CN101708307A - Medicament for treating hyperplasia of mammary glands and preparation method thereof - Google Patents
Medicament for treating hyperplasia of mammary glands and preparation method thereof Download PDFInfo
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- CN101708307A CN101708307A CN200910092618A CN200910092618A CN101708307A CN 101708307 A CN101708307 A CN 101708307A CN 200910092618 A CN200910092618 A CN 200910092618A CN 200910092618 A CN200910092618 A CN 200910092618A CN 101708307 A CN101708307 A CN 101708307A
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Abstract
The invention relates to a medicament for treating hyperplasia of mammary glands and a preparation method thereof. The medicament consists of the following medicinal materials: oyster shell, astragalus, common burreed rhizome, malt, asparagus root, myrrh, asparagus root, epimedium herb, danshen root, largehead atractylodes rhizome, seaweed, Chinese thorowax root, zedoary, chicken's gizzard-membrane, green tangerine peel and frankincense. The preparation method comprises the steps: crushing the common burreed rhizome, the malt, the myrrh, the largehead atractylodes rhizome, the Chinese thorowax root, the zedoary, the chicken's gizzard-membrane, the green tangerine peel and the frankincense of the fifteen gouts of medicinal materials into fine powder for later use; adding water of which the amount is 10 times that of the rest six gouts of medicinal materials into the rest six gouts of medicinal materials such as the oyster shell and the like for decoction thrice, wherein the decoction time of each time is 2 hours, 1.5 hours and 1 hour; performing multiple filtration, merging filter liquor and decompressing and concentrating the filter liquor (at the temperature of 65 and 70 DEG C and under the pressure of -0.08 MPa) to obtain a thick paste of which the relative density is between 1.30 and 1.35 (at the temperature of 60 DEG C), adding the fine powder and uniform mixing, and decompressing and drying the mixture (at the temperature of 65 and 70 DEG C and under the pressure of -0.08 MPa) to prepare a dry extract for later use; and crushing the dry extract into fine powder, sieving 100-mesh sieve, and adding 40 grams of sodium carboxymethyl starch, 200 grams of microcrystalline cellulose and starch until the total weight is 1,000 grams to prepare the medicament through damp mass preparation, pressed pilling, drying and subpackage. In order to ensure the quality of products, all operations are performed under the clean and drying environment.
Description
Technical field
This belongs to field of traditional Chinese, specially refers to a kind of medicine that is used for the treatment of cyclomastopathy.
The invention still further relates to manufacturing method for above mentioned medicine.
Background technology
Cyclomastopathy claims cystic hyperplasia of breast again, is that lump in breast is a clinical characters with breast periodicity pain.Modern medicine thinks that this disease is that the non-inflammatory of a mammary gland essence and a matter and non-neoplastic hyperplasia sexually transmitted disease (STD) become, and belongs to categories such as the traditional Chinese medical science " nodules of the breast ", " newborn painful abdominal mass ", and how owing to depression of liver-QI, the expectorant blood coagulation stasis of blood is due to the Chong and Ren channel disorder.Modern medicine does not still have the definite effective Therapeutic Method to this disease, and Chinese medicine has unique advantage to the treatment of this disease.
Summary of the invention
The object of the present invention is to provide a kind of medicine that is used for the treatment of cyclomastopathy.
Another purpose of the present invention is to provide the method for preparing said medicine.
The purpose of this invention is to provide a kind of medicine that is used for the treatment of cyclomastopathy, is a kind of breast peace ball (concentrated pill), according to the peace of the breast in " national standard for traditional Chinese medicines compilation " sheet, it is improved, and its prescription ratio and former tablet form are consistent.Former tablet formulation consists of: Concha Ostreae 78.5g, Radix Astragali 117.8g, rhizoma sparganic 15.7g, Fructus Hordei Germinatus 13.1g, Radix Asparagi 78.5g, Myrrha 31.4g, Herba Epimedii 78.5g, Radix Salviae Miltiorrhizae 78.5g, Rhizoma Atractylodis Macrocephalae 15.7g, Sargassum 78.5g, Radix Bupleuri 15.7g, Rhizoma Curcumae 15.7g, Endothelium Corneum Gigeriae Galli 21g, Pericarpium Citri Reticulatae Viride 15.7g, Olibanum 15.7g; Function cures mainly and is regulating the flow of QI to dissipate blood stasis, hard masses softening and resolving; Be used for nodules of the breast genus-syndrome of qi stagnation and blood stasis person.
