阅读说明：本技术 一种治疗乳腺增生的红花逍遥制剂及其制备方法和应用 (A kind of safflower care-free preparation and its preparation method and application for treating the proliferation of mammary gland ) 是由 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 于 2019-09-22 设计创作，主要内容包括：本发明属于红花逍遥片的制备及应用领域,具体涉及一种治疗乳腺增生的红花逍遥制剂及其制备方法；按照重量份数计,包括以下原料：当归18-67份、白芍100-150份、白术30-55份、茯苓105-135份、红花110-160份、皂角刺20-35份、竹叶柴胡80-140份、薄荷45-85份、甘草20-75份；该药物具有较好的乳腺增生的治疗效果,通过特定的制备方法制成的红花逍遥制剂能很好地发挥药物的有效作用,并使得红花逍遥制剂对女性的内分泌起到很好的调节作用。(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.)

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.

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