CN102319391A - Chinese medicinal soft capsule for treating uterine fibroid and preparation method thereof - Google Patents
Chinese medicinal soft capsule for treating uterine fibroid and preparation method thereof Download PDFInfo
- Publication number
- CN102319391A CN102319391A CN201110218360A CN201110218360A CN102319391A CN 102319391 A CN102319391 A CN 102319391A CN 201110218360 A CN201110218360 A CN 201110218360A CN 201110218360 A CN201110218360 A CN 201110218360A CN 102319391 A CN102319391 A CN 102319391A
- Authority
- CN
- China
- Prior art keywords
- parts
- mentioned
- subsequent use
- add
- weight ratio
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
The invention relates to a Chinese medicinal soft capsule for treating uterine fibroid and a preparation method thereof. The soft capsule is prepared by extracting and purifying the following raw materials in parts by weight: 210 parts of oyster, 128 parts of prepared nutgrass galingale rhizome, 64 parts of rhizoma sparganii, 64 parts of curcuma zedoary, 64 parts of ground beetle, 64 parts of pilose asiabell root, 64 parts of bighead atractylodes rhizome, 64 parts of evodia rutaecarpa, 210 parts of spreading hedyotis herb, 126 parts of hairyvein agrimony and 128 parts of tree peony bark together with pharmaceutically acceptable auxiliary materials according to a certain process. The Chinese medicinal preparation provided by the invention has the characteristics of simple and practical preparation process, safety and effectiveness and remarkable pharmacological efficacy.
Description
Technical field
The present invention relates to a kind of Chinese medicinal soft capsule agent of treating hysteromyoma and preparation method thereof, belong to the pharmaceutical preparations technology field.
Background technology
Hysteromyoma is claimed fibroma uteri again, is the modal benign tumor of female reproductive system, and period of duration women sickness rate is about 25%, in all benign tumors of women, accounts for 51.87%, is its common complication by its pain that causes, inflammatory swelling etc.Its modal clinical symptoms is: metrorrhagia, hypogastralgia and dysmenorrhea, pressure symptom; Vaginal secretions increases, anemia, even cause infertile; Seriously affect the healthy of women and daily life work,, might change malignant tumor into like untimely treatment.
The cause of disease and pathogenesis for hysteromyoma is complicated at present, and classical research thinks that hysteromyoma is a kind of ovary sex hormone dependent benign tumor, and estrogen plays a crucial role in it takes place, and estrogenic over-effect has promoted the incidence and development of hysteromyoma.Clinically medicine and operative treatments such as mifepristone, androgen, Tripterygium glycosides are generally adopted in the treatment of hysteromyoma; Though hysteromyoma has and dwindles after the above Drug therapy, side effect is big, can influence the normal hormone secretion level of inside of human body usually; Destroy human body normal physiological balance; Manlike characteristic in various degree occurs, muscular tumor is grown again after the drug withdrawal, finally is difficult to thoroughly obtain radical cure.Effect of surgical treatment is good, yet operative treatment brings bigger wound to the patient, prolongs convalescent period, and patient's ability to accept is poor.
Motherland's medical science is included in hysteromyoma in the diseases such as " mass in the abdomen ", " leukorrhagia ", " metrorrhagia ", and the traditional Chinese medical science thinks that its pathogenesis is the stagnation of QI, blood stasis, phlegm-damp, seven emotions too, liver is lost bar and reaches reasons such as Chong and Ren channel disorder.The traditional Chinese medical science is to the treatment of hysteromyoma, and with the removing blood stasis heavily fortified point that disappears, regulating the flow of vital energy stagnates and be main rule, must depressed liver-energy dispersing and QI regulating on the basis of blood stasis dispelling, and Chong and Ren Meridians regulating is with Zhi Qiben.Because people are to the New understanding again of Chinese medicine theory elite, solve the hysteromyoma problem with the method for Chinese medicine and more and more come into one's own, Chinese medicine is on hysteromyoma is treated, and following advantage is arranged: 1. therapeutic effect is remarkable; 2. have no side effect; 3. there is not operation wound; 4. the patient recovers fast.Therefore, solve the new trend that hysteromyoma problem has clinically become development with Chinese medicine, can reach treating both the principal and secondary aspects of a disease, the absolute advantages that side effect is little has vast potential for future development to the development and the exploitation of this type of medicine.
Between this, we have successively applied for patent of invention and have obtained mandate that application number is in 02153455.1 patent application document; Mainly be from preparation prescription; The protection of aspects such as dosage form preparation technology, the present invention are to carry out a large amount of experimentatioies on this basis, with further replenishment of process method for preparing; Improving medicine stability and bioavailability is purpose, and creationary a kind of Chinese medicine preparation of treating hysteromyoma of succeeding in developing.
Summary of the invention
The object of the present invention is to provide a kind of steady quality, curative effect is reliable, the Chinese medicinal soft capsule agent of the treatment hysteromyoma that bioavailability is high.The soft capsule that the present invention prepares is through corresponding pharmacodynamics test research, and the result shows this Chinese medicinal soft capsule agent stable curative effect, effective, reliable.
Technical scheme of the present invention is to be formed by following prepared:
A. raw material is formed: 210 parts of Concha Ostreaes, 128 parts of Rhizoma Cyperi (processed), triangular 64 parts, 64 parts of Rhizoma Curcumae, 64 parts of Eupolyphaga Seu Steleophagas, 64 parts of Radix Codonopsis, 64 parts of the Rhizoma Atractylodis Macrocephalaes, 64 parts of Fructus Evodiaes, 210 parts of Herba Hedyotidis Diffusaes, 126 parts of Herba Agrimoniaes, 128 parts of Cortex Moutans;
B. preparation technology: with 11 flavor raw material of Chinese medicine among the above-mentioned A, by following procedure:
(1) get triangular, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, soak and ultrasonic Treatment after, extract volatile oil with steam distillation; Collect volatile oil and use beta-cyclodextrin inclusion compound; It is subsequent use that aqueous solution after the distillation filters the back, and medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan, add alcohol reflux; Filter filtrate recycling ethanol and to be condensed into clear paste subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, soak, after heating decocts and extracts; Filter; Aqueous solution after filtrating is distilled with above-mentioned (1) is middle merges the back and adds ethanol, centrifugalize after leaving standstill, and centrifugal liquid recovery ethanol and concentrating under reduced pressure become clear paste subsequent use;
(3) after heating and melting becomes glue according to a certain percentage with glycerol, gelatin and water, add opacifier, antiseptic, degasification, it is subsequent use to process rubber;
(4) clear paste that two places in above-mentioned (1) and (2) is got merges, and is dried and crushed into dried cream powder; Concha Ostreae powder is broken into fine powder, mixes with the volatile oil clathrate compound of gained in dried cream powder and above-mentioned (1), and add dispersant, suspending agent after stirring capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and promptly gets.
What the opacifier among the preparation technology of above-mentioned soft capsule was selected for use is a kind of or mixture in titanium dioxide, the zinc oxide; Antiseptic is selected for use is one or more the mixture in benzoic acid, sodium benzoate, ethyl hydroxybenzoate, sorbic acid, the potassium sorbate; What dispersant was selected for use is polyethylene glycols or vegetable oil; Suspending agent is selected for use is one or more the mixture in Cera Flava, lecithin, aluminum monostearate, ethyl cellulose, the propylene glycol.
