CN104547942B - Rukang granules agent with slow releasing function and preparation method thereof - Google Patents
Rukang granules agent with slow releasing function and preparation method thereof Download PDFInfo
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Abstract
The invention provides newborn health preparation, it is made up of newborn health extract and pharmaceutic adjuvant, and wherein pharmaceutic adjuvant is chitosan, sodium alginate, lactose and sucrose.This newborn health preparation has slow releasing function, makes medicining times once become 12 hours once from existing 6 hours.In addition, the present invention also provides the preparation method and application etc. of this newborn health preparation.
Description
Technical field
The invention belongs to technical field of Chinese medicines, specifically, the present invention relates to Rukang granules preparation, preparation method and application etc.
Background technology
Cyclomastopathy is one of common frequently-occurring disease of women, and be more common in the women in 25-45 year, the sickness rate of cyclomastopathy accounts for the first place of mastopathy.This sick sickness rate is in rising year by year in recent years, and has the trend of the development that becomes younger.It is the disorder of the mammary gland normal configuration that a kind of physiology hypertrophy and subinvolution cause in essence.Its main clinical characteristics is lump in breast and mastalgia.
Breast Kang Fang is treatment cyclomastopathy conventional side also, and have into liver resolving depression, regulating QI to relieve pain, promote blood circulation to disperse blood clot, passiveness is reduced phlegm, hard masses softening and resolving, the function of air making-up and spleen enlivening.Clinical treatment display the party is better than conventional treatment cyclomastopathy medicine tamoxifen for the therapeutic effect of cyclomastopathy, and toxic and side effects is low, is widely used in clinical treatment cyclomastopathy at present.
No. 201210067351.5th, Chinese patent discloses RUKANG PIAN and preparation method thereof, comprises 1) get Concha Ostreae, Olibanum, Fructus Trichosanthis, Sargassum, the Radix Astragali, Myrrha, Radix Asparagi, Spica Prunellae, Rhizoma Sparganii, Radix Scrophulariae, the Rhizoma Atractylodis Macrocephalae, Bulbus Fritillariae Thunbergii, Rhizoma Curcumae, Radix Salviae Miltiorrhizae, Endothelium Corneum Gigeriae Galli; 2) get the Endothelium Corneum Gigeriae Galli of above proportioning, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha four taste be ground into coarse powder; 3) ten Herba indigoferae Pseudotinctoriae got beyond the four Chinese medicine described in step 2 decoct with water twice, filter, add chitin or chitosan stirring, leave standstill, filter, filtrate concentrates, and adds the coarse powder pulverized in step 2, after mixing drying, pulverizes, add appropriate amount of auxiliary materials, granulate, dry, tabletted.
Although it has been generally acknowledged that adjuvant can not form impact to active constituents of medicine, but the present inventor is from thousands adjuvant and incalculable combination, find that chitosan, sodium alginate, lactose and the sucrose curative effect to newborn health extract has facilitation, and make pharmaceutical preparation with slow releasing function, medicining times can be reduced, more surprisingly, the probability of happening that single taking dose does not but increase, even decreases untoward reaction is strengthened like this.In addition, the present inventor finds, when extracting newborn health extract, if do not add the adjuvant such as chitin or chitosan, can improve the content of the effective ingredient such as danshensu, the conversion of certainly returning newborn health extract provides motility.
Summary of the invention
The technical problem to be solved in the present invention is to provide new newborn health preparation.In addition, present invention also offers the preparation method and application etc. thereof of said preparation.
Specifically, in first aspect, the invention provides newborn health preparation, it is made up of newborn health extract and pharmaceutic adjuvant, and wherein pharmaceutic adjuvant is chitosan, sodium alginate, lactose and sucrose.
Preferably in the newborn health preparation of first aspect present invention, the weight ratio of breast health extract, chitosan, sodium alginate, lactose and sucrose is 25-35:12-18:8-12:22-30:16-22, be preferably 28-32:14-16:9-11:24-28:18-20, be more preferably 30:15:10:26:19.
Preferably in the newborn health preparation of first aspect present invention, breast health extract is prepared from by Concha Ostreae, Olibanum, Fructus Trichosanthis, Sargassum, the Radix Astragali, Myrrha, Radix Asparagi, Spica Prunellae, Rhizoma Sparganii, Radix Scrophulariae, the Rhizoma Atractylodis Macrocephalae, Bulbus Fritillariae Thunbergii, Rhizoma Curcumae, Radix Salviae Miltiorrhizae and Endothelium Corneum Gigeriae Galli, wherein newborn health extract does not comprise pharmaceutic adjuvant (e.g., chitin or chitosan).