The breast put down in writing in " national standard for traditional Chinese medicines compilation " peace sheet diseases such as the mastalgia that causes of application of treatment cyclomastopathy, lump clinically has satisfied curative effect.But its dose is big, is difficult for taking.Aborning, medical materials such as Endothelium Corneum Gigeriae Galli, Olibanum, Myrrha stay powder, are difficult for tabletting during compression moulding.The while pill is as the conventional dosage forms of China, and is of long standing and well established, meets the characteristics of tcm clinical practice medication, and the patient is acceptant.Through market survey, serve as pill market or the blank that basic prescription is made with breast peace sheet.
After changing tablet into concentrated pill, because of pill is little, the patient is acceptant, takes more convenient.And pill prepares easy, and production equipment and specification requirement are simple, and machine-processed legal system is equipped with concentrated pill yield rate height, has solved the shortcoming of the easy moisture absorption in the former tablet technology, steady quality.The also clinical verification of breast peace sheet proves its stable curative effect and safety reliably, is effective Chinese patent medicine of treatment cyclomastopathy.
For achieving the above object, the medicine of treatment cyclomastopathy provided by the invention is the medicament that is mixed with by the following weight proportion raw material:
Concha Ostreae 157g Radix Astragali 235.6g rhizoma sparganic 31.4g
Fructus Hordei Germinatus 26.2g Radix Asparagi 157g Myrrha 62.8g
Herba Epimedii 157g Radix Salviae Miltiorrhizae 157g Rhizoma Atractylodis Macrocephalae 31.4g
Sargassum 157g Radix Bupleuri 31.4g Rhizoma Curcumae 31.4g
Endothelium Corneum Gigeriae Galli 42g Pericarpium Citri Reticulatae Viride 31.4g Olibanum 31.4g
Manufacturing method for above mentioned medicine provided by the invention, step has:
1. above ten five tastes medical materials, rhizoma sparganic, Fructus Hordei Germinatus, Myrrha, the Rhizoma Atractylodis Macrocephalae, Radix Bupleuri, Rhizoma Curcumae, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae Viride, frankincense powder are broken into fine powder, and be standby;
2. Six-element such as all the other Concha Ostreaes adds 10 times of water gagings and decocts three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, gradation filtered, (65～70 ℃ of merging filtrate and concentrating under reduced pressure,-0.08MPa) be the thick paste of 1.30～1.35 (60 ℃) to relative density, add above-mentioned fine powder, mixing, (65～70 ℃ of drying under reduced pressure,-0.08MPa), get dry extract, standby;
3. dry extract is broken into fine powder, crosses 100 mesh sieves, adds carboxymethylstach sodium 40g, microcrystalline Cellulose 200g, and add starch to total amount 1000g, and the system soft material is pressed into ball, drying, and packing, promptly.
For guaranteeing product quality, all operations all should carry out in clean and dry environment.
Breast peace ball (concentrated pill) involved in the present invention is compared with breast peace sheet, has following beneficial effect:
1 takes: the breast peace ball (concentrated pill) that adopts technique scheme to make is bigger with the volume of every in former tablet, the inconvenience of swallowing, and this product is taken for a long time, bring big difficulty for the part patient, after the transformation of the way was concentrated pill, pill was less, easily swallows, and coating has been covered bad smell later on, and the patient is acceptant.
On 2 technologies: the breast peace ball (concentrated pill) that adopts technique scheme to make stays powder to form by medicinal substances extract and medical material, medical material stays the powder large percentage, the very suitable pill of making, and pill production equipment and specification requirement are simple, and mould method for making and prepare concentrated pill yield rate height, difficult problems such as sliver have been solved in the former tablet technology easily, steady quality.