Technical scheme of the present invention specifically is to be prepared from following steps:
(1) get triangular, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, add with the medical material weight ratio be that 8～12 times of water gagings soak, and with behind 40kHz～100kHz supersound process 15～45min; Extract volatile oil 2～3 times with steam distillation, each 1～2h is behind the collection volatile oil; Use is the beta-cyclodextrin inclusion compound of 2～4 times of amounts with the volatile oil weight ratio, and it is subsequent use that the aqueous solution after the distillation filters the back, and medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan; Adding is the ethanol of 6～10 times of amounts with the medical material weight ratio, heating and refluxing extraction 1～3 time, and each 1～2h filters; The merging filtrate decompression recycling ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.10～1.30 clear paste is subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, adding is that 8～12 times of water gagings soak with the medical material weight ratio, and heating decocts extraction 2～3 times; Behind each 0.5～1.5h, filter, after the aqueous solution after filtrating is distilled with above-mentioned (1) is middle merges; Add ethanol and make that containing the alcohol amount is 50%～80%; Leave standstill centrifugalize behind 24～48h, centrifugal liquid reclaims ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.10～1.30 clear paste is subsequent use;
(3) after heating and melting becomes glue according to a certain percentage with glycerol, gelatin and water, add opacifier, antiseptic, degasification, it is subsequent use to process rubber;
(4) clear paste that two places in above-mentioned (1) and (2) is got merges, and is dried and crushed into dried cream powder; Concha Ostreae powder is broken into fine powder, crosses 100 mesh sieves, mixes with the volatile oil clathrate compound of gained in dried cream powder and above-mentioned (1), and add dispersant, suspending agent after stirring capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and promptly gets.
The comparatively concrete technical scheme of the present invention is to be prepared from following steps:
(1) get triangular, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, add with the medical material weight ratio be that 10 times of water gagings soak, and with behind the 80kHz supersound process 30min; Extract volatile oil 2 times with steam distillation, each 1h is behind the collection volatile oil; Use is the beta-cyclodextrin inclusion compound of 3 times of amounts with the volatile oil weight ratio, and it is subsequent use that the aqueous solution after the distillation filters the back, and medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan; Adding is the ethanol of 8 times of amounts with the medical material weight ratio, heating and refluxing extraction 2 times, each 1h; Filter, the merging filtrate decompression recycling ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, adding is that 10 times of water gagings soak with the medical material weight ratio, and heating decocts extraction 2 times; Behind each 1h, filter, after the aqueous solution in filtrating and above-mentioned (1) after the distillation merges; Add ethanol and make that containing the alcohol amount is 70%; Leave standstill centrifugalize behind the 24h, centrifugal liquid reclaims ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is subsequent use;
(3) with glycerol, gelatin and water by weight being 0.3～1.0: after 1.0: 1.0～1.6 heating and meltings become glue; Adding and glycerol, gelatin and water three gross weight are than the opacifier that is 1%～5%; With glycerol, gelatin and water three gross weight than the antiseptic that is 3%～10%; Degasification, it is subsequent use to process rubber;
(4) clear paste that two places in above-mentioned (1) and (2) is got merges, and is dried and crushed into dried cream powder; Concha Ostreae powder is broken into fine powder, crosses 100 mesh sieves, mixes with the volatile oil clathrate compound of gained in dried cream powder and above-mentioned (1), and add dispersant, suspending agent after stirring capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and promptly gets.
Final preferable preparation technique method is following in the technical scheme of the present invention:
(1) get triangular, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, add with the medical material weight ratio be that 10 times of water gagings soak, and with behind the 80kHz supersound process 30min; Extract volatile oil 2 times with steam distillation, each 1h is behind the collection volatile oil; Use is the beta-cyclodextrin inclusion compound of 3 times of amounts with the volatile oil weight ratio, and it is subsequent use that the aqueous solution after the distillation filters the back, and medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan; Adding is the ethanol of 8 times of amounts with the medical material weight ratio, heating and refluxing extraction 2 times, each 1h; Filter, the merging filtrate decompression recycling ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, adding is that 10 times of water gagings soak with the medical material weight ratio, and heating decocts extraction 2 times; Behind each 1h, filter, after the aqueous solution in filtrating and above-mentioned (1) after the distillation merges; Add ethanol and make that containing the alcohol amount is 70%; Leave standstill centrifugalize behind the 24h, centrifugal liquid reclaims ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is subsequent use;
(3) with glycerol, gelatin and water by weight being after 0.6: 1.0: 1.2 heating and melting becomes glue, adding and glycerol, gelatin and water three gross weight be than being 3% titanium dioxide, 6% benzoic acid, degasification, it is subsequent use to process rubber;
(4) clear paste that two places in above-mentioned (1) and (2) is got merges, and is dried and crushed into dried cream powder; Concha Ostreae powder is broken into fine powder, crosses 100 mesh sieves, mixes with the volatile oil clathrate compound of gained in dried cream powder and above-mentioned (1), add an amount of soybean oil, lecithin stir capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and promptly gets.
Technical scheme of the present invention than the patent 02153455.1 in first to file, mainly has following creationary useful technique effect in the middle of the research process of reality:
1. the extraction of medical material, purification and molding research:
A. Chinese medicine preparation of the present invention is made up of 11 flavor Chinese crude drugs such as Concha Ostreae, Rhizoma Cyperi (processed), triangular and Rhizoma Curcumae, and its prescription is simplified proper; Contain a large amount of volatile oils, water solublity and pure dissolubility effective ingredient in wherein triangular, Rhizoma Curcumae and the Rhizoma Atractylodis Macrocephalae 3 flavor medical materials; Therefore; After earlier it being carried out steam distillation extraction volatile oil, and adopt beta-cyclodextrin inclusion compound, to guarantee the operability of its stability and subsequent technique.Aqueous solution is continued to employ, and then medicinal residues is carried out alcohol extraction with Rhizoma Cyperi (processed), Cortex Moutan.So both can reduce operating procedure, and can extract the effective ingredient of various different physicochemical properties again as much as possible, also reach the effect that improves extraction efficiency simultaneously.In addition,, carry out the water boiling and extraction aqueous soluble active constituent, add the remove impurity of ethanol precipitate with ethanol then, finally reach the purpose of efficient medication Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae and Herba Agrimoniae.
B. we chance on need are extracted medical material earlier through after the ultrasonic pretreatment in the middle of the research process of invention, and its extraction ratio of effective constituents significantly improves; Mainly be because the chemical constituent in the medical material that prescription is formed; Through cavitation effect of ultrasonic waves, vibration effect and heating effect, can make the destruction of crude drug cell, thereby quicken the release and the stripping of effective ingredient; To be a very big saving to production cost and production capacity like this, finally be of value to the popularization of industrialization.
C. in the Chinese medicine preparation prescription of the present invention, be monarch drug, have resolving phlegm and softening hard masses, yin fluid astringing YANG hyperactivity suppressing, the effect of hidroschesis arresting seminal emission with the Concha Ostreae.In addition, the Concha Ostreae quality is hard, and mealiness is stronger, and water absorption is relatively poor, therefore considers and brings into play its effect to greatest extent, is used as medicine so we are ground into fine powder with it; In addition, can also play the effect of " the auxilliary unification of medicine ", demonstrate fully the flexibility ratio and the novelty of Chinese medicine preparation preparation.
