CN101647929A - Medicament for treating climacteric syndrome and preparation method thereof - Google Patents
Medicament for treating climacteric syndrome and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a pharmaceutical composition for treating climacteric syndrome and a preparation method thereof. The pharmaceutical composition is prepared from acanthopanax obouatus hoo, prepared rehmannia roots, cinnamon, prepared aconite, medlar, prepared ligustrum lucidum, yam, tuckahoe, prepared dodder, prepared cistanche salsa, tree peony barks and alisma orientale. The invention aims to solve the defects of the prior oral solid pharmaceutical composition for treating climacteric syndrome and provides a condensed pill which is smaller and is easy to swallow as well as is easily accepted by patients. The preparation method of the pharmaceutical composition for treating climacteric syndrome comprises the following steps: respectively crushing the yam, the cinnamon and the treepeony barks into fine powder, and mixing the fine powder for later use; adding ten times of water into other nine Chinese medicines comprising the prepared rehmannia roots and the like to carry out decoction twice, wherein the first decoction time is 2 hours, and the second decoction time is 1 hour; combining decoction liquors, and filtering; under the conditions of the temperature of 65-70 DEG Cand the pressure of -0.08MPa, depressurizing and condensing the filter liquor into clear paste with relative density of 1.08-1.12 at the temperature of 60-70 DEG C, cooling, adding the same amount ofalcohol, stirring, and standing for one night; filtering supernatant fluid, depressurizing and recovering alcohol, and condensing the supernatant fluid into clear paste with relative density of 1.20-1.25 at the temperature of 60-70 DEG C; mixing the clear paste and the fine power, depressurizing and drying, crashing the dry paste, screening by a sieve of 100 meshes, adding 10g of carboxyrnethyl starch sodium and a proper amount of starch, and mixing.
Description
Technical field
The invention belongs to field of traditional Chinese, particularly relate to a kind of medicine that is used for the treatment of climacteric syndrome
The invention still further relates to manufacturing method for above mentioned medicine.
Background technology
Climacteric syndrome is a kind of common disease of puzzlement climacteric women, be among the human aging process since hypo-ovaria cause that the hypothalamic-pituitary-ovarian functional disorder occurs based on face is warmed, vegetative nervous functions such as hectic fever, perspiration, irritable emotion are lacked of proper care syndrome.Symptom in various degree can appear in 90% women, and causes relevant disease in view of the above, and is wherein common with cardiovascular and cerebrovascular disease and osteoporosis.Because of with other endocrine symptoms,, have a strong impact on personal health and quality of life so its treatment is relatively more difficult.
Summary of the invention
The object of the present invention is to provide a kind of medicine that is used for the treatment of climacteric syndrome.
Another object 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 for the treatment of climacteric syndrome, it is a kind of good Rong's ball (concentrated pill), with its improvement, its prescription ratio and former tablet are consistent according to the good Rong's sheet of National Drug Administration's standard (trying) (standard No.: WS-11125 (ZD-1125)-2002).Former tablet formulation consists of: Acanthopanax obouatus Hoo 130g, Radix Rehmanniae Preparata 200g, Cortex Cinnamomi 35g, Radix Aconiti Lateralis Preparata (system) 90g, Fructus Lycii 130g, Fructus Ligustri Lucidi (system) 100g, Rhizoma Dioscoreae 100g, Poria 70g, Semen Cuscutae (system) 130g, Herba Cistanches (system) 130g, Cortex Moutan 70g, Rhizoma Alismatis 70g make 1000 grams, function cures mainly and is YIN nourishing invigorating YANG, the kidney invigorating and essence nourishing.Be used for the climacteric syndrome syndrome of deficiency of both yin and yang of kidney, disease opinion is warmed sweating, and fear of cold is afraid of cold, soreness of the waist and knees.
Its tablet is used verification treatment climacteric syndrome clinically and has been obtained satisfied curative effect.For outstanding Chinese medicine characteristic, reduce relevant production cost simultaneously, be convenient to the patient and take for a long time, it is improved to concentrated pill.After the transformation of the way was concentrated pill, pill was less, easily swallows, and has covered bad smell behind the coating, and the patient is acceptant.Medicine of the present invention stays powder to form by medicinal substances extract and medical material, and 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, solved in the former tablet technology easily difficult problems such as sliver, steady quality.
For achieving the above object, the medicine of treatment climacteric syndrome provided by the invention is the medicament that is become by following weight proportioning ground preparation of raw material:
Acanthopanax obouatus Hoo 260g Radix Rehmanniae Preparata 400g Cortex Cinnamomi 70g
Radix Aconiti Lateralis Preparata (system) 180g Fructus Lycii 260g Fructus Ligustri Lucidi (system) 200g
Rhizoma Dioscoreae 200g Poria 140g Semen Cuscutae (system) 260g
Herba Cistanches (system) 260g Cortex Moutan 140g Rhizoma Alismatis 140g
Manufacturing method for above mentioned medicine provided by the invention, step has: above 12 flavor medical materials, Rhizoma Dioscoreae, Cortex Cinnamomi, Cortex Moutan pulverize separately become fine powder, and mixing is standby.Nine flavors such as all the other Radix Rehmanniae Preparata add 10 times of water gagings and decoct secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, filtrate decompression (65～70 ℃ ,-0.08MPa) be concentrated into the clear paste that relative density is 1.08～1.12 (60～70 ℃), put cold, add equivalent ethanol, stir evenly, standing over night, the leaching supernatant, decompression recycling ethanol also continues to be concentrated into the clear paste that relative density is 1.20～1.25 (60～70 ℃), with above-mentioned fine powder mixing, drying under reduced pressure, dried cream powder is broken, crosses 100 mesh sieves, add carboxymethylstach sodium 10g and an amount of starch, mixing is made wetting agent with warm water, pill, the bag film-coat, drying is made 1000g, promptly.For guaranteeing product quality, all operations all should carry out in clean and dry environment.
Good Rong's ball (concentrated pill) involved in the present invention is compared with former good Rong's sheet, has following beneficial effect:
1 takes: the good Rong's 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 good Rong's 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 good Rong's 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 good Rong's 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 with several groups of specific embodiments, be described further with regard to prescription of good Rong's ball of the present invention (concentrated pill) and preparation method thereof.
Experimental example 1:
Stay the pulverizing yield of powder medical material and the technical study of sterilization
1.1 stay the investigation of powder pulverizing medicinal materials yield
The former preparation of this product stays the powder pulverizing medicinal materials, for ease of control, crosses 100 mesh sieves after testing tentative pulverizing medicinal materials, and the pulverizing yield of staying the powder medical material is investigated.
Test method: take by weighing dry Rhizoma Dioscoreae 1000g Cortex Cinnamomi 350g Cortex Moutan 700g, amount to the 2050g medical material, each 2 parts, mix respectively, pulverize, cross 100 mesh sieves, collect fine powder respectively, weigh, calculate flour extraction.The results are shown in Table 1.
Table 1 is pulverized the investigation of yield
The result shows that this product stays the pulverizing yield of powder medical material to be about about 96%.
1.2 stay the selection of powder medical material sterilizing methods
Actual in conjunction with pharmaceutical factory production at present, determine to adopt the Co-60 radiation sterilization to staying the sterilization of powder medical material, actual conditions: 6～8kGy, can reach ideal sterilization effect at 1 hour time.
Experimental example 2: Study on extraction
2.1 trial test
In the prescription ratio, accurately take by weighing Acanthopanax obouatus Hoo 65g, Radix Rehmanniae Preparata 100g, Radix Aconiti Lateralis Preparata (system) 45g, Fructus Lycii 65g, Fructus Ligustri Lucidi (system) 50g, Poria 35g, Semen Cuscutae (system) 65g, Herba Cistanches (system) 65g, Rhizoma Alismatis 35g add 10 times of water gagings and decocted 2 hours, collecting decoction, filter, calculate liquid absorption.
Conclusion: 10 times of water yield 5250ml-of medicinal residues liquid absorption filtrate 4000ml=liquid absorption 1250ml, the medical material liquid absorption is 2.4 times.
2.2 test
Doubly measure preferred because principal elements such as the extraction time that former extraction process by water boils decocting, extraction time have been formulated comparatively detailed reasonable parameter 2.2.1 add water, that is: nine flavors such as all the other Radix Rehmanniae Preparata decoct with water secondary, and 2 hours for the first time, 1 hour for the second time.Be further process for refining, extraction time, extraction time be according to former technological standards, selects doubly to measure as the investigation factor with solvent, according to the trial test result, determines that following three levels carry out optimal process, factor level table 2.
Table 2 extraction process by water factor level table
2.2.2 design experiment
Accurately take by weighing 1/10 times of recipe quantity medical material in the prescription ratio, add 10 times of amounts of water and decoct secondary, 2 hours for the first time, 1 hour for the second time, run decocting liquid jointly, filter, filtrate is concentrated into the clear paste that relative density is 1.08～1.12 (60～70 ℃), puts coldly, adds equivalent ethanol, stir evenly, standing over night filters, filtrate recycling ethanol, concentrate, be settled to 250ml, standby.
2.2.3 the selection of index composition
Decocting boils each medical material in the side does not all have clear and definite assay index, the monarch drug Acanthopanax obouatus Hoo contains more flavones ingredient, document also has report with ultraviolet spectrophotometry its total flavones to be measured, and this method is very ripe, so determine with the total flavones to be that index components is boiled technology to decocting and carried out preferably.Medical material Acanthopanax obouatus Hoo, Radix Rehmanniae Preparata, Fructus Ligustri Lucidi (system), Herba Cistanches (system), Semen Cuscutae (system) etc. all have compositions such as more saponin, sterol in addition, can be dissolved in the middle polarity n-butyl alcohol, are index so select with the n-butyl alcohol extract content simultaneously.
2.2.4 determination of total flavonoids method
105 ℃ of control substance of Rutin 10.20mg that are dried to constant weight are got in the preparation of reference substance solution, and accurate the title decides, and puts in the 50ml measuring bottle, adds 70% ethanol, shakes up, and promptly gets (containing the about 0.204mg of control substance of Rutin among every 1ml).
The preparation precision of need testing solution is measured reserve liquid 100ml, is concentrated in right amount, adds ethanol and makes in right amount and contain the alcohol amount and reach 70%, filters, and filtrate is settled in the 100ml volumetric flask with 70% ethanol, shakes up, promptly.
The preparation precision of standard curve is measured control substance of Rutin solution 1.0,2.0,3.0,4.0,5.0ml puts respectively in the 25ml measuring bottle, add 5% sodium nitrite solution 1ml, shake up, placed 6 minutes, add 10% aluminum nitrate solution 1ml, shake up, placed 6 minutes, and added 4% sodium hydroxide solution 10ml, shake up, placed 10 minutes, measuring absorbance in 510nm wavelength place according to spectrophotography (appendix VB of Chinese Pharmacopoeia version in 2000), is vertical coordinate with the absorbance, and concentration is abscissa, the drawing standard curve the results are shown in Table 3.
Table 3 standard curve data
Trying to achieve regression equation by concentration and absorbance linear relationship is: A=15.922C-0.009 r=0.9999.Result of the test shows that reference substance concentration is good in 0.008～0.04mg/ml scope internal linear relation.
The algoscopy precision is measured above-mentioned reference substance solution and each 4ml of need testing solution, puts respectively in the 25ml measuring bottle, adds 5% sodium nitrite solution 1ml, shake up, placed 6 minutes, add 10% aluminum nitrate solution 1ml, shake up, placed 6 minutes, and added 4% sodium hydroxide solution 10ml, shake up, place and (got 70% alcoholic solution and each 4ml of need testing solution in addition respectively in 10 minutes, except that not adding 4% sodium hydroxide solution, all with method operation, the blank solution of solution and need testing solution in contrast respectively).Measure absorbance in 510nm wavelength place according to spectrophotography (appendix VB of Chinese Pharmacopoeia version in 2000), calculate, promptly.
2.2.5 n-butyl alcohol determination of extractives method
Precision is measured reserve liquid 100ml, is concentrated into about 20ml, puts in the separatory funnel, with water saturated n-butanol extraction three times, each 20ml merges n-butyl alcohol liquid, 30ml washes once with the n-butyl alcohol saturation water, puts in the evaporating dish that oneself is dried to constant weight evaporate to dryness, put 105 ℃ of dryings 3 hours, in the dislocation exsiccator, cooled off 30 minutes, weight decided in accurate title, calculate, promptly.
2.3 test results test the results are shown in Table 4.
Table 4 extraction process result of the test
By table 4 result as can be known, add 10 times of amounts, that 12 times of water gagings decoct results is close, all is better than adding the effect that 8 times of water gagings extract, and from energy savings, reduces the composition loss, select to add 10 times of water gagings and decoct and get final product.
So extraction process is: nine flavors such as all the other Radix Rehmanniae Preparata add 10 times of water gagings and decoct secondary, 2 hours for the first time, and 1 hour for the second time.
Experimental example 3: concentration technology research
3.1 medicinal liquid method for concentration
Adopt pressure regulating equipment to concentrate at present in the commercial production mostly, this method is the efficient height not only, and is beneficial to the reservation effective ingredient.Therefore after extracting medicinal liquid and reclaiming ethanol, adopt concentrating under reduced pressure.By experiment, determine its concentrated condition for decompression (65～70 ℃ ,-0.08MPa) concentrate, test shows this method efficient height, no bumping, therefore definite this condition.
3.2 reclaim the ethanol condition
Decompression recycling ethanol efficient height is fit to that industry is big produces, and the present invention adopts decompression recycling ethanol and its concrete technological parameter is investigated, in conjunction with experience and test, determine (65～70 ℃ ,-0.08MPa) decompression recycling ethanol down.
The research of 4 drying processes
After changing concentrated pill into, will stay the powder medical material to admix thick paste and carry out drying, this prescription stays that paeonol and cinnamic aldehyde are the easily loss composition that is heated in the powder medical material, adopt constant pressure and dry efficient low, loss of effective components is many, adopts the drying under reduced pressure time short, the composition loss is few, so determine to adopt drying under reduced pressure.Result of the test shows, this product (55～65 ℃ ,-0.08MPa) drying under reduced pressure under the condition, efficient height, and cinnamic aldehyde and paeonol loss are less, dried cream is loose, sample quality is good, so definite this method.
The examination of 5 technology paste-forming rates
According to the preferred experimental condition of institute, its the rate of extract that extracts medical material is about 10%, stay the pulverizing yield of powder medical material to be about about 96%, on this basis, done the test of two batches of extensive magnitudes again, got the medical material of 3,5 times of recipe quantities, by preferred technology pulverize, extract, make with extra care, concentrate, dry, survey total paste-forming rate of technology, data see Table 6.
Table 6 paste-forming rate is investigated result of the test
Experimental result shows, the technology of this product prescription is must the cream rate basicly stable about 24%.
Experimental example 6: moulding process is investigated
6.1 the selection of adjuvant
After changing concentrated pill into, through above test, 1 times of recipe quantity of the present invention powder that gets dry extract is about 95g, and staying powder medical material amount in the prescription is 205g, because the extract powder ratio is little, it is big not add the direct pill difficulty of adjuvant.As required, must add appropriate amount of auxiliary materials dilutes.Consider that starch suppresses the stickiness of extract powder, guarantee that medicine has certain disintegration, prevent the moisture absorption, consider factors such as cheap and easy to get simultaneously, select starch as main adjuvant.
6.2 the wetting agent kind is preferred
The present invention sneaks into the concentrated pill that extractum is made for the part medical material stays powder.Test is attempted 30% ethanol, 10% ethanol, cold water, warm water respectively as wetting agent, the pill bar.The result proves, makes wetting agent with 30% ethanol, 10% ethanol and cold water, and the soft material stickiness is low, and it is easily broken to extrude the ball bar, it is effective to do wetting agent with warm water, can increase the soft material stickiness, extrude the moderate ball bar of viscosity, and consumption is little, it is fast to become a useful person, and the efficient height is so select to do wetting agent with an amount of warm water.
6.3 the wetting agent consumption is preferred
According to above preferred result, select to add starch as adjuvant, selection as wetting agent, on above basis, is further investigated warm water consumption, process for refining parameter in therefore testing with warm water.
According to trial test, per 100 gram medicated powder select to add 30ml, 20ml respectively, 10ml warm water is tested as wetting agent, the preparation soft material, close and stick together, with small-sized pellet processing machine pill, observe the soft or hard degree and the viscosity of soft material, and glutinous company whether when investigating the roundness of gained concentrated pill and round, come the consumption of preferred wetting agent.The results are shown in Table 7.
The preferred table of table 7 warm water addition
By above result as can be known, it is good that per 100 gram medicated powder adding 20ml warm water make the soft material stickiness as wetting agent, and glutinous wall and pill shaped circle are whole, and glutinous the company lacked; And add 30ml warm water when making wetting agent soft material softer, be difficult for being extruded into bar, the ball type is bad; Soft material is more less sticky when making wetting agent with 10ml warm water, is difficult for being extruded into bar, and ball easily splits.Make the wetting agent pill so select per 100 gram medicated powder to add 20ml warm water.
6.4 the selection of disintegrating agent
Up to specification for the dissolve scattered time limit that guarantees pill, can suitably add disintegrating agent, accelerate its molten loosing.Carboxymethylstach sodium is efficient disintegrating agent, can obviously improve the disintegrate of tablet, pill etc., so this product selects carboxymethylstach sodium as disintegrating agent, and its addition is investigated.Select the carboxymethylstach sodium of adding 0.5%, 1%, 2% in the test, according to " the dissolve scattered time limit inspection technique is checked pill among appendix IA of Chinese pharmacopoeia.The results are shown in Table 8.
The preferred table of table 8 disintegrating agent addition
As seen from the experiment, the disintegration that the carboxymethylstach sodium of adding 1% can obviously improve pill is so select the carboxymethylstach sodium of adding 1% to get final product.
6.5 the selection of coating material
The moist degree difference of different regions is bigger, all can produce harmful effect for production, transportation, the storage process of pill.Coating is very big to the quality influence of concentrated watered pill, so the research art for coating is of practical significance to the raising of concentrated watered pill quality.The coating of the watered pill is meant that the ball surface wraps up in layer of substance, the process that makes it to be hedged off from the outer world.Its purpose mainly is: increase stability of drug, storage is easy to carry; Reduce the zest of medicine, be convenient to take; Control pill disintegration; Improve outward appearance, be beneficial to identification.
Former Chinese medicine pill adopts the active carbon coating method to carry out coating more, but the moisture resistance of this method is not ideal enough, especially some is contained the more medicine pill of sugar.
This preparation has selected external novel thin film clothing packaging material Opadry (OPADRY) to this ball bag film-coat, and measures coating of pill front and back put procedure water content in accordance with the law, and result of the test shows that through the pill of Opadry packaging material coating, its moistureproof ability strengthens greatly.The quality that this packaging technique is easy to operate, saved time, improved this product.
The conversion of 7 recipe quantities
Former good Rong's sheet crude drug total amount is 1255g, makes 1000 in flakes altogether, and each dose is 4～5, and 3 times on the one, a day clothes crude drug amount is: 1000 * 4～5 * 3 times=15.06～18.825g of 1255g ÷.Behind the transformation of the way pill, planning its prescription expansion is twice, new recipe crude drug amount is 2510g, according to existing pharmacopeia requirement, make pill 1000g, obey 2～2.5g at every turn, 3 times on the one, obeying the crude drug amount day is that 2510 ÷ 1000g * (2～2.5g) * 3 times=15.06～18.825g, i.e. the transformation of the way is identical with former tablet for obeying the crude drug amount day behind the pill.So determine new recipe quantity be:
Acanthopanax obouatus Hoo 260g Radix Rehmanniae Preparata 400g Cortex Cinnamomi 70g Radix Aconiti Lateralis Preparata (system) 180g
Fructus Lycii 260g Fructus Ligustri Lucidi (system) 200g Rhizoma Dioscoreae 200g Poria 140g
Semen Cuscutae (system) 260g Herba Cistanches (system) 260g Cortex Moutan 140g Rhizoma Alismatis 140g
8: three batches of pilot scale creation datas of experimental example:
According to above preferred technology, produce three batches in test agent: adopt in the production equipments such as multipotency extraction pot, concentrating under reduced pressure jar, triple effect concentration tank, vacuum drying oven, pellet processing machine and carry out.
The 10 times of recipe quantities that feed intake, to each batch paste-forming rate, yield rate, and physical and chemical index and paeonol, cinnamic aldehyde content are investigated.The result shows that the technology of said preparation is basicly stable, and every data see Table 9.
The specific embodiment
Embodiment 1:
Prescription Acanthopanax obouatus Hoo 260g Radix Rehmanniae Preparata 400g Cortex Cinnamomi 70g
Radix Aconiti Lateralis Preparata (system) 180g Fructus Lycii 260g Fructus Ligustri Lucidi (system) 200g
Rhizoma Dioscoreae 200g Poria 140g Semen Cuscutae (system) 260g
Herba Cistanches (system) 260g Cortex Moutan 140g Rhizoma Alismatis 140g
Method for making: for guaranteeing product quality, all operations all should carry out in clean and dry environment.
More than 12 the flavor medical materials, Rhizoma Dioscoreae, Cortex Cinnamomi, Cortex Moutan pulverize separately become fine powder, mixing is standby.Nine flavors such as the surplus Radix Rehmanniae Preparata of tool add 10 times of water gagings and decoct secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, filtrate decompression (65～70 ℃ ,-0.08MPa) be concentrated into the clear paste that relative density is 1.08～1.12 (60～70 ℃), put cold, add equivalent ethanol, stir evenly, standing over night, the leaching supernatant, decompression recycling ethanol also continues to be concentrated into the clear paste that relative density is 1.20～1.25 (60～70 ℃), with above-mentioned fine powder mixing, drying under reduced pressure, dried cream powder is broken, crosses 100 mesh sieves, add carboxymethylstach sodium 10g and an amount of starch, mixing is made wetting agent with warm water, pill, the bag film-coat, drying is made 1000g, promptly.
Embodiment 2: 30 times of amounts selecting recipe quantity
Prescription Acanthopanax obouatus Hoo 7.8kg Radix Rehmanniae Preparata 12kg Cortex Cinnamomi 2.1kg
Radix Aconiti Lateralis Preparata (system) 5.4kg Fructus Lycii 7.8kg Fructus Ligustri Lucidi (system) 6kg
Rhizoma Dioscoreae 6kg Poria 4.2kg Semen Cuscutae (system) 7.8kg
Herba Cistanches (system) 7.8kg Cortex Moutan 4.2kg Rhizoma Alismatis 4.2kg
Method for making: for guaranteeing product quality, all operations all should carry out in clean and dry environment.
More than 12 the flavor medical materials, Rhizoma Dioscoreae, Cortex Cinnamomi, Cortex Moutan pulverize separately become fine powder, mixing is standby.Nine flavors such as all the other Radix Rehmanniae Preparata add 10 times of water gagings and decoct secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, filtrate decompression (65～70 ℃ ,-0.08MPa) be concentrated into the clear paste that relative density is 1.08～1.12 (60～70 ℃), put cold, add equivalent ethanol, stir evenly, standing over night, the leaching supernatant, decompression recycling ethanol also continues to be concentrated into the clear paste that relative density is 1.20～1.25 (60～70 ℃), with above-mentioned fine powder mixing, drying under reduced pressure, dried cream powder is broken, crosses 100 mesh sieves, add carboxymethylstach sodium 300g and an amount of starch, mixing is made wetting agent with warm water, pill, the bag film-coat, drying is made 30kg, promptly.
Embodiment 3: 100 times of amounts selecting recipe quantity
Prescription Acanthopanax obouatus Hoo 26kg Radix Rehmanniae Preparata 40kg Cortex Cinnamomi 7kg
Radix Aconiti Lateralis Preparata (system) 18kg Fructus Lycii 26kg Fructus Ligustri Lucidi (system) 20kg
Rhizoma Dioscoreae 20kg Poria 14kg Semen Cuscutae (system) 26kg
Herba Cistanches (system) 26kg Cortex Moutan 14kg Rhizoma Alismatis 14kg
Method for making: for guaranteeing product quality, all operations all should carry out in clean and dry environment.
More than 12 the flavor medical materials, Rhizoma Dioscoreae, Cortex Cinnamomi, Cortex Moutan pulverize separately become fine powder, mixing is standby.Nine flavors such as all the other Radix Rehmanniae Preparata add 10 times of water gagings and decoct secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, filtrate decompression (65～70 ℃ ,-0.08MPa) be concentrated into the clear paste that relative density is 1.08～1.12 (60～70 ℃), put cold, add equivalent ethanol, stir evenly, standing over night, the leaching supernatant, decompression recycling ethanol also continues to be concentrated into the clear paste that relative density is 1.20～1.25 (60～70 ℃), with above-mentioned fine powder mixing, reduce pressure in dry, dried cream powder is broken, crosses 100 mesh sieves, add carboxymethylstach sodium 1kg and an amount of starch, mixing is made wetting agent with warm water, pill, the bag film-coat, drying is made 100kg, promptly.
Embodiment 4: 300 times of amounts selecting recipe quantity
Prescription Acanthopanax obouatus Hoo 78kg Radix Rehmanniae Preparata 120kg Cortex Cinnamomi 21kg
Radix Aconiti Lateralis Preparata (system) 54kg Fructus Lycii 78kg Fructus Ligustri Lucidi (system) 60kg
Rhizoma Dioscoreae 60kg Poria 42kg Semen Cuscutae (system) 78kg
Herba Cistanches (system) 78kg Cortex Moutan 42kg Rhizoma Alismatis 42kg
Method for making: for guaranteeing product quality, all operations all should carry out in clean and dry environment.
More than 12 the flavor medical materials, Rhizoma Dioscoreae, Cortex Cinnamomi, Cortex Moutan pulverize separately become fine powder, mixing is standby.Nine flavors such as all the other Radix Rehmanniae Preparata add 10 times of water gagings and decoct secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, filtrate decompression (65～70 ℃ ,-0.08MPa) be concentrated into the clear paste that relative density is 1.08～1.12 (60～70 ℃), put cold, add equivalent ethanol, stir evenly, standing over night, the leaching supernatant, decompression recycling ethanol also continues to be concentrated into the clear paste that relative density is 1.20～1.25 (60～70 ℃), with above-mentioned fine powder mixing, drying under reduced pressure, dried cream powder is broken, crosses 100 mesh sieves, add carboxymethylstach sodium 3kg and an amount of starch, mixing is made wetting agent with warm water, pill, the bag film-coat, drying is made 300kg, promptly.
Three batches of pilot scale creation datas of table 9
Claims (10)
1. medicine that is used for the treatment of climacteric syndrome is characterized in that the weight ratio of each crude drug of this pharmaceutical composition is:
Prescription Acanthopanax obouatus Hoo 260g Radix Rehmanniae Preparata 400g Cortex Cinnamomi 70g
Radix Aconiti Lateralis Preparata (system) 180g Fructus Lycii 260g Fructus Ligustri Lucidi (system) 200g
Rhizoma Dioscoreae 200g Poria 140g Semen Cuscutae (system) 260g
Herba Cistanches (system) 260g Cortex Moutan 140g Rhizoma Alismatis 140g
2. medicine according to claim 1, its preparation method may further comprise the steps::
Described 12 herbal medicines of claim 1, Rhizoma Dioscoreae, Cortex Cinnamomi, Cortex Moutan pulverize separately become fine powder, and mixing is standby.Nine flavors such as all the other Radix Rehmanniae Preparata add 10 times of water gagings and decoct secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, filtrate decompression (65～70 ℃ ,-0.08MPa) be concentrated into the clear paste that relative density is 1.08～1.12 (60～70 ℃), put cold, add equivalent ethanol, stir evenly, standing over night, the leaching supernatant, decompression recycling ethanol also continues to be concentrated into the clear paste that relative density is 1.20～1.25 (60～70 ℃), with above-mentioned fine powder mixing, drying under reduced pressure, dried cream powder is broken, cross 100 mesh sieves, add carboxymethylstach sodium 10g and an amount of starch, mixing, make wetting agent with warm water, pill, the bag film-coat, drying forms; 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 climacteric syndrome as claimed in claim 2 is characterized in that adding that water doubly measures is 10 times of amounts, and decocting time is 2 hours for the first time, 1 hour for the second time.
4. a kind of process for preparing medicine that is used for the treatment of climacteric syndrome as claimed in claim 2 is characterized in that the spissated condition of filtrate decompression is 65～70 ℃ ,-0.08MPa, and relative density is the clear paste of 1.08～1.12 (60～70 ℃ of surveys).
5. a kind of process for preparing medicine that is used for the treatment of climacteric syndrome as claimed in claim 2, it is characterized in that reclaiming the relative density that the medicinal liquid of gained behind the ethanol is condensed into thick paste is 1.20～1.25 (60～70 ℃ of surveys).
6. a kind of process for preparing medicine that is used for the treatment of climacteric syndrome 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 climacteric syndrome as claimed in claim 2 it is characterized in that used disintegrating agent is a carboxymethylstach sodium, and use amount is 1% of an obtained output.
8. a kind of process for preparing medicine that is used for the treatment of climacteric syndrome as claimed in claim 2 is characterized in that used lubricant is a warm water.
9. as claim 1,2 described a kind of process for preparing medicine that are used for the treatment of climacteric syndrome, it is characterized in that described medicament is a concentrated pill.
10. as claim 1,2 described a kind of process for preparing medicine that are used for the treatment of climacteric syndrome, it is characterized in that the use of regulating prescription doubly measures, can obtain the output under the corresponding proportion.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102755521A (en) * | 2012-07-31 | 2012-10-31 | 施慧达药业集团(吉林)有限公司 | Chinese materia medica preparation for treating climacteric syndrome and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102755521A (en) * | 2012-07-31 | 2012-10-31 | 施慧达药业集团(吉林)有限公司 | Chinese materia medica preparation for treating climacteric syndrome and preparation method thereof |
| CN102755521B (en) * | 2012-07-31 | 2014-01-29 | 施慧达药业集团(吉林)有限公司 | Chinese materia medica preparation for treating climacteric syndrome and preparation method thereof |
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Open date: 20100217 |