On 3 curative effect of medication: the breast peace ball (concentrated pill) that adopts technique scheme to make is used for the treatment of the climacteric syndrome syndrome of deficiency of both yin and yang of kidney, the good Rong's ball (concentrated pill) that adopts technique scheme to make is made concentrated pill, the advantage that has kept pill, meet traditional Chinese medical science tradition medication characteristics, and taking convenience, patient Geng Yi accepts.
Generally speaking, use the Chinese medicine preparation advantage that breast peace ball (concentrated pill) that technical solutions according to the invention obtain has triple effect (quick-acting, efficient, long-acting), three little (taking dose is little, toxicity is little, side effect little), five convenience (convenient for production, store convenience, convenient transportation, easy to carry, easy to use).
Description of drawings: Fig. 1 is technological process of production figure of the present invention
The specific embodiment
Can further be well understood to the present invention by specific embodiments of the invention given below and comparing embodiment.But they are not limitation of the invention.
Now, be described further with regard to newborn prescription of pacifying ball (concentrated pill) of the present invention and preparation method thereof with several groups of specific embodiments.
Experimental example 1 stays powder pulverizing medicinal materials technical study
In the technological standards of former breast peace sheet, stay the disintegrating process of powder medical material to be: above ten five tastes medical materials, rhizoma sparganic, Fructus Hordei Germinatus, Myrrha, the Rhizoma Atractylodis Macrocephalae, Radix Bupleuri, Rhizoma Curcumae, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae Viride, frankincense powder are broken into fine powder.This product is investigated granularity and the sterilizing methods pulverized, and the investigation method is as follows:
1.1 pulverizing order number investigation this product investigates pulverizing the order number.Method is: get rhizoma sparganic 15.7g, Fructus Hordei Germinatus 13.1g, Myrrha 31.4g, Rhizoma Atractylodis Macrocephalae 15.7g, Radix Bupleuri 15.7g, Rhizoma Curcumae 15.7g, Endothelium Corneum Gigeriae Galli 21g, Pericarpium Citri Reticulatae Viride 15.7g, Olibanum 15.7g, respectively get three parts, pulverize separately is crossed 80 mesh sieves, 100 mesh sieves, 120 mesh sieves, calculates the powder rate, the results are shown in Table 1.
Table 1 is pulverized the order number and is investigated
According to above result of the test, determine that this product stays the powder pulverizing medicinal materials to cross 100 mesh sieves, powder rate height, be easy to be uniformly dispersed and molding.
After 1.2 sterilizing methods investigation this product stays the powder pulverizing medicinal materials to become fine powder, owing to be directly to be used as medicine to be made to the product preparation, the research so need sterilize, this product is investigated with dual modes such as cobalt 60 irradiation sterilizations, ethylene oxide sterilizings respectively, result of the test shows, better with the effect that the mode of cobalt 60 irradiation sterilizations is sterilized, intensity reaches 4～8kGy and gets final product during irradiation.
The research of experimental example 2 water extraction process
In the technological standards of former breast peace sheet, the technology of water extraction medical material is: Six-elements such as all the other Concha Ostreaes decoct with water three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, gradation filters, and merging filtrate also is evaporated to the thick paste that relative density is 1.30～1.35 (60 ℃).Primary standard to the major parameter of water extraction extract solvent, decocting time has been done detailed setting, another major parameter is not added water and doubly measures and investigate, this product is doubly measured and is investigated the water that adds of water extraction process, and spissated method is investigated.
2.1 extraction process is investigated and to be measured three levels with 8 times of amounts, 10 times of amounts, 12 times and doubly measure and investigate adding water.
Test method is in the prescription ratio, take by weighing Concha Ostreae 78.5g, Radix Astragali 117.8g, Radix Asparagi 78.5g, Herba Epimedii 78.5g, Radix Salviae Miltiorrhizae 78.5g Sargassum 78.5g, respectively get three parts, add 8 times of amounts, 10 times of amounts, 12 times of water gagings respectively and decoct three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, filter, merging filtrate is standby separately.