D. the present invention is a soft capsule dosage form; Compared to hard capsule; Have that the medicine height concentrates, the capsule volume lessly is easy to take, diffusion absorbs advantages such as very fast after the preparation disintegrate, but also has the medicine not shortcoming such as easy-formation, stable relative mistake of difficult, dosage form of purifying simultaneously, therefore soft capsule prepn of the present invention is in moulding process; Our combine to write out a prescription result of study of flavour of a drug character and extraction and purification process thereof; Chance on glycerol, gelatin and water according to certain ratio, and then add certain amount of dispersant, suspending agent and antiseptic, process reliable, the stay-in-grade soft capsule prepn of curative effect with the various extracts in the technical scheme.
2. pharmacodynamic study
Owing to content of the present invention is to be to improve on 02153455.1 basis at application number, so our high spot reviews and this public technology comparison of project in pharmacodynamics test.Because writing out a prescription, both form and the identical Chinese medicine preparation preparation technology of ratio; In line with contrast experiment's principle parallel, reasonable, that practice thrift; We bring different must the disturbing of curative effect at the dosage form difference of forgoing under study for action; The two pharmacodynamics difference in the medicinal material extract purifying process is relatively only promptly all processed the mode that dried cream powder is mixed with the same concentrations administering medical liquids then according to extraction process scheme separately with the two respectively and is compared.We mainly study from aspects such as anti-leiomyoma of uterus appearance proliferative effect, anastalsis, antiinflammatory and analgesias in the test of pesticide effectiveness; Reach science, effectively illustrate the remarkable curative effect of medication of content of the present invention, the useful technique effect of finally the present invention being described and being reached.
2.1 laboratory animal: female adult unpregnancy Cavia porcellus, the Wistar rat, Kunming kind white mice, female, the cleaning level is provided by The Fourth Military Medical University's Experimental Animal Center.
2.2 positive control drug: Aspirin Enteric-coated Tablets, Tianjin Sino-U.S. SmithKline pharmaceutical Co. Ltd produces.
2.3 the preparation of experiment drug group:
A. the preparation of drug group of the present invention: triangular 64g, Rhizoma Curcumae 64g, Rhizoma Atractylodis Macrocephalae 64g are got in (1), and adding is that 10 times of water gagings soak with the medical material weight ratio, and with behind the 80kHz supersound process 30min; Extract volatile oil 2 times with steam distillation, each 1h is behind the collection volatile oil; Use is the beta-cyclodextrin inclusion compound of 3 times of amounts with the volatile oil weight ratio, and it is subsequent use that the aqueous solution after the distillation filters the back, and medicinal residues add Rhizoma Cyperi (processed) 128g, Cortex Moutan 128g; Adding is the ethanol of 8 times of amounts with the medical material weight ratio, heating and refluxing extraction 2 times, each 1h; Filter, the merging filtrate decompression recycling ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is subsequent use;
(2) get Eupolyphaga Seu Steleophaga 64g, Radix Codonopsis 64g, Fructus Evodiae 64g, Herba Hedyotidis Diffusae 210g, Herba Agrimoniae 126g, adding is that 10 times of water gagings soak with the medical material weight ratio, and heating decocts extraction 2 times; Behind each 1h, filter, after the aqueous solution in filtrating and above-mentioned (1) distillation back merges; Add ethanol and make that containing the alcohol amount is 70%; Leave standstill centrifugalize behind the 24h, centrifugal liquid reclaims ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is subsequent use;
(3) clear paste that two places in above-mentioned (1) and (2) is got merges, and is dried and crushed into dried cream powder; 210g is ground into fine powder with Concha Ostreae, crosses 100 mesh sieves, and is with the volatile oil clathrate compound mix homogeneously of gained in dried cream powder and above-mentioned (1), subsequent use.
B. the preparation of application number 02153455.1 drug group: get triangular 64g, Rhizoma Curcumae 64g, Rhizoma Cyperi (processed) 128g, Cortex Moutan 128g, it is subsequent use to be ground into fine powder; Get Concha Ostreae 210g, Eupolyphaga Seu Steleophaga 64g, Herba Hedyotidis Diffusae 210g, Herba Agrimoniae 126g, Fructus Evodiae 64g, Radix Codonopsis 64g, Rhizoma Atractylodis Macrocephalae 64g, decocte with water 2 times was fried in shallow oil 1.5 hours for the first time, fried in shallow oil 1.0 hours for the second time; Filter, merging filtrate, concentrating under reduced pressure becomes clear paste, adds ethanol and makes and contain the alcohol amount and reach 50%; Cold preservation 24 hours filters, decompression filtrate recycling ethanol, and continue to be condensed into thick paste; Stir with above-mentioned fine powder, vacuum drying, dried cream powder is broken, and is subsequent use.
The dried cream powder that above-mentioned A, B are prepared gained face with before, be mixed with the same concentrations administering medical liquids with distilled water.
2.4 the research of anti-leiomyoma of uterus appearance proliferative effect:
40 Cavia porcelluss are divided into blank group, model group, drug group of the present invention and application number 02153455.1 drug group, 10 every group at random.Except that the blank group, all the other each groups are all by following mode modeling: only get Cavia porcellus intramuscular injection estradiol benzoate 0.2mg/, and 3 times weekly, after continuous 3 months, add a Progesterone 1.5mg/ intramuscular injection, 2 times/week, continuous 1 month.Administering mode: every group of modeling simultaneously, model group is irritated stomach and only take normal saline 2ml/ every day, and drug group of the present invention and application number 02153455.1 drug group are irritated stomach every day respectively and taken 1.1g/kg (in the crude drug amount).The blank group is conventional raises, and irritates stomach every day and only take normal saline 2ml/.After 3 months, all animals are weighed, the execution of tapping the head; Cut open the belly and observe the uterus general form, weigh in clip uterus, bladder junction along the uterus; Calculate uterus coefficient (uterus weight/body weight * 100), measure the above and subangle uterus root transverse diameter of cervix uteri, measure smooth muscle thickness in the microscopically micrometer then; Average, its result is following:
The influence of table 1 pair Cavia porcellus uterus weight
Annotate: compare with the blank group,
###P＜0.001; Compare with model group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with application number 02153455.1 drug group,
△P＜0.05,
△ △P＜0.01.
Result by table 1 can know: compare with the blank group, the Cavia porcellus body weight of model group, uterus weight, uterus coefficient numerical value all have highly significant difference, prompting modeling success; Compare with model group, drug group of the present invention and application number 02153455.1 drug group show that all having significant difference aspect the indexs such as increase, uterus weight decline and uterus coefficient minimizing of Cavia porcellus body weight each administration group all has clear and definite curative effect; Compare with application number 02153455.1 drug group, drug group curative effect of the present invention has the curative effect difference of significance.
