CN102319391B - 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
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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 for the treatment of hysteromyoma and preparation method thereof, belong to the pharmaceutical preparations technology field.
Background technology
Hysteromyoma claims again fibroma uteri, is the modal benign tumor of female reproductive system, and the women at fertile age sickness rate is about 25%, accounts for 51.87% in all benign tumors of women, 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, such as untimely treatment, might change malignant tumor into.
The cause of disease and pathogenesis for hysteromyoma is complicated at present, and classical research thinks that hysteromyoma is a kind of ovarian sex hormone dependency benign tumor, and estrogen plays a crucial role in it occurs, and estrogenic over-effect has promoted the genesis of hysteromyoma.Clinically medicine and the 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; but side effect is large; usually can affect the normal hormone secretion level of inside of human body; destroy the human normal physiological equilibrium; manlike feature in various degree occurs, muscular tumor is grown again after the drug withdrawal, finally is difficult to thoroughly obtain radical cure.Operative treatment effective, however operative treatment brings larger 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 the 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 solve the hysteromyoma problem with the method for Chinese medicine and more and more come into one's own the again understanding again of Chinese medicine theoretical essence, Chinese medicine is on hysteromyoma is treated, and following advantage is arranged: 1. therapeutic effect is remarkable; 2. have no side effect; 3. without 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 development and the exploitation of this type of medicine.
Between this; we have successively applied for patent of invention and have obtained mandate; application number is in 02153455.1 patent application document; mainly be from preparation prescription; the protection of the aspects such as dosage form preparation technology, the present invention are to carry out on this basis a large amount of experimentatioies, with further replenishment of process preparation method; improving medicine stability and bioavailability is purpose, and creationary a kind of Chinese medicine preparation for the treatment of 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 solution of the present invention is to be prepared from by following technique:
A. raw material forms: 210 parts of Concha Ostreaes, 128 parts of Rhizoma Cyperi (processed), 64 parts of rhizoma sparganic, 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, in the steps below operations among the above-mentioned A:
(1) gets rhizoma sparganic, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, soak and ultrasonic Treatment after, use extraction by steam distillation volatile oil, collect volatile oil and use beta-cyclodextrin inclusion compound, aqueous solution after the distillation is for subsequent use after filtering, and medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan, add alcohol reflux, filter filtrate recycling ethanol and to be condensed into clear paste for subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, soak, after heating decocts and extracts, filter, add ethanol after aqueous solution in filtrate and above-mentioned (1) after the distillation merges, leave standstill rear centrifugalize, centrifugal liquid Recycled ethanol and concentrating under reduced pressure become clear paste for 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 for subsequent use to make 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 evenly capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and be get final product.
Opacifier among the preparation technology of above-mentioned soft capsule is selected is a kind of or mixture in titanium dioxide, the zinc oxide; Antiseptic is selected is one or more mixture in benzoic acid, sodium benzoate, ethyl hydroxybenzoate, sorbic acid, the potassium sorbate; What dispersant was selected is polyethylene glycols or vegetable oil; Suspending agent is selected is one or more mixture in Cera Flava, lecithin, aluminum monostearate, ethyl cellulose, the propylene glycol.
Technical solution of the present invention specifically is prepared from by following steps:
(1) gets rhizoma sparganic, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, adding with the medical material weight ratio is that 8～12 times of water gagings soak, and with behind 40kHz～100kHz supersound process 15～45min, with extraction by steam distillation volatile oil 2～3 times, each 1～2h, after collecting volatile oil, with with the volatile oil weight ratio be the beta-cyclodextrin inclusion compound of 2～4 times of amounts, aqueous solution after the distillation is for subsequent use after filtering, and medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan, adding with the medical material weight ratio is the ethanol of 6～10 times of amounts, heating and refluxing extraction 1～3 time, 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 for subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, adding with the medical material weight ratio is that 8～12 times of water gagings soak, heating decocts extracts 2～3 times, behind each 0.5～1.5h, filter, after the aqueous solution in filtrate and above-mentioned (1) after the distillation merges, add ethanol to contain the alcohol amount be 50%～80%, leave standstill centrifugalize behind 24～48h, the centrifugal liquid Recycled ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.10～1.30 clear paste is for 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 for subsequent use to make 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 evenly capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and be get final product.
