CN105412555A - Medicine composition for promoting postpartum lactating and preparation method thereof - Google Patents

Medicine composition for promoting postpartum lactating and preparation method thereof Download PDF

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CN105412555A
CN105412555A CN201610038308.4A CN201610038308A CN105412555A CN 105412555 A CN105412555 A CN 105412555A CN 201610038308 A CN201610038308 A CN 201610038308A CN 105412555 A CN105412555 A CN 105412555A
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parts
pharmaceutical composition
promoting
herba
milk secretion
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王传秀
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Qingdao Yuntian Biotechnology Co Ltd
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Qingdao Yuntian Biotechnology Co Ltd
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Abstract

The invention relates to a medicine composition for promoting postpartum lactating and a preparation method of the medicine composition. Because an existing therapeutic medicine has a poor effect for treating postpartum hypogalactia, the invention provides the medicine composition for promoting postpartum lactating. The medicine composition is prepared from the following traditional Chinese medicine ingredients in parts by weight: 45 to 60 parts of medulla tetrapanacis, 5.5 to 7 parts of herba epimedii, 30 to 40 parts of nutmeg, 25 to 30 parts of cape jasmine, 30 to 35 parts of angelica sinensis, 85 to 90 parts of fructus viticis, 15 to 20 parts of eucommia ulmoides, 12 to 15 parts of ligusticum wallichii, 5 to 10 parts of radix achyranthis bidentatae, 9 to 15 parts of lotus nuts, 10 to 15 parts of lily, 6 to 9 parts of andrographis paniculata and 10 to 15 parts of rhizoma anemarrhenae. The medicine composition for promoting postpartum lactating, disclosed by the invention, can be used for improving a clinical symptom of a patient who suffers from postpartum hypogalactia, so that the medicine composition is suitable for being promoted and used in clinical application.

Description

A kind of for pharmaceutical composition promoting postpartum milk secretion and preparation method thereof
Technical field
The invention belongs to the field of Chinese medicines, relate to a kind of for pharmaceutical composition promoting postpartum milk secretion and preparation method thereof.
Background technology
National breast feeding condition survey in recent years, China's city breastfeeding rate is only 32.5-62.6% (indivedual city drops to 13%, and rural area is 46.6-78.5%), and the major reason causing breastfeeding rate low is exactly puerperal hypogalactia.Puerperal hypogalactia refer to puerpera when suckling milk very less or completely without, enough even can feeding infant, degree and the situation of hypogalactia are different: lack during the beginning suckling had, later slightly many but still inadequate; Have completely without milk, can not breast be fed completely; The normal suckling had, high heat or seven emotions are crossed extremely suddenly, and milk is suddenly few, is not enough to feeding infant.The reason of puerperal hypogalactia has several as follows: (1) congenital constitution physiological relation; (2) deficient qi and blood; (3) seven emotions are excessive; (4) just galactopoiesis arteries and veins end is logical; (5) Tianjin blood is too much consumed in galactopoiesis.But seeing clinically, is many with QI and blood deficiency and stagnation of QI due to depression of the liver.The former is as empty in health element, and spleen and stomach function is poor, affects absorption of nutrient ingredients, or severe loss of blood during childbirth, and wasting of QI following consumption of blood, all can cause insufficiency of vital energy and blood, the biochemical weary source of milk.The latter is because of depressed emotion in puerperal, or nervous, the liver losing its smoothly moving state, functional activity of QI being not smooth, and passages through which vital energy circulates ridge is stagnant, affects milk biochemical.
From the treatment of puerperal hypogalactia, in foreign literature, only have the clinical report of minority sulpiride or paspertin metoclopramide lactogenic, and by conventional chemical Drug therapy mastitis for still having certain risk for the puerpera of suckling puerpera, and improve poor effect.Therefore the medicine being devoted to develop treatment puerperal hypogalactia merging mastitis is safely and efficiently own, and through becoming the task of top priority, this is for the deficiency making up current hypogalactia medicine, raising breastfeeding rate, realizes China and global breast feeding strategic objective is significant.Motherland's medical science have accumulated abundant clinical experience in treatment puerperal hypogalactia, and motherland's medical science thinks that milk comes from internal organs, QI and blood, punching are appointed.Internal organs are healthy and vigorous, QI and blood is abundant, rush Ren Tongsheng, then galactopoiesis is normal.