Preferably in the newborn health preparation of first aspect present invention, newborn health extract is adopted and is made with the following method:
Prescription:
Concha Ostreae 75 weight portion Olibanum 30 weight portion Fructus Trichosanthis 75 weight portion
The Sargassum 60 weight portion Radix Astragali 120 weight portion Myrrha 30 weight portion
Radix Asparagi 60 weight portion Spica Prunellae 75 weight portion Rhizoma Sparganii 30 weight portion
The Radix Scrophulariae 60 weight portion Rhizoma Atractylodis Macrocephalae 60 weight portion Bulbus Fritillariae Thunbergii 30 weight portion
Rhizoma Curcumae 30 weight portion Radix Salviae Miltiorrhizae 75 weight portion Endothelium Corneum Gigeriae Galli 30 weight portion
The preparation of breast health extract:
Above ten five tastes, Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha are ground into fine powder, sieve, mixing; All the other Concha Ostreaes etc. ten decoct with water secondary simply, each 12 times (all the other Concha Ostreaes etc. ten crude drug weight simply) water gagings, decoct 2 hours, collecting decoction, filter, filtrate is concentrated into relative density 1.10(60 DEG C), add ethanol and make alcohol content reach 70%, leave standstill 24 hours, filter, it is 1.30 ~ 1.35(60 DEG C that filtrate is concentrated into relative density), add above-mentioned medicated powder, mixing is newborn health extract.
The newborn health preparation of preferred first aspect present invention is tablet, granule or powder, preferably granule.
The newborn health preparation of first aspect present invention is newborn health slow releasing preparation, the repeatedly taking dose of existing newborn health preparation can be merged into less number of times and take.Although make single dose larger owing to merging to take, surprisingly, the newborn health preparation of first aspect present invention does not but produce significant untoward reaction, and the probability that even untoward reaction occurs presents decline.So the newborn health preparation of preferred first aspect present invention has slow releasing function, namely preferably first aspect present invention provides newborn health slow releasing preparation.In the specific embodiment of the present invention, the medicining times (frequency) of the newborn health preparation of first aspect present invention is one day twice, relative to existing newborn health preparation, is easier to promote.
The newborn health preparation of preferred first aspect present invention is prepared by following methods:
1) by the microgranule that newborn health extract is ground into, Chinese medicinal powder is made;
2) Chinese medicinal powder that step 1) obtains is mixed homogeneously with chitosan and sodium alginate;
3) lactose and sucrose is pulverized, with step 2) mixture that obtains mixs homogeneously; With,
4) optionally, drying and granulating after moistening.
More preferably wherein,
Step 1) in, pulverizing is ground into diameter between the microgranule of 0.3-2 μm, and preferred powder is broken into diameter between the microgranule of 0.5-1 μm;
Step 4) in, moistening, for use alcoholic solution moistening, is preferably with 70%(v/v) alcoholic solution moistening; And/or,
Step 4) in, dry temperature is 50 ~ 70 DEG C, is preferably 60 DEG C.
In second aspect, the invention provides the preparation method of the newborn health preparation of first aspect present invention, it comprises
1) by the microgranule that newborn health extract is ground into, Chinese medicinal powder is made;
2) Chinese medicinal powder that step 1) obtains is mixed homogeneously with chitosan and sodium alginate;
3) lactose and sucrose is pulverized, with step 2) mixture that obtains mixs homogeneously; With,
4) optionally, drying and granulating after moistening.
In preparation method preferably in the present invention two,
Step 1) in, pulverizing is ground into diameter between the microgranule of 0.3-2 μm, and preferred powder is broken into diameter between the microgranule of 0.5-1 μm;
Step 4) in, moistening, for use alcoholic solution moistening, is preferably with 70%(v/v) alcoholic solution moistening; And/or,
Step 4) in, dry temperature is 50 ~ 70 DEG C, is preferably 60 DEG C.
In the third aspect, the invention provides the application of newborn health preparation in the medicine for the preparation for the treatment of or prevention mastopathy of first aspect present invention.
Preferably in the application of third aspect present invention, mastopathy is cyclomastopathy, as, reduce lump in breast maximum transverse diameter, reduce the maximum vertical footpath of lump in breast, reduce mastalgia score, increase clinical recovery rate, increase total obvious effective rate and/or reduce tcm syndrome total mark.
Preferably in the application of third aspect present invention, medicine is slow releasing pharmaceutical, is more preferably the medicine that medicining times is twice on the one.
In this article, as do not specialized, term "and/or" represent coordination be " with " or "or".