The comparatively concrete technical scheme of the present invention is to be prepared from by following steps:
(1) gets rhizoma sparganic, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, adding with the medical material weight ratio is that 10 times of water gagings soak, and with behind the 80kHz supersound process 30min, with extraction by steam distillation volatile oil 2 times, each 1h, after collecting volatile oil, with with the volatile oil weight ratio be the beta-cyclodextrin inclusion compound of 3 times of amounts, aqueous solution after the distillation is for subsequent use after filtering, medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan, adding with the medical material weight ratio is the ethanol of 8 times of amounts, heating and refluxing extraction 2 times, each 1h filters, 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 for subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, adding with the medical material weight ratio is that 10 times of water gagings soak, heating decocts extracts 2 times, behind each 1h, filter, after the aqueous solution in filtrate and above-mentioned (1) after the distillation merges, add ethanol to contain the alcohol amount be 70%, leave standstill centrifugalize behind the 24h, the centrifugal liquid Recycled ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is for subsequent use;
(3) be after 0.3～1.0: 1.0: 1.0～1.6 heating and meltings become glue by weight with glycerol, gelatin and water, 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 for subsequent use to make 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 evenly capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and be get final product.
Final preferred process of preparing is as follows in the technical solution of the present invention:
(1) gets rhizoma sparganic, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, adding with the medical material weight ratio is that 10 times of water gagings soak, and with behind the 80kHz supersound process 30min, with extraction by steam distillation volatile oil 2 times, each 1h, after collecting volatile oil, with with the volatile oil weight ratio be the beta-cyclodextrin inclusion compound of 3 times of amounts, aqueous solution after the distillation is for subsequent use after filtering, medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan, adding with the medical material weight ratio is the ethanol of 8 times of amounts, heating and refluxing extraction 2 times, each 1h filters, 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 for subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, adding with the medical material weight ratio is that 10 times of water gagings soak, heating decocts extracts 2 times, behind each 1h, filter, after the aqueous solution in filtrate and above-mentioned (1) after the distillation merges, add ethanol to contain the alcohol amount be 70%, leave standstill centrifugalize behind the 24h, the centrifugal liquid Recycled ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is for subsequent use;
(3) be after 0.6: 1.0: 1.2 heating and melting becomes glue by weight with glycerol, gelatin and water, adding and glycerol, gelatin and water three gross weight be than being 3% titanium dioxide, 6% benzoic acid, degasification, and it is for subsequent use to make 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 stirs evenly to get capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and be get final product.
Technical solution 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 comprised of the 11 flavor Chinese crude drugs such as Concha Ostreae, Rhizoma Cyperi (processed), rhizoma sparganic and Rhizoma Curcumae, and its prescription is simplified proper; Wherein contain a large amount of volatile oils, water solublity and pure dissolubility effective ingredient in rhizoma sparganic, Rhizoma Curcumae and the Rhizoma Atractylodis Macrocephalae 3 flavor medical materials, therefore, after first it being carried out extraction by steam distillation 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 as much as possible again the effective ingredient of various different physicochemical properties, also reach simultaneously the effect that improves extraction efficiency.In addition, with Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae and Herba Agrimoniae, carry out the water boiling and extraction aqueous soluble active constituent, then add the remove impurity of ethanol precipitate with ethanol, finally reach the purpose of efficient medication.
B. we are in the middle of the research process of invention, chance on need are extracted medical material and pass through ultrasonic pretreatment first after, the extraction ratio of its effective ingredient significantly improves, mainly be because the chemical constituent in the medical material that prescription forms, by hyperacoustic cavitation, effect of vibration and heating effect, can be so that the destruction of crude drug cell, thus accelerate release and the stripping of effective ingredient, to be a very large 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, take Concha Ostreae as monarch drug, has resolving phlegm and softening hard masses, yin fluid astringing YANG hyperactivity suppressing, the effect of hidroschesis arresting seminal emission.In addition, the Concha Ostreae quality is hard, and mealiness is stronger, and water absorption is relatively poor, therefore considers and brings into play to greatest extent its effect, is used as medicine so we are ground into fine powder with it; In addition, can also play the effect of " the auxiliary unification of medicine ", demonstrate fully flexibility ratio and the novelty of Chinese medicine preparation preparation.
D. the present invention is soft capsule dosage form, compared to hard capsule, it is concentrated to have the medicine height, the capsule small volume is easy to take, the advantage such as diffusion absorption is very fast after the preparation disintegrate, but it is difficult also to exist medicine to purify simultaneously, dosage form is easy-formation not, the shortcomings such as stability relative mistake, therefore soft capsule preparation of the present invention is in moulding process, we are in conjunction with the result of study of prescription flavour of a drug character and extraction and purification process thereof, chance on glycerol, gelatin and water are according to certain ratio, and then add a certain amount of dispersant, suspending agent and antiseptic, to make curative effect reliable with the various extracts in the technical scheme, stay-in-grade soft capsule preparation.