Principal agent in the selection Herba Epimedii side of being of index composition, its main component is an icariin, so this product is the index composition with the icariin, the optimal processing parameter that preferred water is extracted.
Measure according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 D).
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Acetonitrile-water (25: 75) is a mobile phase; The detection wavelength is 270nm.Number of theoretical plate calculates by the icariin peak should be not less than 2000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the icariin reference substance, adds methanol and make the solution that every 1ml contains 25 μ g, promptly.
1/200 amount of extracting solution is got in the preparation of need testing solution, is evaporated to be about 25ml, puts in the 50ml measuring bottle, adds dehydrated alcohol 50ml, shake up, filter, precision is measured subsequent filtrate 10ml, evaporate to dryness, residue adds water 10ml makes dissolving, extracts 3 times with the ethyl acetate jolting, each 10ml, merge ethyl acetate liquid, evaporate to dryness, residue add methanol makes dissolving, and be transferred in the 100ml measuring bottle, add methanol and be diluted to scale, shake up, filter with microporous filter membrane (0.45 μ m), get subsequent filtrate, promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of algoscopy inject chromatograph of liquid, measure, promptly.
Result of the test is by above method test, and extracting solution is that index is carried out optimal process with icariin content, the results are shown in Table 2.
Table 2 extraction process result of the test
Icariin content is 0.74% in the used epimedium herb.
According to above-mentioned result of the test, it is close with 12 times of amount results to add 10 times of amounts of water, all obviously is better than adding the extraction effect of 8 times of amounts of water, and for saving solvent, energy savings selects to add 10 times of amounts of water.
2.2 concentration technology is investigated in the primary standard of breast peace sheet, method for concentration is: merging filtrate also is evaporated to the thick paste that relative density is 1.30～1.35 (60 ℃).So this product is still continued to use the method for primary standard, being evaporated to relative density is the thick paste of 1.30～1.35 (60 ℃), and the condition of concentrating under reduced pressure is investigated.Through overtesting, for reduce loss of active ingredients as far as possible, vacuum reaches-0.08MPa when determining concentrating under reduced pressure, temperature in 65～70 ℃ of scopes the time effect better, being concentrated into relative density is the thick paste of 1.30～1.35 (60 ℃).
The research of experimental example 3 drying processes
Water intaking is extracted and is concentrated the gained thick paste, adds the medical material fine powder that stays powder, and mixing is divided into three parts, carries out the research of drying process.Adopt constant pressure and dry, two kinds of methods of drying under reduced pressure to carry out drying, drying condition is as follows, and each drying mode is compared.Concrete test data and the results are shown in Table 3.
Table 3 drying means comparative test table
According to above-mentioned result of the test, constant pressure and dry speed is slow, the dry thing appearance poor of gained, and composition destroys more; Drying under reduced pressure speed is very fast, and the dry beyond the region of objective existence of gained is seen better, and composition destruction is few, so adopt drying under reduced pressure, destroys for the long-time heating that reduces effective ingredient as far as possible, should adopt low temperature during drying under reduced pressure as far as possible, is advisable with 65～70 ℃.
The investigation of experimental example 4 technology paste-forming rates
In the optimal process test in front, once the rate of extract of each extracting mode was investigated, according to preferred process conditions, its the rate of extract is about 20%, on this basis, do the test of two batches of extensive magnitudes again, got the medical material of 5 times of recipe quantities, by preferred technology extract, concentrate, dry, survey the paste volume of technology.Concrete outcome sees Table 4.
Table 4 paste-forming rate is investigated result of the test
Above result of the test shows that the paste-forming rate of technology is basicly stable about 20%.
Experimental example 5 moulding processs are investigated
5.1 the selection of disintegrating agent is got this product extract and stayed the powder medical material, respectively gets three parts, first part directly adds starch to total amount; Behind second part of adding 20% microcrystalline Cellulose, add starch to total amount; The 3rd part add 4% carboxymethylstach sodium, 20% microcrystalline Cellulose after, add starch to total amount.With water respectively adhesive system soft material, pill, drying, the molding situation and the dissolve scattered time limit of observation pill, result of the test sees Table 5.