The excellent effect obtained of the present invention comprises: determined curative effect, steady quality, and drug effect improves; Preparation has slow releasing function, takes easy and safe and reliable, medicining times (frequency) is reduced to one day twice, thus is easier to actual promoting the use of, and does not increase, even decreases the probability of happening of untoward reaction; Production stage is simple, and product quality monitoring is convenient, and intermediate products conversion flexibly, and can retain to a greater degree and/or increase active component.
For the ease of understanding, below will be described in detail the present invention by specific embodiment.It is important to note that these descriptions are only exemplary descriptions, do not form limitation of the scope of the invention.According to the discussion of this description, many changes of the present invention, to change concerning one of ordinary skill in the art be all apparent.
In addition, the present invention refer to open source literature, and these documents are to more clearly describe the present invention, and their entire contents is all included in and carried out reference herein, just looks like that repeated description is excessively the same in this article for their full text.
Specific embodiment
Further illustrate content of the present invention by the following examples.As do not specialized, the conventional means that technological means used in embodiment is well known to those skilled in the art and commercially available common instrument, can see the relevant regulations and guide etc. of " Chinese Pharmacopoeia " and SFDA.
the preparation method of embodiment 1 Rukang granules preparation.
1. prescription:
Concha Ostreae 75g Olibanum 30g Fructus Trichosanthis 75g
Sargassum 60g Radix Astragali 120g Myrrha 30g
Radix Asparagi 60g Spica Prunellae 75g Rhizoma Sparganii 30g
Radix Scrophulariae 60g Rhizoma Atractylodis Macrocephalae 60g Bulbus Fritillariae Thunbergii 30g
Rhizoma Curcumae 30g Radix Salviae Miltiorrhizae 75g Endothelium Corneum Gigeriae Galli (stir-fry) 30g.
2. the preparation of Chinese medicine extract (newborn health extract):
Above ten five tastes, Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha are ground into fine powder, sieve, mixing; All the other Concha Ostreaes etc. ten decoct with water secondary simply, each 12 times of water gagings, decoct 2 hours, collecting decoction, filter, filtrate is concentrated into relative density 1.10(60 DEG C), add ethanol and make ethanol content reach 70%(V/V), leave standstill 24 hours, filter, it is 1.30 ~ 1.35(60 DEG C that filtrate is concentrated into relative density), add above-mentioned fine powder, mixing is Chinese medicine extract.
3. the preparation of granule
Prescription:
By Chinese medicine extract, be ground into diameter between the microgranule of 0.5-1 μm, then with chitosan, sodium alginate mix homogeneously with jet mill; 100 mesh sieves pulverized by sucrose, lactose, mix, add 70% alcohol granulation with above-mentioned thing powder, 60 DEG C of drying and granulatings, to be evaporated fall after alcoholic solution, obtain granule.
Get granule 205g, porphyrize, accurately weighed, put in tool plug conical flask, precision adds methanol 20ml, weighed weight, supersound process (power 160w, frequency 50Khz) 30min, let cool, weighed weight again, add the weight that methanol supplies less loss, shake up, filter, precision measures filtrate 10ml, evaporate to dryness, residue adds 2% hydrochloric acid solution 15ml makes dissolving, 4 times are extracted by ethyl acetate, each 15ml, combined ethyl acetate liquid, put evaporate to dryness in water-bath, residue adds methanol to be made dissolving in right amount and is transferred in 10ml measuring bottle, add methanol dilution to scale, shake up, namely centrifuging and taking supernatant obtains detection sample, carrying out HPLC detection (take octadecylsilane chemically bonded silica as filler, with methanol-water-glacial acetic acid (V:V:V=10:92:0.45) for mobile phase, determined wavelength: 280nm, flow velocity is 1.0ml/min, with 50% methanol solution containing danshensu 70 μ g/ml for contrast) detect.Detect and find that in granule of the present invention, content of Danshensu is not less than 0.133mg/g, more existing RUKANG PIAN content is higher.
embodiment 2 contrasts with existing RUKANG PIAN evaluates random, the double blind that Rukang granules of the present invention treats the safety and efficacy of cyclomastopathy (syndrome of qi stagnation and blood stasis).
Trial drug:
1, investigational agent: Rukang granules (preparation of embodiment 1 method);
2, medicine is contrasted: RUKANG PIAN (Ankang Chia Tai Pharmaceutical Co., Ltd., the accurate word Z20003227 of traditional Chinese medicines), its preparation method can refer to No. 201210067351.5th, Chinese patent.