The table 2 pair influence
that Cavia porcellus uterus transverse diameter changes
| Group | n | Under the subangle (cm) | Subangle root (cm) |
| The blank group | 10 | 0.55±0.10 | 0.28±0.06 |
| Model group | 10 | 1.42±0.21 ### | 0.62±0.12 ### |
| Drug group of the present invention | 10 | 0.98±0.12 ***△△ | 0.38±0.09 *** |
| Application number 02153455.1 drug group | 10 | 1.03±0.09 ** | 0.40±0.12 ** |
Annotate: compare with the blank group,
###P＜0.001; Compare with the model group group,
*P＜0.05,
*P＜0.01,
* *P＜0.001; Compare with application number 02153455.1 drug group,
△ △P＜0.01.
Result by table 2 can know: compare with the blank group, the uterus transverse diameter of model group changes each index all has highly significant difference, prompting modeling success; Compare with model group, drug group of the present invention and application number 02153455.1 drug group all have significant difference; With application number 02153455.1 drug group relatively, in the measurement under the subangle, show that drug group of the present invention has significant difference, in the The measured results show of subangle root trend is preferably arranged; Results suggest: drug group of the present invention and application number 02153455.1 drug group relatively have more excellent therapeutical effect for the variation of uterus transverse diameter.
The influence
of table 3 pair Cavia porcellus uterine smooth muscle thickness
| Group | n | Thickness (mm) |
| The blank group | 10 | 25.98±2.57 |
| Model group | 10 | 54.57±6.52 ### |
| Drug group of the present invention | 10 | 32.51±7.54 *** |
| Application number 02153455.1 drug group | 10 | 35.05±8.24 *** |
Annotate: compare with the blank group,
###P＜0.001; Compare with model group,
* *P＜0.001.
Result by table 3 can know: compare with the blank group, the uterine smooth muscle thickness of model group has significant difference, prompting modeling success; Compare with model group, drug group of the present invention and application number 02153455.1 drug group all have significant difference (p＜0.001); Compare with application number 02153455.1 drug group, though drug group of the present invention does not have the difference of significance, its uterine smooth muscle thickness obviously reduces, and shows the effect that it has better treatment hysteromyoma.
Can know by table 1,2 and 3 result: with application number 02153455.1 drug group relatively, drug group of the present invention has tangible anti-leiomyoma of uterus appearance proliferative effect, and the pathological symptom of hysteromyoma is had the good curing effect.
2.5 analgesic activity research:
2.5.1 mice acetic acid is caused the effect of writhing response: 30 of mices; Be divided into 3 groups at random, gastric infusion every day once (the drug group dosage is in the crude drug amount), successive administration 5 days; Behind last gastric infusion 1h; Lumbar injection 0.6% glacial acetic acid 0.2ml/, observe and write down the number of times of mouse writhing reaction in the 20min (abdominal part indent, stretching, extension hind leg, buttocks are raised), the result sees table 4.
The analgesic activity
of table 4 pair mice acetic acid twisting reaction
| Group | Dosage (g/kg) | n | Turn round body number of times (t=20min) |
| The normal saline matched group | - | 10 | 25.38±4.15 |
| Drug group of the present invention | 1.8 | 10 | 12.16±2.01 ###△△ |
| Application number 02153455.1 drug group | 1.8 | 10 | 16.48±3.70 ### |
Annotate: compare with the normal saline group,
###P＜0.001; Compare with application number 02153455.1 drug group,
△ △P＜0.01.
2.5.2 the influence to mice electricity irritation whipping pain threshold: 30 of mices are divided into 3 groups, gastric infusion every day once (the drug group dosage is in the crude drug amount) at random; Successive administration 5 days behind last gastric infusion lh, is put in an electrode on the mice foot; Another electrode stimulating afterbody, after the energising, the pain threshold when observing the mice whipping; And calculating the analgesia suppression ratio, the result sees table 5.
Analgesia suppression ratio=(administration group pain threshold-matched group pain threshold)/matched group pain threshold * 100%
The influence
of table 5 pair mice electricity irritation whipping pain threshold
| Group | Dosage (g/kg) | n | Pain threshold (mA) | Analgesia suppression ratio (%) |
| The normal saline matched group | - | 10 | 0.30±0.11 | |
| Drug group of the present invention | 1.8 | 10 | 0.53±0.064 ###△△ | 76.7％ |
| Application number 02153455.1 drug group | 1.8 | 10 | 0.45±0.025 # | 50.0％ |
Annotate: compare with the normal saline group,
#P＜0.05,
###P＜0.001; Compare with application number 02153455.1 drug group,
△ △P＜0.01.
Research by above-mentioned table 4 and table 5 can be known: compare with the normal saline group, drug group of the present invention and application number 02153455.1 drug group all have the analgesic effect of the significance difference opposite sex; With application number 02153455.1 drug group relatively, drug group of the present invention has the analgesic effect of significant difference, pain complication that can the efficacious therapy hysteromyoma.
2.6 the research of antiinflammatory action:
2.6.1 the influence of the mice ear that xylol causes:
Get 40 of mices, be divided into 4 groups at random, 10 every group, gastric infusion 1 time every day (the drug group dosage is in the crude drug amount); Continuous 5 days, after the last administration 30 minutes, xylene only dripped in mouse right ear by 20 μ l/ carry on the back; Put to death animal after 15 minutes, with the 5mm card punch along the left and right sides auricle same area punching draw materials, weigh respectively; Represent the swelling degree with the two auricle method of double differences, respectively organize the swelling degree and obtain and press down swollen rate, the result sees table 6.
Press down swollen rate=(auris dextra sheet weight-left auricle weight)/left ear weight * 100%
The influence of the mice ear that table 6 xylol causes
Annotate: compare with the normal saline group,
#P＜0.05,
##P＜0.01,
###P＜0.001; Compare with application number 02153455.1 drug group,
△P＜0.05.
Experimental result by table 6 shows: compare with the normal saline group, aspirin matched group, drug group of the present invention and application number 02153455.1 drug group all have the antiphlogistic effects of the significance difference opposite sex; Though drug group of the present invention and application number 02153455.1 drug group comparison there was no significant difference, it has more excellent antiinflammatory action trend.
2.6.2 influence to the rat uterus inflammation:
Get 40 of mices, use the ether light anaesthesia, hypogastric region cropping, skin degerming; The pubic symphysis upper abdomen exposes the uterus along midline incision 2cm, makes a transverse incision along 1cm place on the uterus, left side, and a plastic tube is positioned over intrauterine; With the uterine incision sutured, with slip-off preventing, layering peritoneal suture and skin.At random be divided into 4 group with experimental rat next day, and 10 every group, gastric infusion 1 time every day (the drug group dosage is in the crude drug amount); Continuous 7 days, behind last administration 1h, weigh, put to death; Subangle is got plastic tube to uterus, clip both sides, fallopian tube junction from the uterus, and weighing bilateral uterus is heavy; Calculate inflammation swelling rate and inhibitory rate of intumesce thereof, the result sees table 7.
The swelling rate: (weight-right side, left side is heavy)/right side is heavy
Inhibitory rate of intumesce=(the average swelling rate of the blank control group-average swelling rate of administration group)/average swelling rate of blank control group (%)
The influence of table 7 pair rat uterus inflammation
| Group | Dosage (g/kg) | Swelling rate (%) | Press down swollen rate (%) |
| The normal saline matched group | - | 55.36±8.1 | |
| The aspirin matched group | 0.2 | 20.36±12.3 ###△ | 63.22％ |
| Drug group of the present invention | 1.2 | 24.78±14.02 ###△ | 55.24％ |
| Application number 02153455.1 drug group | 1.2 | 35.88±12.36 ## | 35.19％ |
Annotate: compare with the normal saline group,
##P＜0.01,
###P＜0.001; Compare with application number 02153455.1 drug group,
△P＜0.05.
