CN110507708A - A kind of safflower care-free preparation and its preparation method and application for treating the proliferation of mammary gland - Google Patents

A kind of safflower care-free preparation and its preparation method and application for treating the proliferation of mammary gland Download PDF

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CN110507708A
CN110507708A CN201910896093.3A CN201910896093A CN110507708A CN 110507708 A CN110507708 A CN 110507708A CN 201910896093 A CN201910896093 A CN 201910896093A CN 110507708 A CN110507708 A CN 110507708A
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parts
safflower
preparation
mammary gland
care
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CN110507708B (en
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陈梁
李小锋
刘厚权
夏淑英
胡吉忠
张俊英
张金良
周朝忠
毛金娣
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JIANGXI PUZHENG PHARMACEUTICAL CO Ltd
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JIANGXI PUZHENG PHARMACEUTICAL CO Ltd
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    • A—HUMAN NECESSITIES
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
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    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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Abstract

The invention belongs to the preparation of safflower care-free tablet and application fields, and in particular to a kind of safflower care-free preparation and preparation method thereof for treating the proliferation of mammary gland；In parts by weight, including following raw material: 18-67 parts of Radix Angelicae Sinensis, 100-150 parts of Radix Paeoniae Alba, 30-55 parts of Rhizoma Atractylodis Macrocephalae, 105-135 parts of Poria cocos, 110-160 parts of safflower, 20-35 parts of spina gleditsiae, 80-140 parts of HERBA BUPLEURI, 45-85 parts of peppermint, 20-75 parts of Radix Glycyrrhizae；The drug has the therapeutic effect of the preferable proliferation of mammary gland, and the safflower care-free preparation made of specific preparation method can play well the useful effect of drug, and safflower care-free preparation is made to play good adjustment effect to the endocrine of women.

Description

A kind of safflower care-free preparation and its preparation method and application for treating the proliferation of mammary gland
Technical field
The invention belongs to the preparation of safflower care-free tablet and application fields, and in particular to a kind of safflower for treating the proliferation of mammary gland is free and unfettered Distant preparation and its preparation method and application.
Background technique
Cyclomastopathy is also known as mammary dysplasia, is main syndrome with lump in breast, cream pain, nipple discharge Common mammary gland disease is the degeneration and progressive lesion [1] of breast duct and leaflet in structure.The proliferation of mammary gland does not belong to not only In the scope of tumour, and it is not belonging to the range of inflammation, but the variation [2] of lobule of mammary gland and breast duct in structure.Foundation Pathology can be divided into pure breast epithelium hyperplasia disease, cystic hyperplasia of mammary gland disease and adenosis of mammary glands.The Major Clinical of the proliferation of mammary gland Feature is lump in breast and breast periodicity distending pain.Cyclomastopathy accounts for about 70% or more of whole mammary gland diseases, is reproduction age woman The most common mastosis of female, disease incidence account for about the 50% of the women of child-bearing age, and its illness rate presents rise year by year in recent years Trend largely affects the normal life of patient.It is the danger of breast cancer that the disease has development to a certain extent, The health for seriously threatening women studies the Current medicine treatment of this disease and carries out effectively preventing to it with important reality Meaning.
Safflower is the drying tubular corolla also known as Chinese milk vetch, safflower dish, Flos Carthami, thorn safflower of compositae plant safflower, because of it For leaf like indigo also known as red blue flower, the name of red blue flower says " red blue flower, i.e. safflower " first appeared in " Bencao Tujing ".Its property is acrid in flavour and warm in nature. Converge to heart and liver channels have the effect of blood circulation, removing blood stasis and acesodyne, cure mainly menostasis, dysmenorrhea, lochia, abdominal mass and lump, the thoracic obstruction heart Bitterly, the diseases such as stasis of blood, pricking pain in the chest, injury from falling down, sore swell and ache curative.Modern pharmacological studies have shown that safflower can the slight excited heart Dirty, reduction coronary resistance, increase coronary flow；Protection and improve myocardial ischemia, to anti-arrhythmia, reduce blood pressure, inhibit blood Platelet aggregation；Improve hypoxia-bearing capability.In addition, safflower can also calm, analgesia, anti-inflammatory, immunosupress, decoction is to uterus and intestines Road smooth muscle has excitation.Clinic is chiefly used in the treatment of the diseases such as disease of cardiovascular system, gynecological disease, nervous system, main Wanting effective component is carthamin yellow, Sydroxy carthamin, carthamic acid, safflower oil etc..Chang Youyong safflower in the prior art Chinese medicine composition treats proliferation of mammary gland drug to prepare.