China Patent Publication No. 101803735B discloses " a kind of promotion lactogenic composition and method of making the same ", adopts Fructus Hordei Germinatus (parched), Hulless oate composition; Chinese invention patent publication number CN1159333A once disclosed " a kind of oral liquid and growing method promoting lactogenic ", adopted the preparations such as Rhizoma Dioscoreae, Semen Nelumbinis, unfresh towel gourd, Fructus Lycii, Unguis Sus domestica and Pericarpium Citri Reticulatae to promote galactopoiesis and improved the oral liquid of milk quality; Chinese invention patent publication number CN1895402A once disclosed " a kind of Chinese medicine preparation and preparation method promoting lactogenic ", adopted Rhizoma Dioscoreae Nipponicae, Rhizoma Chuanxiong, Fructus Chaenomelis, Flos Rosae Chinensis, Poria, Colla Corii Asini, Fructus Mori to be that effective ingredient made by raw material; It is main that the rule for the treatment of of these patents of invention " is invigorated blood circulation ", and Chinese crude drug composition concentrates on promoting blood circulation to remove obstruction in the collateral class medical material mostly, and does not relate to the pathomechanism of " expectorant " and " wetting ".
Medicine therapeutic effect at present clinically for puerperal hypogalactia is unsatisfactory, and chemicals often can cause serious side effect in medication process, therefore, finds a kind of effective promotion postpartum milk secretion and the little medicine of side effect becomes and is badly in need of in the industry.
Summary of the invention
Not good enough and side effect is large to puerperal hypogalactia therapeutic effect for chemicals of the prior art, and the therapeutic effect of Chinese medicine imprecise.For this reason, the invention provides a kind of for promoting the pharmaceutical composition of postpartum milk secretion, this pharmaceutical composition can alleviate rapidly the symptom of puerperal hypogalactia patient, and the low therapeutic effect of relapse rate is better than existing medicine, is therefore suitable for promoting the use of in clinical.
The present invention is solved the problems of the technologies described above by following technical proposals:
The invention provides a kind of for promoting the pharmaceutical composition of postpartum milk secretion, it is prepared by the Chinese medicinal components of following weight portion: Medulla Tetrapanacis 45 ~ 60 parts, Herba Epimedii 5.5 ~ 7 parts, Semen Myristicae 30 ~ 40 parts, Fructus Gardeniae 25 ~ 30 parts, Radix Angelicae Sinensis 30 ~ 35 parts, Fructus Viticis 85 ~ 90 parts, the Cortex Eucommiae 15 ~ 20 parts, Rhizoma Chuanxiong 12 ~ 15 parts, Radix Achyranthis Bidentatae 5 ~ 10 parts, Plumula Nelumbinis 9 ~ 15 parts, Bulbus Lilii 10 ~ 15 parts, Herba Andrographis 6 ~ 9 parts, the Rhizoma Anemarrhenae 10 ~ 15 parts.
In pharmaceutical composition described above, the Chinese medicine used all uses its conventional medicinal part to be used as medicine, and the dosage of drug used is reasonable, and can alleviate rapidly the symptom of puerperal hypogalactia patient after all medicines share, relapse rate is low.Improve effect to strengthen it further, described Chinese medicine granules also comprises 15 ~ 18 portions of Semen Euryaless and 10 ~ 14 parts of Herba Violaes.
As a kind of embodiment preferred for this invention, described pharmaceutical composition is prepared by the Chinese medicinal components of following weight portion: Medulla Tetrapanacis 52.5 parts, Herba Epimedii 6.5 parts, Semen Myristicae 35 parts, Fructus Gardeniae 27.5 parts, Radix Angelicae Sinensis 32.5 parts, Fructus Viticis 87.5 parts, the Cortex Eucommiae 17.5 parts, Rhizoma Chuanxiong 13.5 parts, Radix Achyranthis Bidentatae 7.5 parts, Plumula Nelumbinis 12 parts, Bulbus Lilii 12.5 parts, Herba Andrographis 7.5 parts, the Rhizoma Anemarrhenae 12.5 parts.
As another kind of embodiment preferred for this invention, described pharmaceutical composition is prepared by the Chinese medicinal components of following weight portion: Medulla Tetrapanacis 52.5 parts, Herba Epimedii 6.5 parts, Semen Myristicae 35 parts, Fructus Gardeniae 27.5 parts, Radix Angelicae Sinensis 32.5 parts, Fructus Viticis 87.5 parts, the Cortex Eucommiae 17.5 parts, Rhizoma Chuanxiong 13.5 parts, Radix Achyranthis Bidentatae 7.5 parts, Plumula Nelumbinis 12 parts, Bulbus Lilii 12.5 parts, Herba Andrographis 7.5 parts, the Rhizoma Anemarrhenae 12.5 parts, Semen Euryales 16.5 parts, Herba Violae 12 parts.
