution of the present invention content that do not depart from, any simple modification, equivalent variations and the remodeling above embodiment done according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.
Claims (9)
1. for improving the Chinese medicine composition of puerperal hypogalactia, it is characterized in that: described Chinese medicine composition is only made up of Semen Vaccariae, Fructus Liquidambaris, the Radix Astragali, Rhizoma Polygonati, the Rhizoma Atractylodis Macrocephalae, Cortex Albiziae, Radix Achyranthis Bidentatae, Rhizoma Kaempferiae, Radix Rehmanniae Preparata, Caulis Polygoni Multiflori, Herba Dianthi, Herba Plantaginis, Folium Pyrrosiae, Semen Coicis, Radix Platycodonis, Folium Apocyni Veneti, Rhizoma Gastrodiae, Radix Notoginseng, Rhizoma Curcumae Longae, Herba Ardisiae Japonicae, Pericarpium Citri Reticulatae Viride and Fructus Citri Sarcodactylis;
In described Chinese medicine composition, each constituent content is Semen Vaccariae 50～60 weight portions, Fructus Liquidambaris 37～47 weight portions, the Radix Astragali 71～81 weight portions, Rhizoma Polygonati 22～32 weight portions, the Rhizoma Atractylodis Macrocephalae 19～29 weight portions, Cortex Albiziae 16～26 weight portions, Radix Achyranthis Bidentatae 25～35 weight portions, Rhizoma Kaempferiae 13～23 weight portions, Radix Rehmanniae Preparata 17～27 weight portions, Caulis Polygoni Multiflori 43～53 weight portions, Herba Dianthi 21～31 weight portions, Herba Plantaginis 12～22 weight portions, Folium Pyrrosiae 15～25 weight portions, Semen Coicis 20～30 weight portions, Radix Platycodonis 14～24 weight portions, Folium Apocyni Veneti 26～36 weight portions, Rhizoma Gastrodiae 19～29 weight portions, Radix Notoginseng 26～36 weight portions, Rhizoma Curcumae Longae 29～39 weight portions, Herba Ardisiae Japonicae 23～33 weight portions, Pericarpium Citri Reticulatae Viride 16～26 weight portions and Fructus Citri Sarcodactylis 11～21 weight portions.
2. Chinese medicine composition as claimed in claim 1, it is characterized in that: in described Chinese medicine composition, each constituent content is Semen Vaccariae 55～60 weight portions, Fructus Liquidambaris 42～47 weight portions, the Radix Astragali 76～81 weight portions, Rhizoma Polygonati 27～32 weight portions, the Rhizoma Atractylodis Macrocephalae 24～29 weight portions, Cortex Albiziae 21～26 weight portions, Radix Achyranthis Bidentatae 30～35 weight portions, Rhizoma Kaempferiae 18～23 weight portions, Radix Rehmanniae Preparata 22～27 weight portions, Caulis Polygoni Multiflori 48～53 weight portions, Herba Dianthi 26～31 weight portions, Herba Plantaginis 17～22 weight portions, Folium Pyrrosiae 20～25 weight portions, Semen Coicis 25～30 weight portions, Radix Platycodonis 19～24 weight portions, Folium Apocyni Veneti 31～36 weight portions, Rhizoma Gastrodiae 24～29 weight portions, Radix Notoginseng 31～36 weight portions, Rhizoma Curcumae Longae 34～39 weight portions, Herba Ardisiae Japonicae 28～33 weight portions, Pericarpium Citri Reticulatae Viride 21～26 weight portions and Fructus Citri Sarcodactylis 16～21 weight portions.
3. Chinese medicine composition as claimed in claim 1, it is characterized in that: in described Chinese medicine composition, each constituent content is Semen Vaccariae 55 weight portions, Fructus Liquidambaris 42 weight portions, the Radix Astragali 76 weight portions, Rhizoma Polygonati 27 weight portions, the Rhizoma Atractylodis Macrocephalae 24 weight portions, Cortex Albiziae 21 weight portions, Radix Achyranthis Bidentatae 30 weight portions, Rhizoma Kaempferiae 18 weight portions, Radix Rehmanniae Preparata 22 weight portions, Caulis Polygoni Multiflori 48 weight portions, Herba Dianthi 26 weight portions, Herba Plantaginis 17 weight portions, Folium Pyrrosiae 20 weight portions, Semen Coicis 25 weight portions, Radix Platycodonis 19 weight portions, Folium Apocyni Veneti 31 weight portions, Rhizoma Gastrodiae 24 weight portions, Radix Notoginseng 31 weight portions, Rhizoma Curcumae Longae 34 weight portions, Herba Ardisiae Japonicae 28 weight portions, Pericarpium Citri Reticulatae Viride 21 weight portions and Fructus Citri Sarcodactylis 16 weight portions.
4. Chinese medicine composition as claimed in claim 1, it is characterized in that: in described Chinese medicine composition, add Herba Taraxaci, Spica Prunellae, described Herba Taraxaci and the Spica Prunellae content in described Chinese medicine composition is Herba Taraxaci 17～27 weight portions, Spica Prunellae 12～22 weight portions.
5. Chinese medicine composition as claimed in claim 1, is characterized in that: in described Chinese medicine composition, add Retinervus Luffae Fructus and Rhizoma Sparganii, described Retinervus Luffae Fructus and the Rhizoma Sparganii content in described Chinese medicine composition is Retinervus Luffae Fructus 24～34 weight portions, Rhizoma Sparganii 15～25 weight portions.
6. the preparation method of the Chinese medicine composition described in claim 1 to 5 any one, is characterized in that: in the time that the dosage form of described Chinese medicine composition is oral liquid, it comprises the following steps,
The first step, described component is mixed in proportion, be placed in super micron mill and pulverize 20 minutes～40 minutes, in the ethanol that is 85%～95% in determining alcohol by the powder dissolution after pulverizing, flood 12 hours～18 hours, adopt the speed slowly percolation of percolation with 1～2ml per minute, collect percolate, the quality of the ethanol adding is 2～4 times of mixed-powder quality, is evaporated to 1/10 of original volume, 15000rpm pipeline is centrifugal, obtains supernatant;
Second step, the supernatant that the first step is obtained is crossed macroporous resin column absorption, first use the water elution of 2～4 times of mixture qualities that obtain with respect to the first step to discard, then gradient ethanol elution, use for the first time 3～5 times of determining alcohol 70%～80% ethanol elutions of mixture quality that obtain with respect to the first step, use again 3～5 times of determining alcohol 85%～95% ethanol elutions of mixture quality that obtain with respect to the first step, merge gradient ethanol elution, 200～400 object powder are pulverized and be screened into decompression recycling ethanol, to most, lyophilization, subsequently;
The 3rd step, the powder that second step is obtained mixes with saccharin sodium and is dissolved in water, and sodium carboxymethyl cellulose is dispersed in hot water, cooling, then mix with the aqueous suspension that contains saccharin sodium, preparing solution is become to volume required and mix homogeneously, concentrated, subpackage after sterilizing, obtain oral liquid, with respect to the powder of 100 weight portions, the weight fraction of described saccharin sodium is 2～4 weight portions, the weight fraction of described sodium carboxymethyl cellulose is 3～5 weight portions, water 1000～10000 weight portions.
7. the preparation method of the Chinese medicine composition described in claim 1 to 5 any one, is characterized in that: in the time that the dosage form of described Chinese medicine composition is powder, it comprises the following steps,
The first step, described component is mixed in proportion, be placed in super micron mill and pulverize 20 minutes～40 minutes, in the ethanol that is 85%～95% in determining alcohol by the powder dissolution after pulverizing, flood 12 hours～18 hours, adopt the speed slowly percolation of percolation with 1～2ml per minute, collect percolate, the quality of the ethanol adding is 2～4 times of mixed-powder quality, is evaporated to 1/10 of original volume, 15000rpm pipeline is centrifugal, obtains supernatant;
Second step, the supernatant that the first step is obtained is crossed macroporous resin column absorption, first use the water elution of 2～4 times of mixture qualities that obtain with respect to the first step to discard, then gradient ethanol elution, use for the first time 3～5 times of determining alcohol 70%～80% ethanol elutions of mixture quality that obtain with respect to the first step, use again 3～5 times of determining alcohol 85%～95% ethanol elutions of mixture quality that obtain with respect to the first step, merge gradient ethanol elution, 200～400 object powder are pulverized and be screened into decompression recycling ethanol, to most, lyophilization, subsequently;
The 3rd step, by the powder of second step acquisition, with respect to the protein sugar of 0.01～0.05 times of its quality, the dextrin of 0.1～0.2 times, the starch of 1～2 times is put into blender and is stirred 30 minutes～1 hour, makes powder, with racking machine subpackage.
8. the preparation method of the Chinese medicine composition described in claim 1 to 5 any one, is characterized in that: in the time that the dosage form of described Chinese medicine composition is capsule, it comprises the following steps,
The first step, described component is mixed in proportion, be placed in super micron mill and pulverize 20 minutes～40 minutes, in the ethanol that is 85%～95% in determining alcohol by the powder dissolution after pulverizing, flood 12 hours～18 hours, adopt the speed slowly percolation of percolation with 1～2ml per minute, collect percolate, the quality of the ethanol adding is 2～4 times of mixed-powder quality, is evaporated to 1/10 of original volume, 15000rpm pipeline is centrifugal, obtains supernatant;
Second step, the supernatant that the first step is obtained is crossed macroporous resin column absorption, first use the water elution of 2～4 times of mixture qualities that obtain with respect to the first step to discard, then gradient ethanol elution, use for the first time 3～5 times of determining alcohol 70%～80% ethanol elutions of mixture quality that obtain with respect to the first step, use again 3～5 times of determining alcohol 85%～95% ethanol elutions of mixture quality that obtain with respect to the first step, merge gradient ethanol elution, 200～400 object powder are pulverized and be screened into decompression recycling ethanol, to most, lyophilization, subsequently;
The 3rd step, above-mentioned fine powder and starch are mixed, the ratio of the quality sum of the quality of described starch and the fine powder obtaining is 0.1:1～0.3:1, carry out subsequently pelletization treatment, dried, obtain compound particles, more further in compound particles, add magnesium stearate, described magnesium stearate and described compound particles mass ratio are 0.15～100:0.5～100, obtain capsule 's content, described capsule 's content is incapsulated and in housing, obtains capsule.
9. the Chinese medicine composition described in claim 1 to 5 any one is in the application for the preparation of improving in the medicine of puerperal hypogalactia symptom.
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| CN105435105A (en) * | 2015-12-17 | 2016-03-30 | 范健身 | Traditional Chinese medicine composition used for increasing postpartum lactation yield |
| CN105381371A (en) * | 2015-12-30 | 2016-03-09 | 张晓莉 | Traditional Chinese medicine for treating phlegmatic hygrosis obstructing postpartum hypogalactia and preparing method thereof |
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| CN1857512A (en) * | 2006-03-10 | 2006-11-08 | 辽宁好护士药业（集团）有限责任公司 | Chinese medicine for treating puerperal hypogalactia and its preparing method |
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