104958693 A of Chinese patent application CN discloses a kind of Chinese medicine for treating the proliferation of mammary gland, raw medicinal material are as follows: summer 5~15 parts of withered grass, 15-25 parts of safflower, 15-25 parts of Radix Salviae Miltiorrhizae, 5-15 parts of spina gleditsiae, 10-20 parts of Radix Glycyrrhizae, 5-15 parts of Radix Angelicae Sinensis, radix paeoniae rubra 5-15 parts, 5-15 parts of radix bupleuri, 10-20 parts of Radix Curcumae, due to the limitation of its treatment method, the extraction of effective component is simultaneously insufficient, tool There is certain side effect, therapeutic effect need to be improved.
1055623 A of Chinese patent application CN discloses a kind of Chinese patent drug for treating hyperplasia of mammary glands, main component For radix paeoniae rubra, rhizome of chuanxiong, radix achyranthis bidentatae, Radix Salviae Miltiorrhizae, safflower, peach kernel, river fibert, green peel, radix bupleuri, Prunella vulgaris, Radix Glycyrrhizae, Poria cocos；By therein Promoting blood circulation to remove blood stasis and the soothing the liver strongly fragrant composition of being situated between, have the problem of dissipation lump, and present patent application also due to preparation method office Sex-limited, effect specific aim is poor, can not play the useful effect of drug well.
Studies have shown that taking safflower for a long time, serious damage can be caused to nerve, uropoiesis and digestive system, but also same When be mixed with the adverse reactions such as skin allergy, anaphylactic shock.Such as headache, fash, whelk, constipation, excessive internal heat, menstruation are mixed Disorderly, it feels run-down, hypogastralgia, gastrointestinal haemorrhagia, unconsciousness, pulse are thin and delicate etc..These are all the systems for taking safflower for a long time Column adverse reaction.Therefore, it reasonably prepares and application safflower has and its important role.
Summary of the invention
To overcome the above technical problem, the present invention provides a kind of safflower care-free preparation for treating the proliferation of mammary gland and its preparations Method, which has the effect of preferably treating the proliferation of mammary gland, by specific preparation method, the safflower care-free that is prepared Preparation can play well the useful effect of drug, and safflower care-free preparation is made to play good adjusting to the endocrine of women Effect.
In order to achieve the above object, technical solution provided by the invention is as follows:
A kind of safflower care-free preparation for treating the proliferation of mammary gland, in parts by weight, including following raw material: Radix Angelicae Sinensis 18-67 Part, 100-150 parts of Radix Paeoniae Alba, 30-55 parts of Rhizoma Atractylodis Macrocephalae, 105-135 parts of Poria cocos, 110-160 parts of safflower, 20-35 parts of spina gleditsiae, leaf of bamboo bavin 80-140 parts of Hu, 45-85 parts of peppermint, 20-75 parts of Radix Glycyrrhizae；
Preferably, the safflower care-free preparation of the treatment proliferation of mammary gland, in parts by weight, including following raw material: when Return 20-53 parts, 125-145 parts of Radix Paeoniae Alba, 45-50 parts of Rhizoma Atractylodis Macrocephalae, 125-130 parts of Poria cocos, 123-153 parts of safflower, spina gleditsiae 25-30 Part, 95-120 parts of HERBA BUPLEURI, 55-80 parts of peppermint, 35-65 parts of Radix Glycyrrhizae；
Preferably, the safflower care-free preparation of the treatment proliferation of mammary gland, in parts by weight, including following raw material: when Return 32 parts, 130 parts of Radix Paeoniae Alba, 50 parts of Rhizoma Atractylodis Macrocephalae, 127 parts of Poria cocos, 140 parts of safflower, 28 parts of spina gleditsiae, 110 parts of HERBA BUPLEURI, peppermint 65 Part, 55 parts of Radix Glycyrrhizae.
Another object of the present invention, which also resides in, provides a kind of preparation side of the safflower care-free preparation for the treatment of proliferation of mammary gland Method, comprising the following steps:
(1) after crushing safflower, Radix Glycyrrhizae, HERBA BUPLEURI, add water mixing to extract, obtain Aqueous extracts A and the dregs of a decoction 1；Aqueous extracts A is logical The absorption of macroporous absorbent resin chromatographic column is crossed, Aqueous extracts B, macroporous adsorption resin chromatography will be obtained after Aqueous extracts remaining after absorption concentration Column elutes to obtain alcoholic solution 1 through ethanol water；
(2) ethyl alcohol is added in the dregs of a decoction 1 to extract, obtains alcohol extract, alcohol extract and Aqueous extracts B are mixed, through silica gel column chromatography point From；Silica gel chromatographic column is first eluted through ethyl acetate, is eluted by dimethyl carbonate-alcohol mixeding liquid, and concentration, recrystallization must tie Brilliant C；
(3) Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae, peppermint are subjected to ethyl alcohol extraction, obtain alcoholic solution 2 and the dregs of a decoction 2；
(4) dregs of a decoction 2, Poria cocos, spina gleditsiae and Radix Paeoniae Alba progress water are mentioned, after adding flocculant process, obtains aqueous solution 1；
(5) crystallization C dissolution is added after mixing alcoholic solution 1, alcoholic solution 2, aqueous solution 1, then is concentrated to give concentrate；
(6) concentration liquid formulation is arrived into safflower care-free preparation to obtain the final product.