Experimental result by table 7 shows: compare with the normal saline group, aspirin matched group, drug group of the present invention and application number 02153455.1 drug group all have the effect of Chinese People's Anti-Japanese Military and Political College's Mus inflammation of uterus swelling rate of the significance difference opposite sex; Compare with application number 02153455.1, aspirin matched group and drug group of the present invention all have the effect of Chinese People's Anti-Japanese Military and Political College's Mus inflammation of uterus swelling rate of significant difference.
Result of study prompting by above-mentioned table 6 and table 7: drug group of the present invention has good antiphlogistic effects.
2.7 to the hemorrhage influence of mice docking:
Get 30 of mices, be divided into 3 groups at random, gastric infusion 1 time every day (the drug group dosage is in the crude drug amount); For three days on end, after last administration 2 hours, respectively that mouse tail point 0.5cm place is cross-section; When treating that blood flows out voluntarily; The every suction with filter paper at a distance from 15 seconds dehematized droplet for 1 time, stops naturally until blood, and the result sees table 8.
The table 8 pair hemorrhage influence
of mice docking
| Group | Animal (n) | Dosage (g/kg) | Bleeding time (min) |
| The normal saline matched group | 10 | - | 12.32±1.25 |
| Drug group of the present invention | 10 | 1.8 | 8.01±0.87 ###△△ |
| Application number 02153455.1 drug group | 10 | 1.8 | 9.74±0.96 ### |
Annotate: compare with the normal saline group,
###P＜0.001; Compare with application number 02153455.1 drug group,
△ △P＜0.01.
Experimental result by table 8 shows: compare with the normal saline group, drug group of the present invention and application number 02153455.1 drug group all have the obvious shortening mice docking bleeding time; Compare with application number 02153455.1, the effect that drug group of the present invention shortens the mice docking bleeding time has reached significant difference.Because patients with uterine myoma is attended by bleeding in various degree usually, so drug group of the present invention has anastalsis and will help the hysteromyoma treatment of diseases, strengthens patient's body constitution, promotes absorbing of medicine.
Show according to above research contents; Technology contents of the present invention is on the basis of application number 02153455.1; The Chinese medicine preparation of the treatment hysteromyoma of succeeding in developing in conjunction with the new technique of modern Chinese medicine development, it has steady quality, and bioavailability is high; Drug action obviously is superior to the distinguishing feature of application number 02153455.1, and this will bring great potential and development space for this clinical practice of inventing preparation.
The specific embodiment
Below be the specific embodiment of content of the present invention, be used for setting forth the technical scheme that present specification is wanted the technical solution problem, to help it will be apparent to those skilled in the art that content of the present invention.But the realization of technical scheme of the present invention is not limited to these embodiment.
Embodiment 1
(1) get triangular 64g, Rhizoma Curcumae 64g, Rhizoma Atractylodis Macrocephalae 64g, adding is that 10 times of water gagings soak with the medical material weight ratio, and with behind the 80kHz supersound process 30min; Extract volatile oil 2 times with steam distillation, each 1h is behind the collection volatile oil; Use is the beta-cyclodextrin inclusion compound of 3 times of amounts with the volatile oil weight ratio, and it is subsequent use that the aqueous solution after the distillation filters the back, and medicinal residues add Rhizoma Cyperi (processed) 128g, Cortex Moutan 128g; Adding is the ethanol of 8 times of amounts with the medical material weight ratio, heating and refluxing extraction 2 times, each 1h; Filter, the merging filtrate decompression recycling ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is subsequent use;
(2) get Eupolyphaga Seu Steleophaga 64g, Radix Codonopsis 64g, Fructus Evodiae 64g, Herba Hedyotidis Diffusae 210g, Herba Agrimoniae 126g, adding is that 10 times of water gagings soak with the medical material weight ratio, and heating decocts extraction 2 times; Behind each 1h, filter, after the aqueous solution in filtrating and above-mentioned (1) after the distillation merges; Add ethanol and make that containing the alcohol amount is 70%; Leave standstill centrifugalize behind the 24h, centrifugal liquid reclaims ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is subsequent use;
(3) with glycerol, gelatin and water by weight being after 0.6: 1.0: 1.2 heating and melting becomes glue, adding and glycerol, gelatin and water gross weight be than being 3% titanium dioxide, 6% benzoic acid, degasification, it is subsequent use to process rubber;
(4) clear paste that two places in above-mentioned (1) and (2) is got merges, and is dried and crushed into dried cream powder; 210g is ground into fine powder with Concha Ostreae, cross 100 mesh sieves after, mixes with the volatile oil clathrate compound of gained in dried cream powder and above-mentioned (1), add an amount of soybean oil, lecithin stir capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and promptly gets.
Embodiment 2
(1) get triangular 64g, Rhizoma Curcumae 64g, Rhizoma Atractylodis Macrocephalae 64g, adding is that 8 times of water gagings soak with the medical material weight ratio, and with behind the 40kHz supersound process 45min; Extract volatile oil 3 times with steam distillation, each 1.5h is behind the collection volatile oil; Use is the beta-cyclodextrin inclusion compound of 4 times of amounts with the volatile oil weight ratio, and it is subsequent use that the aqueous solution after the distillation filters the back, and medicinal residues add Rhizoma Cyperi (processed) 128g, Cortex Moutan 128g; Adding is the ethanol of 10 times of amounts with the medical material weight ratio, heating and refluxing extraction 1 time, each 1.5h; Filter, the merging filtrate decompression recycling ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.30 clear paste is subsequent use;
(2) get Eupolyphaga Seu Steleophaga 64g, Radix Codonopsis 64g, Fructus Evodiae 64g, Herba Hedyotidis Diffusae 210g, Herba Agrimoniae 126g, adding is that 12 times of water gagings soak with the medical material weight ratio, and heating decocts extraction 3 times; Behind each 0.5h, filter, after the aqueous solution in filtrating and above-mentioned (1) after the distillation merges; Add ethanol and make that containing the alcohol amount is 50%; Leave standstill centrifugalize behind the 48h, centrifugal liquid reclaims ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.10 clear paste is subsequent use;
(3) with glycerol, gelatin and water by weight being after 0.3: 1.0: 1.0 heating and melting becomes glue, adding and glycerol, gelatin and water gross weight be than being 1% titanium dioxide, 3% sodium benzoate, degasification, it is subsequent use to process rubber;
(4) clear paste that two places in above-mentioned (1) and (2) is got merges, and is dried and crushed into dried cream powder; 210g is ground into fine powder with Concha Ostreae, cross 100 mesh sieves after, mixes with the volatile oil clathrate compound of gained in dried cream powder and above-mentioned (1), add an amount of vegetable oil, Cera Flava stir capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and promptly gets.