The present invention also provides described a kind of for promoting the preparation method of the pharmaceutical composition of postpartum milk secretion, and it comprises the steps:
(1) get Semen Myristicae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Plumula Nelumbinis and Bulbus Lilii and soak 1 hour, extract volatile oil with volatile oil extractor, then obtain volatile oil with anhydrous sodium sulfate drying, then use beta-cyclodextrin inclusion compound, obtained clathrate, clathrate and medicinal residues for subsequent use;
(2) get Fructus Viticis, Medulla Tetrapanacis, Radix Achyranthis Bidentatae, the Cortex Eucommiae and Herba Violae and add 70% ethanol extraction 2 times, each 1.5 hours, merge medicinal liquid, leave standstill 24 hours, for subsequent use;
(3) getting Fructus Gardeniae, Herba Epimedii, Herba Andrographis, the Rhizoma Anemarrhenae and gorgon euryale seed powder to be broken into after fine powder and the mixing of step (1) Chinese medicine slag with appropriate 75% ethanol extraction 2 times, each 1 hour, collects extracting solution, leaves standstill 24 hours, for subsequent use;
(4) supernatant obtained in (2) and (3) step is got, decompression recycling ethanol, be concentrated into 60 DEG C ~ 70 DEG C, density is the extractum of 1.03 ~ 1.09, for subsequent use after dry, in extractum, add Benexate Hydrochloride obtained in (1) step, measure its weight, add the lactose of its weight 10% and the mixture of dextrin, in the mixture of wherein lactose and dextrin, the weight ratio of lactose and dextrin is 2:1; Stir and be heated to 80 ~ 90 DEG C, cross 100 mesh sieves, obtain extract powder with spray dryer, namely subpackage obtains granule.
The present invention also provides a kind of medical usage of aforementioned pharmaceutical compositions, and namely described pharmaceutical composition promotes the purposes in postpartum milk secretion medicine in preparation.The embodiment of the present invention 7 experimental result shows, result shows, the impact of pharmaceutical composition of the present invention on PRL level is obvious, medication after the 14th day high, normal, basic three dosage of pharmaceutical composition compare with model group and have significant differences (P < 0.01), illustrate that pharmaceutical composition of the present invention has short breast effect, demonstrate, to puerperal hypogalactia, there is certain therapeutical effect.。
When pharmaceutical composition of the present invention is used for puerperal hypogalactia treatment, compared with prior art there is following advantage:
(1) compared with existing medicine, pharmaceutical composition prescription of the present invention is more reasonable, therapeutic effect for puerperal hypogalactia is better, and effect experiment of the present invention confirms, compared with existing clinical main flow medicine, the treated effect of pharmaceutical composition of the present invention is higher, clinical symptoms is improved more obvious, the impact of pharmaceutical composition of the present invention on PRL level is obvious, medication after the 14th day high, normal, basic three dosage of pharmaceutical composition compare with model group and have significant differences (P < 0.01), illustrate that pharmaceutical composition of the present invention has short breast effect, demonstrate, to puerperal hypogalactia, there is certain therapeutical effect.。
(2) the present invention is made up of plurality of Chinese, and preparation method is simple, and its side effect side effect compared with chemotherapeutic agent is lower, and not easily produces drug resistance.The embodiment of the present invention 8 shows, pharmaceutical composition in the scope of rat dosage 5g/kg/d-20g/kg/d on the general survival condition of rat without impact, on the hepatic and renal function of rat without impact, this dosage range innerlich anwenden safety.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.
Embodiment 1 one kinds is for pharmaceutical composition promoting postpartum milk secretion and preparation method thereof
For promoting a pharmaceutical composition for postpartum milk secretion, it is prepared by the Chinese medicinal components of following weight Kg: Medulla Tetrapanacis 45Kg, Herba Epimedii 5.5Kg, Semen Myristicae 30Kg, Fructus Gardeniae 25Kg, Radix Angelicae Sinensis 30Kg, Fructus Viticis 85Kg, Cortex Eucommiae 15Kg, Rhizoma Chuanxiong 12Kg, Radix Achyranthis Bidentatae 5Kg, Plumula Nelumbinis 9Kg, Bulbus Lilii 10Kg, Herba Andrographis 6Kg, Rhizoma Anemarrhenae 10Kg.
For promoting a preparation method for the pharmaceutical composition of postpartum milk secretion, it comprises the steps:
(1) get Semen Myristicae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Plumula Nelumbinis and Bulbus Lilii and soak 1 hour, extract volatile oil with volatile oil extractor, then obtain volatile oil with anhydrous sodium sulfate drying, then use beta-cyclodextrin inclusion compound, obtained clathrate, clathrate and medicinal residues for subsequent use;
(2) get Fructus Viticis, Medulla Tetrapanacis, Radix Achyranthis Bidentatae, the Cortex Eucommiae and Herba Violae and add 70% ethanol extraction 2 times, each 1.5 hours, merge medicinal liquid, leave standstill 24 hours, for subsequent use;
(3) getting Fructus Gardeniae, Herba Epimedii, Herba Andrographis, the Rhizoma Anemarrhenae and gorgon euryale seed powder to be broken into after fine powder and the mixing of step (1) Chinese medicine slag with appropriate 75% ethanol extraction 2 times, each 1 hour, collects extracting solution, leaves standstill 24 hours, for subsequent use;
(4) supernatant obtained in (2) and (3) step is got, decompression recycling ethanol, be concentrated into 70 DEG C, density is the extractum of 1.03, for subsequent use after dry, in extractum, add Benexate Hydrochloride obtained in (1) step, measure its weight, add the lactose of its weight 10% and the mixture of dextrin, in the mixture of wherein lactose and dextrin, the weight ratio of lactose and dextrin is 2:1; Stir and be heated to 80 DEG C, cross 100 mesh sieves, obtain extract powder with spray dryer, namely subpackage obtains granule.
Embodiment 2 one kinds is for pharmaceutical composition promoting postpartum milk secretion and preparation method thereof
For promoting a pharmaceutical composition for postpartum milk secretion, it is prepared by the Chinese medicinal components of following weight Kg: Medulla Tetrapanacis 60Kg, Herba Epimedii 7Kg, Semen Myristicae 40Kg, Fructus Gardeniae 30Kg, Radix Angelicae Sinensis 35Kg, Fructus Viticis 90Kg, Cortex Eucommiae 20Kg, Rhizoma Chuanxiong 15Kg, Radix Achyranthis Bidentatae 10Kg, Plumula Nelumbinis 15Kg, Bulbus Lilii 15Kg, Herba Andrographis 9Kg, Rhizoma Anemarrhenae 15Kg.
For promoting a preparation method for the pharmaceutical composition of postpartum milk secretion, it comprises the steps:
(1) get Semen Myristicae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Plumula Nelumbinis and Bulbus Lilii and soak 1 hour, extract volatile oil with volatile oil extractor, then obtain volatile oil with anhydrous sodium sulfate drying, then use beta-cyclodextrin inclusion compound, obtained clathrate, clathrate and medicinal residues for subsequent use;
(2) get Fructus Viticis, Medulla Tetrapanacis, Radix Achyranthis Bidentatae, the Cortex Eucommiae and Herba Violae and add 70% ethanol extraction 2 times, each 1.5 hours, merge medicinal liquid, leave standstill 24 hours, for subsequent use;
(3) getting Fructus Gardeniae, Herba Epimedii, Herba Andrographis, the Rhizoma Anemarrhenae and gorgon euryale seed powder to be broken into after fine powder and the mixing of step (1) Chinese medicine slag with appropriate 75% ethanol extraction 2 times, each 1 hour, collects extracting solution, leaves standstill 24 hours, for subsequent use;
(4) supernatant obtained in (2) and (3) step is got, decompression recycling ethanol, be concentrated into 60 DEG C, density is the extractum of 1.09, for subsequent use after dry, in extractum, add β ~ cyclodextrin clathrate obtained in (1) step, measure its weight, add the lactose of its weight 10% and the mixture of dextrin, in the mixture of wherein lactose and dextrin, the weight ratio of lactose and dextrin is 2:1; Stir and be heated to 90 DEG C, cross 100 mesh sieves, obtain extract powder with spray dryer, namely subpackage obtains granule.
Embodiment 3 one kinds is for pharmaceutical composition promoting postpartum milk secretion and preparation method thereof
For promoting a pharmaceutical composition for postpartum milk secretion, it is prepared by the Chinese medicinal components of following weight Kg: Medulla Tetrapanacis 52.5Kg, Herba Epimedii 6.5Kg, Semen Myristicae 35Kg, Fructus Gardeniae 27.5Kg, Radix Angelicae Sinensis 32.5Kg, Fructus Viticis 87.5Kg, Cortex Eucommiae 17.5Kg, Rhizoma Chuanxiong 13.5Kg, Radix Achyranthis Bidentatae 7.5Kg, Plumula Nelumbinis 12Kg, Bulbus Lilii 12.5Kg, Herba Andrographis 7.5Kg, Rhizoma Anemarrhenae 12.5Kg.
For promoting a preparation method for the pharmaceutical composition of postpartum milk secretion, it comprises the steps:
(1) get Semen Myristicae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Plumula Nelumbinis and Bulbus Lilii and soak 1 hour, extract volatile oil with volatile oil extractor, then obtain volatile oil with anhydrous sodium sulfate drying, then use beta-cyclodextrin inclusion compound, obtained clathrate, clathrate and medicinal residues for subsequent use;
(2) get Fructus Viticis, Medulla Tetrapanacis, Radix Achyranthis Bidentatae, the Cortex Eucommiae and Herba Violae and add 70% ethanol extraction 2 times, each 1.5 hours, merge medicinal liquid, leave standstill 24 hours, for subsequent use;
(3) getting Fructus Gardeniae, Herba Epimedii, Herba Andrographis, the Rhizoma Anemarrhenae and gorgon euryale seed powder to be broken into after fine powder and the mixing of step (1) Chinese medicine slag with appropriate 75% ethanol extraction 2 times, each 1 hour, collects extracting solution, leaves standstill 24 hours, for subsequent use;
(4) supernatant obtained in (2) and (3) step is got, decompression recycling ethanol, be concentrated into 65 DEG C, density is the extractum of 1.06, for subsequent use after dry, in extractum, add Benexate Hydrochloride obtained in (1) step, measure its weight, add the lactose of its weight 10% and the mixture of dextrin, in the mixture of wherein lactose and dextrin, the weight ratio of lactose and dextrin is 2:1; Stir and be heated to 85 DEG C, cross 100 mesh sieves, obtain extract powder with spray dryer, namely subpackage obtains granule.
Embodiment 4 one kinds is for pharmaceutical composition promoting postpartum milk secretion and preparation method thereof
For promoting a pharmaceutical composition for postpartum milk secretion, it is prepared by the Chinese medicinal components of following weight Kg: Medulla Tetrapanacis 45Kg, Herba Epimedii 5.5Kg, Semen Myristicae 30Kg, Fructus Gardeniae 25Kg, Radix Angelicae Sinensis 30Kg, Fructus Viticis 85Kg, Cortex Eucommiae 15Kg, Rhizoma Chuanxiong 12Kg, Radix Achyranthis Bidentatae 5Kg, Plumula Nelumbinis 9Kg, Bulbus Lilii 10Kg, Herba Andrographis 6Kg, Rhizoma Anemarrhenae 10Kg, Semen Euryales 15Kg, Herba Violae 18Kg.
A kind of for promoting that the preparation method of the pharmaceutical composition of postpartum milk secretion is with embodiment 1.
Embodiment 5 one kinds is for pharmaceutical composition promoting postpartum milk secretion and preparation method thereof
For promoting a pharmaceutical composition for postpartum milk secretion, it is prepared by the Chinese medicinal components of following weight Kg: Medulla Tetrapanacis 60Kg, Herba Epimedii 7Kg, Semen Myristicae 40Kg, Fructus Gardeniae 30Kg, Radix Angelicae Sinensis 35Kg, Fructus Viticis 90Kg, Cortex Eucommiae 20Kg, Rhizoma Chuanxiong 15Kg, Radix Achyranthis Bidentatae 10Kg, Plumula Nelumbinis 15Kg, Bulbus Lilii 15Kg, Herba Andrographis 9Kg, Rhizoma Anemarrhenae 15Kg, Semen Euryales 18Kg, Herba Violae 14Kg.
A kind of for promoting that the preparation method of the pharmaceutical composition of postpartum milk secretion is with embodiment 2.
Embodiment 6 one kinds is for pharmaceutical composition promoting postpartum milk secretion and preparation method thereof
For promoting a pharmaceutical composition for postpartum milk secretion, it is prepared by the Chinese medicinal components of following weight Kg: Medulla Tetrapanacis 52.5Kg, Herba Epimedii 6.5Kg, Semen Myristicae 35Kg, Fructus Gardeniae 27.5Kg, Radix Angelicae Sinensis 32.5Kg, Fructus Viticis 87.5Kg, Cortex Eucommiae 17.5Kg, Rhizoma Chuanxiong 13.5Kg, Radix Achyranthis Bidentatae 7.5Kg, Plumula Nelumbinis 12Kg, Bulbus Lilii 12.5Kg, Herba Andrographis 7.5Kg, Rhizoma Anemarrhenae 12.5Kg, Semen Euryales 16.5Kg, Herba Violae 12Kg.
A kind of for promoting that the preparation method of the pharmaceutical composition of postpartum milk secretion is with embodiment 3.
Experimental example 7 pharmaceutical composition of the present invention promotes the efficacy assessments of Lactation
1. laboratory animal and grouping
The female Pregnant rats of SD 60, cleaning grade animal, body weight 250 ± 10 grams; Animal is divided into 5 groups, i.e. blank group, model group, high, medium and low pharmaceutical composition decocting liquid three dosage groups, often organizes 12.
2. medication
Except blank group, all the other four groups of rats divide the 3rd day puerperium to take bromocriptine with the dosage of 0.5mg/kg/d to female Mus, medication group gives the pharmaceutical composition according to the embodiment of the present invention 3 formula preparation of gastric infusion various dose respectively, medication group comprises Chinese medicine high group (10g/kg), group (5g/kg) in Chinese medicine, low group of Chinese medicine (1g/kg) is gastric infusion respectively, and all the other each group gavages normal saline, experiment successive administration totally 14 days.
3. Testing index and method
Female Mus Prolactin content: after ZISHU birth, every nest stays 8 female Mus of confession to feed, divide puerperium the 7th and 14 days, female Mus docking point blood sampling totally 2 times, gets serum PRL medicine box and measures Prolactin (PRL), each sample determination 3 times, expression of averaging.
4. experimental result
The impact of pharmaceutical composition of the present invention on PRL level is obvious, medication after the 14th day high, normal, basic three dosage of pharmaceutical composition compare with model group and have significant differences (P < 0.01), illustrate that pharmaceutical composition of the present invention has short breast effect.The results are shown in following table 1.
Table 1 pharmaceutical composition of the present invention is on the impact of P of Rats RL level in puerperal
Compare with blank group, * P < 0.05, * * P < 0.01; Compare with model group, #p < 0.05, ##p < 0.01
The toxicity test of embodiment 8 pharmaceutical composition of the present invention.
1, experiment purpose: general toxicity and the Liver and kidney toxicity of determining pharmaceutical composition.
2, test medicine:
Prepare by the preparation method of above-described embodiment 1: namely it is prepared by the Chinese medicinal components of following weight Kg: Medulla Tetrapanacis 45Kg, Herba Epimedii 5.5Kg, Semen Myristicae 30Kg, Fructus Gardeniae 25Kg, Radix Angelicae Sinensis 30Kg, Fructus Viticis 85Kg, Cortex Eucommiae 15Kg, Rhizoma Chuanxiong 12Kg, Radix Achyranthis Bidentatae 5Kg, Plumula Nelumbinis 9Kg, Bulbus Lilii 10Kg, Herba Andrographis 6Kg, Rhizoma Anemarrhenae 10Kg.It comprises the steps: (1) gets Semen Myristicae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Plumula Nelumbinis and Bulbus Lilii and soaks 1 hour, extract volatile oil with volatile oil extractor, then obtain volatile oil with anhydrous sodium sulfate drying, then use beta-cyclodextrin inclusion compound, obtained clathrate, clathrate and medicinal residues for subsequent use; (2) get Fructus Viticis, Medulla Tetrapanacis, Radix Achyranthis Bidentatae, the Cortex Eucommiae and Herba Violae and add 70% ethanol extraction 2 times, each 1.5 hours, merge medicinal liquid, leave standstill 24 hours, for subsequent use; (3) getting Fructus Gardeniae, Herba Epimedii, Herba Andrographis, the Rhizoma Anemarrhenae and gorgon euryale seed powder to be broken into after fine powder and the mixing of step (1) Chinese medicine slag with appropriate 75% ethanol extraction 2 times, each 1 hour, collects extracting solution, leaves standstill 24 hours, for subsequent use; (4) supernatant obtained in (2) and (3) step is got, decompression recycling ethanol, be concentrated into 70 DEG C, density is the extractum of 1.03, for subsequent use after dry, in extractum, add Benexate Hydrochloride obtained in (1) step, measure its weight, add the lactose of its weight 10% and the mixture of dextrin, in the mixture of wherein lactose and dextrin, the weight ratio of lactose and dextrin is 2:1; Stir and be heated to 80 DEG C, cross 100 mesh sieves, obtain extract powder with spray dryer, namely subpackage obtains granule.
3, experimental technique and index determining:
SD rat, male and female half and half, be divided into 4 groups at random, often organize 10, by heavy dose of group (20g/kg), middle dosage group (10g/kg), small dose group (5g/kg) gastric infusion, the blank group of normal saline gavaging equal volume, rat is stablized 3d and enters test, every day gavage 1 time, successive administration 30 days.
General index determining: period observes rat general status, behavioral activity, often 10d claim a body weight.
Liver function index measures: 24h (water 12h is can't help in fasting) after last medicine, socket of the eye venous blood collection, blood coagulation, and conventional centrifugal, prepares serum, adopts kit method, carries out blood biochemical analysis inspection with automatic clinical chemistry analyzer.
Renal function index measures: tail vein blood at the end of experiment, and metabolic cage collects twenty-four-hour urine liquid, measures urine B2MG, urine AKP, urine Lys.Put to death rat, leave and take kidney and make pathological examination.
4, experimental result
4.1 general index determining results
Table 2 pharmaceutical composition is on the impact of rat body weight
Group 3d before administration Administration 0d Administration 10d Administration 20d Administration 30d
Blank group 149.87±16.36 155.30±18.04 170.33±18.75 183.23±20.06 201.86±19.36
Heavy dose of group 150.03±18.17 156.37±16.31 172.17±22.32 185.21±19.87 200.05±18.14
Middle dosage group 148.32±18.36 154.94±17.26 173.43±19.63 182.19±18.49 198.38±18.35
Small dose group 148.66±19.83 156.41±17.48 169.71±14.38 184.20±22.19 203.63±19.84
Table 2 experimental result shows, pharmaceutical composition heavy dose of group, middle dosage group and small dose group during administration compared with blank group, there was no significant difference in the body weight of rat.All there is not death in each administration group, general status and behavioral activity compare no significant difference with blank group.
4.2 liver function index measurement results
Table 3 pharmaceutical composition is on the impact of rat transaminase
Group ALT/U·L-1 AST/U·L-1
Blank group 76.10±5.32 192.60±20.41
Heavy dose of group 82.70±8.03 206.00±54.60
Middle dosage group 79.90±5.24 194.10±46.94
Small dose group 81.20±7.48 197.60±37.18
Table 3 experimental result shows, pharmaceutical composition heavy dose of group, middle dosage group and small dose group during administration compared with blank group, there was no significant difference in transaminase's content of rat.
4.3 renal function index measurement results
Table 4 pharmaceutical composition is on the impact of Renal Function in Rats index
Group Scr/μmol·L-1 Urine B 2MG/ng·mL-1 Urine AKP/IUL-1 Urine Lys/mgL-1
Blank group 109.86±6.36 0.030±0.004 10.33±1.75 0.23±0.04
Heavy dose of group 110.00±8.14 0.034±0.002 10.17±2.32 0.21±0.07
Middle dosage group 108.38±8.35 0.033±0.005 11.43±1.62 0.19±0.09
Small dose group 108.63±9.84 0.031±0.004 9.71±4.35 0.20±0.09
Table 4 experimental result shows, pharmaceutical composition heavy dose of group, middle dosage group and small dose group during administration compared with blank group, at renal function index (Scr, the urine B of rat 2mG, urine AKP and urine Lys) aspect there was no significant difference.
The change of tissue morphology: blank arrangement of mirrors lower nephron clear in structure, without cast, without proliferative glomerulonephritis, without renal tubular necrosis, without cell infiltration.Heavy dose of group, middle dosage group and small dose group again nephridial tissue morphologic change aspect organize zero difference with blank.
5, experiment conclusion
Pharmaceutical composition in the scope of rat dosage 5g/kg/d-20g/kg/d on the general survival condition of rat without impact, on the hepatic and renal function of rat without impact, this dosage range innerlich anwenden safety.