Preferably, in step (1), the detailed process of described plus water mixing extraction are as follows: temperature is risen into 75-90 DEG C of extraction 1- 2h, then 20-30min is carried out after boiling；
Preferably, in step (1), the macroporous adsorption resin chromatography column are as follows: upper layer AB-8, middle layer are NKA and lower layer For the chromatographic column of NKA-9 composition, wherein the thickness ratio of AB-8, NKA, NKA-9 are 1:1-2:1-2；
Preferably, in step (1), the ethyl alcohol mass concentration of the ethanol water is 30-50%；
Preferably, in step (2), the volume ratio of dimethyl carbonate and ethyl alcohol in the dimethyl carbonate-alcohol mixeding liquid 1:1-3；
Preferably, in step (3), the ethyl alcohol extraction carries out at being 40-60 DEG C in temperature；
Preferably, in step (4), the flocculant is chitosan or gelatin；
Preferably, in step (4), the flocculant is chitosan, and the pH value of Aqueous extracts is first adjusted to 3- by when flocculation treatment 5, add chitosan；
Preferably, in step (4), the flocculant is gelatin, and the temperature of Aqueous extracts is first risen to 50-60 by when flocculation treatment DEG C, add gelatin；
Preferably, in step (6), the preparation is conventional reagent pharmaceutically, including tablet, capsule preparations, pill, mouth Take liquid.
It preferably, further include the pretreatment pretreatment of macroporous adsorption resin chromatography column, detailed process is will in step (1) The chromatographic column ethyl alcohol impregnates 20-30min, then the 2-3h that is soaked in water.
The object of the invention is also to provide the preparation methods of the safflower care-free preparation and safflower care-free preparation to treat Application in proliferation of mammary gland drug.
Compared with the prior art, the technical advantages of the present invention are that:
(1) present invention has it to the treatment proliferation of mammary gland by the improvement to the dosage of each raw material in safflower care-free preparation Preferable therapeutic effect；
(2) in the preparation process of safflower care-free preparation of the present invention, safflower, HERBA BUPLEURI, Radix Glycyrrhizae is mixed to extract and played The dissolution effect for imitating ingredient, is more advantageous to the synergistic effect for playing effective component；Extracting solution first separates, again through macroporous absorbent resin The impurity in drug can be removed well through silica gel column chromatography separation, and effective component is purified, meanwhile, it reduces the secondary of drug and makees With；
(3) Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae, peppermint are carried out ethyl alcohol extraction to be conducive to come out volatile oil extracting therein, with safflower group Divide after being used in conjunction with and be conducive to play synergistic effect, play dispersing stagnated hepatoqi, activating microcirculation and removing stasis medicinal, it is equivalent to adjust endocrine for resolving hard lump Fruit；
(4) present invention is preferably treated by the improvement of preparation method so that safflower care-free preparation has the proliferation of mammary gland Effect, while the effect of reduce the impurity content in the components such as safflower, improve safflower care-free preparation effective component.
Specific embodiment
Embodiment 1
In the present embodiment, the safflower care-free preparation of the proliferation of mammary gland is treated, in parts by weight, including following raw material: when Return 32 parts, 130 parts of Radix Paeoniae Alba, 50 parts of Rhizoma Atractylodis Macrocephalae, 127 parts of Poria cocos, 140 parts of safflower, 28 parts of spina gleditsiae, 110 parts of HERBA BUPLEURI, peppermint 65 Part, 55 parts of Radix Glycyrrhizae.
The preparation method of the safflower care-free preparation of the treatment proliferation of mammary gland, comprising the following steps:
(1) after crushing safflower, Radix Glycyrrhizae, HERBA BUPLEURI, add water mixing to extract, temperature is risen into 80 DEG C of extraction 1.5h, then 25min is carried out after boiling；Obtain Aqueous extracts A and the dregs of a decoction 1；
Take macroporous adsorption resin chromatography column: upper layer AB-8, middle layer are NKA and lower layer is the chromatographic column of NKA-9 composition, In, the thickness ratio of AB-8, NKA, NKA-9 are 1:2:1；The chromatographic column ethyl alcohol is impregnated into 25min, then the 2.5h that is soaked in water；
Aqueous extracts A is adsorbed by macroporous adsorption resin chromatography column, will obtain Aqueous extracts after Aqueous extracts remaining after absorption concentration B, macroporous adsorption resin chromatography column elute to obtain alcoholic solution 1 through the ethanol water that mass concentration is 40%；
(2) ethyl alcohol is added in the dregs of a decoction 1 to extract, obtains alcohol extract, alcohol extract and Aqueous extracts B are mixed, through silica gel column chromatography point From；Silica gel chromatographic column is first eluted through ethyl acetate, is eluted by dimethyl carbonate-alcohol mixeding liquid of volume ratio 1:2, concentration, Recrystallization, must crystallize C；
(3) Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae, peppermint are subjected at 50 DEG C ethyl alcohol extraction, obtain alcoholic solution 2 and the dregs of a decoction 2；
(4) dregs of a decoction 2, Poria cocos, spina gleditsiae and Radix Paeoniae Alba progress water are mentioned, the pH value of Aqueous extracts is adjusted to 3, at shell adding glycan Reason, obtains aqueous solution 1；
(5) crystallization C dissolution is added after mixing alcoholic solution 1, alcoholic solution 2, aqueous solution 1, then is concentrated to give concentrate；
(6) tablet is made in concentrate and obtains safflower care-free tablet.