The selection of table 5 adjuvant
According to above result of the test, this product determines to add 4% carboxymethylstach sodium, 20% microcrystalline Cellulose as disintegrating agent.
5.2 two parts of this product extracts are got in the selection of adhesive, add 20% microcrystalline Cellulose after, add starch to total amount, be adhesive system soft material with water, 30% ethanol respectively, pill, drying is observed the molding situation and the dissolve scattered time limit of pill, result of the test sees Table 6.
The selection of table 6 adhesive
According to above result of the test, this product is determined with water as adhesive.
5.3 4 parts of this product are got in the hygroscopicity inspection, each 2g, and accurate the title, decide, and places 4 weighing botles that have been dried to constant weight respectively, be placed on respectively in the exsiccator of constant humidity (humidity environment that variable concentrations sulphuric acid causes), room temperature is 25 ℃ again, after 1 hour, take out, weigh, calculate hygroscopic capacity.Concrete outcome sees Table 7.
The different relative humidity medicated powder of table 7 hygroscopic capacity
The result shows, RH＞72% o'clock, and this product hygroscopicity is stronger, and then hygroscopicity is not strong when following 58% for RH, carries out smoothly for guaranteeing to produce, and the control relative humidity is below 58%, and so then water content can not exceed standard.
The conversion of 6 recipe quantities
Former breast peace sheet is made 1000 in tablet with recipe quantity medical material 670g, takes 5～8 at every turn, and each suitable crude drug amount of dose is 3.35～5.36g.After this product is changed system into pill, intend taking 2.5～4g, take the crude drug amount still is 3.35～5.36g at every turn at every turn, and it is 1.34g that then every 1g pill is equivalent to the crude drug amount, by former breast peace tablet recipe dose ratio, converts, and determines that prescription of this product and prescribed dose are:
Concha Ostreae 157g Radix Astragali 235.6g rhizoma sparganic 31.4g
Fructus Hordei Germinatus 26.2g Radix Asparagi 157g Myrrha 62.8g
Herba Epimedii 157g Radix Salviae Miltiorrhizae 157g Rhizoma Atractylodis Macrocephalae 31.4g
Sargassum 157g Radix Bupleuri 31.4g Rhizoma Curcumae 31.4g
Endothelium Corneum Gigeriae Galli 42g Pericarpium Citri Reticulatae Viride 31.4g Olibanum 31.4g
6 three batches of pilot scale creation datas of experimental example are according to above preferred technology, test agent is produced in the our factory in three batches: adopt the multipotency extraction pot to extract, the concentrating under reduced pressure jar reclaims ethanol, concentrating under reduced pressure, and the vacuum drying oven drying is carried out in the big production equipment such as automatic pellet processing machine.Three batches of 10 times of recipe quantities that all feed intake are investigated paste-forming rate, yield rate, inspection and the icariin content of each batch.The result shows that the technology of said preparation is basicly stable, and this technology advanced person is described, and is feasible, is fit to big production.Every data see Table 8.
The specific embodiment
Embodiment 1:
Prescription Concha Ostreae 157g Radix Astragali 235.6g rhizoma sparganic 31.4g
Fructus Hordei Germinatus 26.2g Radix Asparagi 157g Myrrha 62.8g
Herba Epimedii 157g Radix Salviae Miltiorrhizae 157g Rhizoma Atractylodis Macrocephalae 31.4g
Sargassum 157g Radix Bupleuri 31.4g Rhizoma Curcumae 31.4g
Endothelium Corneum Gigeriae Galli 42g Pericarpium Citri Reticulatae Viride 31.4g Olibanum 31.4g
Method for making is for guaranteeing product quality, and all operations all should carry out in clean and dry environment.
1, above ten five tastes medical materials, rhizoma sparganic, Fructus Hordei Germinatus, Myrrha, the Rhizoma Atractylodis Macrocephalae, Radix Bupleuri, Rhizoma Curcumae, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae Viride, frankincense powder are broken into fine powder, and be standby;
2, Six-element such as all the other Concha Ostreaes adds 10 times of water gagings and decocts three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, gradation filtered, (65～70 ℃ of merging filtrate and concentrating under reduced pressure,-0.08MPa) be the thick paste of 1.30～1.35 (60 ℃) to relative density, add above-mentioned fine powder, mixing, (65～70 ℃ of drying under reduced pressure,-0.08MPa), get dry extract, standby;
3, dry extract is broken into fine powder, crosses 100 mesh sieves, adds carboxymethylstach sodium 40g, microcrystalline Cellulose 200g, and add starch to total amount 1000g, and the system soft material is pressed into ball, drying, and packing, promptly.
Embodiment 2: 30 times of amounts choosing recipe quantity
Prescription Concha Ostreae 4.71kg Radix Astragali 7.068kg rhizoma sparganic 0.942kg
Fructus Hordei Germinatus 0.786kg Radix Asparagi 4.71kg Myrrha 1.884kg
Herba Epimedii 4.71kg Radix Salviae Miltiorrhizae 4.71kg Rhizoma Atractylodis Macrocephalae 0.942kg
Sargassum 4.71kg Radix Bupleuri 0.942kg Rhizoma Curcumae 0.942kg
Endothelium Corneum Gigeriae Galli 1.26kg Pericarpium Citri Reticulatae Viride 0.942kg Olibanum 0.942kg
Method for making is for guaranteeing product quality, and all operations all should carry out in clean and dry environment.
1, above ten five tastes medical materials, rhizoma sparganic, Fructus Hordei Germinatus, Myrrha, the Rhizoma Atractylodis Macrocephalae, Radix Bupleuri, Rhizoma Curcumae, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae Viride, frankincense powder are broken into fine powder, and be standby;
2, Six-element such as all the other Concha Ostreaes adds 10 times of water gagings and decocts three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, gradation filtered, (65～70 ℃ of merging filtrate and concentrating under reduced pressure,-0.08MPa) be the thick paste of 1.30～1.35 (60 ℃) to relative density, add above-mentioned fine powder, mixing, (65～70 ℃ of drying under reduced pressure,-0.08MPa), get dry extract, standby;
3, dry extract is broken into fine powder, crosses 100 mesh sieves, adds carboxymethylstach sodium 1.2kg, microcrystalline Cellulose 6kg, and add starch to total amount 30kg, and the system soft material is pressed into ball, drying, and packing, promptly.
Embodiment 3: 100 times of amounts choosing recipe quantity
Prescription Concha Ostreae 15.7kg Radix Astragali 23.56kg rhizoma sparganic 3.14kg
Fructus Hordei Germinatus 2.62kg Radix Asparagi 15.7kg Myrrha 6.28kg
Herba Epimedii 15.7kg Radix Salviae Miltiorrhizae 15.7kg Rhizoma Atractylodis Macrocephalae 3.14kg
Sargassum 15.7kg Radix Bupleuri 3.14kg Rhizoma Curcumae 3.14kg
Endothelium Corneum Gigeriae Galli 4.2kg Pericarpium Citri Reticulatae Viride 3.14kg Olibanum 3.14kg
Method for making is for guaranteeing product quality, and all operations all should carry out in clean and dry environment.
1, above ten five tastes medical materials, rhizoma sparganic, Fructus Hordei Germinatus, Myrrha, the Rhizoma Atractylodis Macrocephalae, Radix Bupleuri, Rhizoma Curcumae, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae Viride, frankincense powder are broken into fine powder, and be standby;
2, Six-element such as all the other Concha Ostreaes adds 10 times of water gagings and decocts three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, gradation filtered, (65～70 ℃ of merging filtrate and concentrating under reduced pressure,-0.08MPa) be the thick paste of 1.30～1.35 (60 ℃) to relative density, add above-mentioned fine powder, mixing, (65～70 ℃ of drying under reduced pressure,-0.08MPa), get dry extract, standby;
3, dry extract is broken into fine powder, crosses 100 mesh sieves, adds carboxymethylstach sodium 4kg, microcrystalline Cellulose 20kg, and add starch to total amount 100kg, and the system soft material is pressed into ball, drying, and packing, promptly.
Embodiment 4: 300 times of amounts choosing recipe quantity
Prescription Concha Ostreae 47.1kg Radix Astragali 70.68kg rhizoma sparganic 9.42kg
Fructus Hordei Germinatus 7.86kg Radix Asparagi 47.1kg Myrrha 18.84kg
Herba Epimedii 47.1kg Radix Salviae Miltiorrhizae 47.1kg Rhizoma Atractylodis Macrocephalae 9.42kg
Sargassum 47.1kg Radix Bupleuri 9.42kg Rhizoma Curcumae 9.42kg
Endothelium Corneum Gigeriae Galli 12.6kg Pericarpium Citri Reticulatae Viride 9.42kg Olibanum 9.42kg
Method for making is for guaranteeing product quality, and all operations all should carry out in clean and dry environment.
1, above ten five tastes medical materials, rhizoma sparganic, Fructus Hordei Germinatus, Myrrha, the Rhizoma Atractylodis Macrocephalae, Radix Bupleuri, Rhizoma Curcumae, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae Viride, frankincense powder are broken into fine powder, and be standby;
2, Six-element such as all the other Concha Ostreaes adds 10 times of water gagings and decocts three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, gradation filtered, (65～70 ℃ of merging filtrate and concentrating under reduced pressure,-0.08MPa) be the thick paste of 1.30～1.35 (60 ℃) to relative density, add above-mentioned fine powder, mixing, (65～70 ℃ of drying under reduced pressure,-0.08MPa), get dry extract, standby;
3, dry extract is broken into fine powder, crosses 100 mesh sieves, adds carboxymethylstach sodium 12kg, microcrystalline Cellulose 60kg, and add starch to total amount 300kg, and the system soft material is pressed into ball, drying, and packing, promptly.
Three batches of pilot scale creation datas of table 8
Claims (11)
1. medicine that is used for the treatment of cyclomastopathy is characterized in that the weight ratio of each crude drug of this pharmaceutical composition is:
Concha Ostreae 157g Radix Astragali 235.6g rhizoma sparganic 31.4g
Fructus Hordei Germinatus 26.2g Radix Asparagi 157g Myrrha 62.8g
Herba Epimedii 157g Radix Salviae Miltiorrhizae 157g Rhizoma Atractylodis Macrocephalae 31.4g
Sargassum 157g Radix Bupleuri 31.4g Rhizoma Curcumae 31.4g
Endothelium Corneum Gigeriae Galli 42g Pericarpium Citri Reticulatae Viride 31.4g Olibanum 31.4g
2. a kind of medicine that is used for the treatment of cyclomastopathy as claimed in claim 1, its preparation method may further comprise the steps:
The described five tastes medicine of claim 1, rhizoma sparganic, Fructus Hordei Germinatus, Myrrha, the Rhizoma Atractylodis Macrocephalae, Radix Bupleuri, Rhizoma Curcumae, Endothelium Corneum Gigeriae Galli, Pericarpium Citri Reticulatae Viride, frankincense powder are broken into fine powder, and be standby; Six-elements such as all the other Concha Ostreaes add 10 times of water gagings and decoct three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, gradation filtered, (65～70 ℃ of merging filtrate and concentrating under reduced pressure,-0.08MPa) be the thick paste of 1.30～1.35 (60 ℃) to relative density, add above-mentioned fine powder, mixing, (65～70 ℃ of drying under reduced pressure,-0.08MPa), get dry extract, standby; Dry extract is broken into fine powder, crosses 100 mesh sieves, adds carboxymethylstach sodium 40g, microcrystalline Cellulose 200g, and add starch to total amount 1000g, and the system soft material is pressed into ball, drying, and packing, promptly.For guaranteeing product quality, all operations all should carry out in clean and dry environment.
3. a kind of process for preparing medicine that is used for the treatment of cyclomastopathy as claimed in claim 2 is characterized in that adding water and doubly measures the 10 times of amounts that are respectively.
4. a kind of process for preparing medicine that is used for the treatment of cyclomastopathy as claimed in claim 2 is characterized in that filtrate is concentrated into the thick paste that relative density is 1.30～1.35 (60 ℃), and condition is 65～70 ℃ ,-0.08Mpa.
5. a kind of process for preparing medicine that is used for the treatment of cyclomastopathy as claimed in claim 2 is characterized in that carrying out drying under reduced pressure after thick paste that filtrate concentrates gained counts fine powder, and its condition is 70～75 ℃ ,-0.07Mpa～-0.08Mpa.
6. a kind of process for preparing medicine that is used for the treatment of cyclomastopathy as claimed in claim 2 is characterized in that broken mistake 100 mesh sieves of dried dried cream powder.
7. a kind of process for preparing medicine that is used for the treatment of cyclomastopathy as claimed in claim 2 is characterized in that used disintegrating agent is that 4% carboxymethylstach sodium, 20% little product cellulose are as disintegrating agent.
8. a kind of process for preparing medicine that is used for the treatment of cyclomastopathy as claimed in claim 2 is characterized in that used adhesive is a water.
9. a kind of process for preparing medicine that is used for the treatment of cyclomastopathy as claimed in claim 2 is characterized in that the relative humidity in the production process is controlled at below 58%.
10. as claim 1,2 described a kind of process for preparing medicine that are used for the treatment of cyclomastopathy, it is characterized in that described medicament is a concentrated pill.
11. as claim 1,2 described a kind of process for preparing medicine that are used for the treatment of cyclomastopathy, it is characterized in that the use of regulating prescription doubly measures, can obtain the output under the corresponding proportion.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN200910092618A CN101708307A (en) | 2009-09-14 | 2009-09-14 | Medicament for treating hyperplasia of mammary glands and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN200910092618A CN101708307A (en) | 2009-09-14 | 2009-09-14 | Medicament for treating hyperplasia of mammary glands and preparation method thereof |
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| CN101708307A true CN101708307A (en) | 2010-05-19 |
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| CN200910092618A Pending CN101708307A (en) | 2009-09-14 | 2009-09-14 | Medicament for treating hyperplasia of mammary glands and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102579983A (en) * | 2012-03-06 | 2012-07-18 | 郑州瑞龙制药股份有限公司 | Preparation method of milk safety capsule |
| CN102671113A (en) * | 2012-03-14 | 2012-09-19 | 安康正大制药有限公司 | Traditional Chinese medicine composition for treating nodules of breasts and preparation method of traditional Chinese medicine composition |
| CN102988543A (en) * | 2012-11-21 | 2013-03-27 | 郑州瑞龙制药股份有限公司 | Traditional Chinese medicine for treating hyperplasia of mammary glands and preparation method of traditional Chinese medicine |
-
2009
- 2009-09-14 CN CN200910092618A patent/CN101708307A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102579983A (en) * | 2012-03-06 | 2012-07-18 | 郑州瑞龙制药股份有限公司 | Preparation method of milk safety capsule |
| CN102671113A (en) * | 2012-03-14 | 2012-09-19 | 安康正大制药有限公司 | Traditional Chinese medicine composition for treating nodules of breasts and preparation method of traditional Chinese medicine composition |
| CN102671113B (en) * | 2012-03-14 | 2013-12-18 | 安康正大制药有限公司 | Traditional Chinese medicine composition for treating nodules of breasts and preparation method of traditional Chinese medicine composition |
| CN102988543A (en) * | 2012-11-21 | 2013-03-27 | 郑州瑞龙制药股份有限公司 | Traditional Chinese medicine for treating hyperplasia of mammary glands and preparation method of traditional Chinese medicine |
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Application publication date: 20100519 |