Embodiment 3
(1) get triangular 64g, Rhizoma Curcumae 64g, Rhizoma Atractylodis Macrocephalae 64g, adding is that 12 times of water gagings soak with the medical material weight ratio, and with behind the 100kHz supersound process 15min; Extract volatile oil 3 times with steam distillation, each 2h is behind the collection volatile oil; Use is the beta-cyclodextrin inclusion compound of 2 times of amounts with the volatile oil weight ratio, and it is subsequent use that the aqueous solution after the distillation filters the back, and medicinal residues add Rhizoma Cyperi (processed) 128g, Cortex Moutan 128g; Adding is the ethanol of 6 times of amounts with the medical material weight ratio, heating and refluxing extraction 3 times, each 2h; Filter, the merging filtrate decompression recycling ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.10 clear paste is subsequent use;
(2) get Eupolyphaga Seu Steleophaga 64g, Radix Codonopsis 64g, Fructus Evodiae 64g, Herba Hedyotidis Diffusae 210g, Herba Agrimoniae 126g, adding is that 8 times of water gagings soak with the medical material weight ratio, and heating decocts extraction 3 times; Behind each 1.5h, filter, after the aqueous solution in filtrating and above-mentioned (1) after the distillation merges; Add ethanol and make that containing the alcohol amount is 80%; Leave standstill centrifugalize behind the 32h, centrifugal liquid reclaims ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.30 clear paste is subsequent use;
(3) with glycerol, gelatin and water by weight being after 1.0: 1.0: 1.6 heating and meltings become glue, adding and glycerol, gelatin and water gross weight be than being 5% zinc oxide, 10% ethyl hydroxybenzoate, degasification, it is subsequent use to process rubber;
(4) clear paste that two places in above-mentioned (1) and (2) is got merges, and is dried and crushed into dried cream powder; 210g is ground into fine powder with Concha Ostreae, cross 100 mesh sieves after, mixes with the volatile oil clathrate compound of gained in dried cream powder and above-mentioned (1), add an amount of Macrogol 4000, aluminum monostearate stir capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and promptly gets.
Embodiment 4
(1) get triangular 64g, Rhizoma Curcumae 64g, Rhizoma Atractylodis Macrocephalae 64g, adding is that 10 times of water gagings soak with the medical material weight ratio, and with behind the 80kHz supersound process 30min; Extract volatile oil 2 times with steam distillation, each 1h is behind the collection volatile oil; Use is the beta-cyclodextrin inclusion compound of 3 times of amounts with the volatile oil weight ratio, and it is subsequent use that the aqueous solution after the distillation filters the back, and medicinal residues add Rhizoma Cyperi (processed) 128g, Cortex Moutan 128g; Adding is the ethanol of 8 times of amounts with the medical material weight ratio, heating and refluxing extraction 2 times, each 1h; Filter, the merging filtrate decompression recycling ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is subsequent use;
(2) get Eupolyphaga Seu Steleophaga 64g, Radix Codonopsis 64g, Fructus Evodiae 64g, Herba Hedyotidis Diffusae 210g, Herba Agrimoniae 126g, adding is that 10 times of water gagings soak with the medical material weight ratio, and heating decocts extraction 2 times; Behind each 1h, filter, after the aqueous solution in filtrating and above-mentioned (1) after the distillation merges; Add ethanol and make that containing the alcohol amount is 70%; Leave standstill centrifugalize behind the 24h, centrifugal liquid reclaims ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is subsequent use;
(3) with glycerol, gelatin and water by weight being after 0.8: 1.0: 1.4 heating and melting becomes glue, adding and glycerol, gelatin and water gross weight be than being 2% titanium dioxide, 8% sorbic acid, degasification, it is subsequent use to process rubber;
(4) clear paste that two places in above-mentioned (1) and (2) is got merges, and is dried and crushed into dried cream powder; 210g is ground into fine powder with Concha Ostreae, cross 100 mesh sieves after, mixes with the volatile oil clathrate compound of gained in dried cream powder and above-mentioned (1), add an amount of polyethylene glycol 6000, ethyl cellulose stir capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and promptly gets.
Embodiment 5
(1) get triangular 64g, Rhizoma Curcumae 64g, Rhizoma Atractylodis Macrocephalae 64g, adding is that 10 times of water gagings soak with the medical material weight ratio, and with behind the 80kHz supersound process 30min; Extract volatile oil 2 times with steam distillation, each 1h is behind the collection volatile oil; Use is the beta-cyclodextrin inclusion compound of 3 times of amounts with the volatile oil weight ratio, and it is subsequent use that the aqueous solution after the distillation filters the back, and medicinal residues add Rhizoma Cyperi (processed) 128g, Cortex Moutan 128g; Adding is the ethanol of 8 times of amounts with the medical material weight ratio, heating and refluxing extraction 2 times, each 1h; Filter, the merging filtrate decompression recycling ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is subsequent use;
(2) get Eupolyphaga Seu Steleophaga 64g, Radix Codonopsis 64g, Fructus Evodiae 64g, Herba Hedyotidis Diffusae 210g, Herba Agrimoniae 126g, adding is that 10 times of water gagings soak with the medical material weight ratio, and heating decocts extraction 2 times; Behind each 1h, filter, after the aqueous solution in filtrating and above-mentioned (1) after the distillation merges; Add ethanol and make that containing the alcohol amount is 70%; Leave standstill centrifugalize behind the 24h, centrifugal liquid reclaims ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is subsequent use;
(3) with glycerol, gelatin and water by weight being after 0.5: 1.0: 1.2 heating and melting becomes glue, adding and glycerol, gelatin and water gross weight be than being 3% zinc oxide, 5% sorbic acid clock, degasification, it is subsequent use to process rubber;
(4) clear paste that two places in above-mentioned (1) and (2) is got merges, and is dried and crushed into dried cream powder; 210g is ground into fine powder with Concha Ostreae, cross 100 mesh sieves after, mixes with the volatile oil clathrate compound of gained in dried cream powder and above-mentioned (1), add an amount of PEG400, propylene glycol stir capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and promptly gets.
Zinc oxide in the above-mentioned technology can replace by the mixture that different proportionings form with zinc oxide with titanium dioxide; Potassium sorbate can use two kinds in benzoic acid, sodium benzoate, ethyl hydroxybenzoate, sorbic acid, the potassium sorbate perhaps two or more, and the mixture that forms by different proportionings replaces; Propylene glycol can use two kinds in Cera Flava, lecithin, aluminum monostearate, ethyl cellulose, the propylene glycol perhaps two or more, and the mixture that forms by different proportionings replaces.