2. pharmacodynamic study
Because content of the present invention is to be that 02153455.1 basis improves at application number, so the contrast of we high spot reviews and the disclosure technical scheme 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 save, 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 namely all made the mode that then dried cream powder be mixed with the same concentrations administering medical liquids according to extraction process scheme separately with the two respectively and is compared.We mainly study from aspects such as anti-leiomyoma of uterus sample 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 that the present invention reaches finally is described.
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 Experimental agents group:
A. the preparation of medicine group of the present invention: (1) gets rhizoma sparganic 64g, Rhizoma Curcumae 64g, Rhizoma Atractylodis Macrocephalae 64g, adding with the medical material weight ratio is that 10 times of water gagings soak, and with behind the 80kHz supersound process 30min, with extraction by steam distillation volatile oil 2 times, each 1h, after collecting volatile oil, with with the volatile oil weight ratio be the beta-cyclodextrin inclusion compound of 3 times of amounts, aqueous solution after the distillation is for subsequent use after filtering, medicinal residues add Rhizoma Cyperi (processed) 128g, Cortex Moutan 128g, adding with the medical material weight ratio is the ethanol of 8 times of amounts, heating and refluxing extraction 2 times, each 1h filters, 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 for subsequent use;
(2) get Eupolyphaga Seu Steleophaga 64g, Radix Codonopsis 64g, Fructus Evodiae 64g, Herba Hedyotidis Diffusae 210g, Herba Agrimoniae 126g, adding with the medical material weight ratio is that 10 times of water gagings soak, heating decocts extracts 2 times, behind each 1h, filter, after the aqueous solution during filtrate and above-mentioned (1) distillation are rear merges, add ethanol to contain the alcohol amount be 70%, leave standstill centrifugalize behind the 24h, the centrifugal liquid Recycled ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is for 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; Concha Ostreae 210g is ground into fine powder, crosses 100 mesh sieves, with the volatile oil clathrate compound mix homogeneously of gained in dried cream powder and above-mentioned (1), for subsequent use.
B. the preparation of application number 02153455.1 medicine group: get rhizoma sparganic 64g, Rhizoma Curcumae 64g, Rhizoma Cyperi (processed) 128g, Cortex Moutan 128g, it is for 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, decoct with water 2 times, 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 alcohol amount and reach 50%, cold preservation 24 hours, filter, decompression filtrate recycling ethanol, and continue to be condensed into thick paste, stir evenly with above-mentioned fine powder, vacuum drying, dried cream powder is broken, and is for subsequent use.
The dried cream powder that above-mentioned A, B are prepared gained is mixed with the same concentrations administering medical liquids with distilled water before use.
2.4 the research of anti-leiomyoma of uterus sample proliferative effect:
40 Cavia porcelluss are divided into blank group, model group, medicine group of the present invention and application number 02153455.1 medicine group, 10 every group at random.Except 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 gavage every day is only taken normal saline 2ml/, medicine group of the present invention and application number 02153455.1 medicine group, and every day, gavage was taken 1.1g/kg (in the crude drug amount) respectively.The blank group is conventional raises, and every day, gavage was only taken normal saline 2ml/.After 3 months, all animals are weighed, the execution of tapping the head is cut open the belly and is observed the uterus general form, along clip uterus, bladder junction, uterus, weigh, calculate uterus coefficient (uterus weight/body weight * 100), measure the above and subangle uterus root transverse diameter of cervix uteri, then measure smooth muscle thickness in the microscopically micrometer, average, its result is as follows:
Table 1 is on the impact of 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 medicine group,
△P＜0.05,
△ △P＜0.01.
As shown in Table 1: 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, medicine group of the present invention and application number 02153455.1 medicine 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 medicine group, medicine group curative effect of the present invention has the Different therapeutical effect of significance.
The impact that table 2 changes Cavia porcellus uterus transverse diameter
| 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 ### |
| Medicine group of the present invention | 10 | 0.98±0.12 ***△△ | 0.38±0.09 *** |
| Application number 02153455.1 medicine 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 medicine group,
△ △P＜0.01.
As shown in Table 2: compare with the blank group, the uterus transverse diameter of model group changes each index all highly significant difference, prompting modeling success; Compare with model group, medicine group of the present invention and application number 02153455.1 medicine group all have significant difference; With application number 02153455.1 medicine group relatively, in the measurement under the subangle, show that medicine group of the present invention has significant difference, show preferably trend in the measurement result of subangle root; Results suggest: medicine group of the present invention and application number 02153455.1 medicine group relatively have more excellent therapeutical effect for the variation of uterus transverse diameter.
Table 3 is on the impact of 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 ### |
| Medicine group of the present invention | 10 | 32.51±7.54 *** |
| Application number 02153455.1 medicine group | 10 | 35.05±8.24 *** |
Annotate: compare with the blank group,
###P＜0.001; Compare with model group,
* *P＜0.001.
As shown in Table 3: compare with the blank group, the uterine smooth muscle thickness of model group has significant difference, prompting modeling success; Compare with model group, medicine group of the present invention and application number 02153455.1 medicine group all have significant difference (p＜0.001); With application number 02153455.1 medicine group relatively, though medicine group of the present invention without the difference of significance, its uterine smooth muscle thickness obviously reduces, and shows the effect that it has better treatment hysteromyoma.
By table 1,2 and 3 result as can be known: with application number 02153455.1 medicine group relatively, medicine group of the present invention has obvious anti-leiomyoma of uterus sample proliferative effect, and the pathological symptom of hysteromyoma is had good therapeutical effect.
2.5 analgesic activity research:
2.5.1 mice acetic acid is caused the effect of writhing response: 30 of mices, be divided at random 3 groups, gastric infusion every day once (medicine 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 record the number of times of mouse writhing reaction in the 20min (abdominal part indent, stretching, extension hind leg, buttocks are raised), the results are shown in Table 4.
The analgesic activity of table 4 pair mice acetic acid twisting reaction
| Group | Dosage (g/kg) | n | Writhing number of times (t=20min) |
| The normal saline matched group | - | 10 | 25.38±4.15 |
| Medicine group of the present invention | 1.8 | 10 | 12.16±2.01 ###△△ |
| Application number 02153455.1 medicine group | 1.8 | 10 | 16.48±3.70 ### |
Annotate: compare with the normal saline group,
###P＜0.001; Compare with application number 02153455.1 medicine group,
△ △P＜0.01.
2.5.2 the impact on mice electricity irritation whipping pain threshold: 30 of mices, be divided at random 3 groups, gastric infusion every day once (medicine group dosage is in the crude drug amount), successive administration 5 days is behind last gastric infusion lh, one electrode is put on the mice foot, another electrode stimulating afterbody, after the energising, the pain threshold when observing the mice whipping, and calculate the analgesia suppression ratio, the results are shown in Table 5.
Analgesia suppression ratio=(administration group pain threshold-matched group pain threshold)/matched group pain threshold * 100%
Table 5 is on the impact of 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 | |
| Medicine group of the present invention | 1.8 | 10 | 0.53±0.064 ###△△ | 76.7％ |
| Application number 02153455.1 medicine 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 medicine group,
△ △P＜0.01.
By the research of above-mentioned table 4 and table 5 as can be known: with the normal saline group relatively, medicine group of the present invention and application number 02153455.1 medicine group all have the analgesic effect of the significance difference opposite sex; Compare with application number 02153455.1 medicine group, medicine group of the present invention has the analgesic effect of significant difference, can effectively treat the Pain Complication of hysteromyoma.
2.6 the research of antiinflammatory action:
2.6.1 the impact of the mice ear that xylol causes:
Get 40 of mices, be divided at random 4 groups, 10 every group, gastric infusion 1 time every day (medicine group dosage is in the crude drug amount), continuous 5 days, after the last administration 30 minutes, dimethylbenzene only dripped in mouse right ear by 20 μ l/ carry on the back, put to death animal after 15 minutes, draw materials along the punching of left and right sides auricle same area with the 5mm card punch, 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 results are shown in Table 6.
Press down swollen rate=(auris dextra sheet weight-left auricle weight)/left ear weight * 100%
The impact 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 medicine group,
△P＜0.05.
Experimental result by table 6 shows: compare the antiphlogistic effects that aspirin matched group, medicine group of the present invention and application number 02153455.1 medicine group all have the significance difference opposite sex with the normal saline group; Though medicine group of the present invention and application number 02153455.1 medicine group comparison there was no significant difference, it has more excellent antiinflammatory action trend.
2.6.2 the impact on 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, fix with Uterine repair, with slip-off preventing, layering peritoneal suture and skin.At random be divided into 4 group with experimental rat next day, every group 10, gastric infusion 1 time every day (medicine group dosage is in the crude drug amount) continuous 7 days, is weighed behind last administration 1h, put to death, to uterus, clip both sides, fallopian tube junction, get plastic tube from the uterus subangle, weighing bilateral uterus is heavy, calculate inflammation swelling rate and inhibitory rate of intumesce thereof, the results are shown in Table 7.
Swelling rate: (weight-right side, left side is heavy)/right side is heavy
Inhibitory rate of intumesce=(blank group average swelling rate-average swelling rate of administration group)/blank group average swelling rate (%)
Table 7 is on the impact of 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％ |
| Medicine group of the present invention | 1.2 | 24.78±14.02 ###△ | 55.24％ |
| Application number 02153455.1 medicine 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 medicine group,
△P＜0.05.
Experimental result by table 7 shows: compare with the normal saline group, aspirin matched group, medicine group of the present invention and application number 02153455.1 medicine 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 medicine 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: medicine group of the present invention has good antiphlogistic effects.
2.7 on the hemorrhage impact of mice docking:
Get 30 of mices, be divided at random 3 groups, gastric infusion 1 time every day (medicine group dosage is in the crude drug amount), for three days on end, after last administration 2 hours, respectively that Mouse Tail-tip 0.5cm place is cross-section, when treating that blood flows out voluntarily, suck drop of blood 1 time every 15 seconds with filter paper, until blood stops naturally, the results are shown in Table 8.
Table 8 is on the hemorrhage impact of mice docking
| Group | Animal (n) | Dosage (g/kg) | Bleeding time (min) |
| The normal saline matched group | 10 | - | 12.32±1.25 |
| Medicine group of the present invention | 10 | 1.8 | 8.01±0.87 ###△△ |
| Application number 02153455.1 medicine group | 10 | 1.8 | 9.74±0.96 ### |
Annotate: compare with the normal saline group,
###P＜0.001; Compare with application number 02153455.1 medicine group,
△ △P＜0.01.
Experimental result by table 8 shows: compare with the normal saline group, medicine group of the present invention and application number 02153455.1 medicine group all have the obvious shortening mice docking bleeding time; Compare with application number 02153455.1, the effect that medicine group of the present invention shortens the mice docking bleeding time has reached significant difference.Because patients with uterine myoma is attended by in various degree bleeding usually, so medicine group of the present invention has the treatment that anastalsis will be conducive to the hysteromyoma disease, strengthens patient's body constitution, promotes absorbing of medicine.
Show according to above research contents, the technology of the present invention content 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, bioavailability is high, drug action obviously is better than the distinguishing feature of application number 02153455.1, and this will bring for the clinical practice of this invention preparation huge potentiality and development space.
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, understand content of the present invention to help those skilled in the art.But the realization of technical solution of the present invention is not limited to these embodiment.
Embodiment 1
(1) gets rhizoma sparganic 64g, Rhizoma Curcumae 64g, Rhizoma Atractylodis Macrocephalae 64g, adding with the medical material weight ratio is that 10 times of water gagings soak, and with behind the 80kHz supersound process 30min, with extraction by steam distillation volatile oil 2 times, each 1h, after collecting volatile oil, with with the volatile oil weight ratio be the beta-cyclodextrin inclusion compound of 3 times of amounts, aqueous solution after the distillation is for subsequent use after filtering, medicinal residues add Rhizoma Cyperi (processed) 128g, Cortex Moutan 128g, adding with the medical material weight ratio is the ethanol of 8 times of amounts, heating and refluxing extraction 2 times, each 1h filters, 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 for subsequent use;
(2) get Eupolyphaga Seu Steleophaga 64g, Radix Codonopsis 64g, Fructus Evodiae 64g, Herba Hedyotidis Diffusae 210g, Herba Agrimoniae 126g, adding with the medical material weight ratio is that 10 times of water gagings soak, heating decocts extracts 2 times, behind each 1h, filter, after the aqueous solution in filtrate and above-mentioned (1) after the distillation merges, add ethanol to contain the alcohol amount be 70%, leave standstill centrifugalize behind the 24h, the centrifugal liquid Recycled ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is for subsequent use;
(3) be after 0.6: 1.0: 1.2 heating and melting becomes glue by weight with glycerol, gelatin and water, adding and glycerol, gelatin and water gross weight be than being 3% titanium dioxide, 6% benzoic acid, degasification, and it is for subsequent use to make 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 210g is ground 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), add an amount of soybean oil, lecithin stirs evenly to get capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and be get final product.
Embodiment 2
(1) gets rhizoma sparganic 64g, Rhizoma Curcumae 64g, Rhizoma Atractylodis Macrocephalae 64g, adding with the medical material weight ratio is that 8 times of water gagings soak, and with behind the 40kHz supersound process 45min, with extraction by steam distillation volatile oil 3 times, each 1.5h, after collecting volatile oil, with with the volatile oil weight ratio be the beta-cyclodextrin inclusion compound of 4 times of amounts, aqueous solution after the distillation is for subsequent use after filtering, medicinal residues add Rhizoma Cyperi (processed) 128g, Cortex Moutan 128g, adding with the medical material weight ratio is the ethanol of 10 times of amounts, heating and refluxing extraction 1 time, each 1.5h filters, 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 for subsequent use;
(2) get Eupolyphaga Seu Steleophaga 64g, Radix Codonopsis 64g, Fructus Evodiae 64g, Herba Hedyotidis Diffusae 210g, Herba Agrimoniae 126g, adding with the medical material weight ratio is that 12 times of water gagings soak, heating decocts extracts 3 times, behind each 0.5h, filter, after the aqueous solution in filtrate and above-mentioned (1) after the distillation merges, add ethanol to contain the alcohol amount be 50%, leave standstill centrifugalize behind the 48h, the centrifugal liquid Recycled ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.10 clear paste is for subsequent use;
(3) be after 0.3: 1.0: 1.0 heating and melting becomes glue by weight with glycerol, gelatin and water, adding and glycerol, gelatin and water gross weight be than being 1% titanium dioxide, 3% sodium benzoate, degasification, and it is for subsequent use to make 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 210g is ground 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), add an amount of vegetable oil, Cera Flava stirs evenly to get capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and be get final product.
Embodiment 3
(1) gets rhizoma sparganic 64g, Rhizoma Curcumae 64g, Rhizoma Atractylodis Macrocephalae 64g, adding with the medical material weight ratio is that 12 times of water gagings soak, and with behind the 100kHz supersound process 15min, with extraction by steam distillation volatile oil 3 times, each 2h, after collecting volatile oil, with with the volatile oil weight ratio be the beta-cyclodextrin inclusion compound of 2 times of amounts, aqueous solution after the distillation is for subsequent use after filtering, medicinal residues add Rhizoma Cyperi (processed) 128g, Cortex Moutan 128g, adding with the medical material weight ratio is the ethanol of 6 times of amounts, heating and refluxing extraction 3 times, each 2h filters, 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 for subsequent use;
(2) get Eupolyphaga Seu Steleophaga 64g, Radix Codonopsis 64g, Fructus Evodiae 64g, Herba Hedyotidis Diffusae 210g, Herba Agrimoniae 126g, adding with the medical material weight ratio is that 8 times of water gagings soak, heating decocts extracts 3 times, behind each 1.5h, filter, after the aqueous solution in filtrate and above-mentioned (1) after the distillation merges, add ethanol to contain the alcohol amount be 80%, leave standstill centrifugalize behind the 32h, the centrifugal liquid Recycled ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.30 clear paste is for subsequent use;
(3) be after 1.0: 1.0: 1.6 heating and meltings become glue by weight with glycerol, gelatin and water, adding and glycerol, gelatin and water gross weight be than being 5% zinc oxide, 10% ethyl hydroxybenzoate, degasification, and it is for subsequent use to make 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 210g is ground into fine powder, excessively behind 100 mesh sieves, 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 stirs evenly to get capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3), compacting, and get final product.
Embodiment 4
(1) gets rhizoma sparganic 64g, Rhizoma Curcumae 64g, Rhizoma Atractylodis Macrocephalae 64g, adding with the medical material weight ratio is that 10 times of water gagings soak, and with behind the 80kHz supersound process 30min, with extraction by steam distillation volatile oil 2 times, each 1h, after collecting volatile oil, with with the volatile oil weight ratio be the beta-cyclodextrin inclusion compound of 3 times of amounts, aqueous solution after the distillation is for subsequent use after filtering, medicinal residues add Rhizoma Cyperi (processed) 128g, Cortex Moutan 128g, adding with the medical material weight ratio is the ethanol of 8 times of amounts, heating and refluxing extraction 2 times, each 1h filters, 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 for subsequent use;
(2) get Eupolyphaga Seu Steleophaga 64g, Radix Codonopsis 64g, Fructus Evodiae 64g, Herba Hedyotidis Diffusae 210g, Herba Agrimoniae 126g, adding with the medical material weight ratio is that 10 times of water gagings soak, heating decocts extracts 2 times, behind each 1h, filter, after the aqueous solution in filtrate and above-mentioned (1) after the distillation merges, add ethanol to contain the alcohol amount be 70%, leave standstill centrifugalize behind the 24h, the centrifugal liquid Recycled ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is for subsequent use;
(3) be after 0.8: 1.0: 1.4 heating and melting becomes glue by weight with glycerol, gelatin and water, adding and glycerol, gelatin and water gross weight be than being 2% titanium dioxide, 8% sorbic acid, degasification, and it is for subsequent use to make 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 210g is ground into fine powder, excessively behind 100 mesh sieves, 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 stirs evenly to get capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3), compacting, and get final product.
Embodiment 5
(1) gets rhizoma sparganic 64g, Rhizoma Curcumae 64g, Rhizoma Atractylodis Macrocephalae 64g, adding with the medical material weight ratio is that 10 times of water gagings soak, and with behind the 80kHz supersound process 30min, with extraction by steam distillation volatile oil 2 times, each 1h, after collecting volatile oil, with with the volatile oil weight ratio be the beta-cyclodextrin inclusion compound of 3 times of amounts, aqueous solution after the distillation is for subsequent use after filtering, medicinal residues add Rhizoma Cyperi (processed) 128g, Cortex Moutan 128g, adding with the medical material weight ratio is the ethanol of 8 times of amounts, heating and refluxing extraction 2 times, each 1h filters, 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 for subsequent use;
(2) get Eupolyphaga Seu Steleophaga 64g, Radix Codonopsis 64g, Fructus Evodiae 64g, Herba Hedyotidis Diffusae 210g, Herba Agrimoniae 126g, adding with the medical material weight ratio is that 10 times of water gagings soak, heating decocts extracts 2 times, behind each 1h, filter, after the aqueous solution in filtrate and above-mentioned (1) after the distillation merges, add ethanol to contain the alcohol amount be 70%, leave standstill centrifugalize behind the 24h, the centrifugal liquid Recycled ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is for subsequent use;
(3) be after 0.5: 1.0: 1.2 heating and melting becomes glue by weight with glycerol, gelatin and water, adding and glycerol, gelatin and water gross weight be than being 3% zinc oxide, 5% sorbic acid clock, degasification, and it is for subsequent use to make 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 210g is ground into fine powder, excessively behind 100 mesh sieves, mixes with the volatile oil clathrate compound of gained in dried cream powder and above-mentioned (1), add an amount of PEG400, propylene glycol stirs evenly to get capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3), compacting, and get final product.
Zinc oxide in the above-mentioned technique can replace by the mixture that different proportionings form from zinc oxide with titanium dioxide; Potassium sorbate can be used in benzoic acid, sodium benzoate, ethyl hydroxybenzoate, sorbic acid, the potassium sorbate two kinds or two or more, and the mixture that forms by different proportionings replaces; Propylene glycol can be used in Cera Flava, lecithin, aluminum monostearate, ethyl cellulose, the propylene glycol two kinds or two or more, and the mixture that forms by different proportionings replaces.
Claims (11)
1. Chinese medicinal soft capsule agent for the treatment of hysteromyoma is characterized in that it is to be prepared from by following technique:
A. raw material forms: 210 parts of Concha Ostreaes, 128 parts of Rhizoma Cyperi (processed), 64 parts of rhizoma sparganic, 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, in the steps below operations among the above-mentioned A:
(1) gets rhizoma sparganic, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, soak and supersound process after, use extraction by steam distillation volatile oil, collect volatile oil and use beta-cyclodextrin inclusion compound, aqueous solution after the distillation is for subsequent use after filtering, and medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan, add alcohol reflux, filter filtrate recycling ethanol and to be condensed into clear paste for subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, soak, after heating decocts and extracts, filter, add ethanol after aqueous solution in filtrate and above-mentioned (1) after the distillation merges, leave standstill rear centrifugalize, centrifugal liquid Recycled ethanol and concentrating under reduced pressure become clear paste for subsequent use;
(3) be 0.3～1.0 by weight with glycerol, gelatin and water: after 1.0: 1.0～1.6 heating and meltings become glue, add opacifier, antiseptic, degasification, it is for subsequent use to make 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 evenly capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and be get final product.
2. the preparation method of the Chinese medicinal soft capsule agent for the treatment of hysteromyoma as claimed in claim 1 is characterized in that:
A. raw material forms: 210 parts of Concha Ostreaes, 128 parts of Rhizoma Cyperi (processed), 64 parts of rhizoma sparganic, 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, in the steps below operations among the above-mentioned A:
(1) gets rhizoma sparganic, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, soak and supersound process after, use extraction by steam distillation volatile oil, collect volatile oil and use beta-cyclodextrin inclusion compound, aqueous solution after the distillation is for subsequent use after filtering, and medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan, add alcohol reflux, filter filtrate recycling ethanol and to be condensed into clear paste for subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, soak, after heating decocts and extracts, filter, add ethanol after aqueous solution in filtrate and above-mentioned (1) after the distillation merges, leave standstill rear centrifugalize, centrifugal liquid Recycled ethanol and concentrating under reduced pressure become clear paste for subsequent use;
(3) be 0.3～1.0 by weight with glycerol, gelatin and water: after 1.0: 1.0～1.6 heating and meltings become glue, add opacifier, antiseptic, degasification, it is for subsequent use to make 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 evenly capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and be get final product.
3. the preparation method of the Chinese medicinal soft capsule agent for the treatment of hysteromyoma as claimed in claim 2 is characterized in that:
(1) gets rhizoma sparganic, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, adding with the medical material weight ratio is that 8～12 times of water gagings soak, and with behind 40kHz～100kHz supersound process 15～45min, with extraction by steam distillation volatile oil 2～3 times, each 1～2h, after collecting volatile oil, with with the volatile oil weight ratio be the beta-cyclodextrin inclusion compound of 2～4 times of amounts, aqueous solution after the distillation is for subsequent use after filtering, medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan, adding with the medical material weight ratio is the ethanol of 6～10 times of amounts, heating and refluxing extraction 1～3 time, 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 for subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, adding with the medical material weight ratio is that 8～12 times of water gagings soak, heating decocts extracts 2～3 times, behind each 0.5～1.5h, filter, after the aqueous solution in filtrate and above-mentioned (1) after the distillation merges, add ethanol and reach 50%～80% so that contain the alcohol amount, leave standstill centrifugalize behind 24～48h, the centrifugal liquid Recycled ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.10～1.30 clear paste is for subsequent use;
(3) be 0.3～1.0 by weight with glycerol, gelatin and water: after 1.0: 1.0～1.6 heating and meltings become glue, add opacifier, antiseptic, degasification, it is for subsequent use to make 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 evenly capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and be get final product.
4. the preparation method of the Chinese medicinal soft capsule agent for the treatment of hysteromyoma as claimed in claim 3 is characterized in that:
(1) gets rhizoma sparganic, Rhizoma Curcumae, the Rhizoma Atractylodis Macrocephalae, adding with the medical material weight ratio is that 10 times of water gagings soak, and with behind the 80kHz supersound process 30min, with extraction by steam distillation volatile oil 2 times, each 1h, after collecting volatile oil, with with the volatile oil weight ratio be the beta-cyclodextrin inclusion compound of 3 times of amounts, aqueous solution after the distillation is for subsequent use after filtering, medicinal residues add Rhizoma Cyperi (processed), Cortex Moutan, adding with the medical material weight ratio is the ethanol of 8 times of amounts, heating and refluxing extraction 2 times, each 1h filters, 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 for subsequent use;
(2) get Eupolyphaga Seu Steleophaga, Radix Codonopsis, Fructus Evodiae, Herba Hedyotidis Diffusae, Herba Agrimoniae, adding with the medical material weight ratio is that 10 times of water gagings soak, heating decocts extracts 2 times, behind each 1h, filter, after the aqueous solution in filtrate and above-mentioned (1) after the distillation merges, add ethanol to contain the alcohol amount be 70%, leave standstill centrifugalize behind the 24h, the centrifugal liquid Recycled ethanol, and to become relative density in 60 ℃ of concentrating under reduced pressure be that 1.20 clear paste is for subsequent use;
(3) be 0.3～1.0 by weight with glycerol, gelatin and water: after 1.0: 1.0～1.6 heating and meltings become glue, add opacifier, antiseptic, degasification, it is for subsequent use to make 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 evenly capsule liquid, the rubber that makes in capsule liquid and above-mentioned (3) is suppressed, and be get final product.
5. such as the preparation method 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 opacifier selects one or both the mixture in titanium dioxide, the zinc oxide.
6. such as the preparation method 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 antiseptic selects one or more the mixture in benzoic acid, sodium benzoate, ethyl hydroxybenzoate, sorbic acid, the potassium sorbate.
7. such as the preparation method 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 dispersant selects polyethylene glycols or vegetable oil.
8. such as the preparation method 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 suspending agent selects one or more the mixture in Cera Flava, lecithin, aluminum monostearate, ethyl cellulose, the propylene glycol.
9. such as the preparation method 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 preparation method of the Chinese medicinal soft capsule agent for the treatment of hysteromyoma as claimed in claim 9, it is characterized in that: the weight ratio of glycerol, gelatin and water is 0.6: 1.0: 1.2.
11. the preparation method of the Chinese medicinal soft capsule agent for the treatment of hysteromyoma as claimed in claim 9 is characterized in that: described opacifier is titanium dioxide, with glycerol, gelatin and water three gross weight ratio be 3%; Described antiseptic is benzoic acid, with glycerol, gelatin and water three gross weight ratio be 6%.
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