Test objective:
1, the Clinical efficacy of cyclomastopathy (syndrome of qi stagnation and blood stasis) is treated with RUKANG PIAN comparative evaluation Rukang granules;
2, the clinical safety of cyclomastopathy (syndrome of qi stagnation and blood stasis) is treated with RUKANG PIAN comparative evaluation Rukang granules.
EXPERIMENTAL DESIGN:
Employing demixing zone group is random, Double-blind double-dummy, multi-center clinical trial method.Selected disease is cyclomastopathy (syndrome of qi stagnation and blood stasis).144 examples are included in plan in, are divided into test group, matched group in 1:1 ratio, and wherein test group 1 is 72 examples, matched group 72 example.
Inclusion criteria:
1) doctor trained in Western medicine Diagnosis of Cyclomastopathy standard is met;
2) the Chinese medical discrimination person that belongs to syndrome of qi stagnation and blood stasis;
3) age 18-55 year (the non-menolipsis person of menstruation rule);
4) this test of voluntary participation, and the person that signs Informed Consent Form.
Exclusion standard:
1) trimester of pregnancy or prepare pregnant person, age of sucking, severe menstrual cycle disorder or dysfunctional uterine hemorrhage women;
2) mammitis and malignant breast tumor person;
3) masculine mastoplasia patient;
4) primary diseases such as severe cardiac, liver, kidney and blood system are had, psychotic;
5) other clinical trial person was participated in 1 month;
6) contraceptive and sex hormone drug person is taken;
7) allergic constitution person.
Therapeutic scheme:
Test the grouping of medication and take mode;
Test group: Rukang granules, oral, one day twice, every 12 hours were once;
Matched group: RUKANG PIAN, oral, four times on the one, every 4 ~ 8 hours are once (on average every 6 hours once);
The course for the treatment of: 8 weeks (menstrual period withdraw).
Drug combination specifies:
Duration of test can not take the Chinese and western drugs for the treatment of cyclomastopathy effect.
Validity evaluation index:
1) drop-out value of rear udder attachment lump is treated;
2) rear udder attachment pain scores drop-out value is treated;
3) cyclomastopathy Evaluation of Synthetic Effect of Holistic;
4) tcm syndrome therapeutic evaluation.
Safety Evaluation Index:
1) the untoward reaction symptom (observing at any time) that may occur;
2) general health check-up project, as temperature pulse respiration, blood pressure etc. (before and after test);
3) routine blood test, routine urinalysis, just routine, electrocardiogram, hepatic and renal function (ALT, AST, TBil, DBIL, ALP, GGT, Cr).
Result:
Lump in breast size efficacy analysis:
1) lump in breast maximum transverse diameter
After treating 8 weeks, test group declines 1.13 cm, and matched group declines 1.05 cm
2) the maximum vertical footpath of lump in breast
After treating 8 weeks, test group declines 0.90 cm, and matched group declines 0.85 cm.
Mastalgia scoring curative effect
After treating 8 weeks, mastalgia score test group declines 4.79, and matched group declines 4.59.
Disease syndrome curative effect:
Test group, matched group clinical recovery rate are respectively 4.96%, 4.10%; Total obvious effective rate is respectively 56.20%, 47.54%.
Tcm syndrome total mark is analyzed:
Tcm syndrome total mark, test group drop-out value is 11.51, and matched group drop-out value is 10.39.
Safety analysis:
Test group has 1 example that adverse events occurs, and untoward reaction is nauseating; Matched group has 2 examples that adverse events occur, and untoward reaction is hyper-menorrhea, dizzy a case each.
Claims (18)
1. newborn health preparation, it is granule, it is made up of newborn health extract and pharmaceutic adjuvant, wherein pharmaceutic adjuvant is chitosan, sodium alginate, lactose and sucrose, wherein the weight ratio of newborn health extract, chitosan, sodium alginate, lactose and sucrose is 25-35:12-18:8-12:22-30:16-22, wherein newborn health extract is prepared from by Concha Ostreae, Olibanum, Fructus Trichosanthis, Sargassum, the Radix Astragali, Myrrha, Radix Asparagi, Spica Prunellae, Rhizoma Sparganii, Radix Scrophulariae, the Rhizoma Atractylodis Macrocephalae, Bulbus Fritillariae Thunbergii, Rhizoma Curcumae, Radix Salviae Miltiorrhizae and Endothelium Corneum Gigeriae Galli, and wherein newborn health extract does not comprise chitin or chitosan.
2. newborn health preparation according to claim 1, wherein the weight ratio of newborn health extract, chitosan, sodium alginate, lactose and sucrose is 28-32:14-16:9-11:24-28:18-20.
3. newborn health preparation according to claim 2, wherein the weight ratio of newborn health extract, chitosan, sodium alginate, lactose and sucrose is 30:15:10:26:19.
4. newborn health preparation according to claim 1, wherein newborn health extract is adopted and is made with the following method:
Prescription:
Concha Ostreae 75 weight portion Olibanum 30 weight portion Fructus Trichosanthis 75 weight portion
The Sargassum 60 weight portion Radix Astragali 120 weight portion Myrrha 30 weight portion
Radix Asparagi 60 weight portion Spica Prunellae 75 weight portion Rhizoma Sparganii 30 weight portion
The Radix Scrophulariae 60 weight portion Rhizoma Atractylodis Macrocephalae 60 weight portion Bulbus Fritillariae Thunbergii 30 weight portion
Rhizoma Curcumae 30 weight portion Radix Salviae Miltiorrhizae 75 weight portion Endothelium Corneum Gigeriae Galli 30 weight portion
The preparation of breast health extract:
Above ten five tastes, Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha are ground into fine powder, sieve, mixing; All the other Concha Ostreaes etc. ten decoct with water secondary simply, each 12 times of water gagings, decoct 2 hours, collecting decoction, filter, filtrate is concentrated into the relative density 1.10 of 60 DEG C, adds ethanol and makes alcohol content reach 70%, leaves standstill 24 hours, filter, the relative density that filtrate is concentrated into 60 DEG C is 1.30 ~ 1.35, adds above-mentioned medicated powder, and mixing is newborn health extract.
5. newborn health preparation according to claim 1, it is prepared by following methods:
1) by the microgranule that newborn health extract is ground into, Chinese medicinal powder is made;
2) Chinese medicinal powder that step 1) obtains is mixed homogeneously with chitosan and sodium alginate;
3) lactose and sucrose is pulverized, with step 2) mixture that obtains mixs homogeneously; With,
4) drying and granulating after moistening.
6. newborn health preparation according to claim 5, wherein
Step 1) in, pulverizing is ground into diameter between the microgranule of 0.3-2 μm;
Step 4) in, moistening is for use alcoholic solution moistening; And/or,
Step 4) in, dry temperature is 50 ~ 70 DEG C.
7. newborn health preparation according to claim 5, wherein step 1) in, pulverizing is ground into diameter between the microgranule of 0.5-1 μm.
8. newborn health preparation according to claim 5, wherein step 4) in, moistening is with 70%(v/v) alcoholic solution moistening.
9. newborn health preparation according to claim 5, wherein dry temperature is 60 DEG C.
10. the preparation method of arbitrary described newborn health preparation of claim 1-9, it comprises
1) by the microgranule that newborn health extract is ground into, Chinese medicinal powder is made;
2) Chinese medicinal powder that step 1) obtains is mixed homogeneously with chitosan and sodium alginate;
3) lactose and sucrose is pulverized, with step 2) mixture that obtains mixs homogeneously; With,
4) drying and granulating after moistening.
11. preparation methoies according to claim 10, wherein
Step 1) in, pulverizing is ground into diameter between the microgranule of 0.3-2 μm;
Step 4) in, moistening is for use alcoholic solution moistening; And/or,
Step 4) in, dry temperature is 50 ~ 70 DEG C.
12. preparation method according to claim 11, wherein steps 1) in, pulverizing is ground into diameter between the microgranule of 0.5-1 μm.
13. preparation method according to claim 11, wherein steps 4) in, moistening is with 70%(v/v) alcoholic solution moistening.
14. preparation methoies according to claim 11, wherein dry temperature is 60 DEG C.
The application of arbitrary described newborn health preparation in the slow releasing pharmaceutical for the preparation for the treatment of or prevention mastopathy of 15. claim 1-9.
16. application according to claim 15, wherein said medicine is used for the treatment of or preventing mammary gland hyperplasia.
17. application according to claim 16, wherein said medicine is scored for reducing lump in breast maximum transverse diameter, the reduction maximum vertical footpath of lump in breast, reduction mastalgia, increase clinical recovery rate, is increased total obvious effective rate and/or reduce tcm syndrome total mark.
18. application according to claim 15, the medicining times of wherein said medicine is the medicine of twice on the one.
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Effective date of registration: 20190311 Address after: 710065 11 Floor of Huixin IBC-B Block No. 1 Zhangba Road, Xi'an High-tech Zone, Shaanxi Province Patentee after: Xi'an Millennium pharmaceutical Limited by Share Ltd Address before: 710077 No. 69 Jinye Road, Xi'an High-tech Zone, Shaanxi Province Patentee before: Xi'an Xintong Pharmaceutical Research Co., Ltd. |