Claims (11)
1. Chinese medicinal soft capsule agent of treating hysteromyoma is characterized in that it is to be formed by following prepared:
A. raw material is formed: 210 parts of Concha Ostreaes, 128 parts of Rhizoma Cyperi (processed), triangular 64 parts, 64 parts of Rhizoma Curcumae, 64 parts of Eupolyphaga Seu Steleophagas, 64 parts of Radix Codonopsis, 64 parts of the Rhizoma Atractylodis Macrocephalaes, 64 parts of Fructus Evodiaes, 210 parts of Herba Hedyotidis Diffusaes, 126 parts of Herba Agrimoniaes, 128 parts of Cortex Moutans;
B. preparation technology: with 11 flavor raw material of Chinese medicine among the above-mentioned A, by following procedure:
(1) get triangular, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, soak and supersound process after, extract volatile oil with steam distillation; Collect volatile oil and use beta-cyclodextrin inclusion compound; It is subsequent use that aqueous solution after the distillation filters the back, and medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan, add alcohol reflux; Filter filtrate recycling ethanol and to be condensed into clear paste subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae; Soak, after the heating decoction extraction, the aqueous solution merging back after filtration filtrating is distilled with above-mentioned (1) is middle adds ethanol; Leave standstill the back centrifugalize, centrifugal liquid reclaims ethanol and concentrating under reduced pressure becomes clear paste subsequent use;
(3) after heating and melting becomes glue according to a certain percentage with glycerol, gelatin and water, add opacifier, antiseptic, degasification, it is subsequent use to process rubber;
(4) clear paste that two places in above-mentioned (1) and (2) is got merges, and is dried and crushed into dried cream powder; After Concha Ostreae powder is broken into fine powder, mixes with the volatile oil clathrate compound of gained in dried cream powder and above-mentioned (1), and add dispersant, suspending agent after stirring capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and promptly gets.
2. the method for preparing of the Chinese medicinal soft capsule agent of treatment hysteromyoma as claimed in claim 1 is characterized in that:
A. raw material is formed: 210 parts of Concha Ostreaes, 128 parts of Rhizoma Cyperi (processed), triangular 64 parts, 64 parts of Rhizoma Curcumae, 64 parts of Eupolyphaga Seu Steleophagas, 64 parts of Radix Codonopsis, 64 parts of the Rhizoma Atractylodis Macrocephalaes, 64 parts of Fructus Evodiaes, 210 parts of Herba Hedyotidis Diffusaes, 126 parts of Herba Agrimoniaes, 128 parts of Cortex Moutans;
B. preparation technology: with 11 flavor raw material of Chinese medicine among the above-mentioned A, by following procedure:
(1) get triangular, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, soak and supersound process after, extract volatile oil with steam distillation; Collect volatile oil and use beta-cyclodextrin inclusion compound; It is subsequent use that aqueous solution after the distillation filters the back, and medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan, add alcohol reflux; Filter filtrate recycling ethanol and to be condensed into clear paste subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, soak, after heating decocts and extracts; Filter; Aqueous solution after filtrating is distilled with above-mentioned (1) is middle merges the back and adds ethanol, centrifugalize after leaving standstill, and centrifugal liquid recovery ethanol and concentrating under reduced pressure become clear paste subsequent use;
(3) after heating and melting becomes glue according to a certain percentage with glycerol, gelatin and water, add opacifier, antiseptic, degasification, it is subsequent use to process rubber;
(4) clear paste that two places in above-mentioned (1) and (2) is got merges, and is dried and crushed into dried cream powder; After Concha Ostreae powder is broken into fine powder, mixes with the volatile oil clathrate compound of gained in dried cream powder and above-mentioned (1), and add dispersant, suspending agent after stirring capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and promptly gets.
3. the method for preparing of the Chinese medicinal soft capsule agent of treatment hysteromyoma as claimed in claim 2 is characterized in that:
(1) get triangular, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, add with the medical material weight ratio be that 8～12 times of water gagings soak, and with behind 40kHz～100kHz supersound process 15～45min; Extract volatile oil 2～3 times with steam distillation, each 1～2h is behind the collection volatile oil; Use is the beta-cyclodextrin inclusion compound of 2～4 times of amounts with the volatile oil weight ratio, and it is subsequent use that the aqueous solution after the distillation filters the back, and medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan; Adding is the ethanol of 6～10 times of amounts with the medical material weight ratio, heating and refluxing extraction 1～3 time, each 1～2h; Filter, the merging filtrate decompression recycling ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.10～1.30 clear paste is subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, adding is that 8～12 times of water gagings soak with the medical material weight ratio, and heating decocts extraction 2～3 times; Behind each 0.5～1.5h, filter, after the aqueous solution after filtrating is distilled with above-mentioned (1) is middle merges; Add ethanol and make that containing the alcohol amount reaches 50%～80%; Leave standstill centrifugalize behind 24～48h, centrifugal liquid reclaims ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.10～1.30 clear paste is subsequent use;
(3) after heating and melting becomes glue according to a certain percentage with glycerol, gelatin and water, add opacifier, antiseptic, degasification, it is subsequent use to process rubber;
(4) clear paste that two places in above-mentioned (1) and (2) is got merges, and is dried and crushed into dried cream powder; Concha Ostreae powder is broken into fine powder, cross 100 mesh sieves after, mixes with the volatile oil clathrate compound of gained in dried cream powder and above-mentioned (1), and add dispersant, suspending agent after stirring capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and promptly gets.
4. the method for preparing of the Chinese medicinal soft capsule agent of treatment hysteromyoma as claimed in claim 3 is characterized in that:
(1) get triangular, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, add with the medical material weight ratio be that 10 times of water gagings soak, and with behind the 80kHz supersound process 30min; Extract volatile oil 2 times with steam distillation, each 1h is behind the collection volatile oil; Use is the beta-cyclodextrin inclusion compound of 3 times of amounts with the volatile oil weight ratio, and it is subsequent use that the aqueous solution after the distillation filters the back, and medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan; Adding is the ethanol of 8 times of amounts with the medical material weight ratio, heating and refluxing extraction 2 times, each 1h; Filter, the merging filtrate decompression recycling ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, adding is that 10 times of water gagings soak with the medical material weight ratio, and heating decocts extraction 2 times; Behind each 1h, filter, after the aqueous solution in filtrating and above-mentioned (1) after the distillation merges; Add ethanol and make that containing the alcohol amount is 70%; Leave standstill centrifugalize behind the 24h, centrifugal liquid reclaims ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is subsequent use;
(3) after heating and melting becomes glue according to a certain percentage with glycerol, gelatin and water, add opacifier, antiseptic, degasification, it is subsequent use to process rubber;
(4) clear paste that two places in above-mentioned (1) and (2) is got merges, and is dried and crushed into dried cream powder; Concha Ostreae powder is broken into fine powder, cross 100 mesh sieves after, mixes with the volatile oil clathrate compound of gained in dried cream powder and above-mentioned (1), and add dispersant, suspending agent after stirring capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and promptly gets.
5. like the opacifier of the Chinese medicinal soft capsule agent of the described treatment hysteromyoma of the arbitrary claim of claim 2-4, it is characterized in that selecting for use one or both the mixture in titanium dioxide, the zinc oxide.
6. like the antiseptic of the Chinese medicinal soft capsule agent of the described treatment hysteromyoma of the arbitrary claim of claim 2-4, it is characterized in that selecting for use one or more the mixture in benzoic acid, sodium benzoate, ethyl hydroxybenzoate, sorbic acid, the potassium sorbate.
7. like the dispersant of the Chinese medicinal soft capsule agent of the described treatment hysteromyoma of the arbitrary claim of claim 2-4, it is characterized in that selecting for use polyethylene glycols or vegetable oil.
8. like the suspending agent of the Chinese medicinal soft capsule agent of the described treatment hysteromyoma of the arbitrary claim of claim 2-4, it is characterized in that selecting for use one or more the mixture in Cera Flava, lecithin, aluminum monostearate, ethyl cellulose, the propylene glycol.