Claims (6)

1. for promoting a pharmaceutical composition for postpartum milk secretion, it is prepared by the Chinese medicinal components of following weight portion: Medulla Tetrapanacis 45 ~ 60 parts, Herba Epimedii 5.5 ~ 7 parts, Semen Myristicae 30 ~ 40 parts, Fructus Gardeniae 25 ~ 30 parts, Radix Angelicae Sinensis 30 ~ 35 parts, Fructus Viticis 85 ~ 90 parts, the Cortex Eucommiae 15 ~ 20 parts, Rhizoma Chuanxiong 12 ~ 15 parts, Radix Achyranthis Bidentatae 5 ~ 10 parts, Plumula Nelumbinis 9 ~ 15 parts, Bulbus Lilii 10 ~ 15 parts, Herba Andrographis 6 ~ 9 parts, the Rhizoma Anemarrhenae 10 ~ 15 parts.
2. as claimed in claim 1 for promoting the pharmaceutical composition of postpartum milk secretion, it is characterized in that, described pharmaceutical composition also comprises 15 ~ 18 portions of Semen Euryaless and 10 ~ 14 parts of Herba Violaes.
3. as claimed in claim 1 for promoting the pharmaceutical composition of postpartum milk secretion, it is characterized in that, described pharmaceutical composition is prepared by the Chinese medicinal components of following weight portion: Medulla Tetrapanacis 52.5 parts, Herba Epimedii 6.5 parts, Semen Myristicae 35 parts, Fructus Gardeniae 27.5 parts, Radix Angelicae Sinensis 32.5 parts, Fructus Viticis 87.5 parts, the Cortex Eucommiae 17.5 parts, Rhizoma Chuanxiong 13.5 parts, Radix Achyranthis Bidentatae 7.5 parts, Plumula Nelumbinis 12 parts, Bulbus Lilii 12.5 parts, Herba Andrographis 7.5 parts, the Rhizoma Anemarrhenae 12.5 parts.
4. as claimed in claim 2 for promoting the pharmaceutical composition of postpartum milk secretion, it is characterized in that, described pharmaceutical composition is prepared by the Chinese medicinal components of following weight portion: Medulla Tetrapanacis 52.5 parts, Herba Epimedii 6.5 parts, Semen Myristicae 35 parts, Fructus Gardeniae 27.5 parts, Radix Angelicae Sinensis 32.5 parts, Fructus Viticis 87.5 parts, the Cortex Eucommiae 17.5 parts, Rhizoma Chuanxiong 13.5 parts, Radix Achyranthis Bidentatae 7.5 parts, Plumula Nelumbinis 12 parts, Bulbus Lilii 12.5 parts, Herba Andrographis 7.5 parts, the Rhizoma Anemarrhenae 12.5 parts, Semen Euryales 16.5 parts, Herba Violae 12 parts.
5. prepare a method for the pharmaceutical composition for promoting postpartum milk secretion described in claim 1 or 2, it comprises the steps:
(1) get Semen Myristicae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Plumula Nelumbinis and Bulbus Lilii and soak 1 hour, extract volatile oil with volatile oil extractor, then obtain volatile oil with anhydrous sodium sulfate drying, then use beta-cyclodextrin inclusion compound, obtained clathrate, clathrate and medicinal residues for subsequent use;
(2) get Fructus Viticis, Medulla Tetrapanacis, Radix Achyranthis Bidentatae, the Cortex Eucommiae and Herba Violae and add 70% ethanol extraction 2 times, each 1.5 hours, merge medicinal liquid, leave standstill 24 hours, for subsequent use;
(3) getting Fructus Gardeniae, Herba Epimedii, Herba Andrographis, the Rhizoma Anemarrhenae and gorgon euryale seed powder to be broken into after fine powder and the mixing of step (1) Chinese medicine slag with appropriate 75% ethanol extraction 2 times, each 1 hour, collects extracting solution, leaves standstill 24 hours, for subsequent use;
(4) supernatant obtained in (2) and (3) step is got, decompression recycling ethanol, be concentrated into 60 DEG C ~ 70 DEG C, density is the extractum of 1.03 ~ 1.09, for subsequent use after dry, in extractum, add Benexate Hydrochloride obtained in (1) step, measure its weight, add the lactose of its weight 10% and the mixture of dextrin, in the mixture of wherein lactose and dextrin, the weight ratio of lactose and dextrin is 2:1; Stir and be heated to 80 ~ 90 DEG C, cross 100 mesh sieves, obtain extract powder with spray dryer, namely subpackage obtains granule.
6. the pharmaceutical composition described in claim 1 or 2 promotes the purposes in postpartum milk secretion medicine in preparation.
CN201610038308.4A 2016-01-20 2016-01-20 Medicine composition for promoting postpartum lactating and preparation method thereof Withdrawn CN105412555A (en)

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