Embodiment 2
A kind of safflower care-free preparation for treating the proliferation of mammary gland, in parts by weight, including following raw material: 18 parts of Radix Angelicae Sinensis, 100 parts of Radix Paeoniae Alba, 55 parts of Rhizoma Atractylodis Macrocephalae, 135 parts of Poria cocos, 110 parts of safflower, 20 parts of spina gleditsiae, 140 parts of HERBA BUPLEURI, 85 parts of peppermint, Radix Glycyrrhizae 20 parts；
The preparation method of the safflower care-free preparation of the treatment proliferation of mammary gland, comprising the following steps:
(1) after crushing safflower, Radix Glycyrrhizae, HERBA BUPLEURI, add water mixing to extract, temperature is risen into 75 DEG C of extraction 1h, then boil 30min is carried out after boiling；Obtain Aqueous extracts A and the dregs of a decoction 1；
Take macroporous adsorption resin chromatography column: upper layer AB-8, middle layer are NKA and lower layer is the chromatographic column of NKA-9 composition, In, the thickness ratio of AB-8, NKA, NKA-9 are 1:1:1；The chromatographic column ethyl alcohol is impregnated into 20min, then the 2h that is soaked in water；
Aqueous extracts A is adsorbed by macroporous adsorption resin chromatography column, will obtain Aqueous extracts after Aqueous extracts remaining after absorption concentration B, macroporous adsorption resin chromatography column elute to obtain alcoholic solution 1 through the ethanol water that mass concentration is 30%；
(2) ethyl alcohol is added in the dregs of a decoction 1 to extract, obtains alcohol extract, alcohol extract and Aqueous extracts B are mixed, through silica gel column chromatography point From；Silica gel chromatographic column is first eluted through ethyl acetate, is eluted by dimethyl carbonate-alcohol mixeding liquid of volume ratio 1:1, concentration, Recrystallization, must crystallize C；
(3) Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae, peppermint are subjected at 40 DEG C ethyl alcohol extraction, obtain alcoholic solution 2 and the dregs of a decoction 2；
(4) dregs of a decoction 2, Poria cocos, spina gleditsiae and Radix Paeoniae Alba progress water are mentioned, the temperature of Aqueous extracts is first risen to 50 DEG C, is added Gelatin processing, obtains aqueous solution 1；
(5) crystallization C dissolution is added after mixing alcoholic solution 1, alcoholic solution 2, aqueous solution 1, then is concentrated to give concentrate；
(6) capsule is made in concentrate and obtains Honghuaxiaoyao capsules.
Embodiment 3
A kind of safflower care-free preparation for treating the proliferation of mammary gland, in parts by weight, including following raw material: 67 parts of Radix Angelicae Sinensis, 150 parts of Radix Paeoniae Alba, 30 parts of Rhizoma Atractylodis Macrocephalae, 105 parts of Poria cocos, 160 parts of safflower, 35 parts of spina gleditsiae, 80 parts of HERBA BUPLEURI, 45 parts of peppermint, Radix Glycyrrhizae 75 parts；
The preparation method of the safflower care-free preparation of the treatment proliferation of mammary gland, comprising the following steps:
(1) after crushing safflower, Radix Glycyrrhizae, HERBA BUPLEURI, add water mixing to extract, temperature is risen into 90 DEG C of extraction 2h, then boil 20min is carried out after boiling；Obtain Aqueous extracts A and the dregs of a decoction 1；
Take macroporous adsorption resin chromatography column: upper layer AB-8, middle layer are NKA and lower layer is the chromatographic column of NKA-9 composition, In, the thickness ratio of AB-8, NKA, NKA-9 are 1:2:2；The chromatographic column ethyl alcohol is impregnated into 30min, then the 3h that is soaked in water；
Aqueous extracts A is adsorbed by macroporous adsorption resin chromatography column, will obtain Aqueous extracts after Aqueous extracts remaining after absorption concentration B, macroporous adsorption resin chromatography column elute to obtain alcoholic solution 1 through the ethanol water that mass concentration is 50%；
(2) ethyl alcohol is added in the dregs of a decoction 1 to extract, obtains alcohol extract, alcohol extract and Aqueous extracts B are mixed, through silica gel column chromatography point From；Silica gel chromatographic column is first eluted through ethyl acetate, is eluted by dimethyl carbonate-alcohol mixeding liquid of volume ratio 1:3, concentration, Recrystallization, must crystallize C；
(3) Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae, peppermint are subjected at 40 DEG C ethyl alcohol extraction, obtain alcoholic solution 2 and the dregs of a decoction 2；
(4) dregs of a decoction 2, Poria cocos, spina gleditsiae and Radix Paeoniae Alba progress water are mentioned, the pH value of Aqueous extracts is adjusted to 5, at shell adding glycan Reason, obtains aqueous solution 1；
(5) crystallization C dissolution is added after mixing alcoholic solution 1, alcoholic solution 2, aqueous solution 1, then is concentrated to give concentrate；
(6) pill is made in concentrate and obtains safflower care-free ball.
Embodiment 4
Preferably, the safflower care-free preparation of the treatment proliferation of mammary gland, in parts by weight, including following raw material: when Return 20 parts, 125 parts of Radix Paeoniae Alba, 45 parts of Rhizoma Atractylodis Macrocephalae, 130 parts of Poria cocos, 153 parts of safflower, 30 parts of spina gleditsiae, 95 parts of HERBA BUPLEURI, peppermint 55 Part, 35 parts of Radix Glycyrrhizae；
The preparation method of the safflower care-free preparation of the treatment proliferation of mammary gland, comprising the following steps:
(1) after crushing safflower, Radix Glycyrrhizae, HERBA BUPLEURI, add water mixing to extract, temperature risen into 75-90 DEG C of extraction 1-2h, 20-30min is carried out after boiling again；Obtain Aqueous extracts A and the dregs of a decoction 1；
Take macroporous adsorption resin chromatography column: upper layer AB-8, middle layer are NKA and lower layer is the chromatographic column of NKA-9 composition, In, the thickness ratio of AB-8, NKA, NKA-9 are 1:1:2；The chromatographic column ethyl alcohol is impregnated into 20-30min, then the 2-3h that is soaked in water；
Aqueous extracts A is adsorbed by macroporous adsorption resin chromatography column, will obtain Aqueous extracts after Aqueous extracts remaining after absorption concentration B, macroporous adsorption resin chromatography column elute to obtain alcoholic solution 1 through the ethanol water that mass concentration is 50%；
(2) ethyl alcohol is added in the dregs of a decoction 1 to extract, obtains alcohol extract, alcohol extract and Aqueous extracts B are mixed, through silica gel column chromatography point From；Silica gel chromatographic column is first eluted through ethyl acetate, is eluted by dimethyl carbonate-alcohol mixeding liquid of volume ratio 1:3, concentration, Recrystallization, must crystallize C；
(3) Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae, peppermint are subjected at 60 DEG C ethyl alcohol extraction, obtain alcoholic solution 2 and the dregs of a decoction 2；
(4) dregs of a decoction 2, Poria cocos, spina gleditsiae and Radix Paeoniae Alba progress water are mentioned, the temperature of Aqueous extracts is risen to 60 DEG C, is added bright Glue processing, obtains aqueous solution 1；Crystallization C dissolution is added after alcoholic solution 1, alcoholic solution 2, aqueous solution 1 are mixed, then is concentrated to give concentration Liquid；
(5) oral solution is made in concentrate and obtains safflower care-free oral solution.
Embodiment 5
Preferably, the safflower care-free preparation of the treatment proliferation of mammary gland, in parts by weight, including following raw material: when Return 53 parts, 145 parts of Radix Paeoniae Alba, 50 parts of Rhizoma Atractylodis Macrocephalae, 125 parts of Poria cocos, 123 parts of safflower, 25 parts of spina gleditsiae, 120 parts of HERBA BUPLEURI, peppermint 80 Part, 65 parts of Radix Glycyrrhizae；
(1) after crushing safflower, Radix Glycyrrhizae, HERBA BUPLEURI, add water mixing to extract, temperature is risen into 80 DEG C of extraction 2h, then boil 30min is carried out after boiling；Obtain Aqueous extracts A and the dregs of a decoction 1；
Take macroporous adsorption resin chromatography column: upper layer AB-8, middle layer are NKA and lower layer is the chromatographic column of NKA-9 composition, In, the thickness ratio of AB-8, NKA, NKA-9 are 1:2:1；The chromatographic column ethyl alcohol is impregnated into 30min, then the 3h that is soaked in water；
Aqueous extracts A is adsorbed by macroporous adsorption resin chromatography column, will obtain Aqueous extracts after Aqueous extracts remaining after absorption concentration B, macroporous adsorption resin chromatography column elute to obtain alcoholic solution 1 through the ethanol water that mass concentration is 50%；
(2) ethyl alcohol is added in the dregs of a decoction 1 to extract, obtains alcohol extract, alcohol extract and Aqueous extracts B are mixed, through silica gel column chromatography point From；Silica gel chromatographic column is first eluted through ethyl acetate, is eluted by dimethyl carbonate-alcohol mixeding liquid of volume ratio 1:2, concentration, Recrystallization, must crystallize C；
(3) Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae, peppermint are subjected at 60 DEG C ethyl alcohol extraction, obtain alcoholic solution 2 and the dregs of a decoction 2；
(4) dregs of a decoction 2, Poria cocos, spina gleditsiae and Radix Paeoniae Alba progress water are mentioned, the pH value of Aqueous extracts is adjusted to 4, adds chitosan Processing, obtains aqueous solution 1；
(5) crystallization C dissolution is added after mixing alcoholic solution 1, alcoholic solution 2, aqueous solution 1, then is concentrated to give concentrate；
(6) tablet is made in concentrate and obtains safflower care-free tablet.
Comparative example 1
Compared with Example 1, difference is only that the dosage of safflower is different.
In the present embodiment, the safflower care-free preparation of the proliferation of mammary gland is treated, in parts by weight, including following raw material: when Return 32 parts, 130 parts of Radix Paeoniae Alba, 50 parts of Rhizoma Atractylodis Macrocephalae, 127 parts of Poria cocos, 200 parts of safflower, 28 parts of spina gleditsiae, 110 parts of HERBA BUPLEURI, peppermint 65 Part, 55 parts of Radix Glycyrrhizae.
(1) preparation method of the safflower care-free preparation of the treatment proliferation of mammary gland, with embodiment 1.
Comparative example 2
Compared with Example 1, difference is only that the dosage of safflower is different.
In the present embodiment, the safflower care-free preparation of the proliferation of mammary gland is treated, in parts by weight, including following raw material: when Return 32 parts, 130 parts of Radix Paeoniae Alba, 50 parts of Rhizoma Atractylodis Macrocephalae, 127 parts of Poria cocos, 80 parts of safflower, 28 parts of spina gleditsiae, 110 parts of HERBA BUPLEURI, peppermint 65 Part, 55 parts of Radix Glycyrrhizae.
(1) preparation method of the safflower care-free preparation of the treatment proliferation of mammary gland, with embodiment 1.
Comparative example 3
Difference with embodiment 1 is only that safflower, HERBA BUPLEURI, Radix Glycyrrhizae are individually extracted；
In the present embodiment, the safflower care-free preparation of the proliferation of mammary gland is treated, in parts by weight, including following raw material: when Return 32 parts, 130 parts of Radix Paeoniae Alba, 50 parts of Rhizoma Atractylodis Macrocephalae, 127 parts of Poria cocos, 140 parts of safflower, 28 parts of spina gleditsiae, 110 parts of HERBA BUPLEURI, peppermint 65 Part, 55 parts of Radix Glycyrrhizae.
The preparation method of the safflower care-free preparation of the treatment proliferation of mammary gland, comprising the following steps:
(1) after crushing safflower, Radix Glycyrrhizae, HERBA BUPLEURI respectively, respectively plus water mixing is extracted, and temperature is risen to 80 DEG C of extractions 1.5h, then 25min is carried out after boiling；Flos Carthami extract, licorice extract, HERBA BUPLEURI extracting solution and safflower medicine are filtered to obtain respectively Slag, liquorice dregs, the HERBA BUPLEURI dregs of a decoction；Flos Carthami extract, licorice extract, HERBA BUPLEURI extracting solution are mixed into obtain Aqueous extracts A；
Take macroporous adsorption resin chromatography column: upper layer AB-8, middle layer are NKA and lower layer is the chromatographic column of NKA-9 composition, In, the thickness ratio of AB-8, NKA, NKA-9 are 1:2:1；The chromatographic column ethyl alcohol is impregnated into 25min, then the 2.5h that is soaked in water；
Aqueous extracts A is adsorbed by macroporous adsorption resin chromatography column, will obtain Aqueous extracts after Aqueous extracts remaining after absorption concentration B, macroporous adsorption resin chromatography column elute to obtain alcoholic solution 1 through the ethanol water that mass concentration is 40%；
(2) the safflower dregs of a decoction, liquorice dregs, the HERBA BUPLEURI dregs of a decoction are added ethyl alcohol and extracted respectively, by the alcohol extracting of three kinds of medicinal materials Object mixes to obtain mixing alcohol extract, and mixing alcohol extract and Aqueous extracts B are mixed, separated through silica gel column chromatography；Silica gel chromatographic column first passes through Ethyl acetate elution is eluted by dimethyl carbonate-alcohol mixeding liquid of volume ratio 1:2, and concentration, recrystallization must crystallize C；
(3)-(6) are the same as embodiment 1.
Comparative example 4
Compared with Example 1, flocculant is not added.
In the present embodiment, the raw material for treating the safflower care-free preparation of the proliferation of mammary gland is same as Example 1.
The preparation method of the safflower care-free preparation of the treatment proliferation of mammary gland, comprising the following steps:
(1)-(3) are the same as embodiment 1；
(4) dregs of a decoction 2, Poria cocos, spina gleditsiae and Radix Paeoniae Alba progress water are mentioned, filters, obtains aqueous solution 1；
(5)-(6) are the same as embodiment 1.
Comparative example 5
Compared with Example 1, the extracting method of effective component is different.
In the present embodiment, the safflower care-free preparation raw material for treating the proliferation of mammary gland is same as Example 1.
The preparation method of the safflower care-free preparation of the treatment proliferation of mammary gland, comprising the following steps:
(1) after crushing safflower, Radix Glycyrrhizae, HERBA BUPLEURI, Poria cocos, spina gleditsiae and Radix Paeoniae Alba, water mixing is added to extract, by temperature liter To 80 DEG C of extraction 1.5h, then 25min is carried out after boiling；Obtain Aqueous extracts A and the dregs of a decoction 1；
(2) dregs of a decoction 1, Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae, peppermint are added ethyl alcohol and extracted, obtain alcohol extract；
(3) alcohol extract and Aqueous extracts A are mixed；It is concentrated to give concentrate again；
(4) tablet is made in concentrate and obtains safflower care-free tablet.
Effect example
(1) rat mammary gland hyperplasia modeling
Take female rats of the weight between 200 ± 20g 120, SPF rank, female, by Jiangning county's Qinglongshan Animal reproduction field provides (SCXK (Soviet Union) 2017-0001).
It is randomly divided into 12 groups, every group 10, respectively embodiment 1-5 and comparative example 1-5, model group and blank control group, 0.9% sodium chloride injection 0.2ml is injected in rear leg muscle daily to every rat in blank control group, continuously injects 30 It, remaining 11 groups, with the estradiol benzoate injection 0.5mgkg of olive oil dilution (1:9)-1, continuous 25d changes on the 26th day The progesterone injection 5mgkg of (1:19) is diluted for olive oil-1, continuous 5d.
(2) the horizontal measurement of E2, P
The safflower made of the embodiment 1-5 and comparative example 1-5 of the 5th day difference feeding 0.25g/kg effective content of modeling Xiaoyao preparation, to the physiological saline of blank control group feeding equivalent.Continuous use 30 days, the 35th day, after 1h is administered in last time, Eye socket takes blood (after 30min, 4000 turns of centrifugation 5min take serum), the level of E2, P in serum measured by radioimmunoassay.Number of results According to being shown in Table 1:
E in 1 rat blood serum of table2With the variation of P content
Remarks: there is significant difference (P < 0.05) between different letters in same row.
Compared with the control group by the influence to rat blood serum E2 and P level, it is known that, model group rats blood serum E2 level is aobvious Raising, the significant decrease of blood-serum P level are write, illustrates modeling success.
Compared with model group, the safflower care-free preparation of 1-5 of the embodiment of the present invention can make rat blood serum E2 level significantly reduce, Blood-serum P is horizontal significantly raised, thus illustrates that safflower care-free preparation of the invention has preferable therapeutic effect to the proliferation of mammary gland, and From the test data of comparative example 1-2: the raw material dosage of safflower care-free preparation has important influence with its effect is compared；Together When, from the test data of comparative example -5: the extracting and developing method of effective component also produces influence to its effect.
(3) breast tissue morphological change
After having surveyed serum, each group rat is put to death using cervical dislocation method, complete breast is removed, with 10% formalin Fixed, conventional film-making, HE dyeing does pathological analysis in light microscopic observation；To in the lobule of mammary gland and leaflet of experiment each group rat Acinus and leaflet interstitial (every pathological section takes 3 different visuals field) carry out three-dimensional meterological measurement, observe measuring index For the density (Vv) of lobule of mammary gland volume and interstitial, the specific surface (S) of mammary gland alveolus.Volume density is reaction observation object and is joining According to ratio (%) shared in being, specific surface area is one sphere of reaction or the ratio between a fascicular texture limitans and volume (%). It the results are shown in Table 2:
2 rat mammary gland leaflet morphology situation of change of table
Remarks: there is significant difference (P < 0.05) between different letters in same row.
There is test data it is found that compared with the control group, lobule of mammary gland volume density, the acinus specific surface of model group have significantly Increase；Leaflet interstitial volume density is substantially reduced, and illustrates modeling success.
Compared with model group, the safflower care-free preparation of 1-5 of the embodiment of the present invention makes lobule of mammary gland volume density, acinus compare table Face is all substantially reduced, and leaflet interstitial volume density significantly increases；Thus illustrate that safflower care-free preparation of the invention has the proliferation of mammary gland Have preferable therapeutic effect, and from the test data of comparative example 1-2: the raw material dosage of safflower care-free preparation is imitated with its is compared Fruit has important influence；Meanwhile from the test data of comparative example -5: the extracting and developing method of effective component is also to it Effect produces influence.
Above-mentioned detailed description is illustrating for one of them possible embodiments of the present invention, the embodiment not to The scope of the patents of the invention is limited, all equivalence enforcements or change without departing from carried out by the present invention are intended to be limited solely by the technology of the present invention In the range of scheme.

Claims (10)

1. a kind of safflower care-free preparation for treating the proliferation of mammary gland, in parts by weight, including following raw material: 18-67 parts of Radix Angelicae Sinensis, 100-150 parts of Radix Paeoniae Alba, 30-55 parts of Rhizoma Atractylodis Macrocephalae, 105-135 parts of Poria cocos, 110-160 parts of safflower, 20-35 parts of spina gleditsiae, HERBA BUPLEURI 80-140 parts, 45-85 parts of peppermint, 20-75 parts of Radix Glycyrrhizae.
2. safflower care-free preparation as described in claim 1, which is characterized in that in parts by weight, including following raw material: Radix Angelicae Sinensis 20-53 parts, 125-145 parts of Radix Paeoniae Alba, 45-50 parts of Rhizoma Atractylodis Macrocephalae, 125-130 parts of Poria cocos, 123-153 parts of safflower, 25-30 parts of spina gleditsiae, 95-120 parts of HERBA BUPLEURI, 55-80 parts of peppermint, 35-65 parts of Radix Glycyrrhizae.
3. safflower care-free preparation as described in claim 1, which is characterized in that in parts by weight, including following raw material: Radix Angelicae Sinensis 32 parts, 130 parts of Radix Paeoniae Alba, 50 parts of Rhizoma Atractylodis Macrocephalae, 127 parts of Poria cocos, 140 parts of safflower, 28 parts of spina gleditsiae, 110 parts of HERBA BUPLEURI, peppermint 65 Part, 55 parts of Radix Glycyrrhizae.
4. treating the preparation method of the safflower care-free preparation of the proliferation of mammary gland as described in claim 1-3 is any, which is characterized in that packet Include following steps:
(1) after crushing safflower, Radix Glycyrrhizae, HERBA BUPLEURI, add water mixing to extract, obtain Aqueous extracts A and the dregs of a decoction 1；Aqueous extracts pass through big The absorption of macroporous adsorbent resin chromatographic column will obtain Aqueous extracts B, macroporous adsorption resin chromatography column warp after Aqueous extracts remaining after absorption concentration Ethanol water elutes to obtain alcoholic solution 1；
(2) ethyl alcohol is added in the dregs of a decoction 1 to extract, obtains alcohol extract, alcohol extract and Aqueous extracts B are mixed, separated through silica gel column chromatography；Silicon Glue chromatographic column is first eluted through ethyl acetate, is eluted by dimethyl carbonate-alcohol mixeding liquid, and concentration, recrystallization must crystallize C；
(3) Radix Angelicae Sinensis, Rhizoma Atractylodis Macrocephalae, peppermint are subjected to ethyl alcohol extraction, obtain alcoholic solution 2 and the dregs of a decoction 2；
(4) dregs of a decoction 2, Poria cocos, spina gleditsiae and Radix Paeoniae Alba progress water are mentioned, after adding flocculant process, obtains aqueous solution 1；
(5) crystallization C dissolution is added after mixing alcoholic solution 1, alcoholic solution 2, aqueous solution 1, then is concentrated to give concentrate；
(6) concentration liquid formulation is arrived into safflower care-free preparation to obtain the final product.
5. the preparation method of the safflower care-free preparation of the treatment proliferation of mammary gland as claimed in claim 4, which is characterized in that step (1) In, the detailed process of described plus water mixing extraction are as follows: temperature is risen into 75-90 DEG C of extraction 1-2h, then carries out 20- after boiling 30min。
6. the preparation method of the safflower care-free preparation of the treatment proliferation of mammary gland as claimed in claim 4, which is characterized in that step (1) In, the macroporous adsorption resin chromatography column are as follows: upper layer AB-8, middle layer are NKA and lower layer is the chromatographic column of NKA-9 composition, In, the thickness ratio of AB-8, NKA, NKA-9 are 1:1-2:1-2.
7. the preparation method of the safflower care-free preparation of the treatment proliferation of mammary gland as claimed in claim 4, which is characterized in that step (2) In, the volume ratio 1:1-3 of dimethyl carbonate and ethyl alcohol in the dimethyl carbonate-alcohol mixeding liquid.
8. the preparation method of the safflower care-free preparation of the treatment proliferation of mammary gland as claimed in claim 4, which is characterized in that step (3) In, the ethyl alcohol extraction carries out at being 40-60 DEG C in temperature.
9. the preparation method of the safflower care-free preparation of the treatment proliferation of mammary gland as claimed in claim 4, which is characterized in that step (4) In, the flocculant is chitosan or gelatin.
10. the safflower care-free preparation or claim 4-9 of the treatment proliferation of mammary gland a method according to any one of claims 1-3 are any described Application of the safflower care-free preparation made of the preparation method of safflower care-free preparation in preparation treatment proliferation of mammary gland drug.
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