9. like the method for preparing of the Chinese medicinal soft capsule agent of the described treatment hysteromyoma of the arbitrary claim of claim 2-4; It is characterized in that: the weight ratio of glycerol, gelatin and water is 0.3～1.0: 1.0: 1.0～1.6; Opacifier is 1%～5% with glycerol, gelatin and water three gross weight ratio, and antiseptic is 3%～10% with glycerol, gelatin and water three gross weight ratio.
10. the method for preparing of the Chinese medicinal soft capsule agent of treatment hysteromyoma as claimed in claim 9 is characterized in that: the weight ratio of glycerol, gelatin and water is 0.6: 1.0: 1.2.
11. the method for preparing of the Chinese medicinal soft capsule agent of treatment hysteromyoma as claimed in claim 9 is characterized in that: said opacifier is a titanium dioxide, with glycerol, gelatin and water three gross weight ratio be 3%; Said antiseptic is a benzoic acid, with glycerol, gelatin and water three gross weight ratio be 6%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011102183605A CN102319391B (en) | 2011-08-01 | 2011-08-01 | Chinese medicinal soft capsule for treating uterine fibroid and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011102183605A CN102319391B (en) | 2011-08-01 | 2011-08-01 | Chinese medicinal soft capsule for treating uterine fibroid and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102319391A true CN102319391A (en) | 2012-01-18 |
| CN102319391B CN102319391B (en) | 2013-04-10 |
Family
ID=45447316
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2011102183605A Active CN102319391B (en) | 2011-08-01 | 2011-08-01 | Chinese medicinal soft capsule for treating uterine fibroid and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102319391B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103385953A (en) * | 2013-07-18 | 2013-11-13 | 上海中医药大学附属岳阳中西医结合医院 | A traditional Chinese medicine composition for the treatment of menopausal uterine fibroids and applications thereof |
| CN107582754A (en) * | 2017-08-11 | 2018-01-16 | 成都市飞龙水处理技术研究所青白江第分所 | A kind of pill medicine for treating leiomyoma of uterus and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1562177A (en) * | 2004-03-17 | 2005-01-12 | 北京奇源益德药物研究所 | Chinese materia medica preparation for treating hysteromyoma and preparation method |
-
2011
- 2011-08-01 CN CN2011102183605A patent/CN102319391B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1562177A (en) * | 2004-03-17 | 2005-01-12 | 北京奇源益德药物研究所 | Chinese materia medica preparation for treating hysteromyoma and preparation method |
Non-Patent Citations (3)
| Title |
|---|
| 时军等: "辅料在软胶囊剂型中的应用", 《中医药学刊》 * |
| 李会军等: "中药液体制剂中防腐剂的应用", 《中国野生植物资源》 * |
| 赖筱琍等: "宫瘤清胶囊治疗子宫肌瘤94例", 《江西中医药》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103385953A (en) * | 2013-07-18 | 2013-11-13 | 上海中医药大学附属岳阳中西医结合医院 | A traditional Chinese medicine composition for the treatment of menopausal uterine fibroids and applications thereof |
| CN103385953B (en) * | 2013-07-18 | 2015-04-08 | 上海中医药大学附属岳阳中西医结合医院 | A traditional Chinese medicine composition for the treatment of menopausal uterine fibroids and applications thereof |
| CN107582754A (en) * | 2017-08-11 | 2018-01-16 | 成都市飞龙水处理技术研究所青白江第分所 | A kind of pill medicine for treating leiomyoma of uterus and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102319391B (en) | 2013-04-10 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102319391B (en) | Chinese medicinal soft capsule for treating uterine fibroid and preparation method thereof | |
| CN102908579B (en) | Traditional Chinese medicine preparation for treating gynecological diseases, liver diseases and prostatitis and preparation method of traditional Chinese medicine preparation | |
| CN100344307C (en) | Traditional Chinese medicine for treating bed sore, and its prepn. method | |
| CN102688361B (en) | A kind of Chinese medicine composition treating dysmenorrhea and preparation thereof | |
| CN100450517C (en) | Dysmenorrhea treating Chinese traditional medicine preparation | |
| CN103405615B (en) | TCM (Traditional Chinese Medicine) composition for invigorating kidney and strengthening Yang and preparation method of TCM composition | |
| CN101332282B (en) | Traditional Chinese medicine composition for treating gynecologic diseases from kidney deficiency and genitals coldness, and its preparation method | |
| CN100473396C (en) | Combination of medication for treating disease of hyperplasia of mammary glands glands and preparation method thereof | |
| CN103768478B (en) | One is treated prostatitic Chinese medicine composition and its production and use | |
| CN102038821B (en) | Method for preparing medicinal composition for treating dysmenorrhea | |
| CN103405614B (en) | TCM (Traditional Chinese Medicine) composition for invigorating kidney and strengthening Yang and preparation method of TCM composition | |
| CN102319392B (en) | Traditional Chinese medicine pill for treating uterine fibroids and preparation method thereof | |
| CN101590126B (en) | TCM composite for treating benign prostatic hyperplasia | |
| CN102274459B (en) | Chinese medicinal preparation for treating uterine fibroid and preparation method thereof | |
| CN108524576B (en) | Pharmaceutical composition for treating impotence, medicine and preparation method of medicine | |
| CN102626502A (en) | Traditional Chinese medicinal composition for treating mammary gland hyperplasia | |
| CN101559196B (en) | Medicament for treating the hyperplasia of mammary glands and preparation method thereof | |
| CN101757309A (en) | Medicament for treating uterine bleeding and preparation process thereof | |
| CN102125671A (en) | Traditional Chinese medicinal composition for treating gynaecopathia caused by deficiency of the kidney and cold and preparation method thereof | |
| CN1330366C (en) | Piles ointment and its preparation method | |
| CN103656063A (en) | Medicine for treating chronic prostatitis | |
| CN103495079B (en) | Chinese herbal compound composition with male infertility therapy effect and preparation method and application of Chinese herbal compound composition | |
| CN102671113B (en) | Traditional Chinese medicine composition for treating nodules of breasts and preparation method of traditional Chinese medicine composition | |
| CN102698126B (en) | Traditional Chinese medicine compound having effect of treating prostatitis and preparation method thereof | |
| CN102188580A (en) | Externally used traditional Chinese medicine composition and cataplasm for treating lobular hyperplasia of mammary gland, and preparation methods thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| ASS | Succession or assignment of patent right |
Owner name: SHAANXI BUCHANG HIGH-TECH. PHARMACEUTICAL CO., LTD Free format text: FORMER OWNER: SHAANXI BUCHANG PHARMACEUTICALS CO., LTD. Effective date: 20121130 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 712000 XIANYANG, SHAANXI PROVINCE TO: 710119 XI AN, SHAANXI PROVINCE |
|
| TA01 | Transfer of patent application right |
Effective date of registration: 20121130 Address after: 710119, No. 70, West Avenue, new industrial zone, Changan District hi tech Development Zone, Shaanxi, Xi'an Applicant after: Shaanxi Buchang High-Tech Pharmaceutical Co., Ltd. Address before: 712000 Xianyang city of Shaanxi province qindouou Weiyang Road West No. 123 Applicant before: Shaanxi Buchang Pharmaceutical Co.,Ltd. |
|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |