CN101480458A - Method for preparing Chinese medicinal composition for preventing and treating menoxenia - Google Patents

Method for preparing Chinese medicinal composition for preventing and treating menoxenia Download PDF

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Publication number
CN101480458A
CN101480458A CNA2008100430146A CN200810043014A CN101480458A CN 101480458 A CN101480458 A CN 101480458A CN A2008100430146 A CNA2008100430146 A CN A2008100430146A CN 200810043014 A CN200810043014 A CN 200810043014A CN 101480458 A CN101480458 A CN 101480458A
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water
time
chinese medicine
extractum
preparation
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虞伟
阮克锋
路钧镧
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Shanghai Traditional Chinese Medicine Pharmaceutical Technology Co Ltd
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Shanghai Traditional Chinese Medicine Pharmaceutical Technology Co Ltd
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Abstract

The invention discloses a preparation method of a traditional Chinese medicine composition for preventing and treating irregular menstruation. The method comprises the following steps: concentrating a certain quantity of raw materials medicine including motherwort, cyperus tuber, sweetgum fruit, hemlock parsley, seed of cowherb and spatholobus stem into water extract diluted extractum by water extraction, or concentrating the raw material medicine into water extraction and alcohol precipitation diluted extractum by water extraction and alcohol precipitation, then putting dextrin, starch or the like used as substrates into a one-step granulating machine, spraying the water extract diluted extractum or the water extraction and alcohol precipitation diluted extractum used as a binding agent into the one-step granulating machine for one-step granulation, finally grinding grains, and adding other auxiliary materials to prepare traditional Chinese medicine preparation for oral administration. The method can significantly reduce the quantity of the auxiliary materials, shorten the processing time and the heating time for condensation and drying, avoid the damage to the effective ingredients of the traditional Chinese medicine composition, simplify the process flow and reduce the energy consumption. The flowability of the prepared granules is high, the disintegration of compressed tablets is fast, the production process is not easily polluted, and the quality of finished products is ensured well.

Description

A kind of preparation method of preventing and treating the Chinese medicine composition of menoxenia
Technical field
The present invention relates to a kind of preparation method of Chinese medicine composition, relate in particular to a kind of preparation method of preventing and treating the Chinese medicine composition of menoxenia.
Background technology
Gynaecopathia---menoxenia refers to menstrual cycle, menstrual period, through amount, through color, unusual through matter, or the symptom of following menstrual cycle to occur is the gynaecopathia of feature, comprise preceeded menorrhea, later stage, nothing regularly, menorrhagia, dysmenorrhea etc., and General Symptomies such as the headache that causes by menoxenia, insomnia, diarrhoea.
Show that according to the Ministry of Public Health investigation statistics China's gynaecopathia sickness rate is up to 75%, wherein menoxenia, dysmenorrhea patient account for 50%.China's menstrual physiology constant cooperative groups investigation finds that also 33.2% has dysmenorrhea among 71746 women, and 13.6% dysmenorrhea patient life is subjected to obvious influence with work.Equally, about 50% menoxenias that have in various degree among the women after U.S.'s adolescence, 10% because of every month need of dysmenorrhea rest 1-3 days.In recent years, the female irregular menstruation age presents rejuvenation trend, and sickness rate improves year by year.This long-term, general and unavoidable gynaecopathia has had a strong impact on healthy and quality of life of China women.Huge disease crowd has facilitated huge gynecological's drug market simultaneously.Calendar year 2001, China gynecological medicine sales volume was up to 9,700,000,000 yuans; And in recent years, continued to be growing trend.Therefore, research and development menoxenia medicine has good social benefit and optimistic market prospect, and is for satisfying the medical clinical demand and the market demand, significant.
Application number is that the patent application of 200710094647.5 (applying date: on December 28th, 2007) discloses a kind of prescription of preventing and treating the Chinese medicine composition of menoxenia, mainly by being selected from two kinds of following weight portion, three kinds, four kinds, the water extract of five kinds or six kinds crude drug or water extracting alcohol hypostasis are formed: Herba Leonuri 5-35 part, Rhizoma Cyperi 5-20 part, Fructus Liquidambaris 5-20 part, Rhizoma Chuanxiong 2-20 part, Semen Vaccariae 3-20 part, Caulis Spatholobi 5-20 part.This patent application also discloses a kind of preparation method of this Chinese medicine composition, promptly adopts water extraction (or alcohol extraction), vacuum drying (or spray drying) and wet granulation technology, is specially: with crude drug water boiling and extraction 2 times a certain amount of, definite composition; Filter, merging filtrate concentrates, and perhaps adds the ethanol precipitate with ethanol, and the adjusting alcoholic degree is 30%-90%, filters, and concentrates alcohol deposit fluid; Adopt vacuum drying or spray drying to carry out drying, get drug extract; Add appropriate amount of auxiliary materials in drug extract after, wet granulation, drying can get the oral preparations of different dosage form, as granule, tablet or capsule behind granulate.Wet granulation is that a kind of traditional swing (or three-phase cutting type) granulates, and technology is with drug extract, medicinal powder and adjuvant, adds swing granulation behind an amount of adhesive mixing, adopts the hot-air oven drying then.Above-mentioned disclosed preparation method adopts wet granulation; Chinese medicine extract need be condensed into thick extractum, and heated time is long, and it is generally darker to make grain color; grain density and size are difficult for evenly, are difficult to make the Chinese medicinal granule of low adjuvant or carry out the tabletting production of later process.
Summary of the invention
The technical problem to be solved in the present invention provides a kind of preparation method of preventing and treating the Chinese medicine composition of menoxenia, the adjuvant amount be can obviously reduce, process time and concentrated, exsiccant heated time shortened, avoid destroying the effective ingredient of this Chinese medicine composition, uniform particles, the good fluidity made, the disintegration of tablet of compacting is faster, and has simplified technological process, has reduced energy consumption, production process is difficult for contaminated, and end product quality obtains better guarantee.
For solving the problems of the technologies described above, the invention provides a kind of preparation method of preventing and treating the Chinese medicine composition of menoxenia, this Chinese medicine composition is mainly by being selected from two kinds of following weight portion, three kinds, four kinds, the water extract of five kinds or six kinds crude drug or water extracting alcohol hypostasis are formed: Herba Leonuri 5-35 part, Rhizoma Cyperi 5-20 part, Fructus Liquidambaris 5-20 part, Rhizoma Chuanxiong 2-20 part, Semen Vaccariae 3-20 part, Caulis Spatholobi 5-20 part, the preparation method of this Chinese medicine composition may further comprise the steps:
(1) with described bulk drugs with water boiling and extraction 2 times, the 6-15 that extracts amount of water for the first time and be dose doubly, extraction time is 0.5-3 hour; The 4-10 that extracts for the second time amount of water and be dose doubly, extraction time is 0.5-3 hour; Filter, merging filtrate is condensed into relative density and is 1.05~1.18 water and carries rare extractum, perhaps adds the ethanol precipitate with ethanol, and adjustings alcoholic degree is 30%-90%, filtration, and it is 1.05~1.18 the rare extractum of water extract-alcohol precipitation that concentrated alcohol deposit fluid becomes relative density;
(2) adopt the fluid bed one-step palletizing: in one-step-granulating method, put into dextrin or starch as substrate, above-mentioned water is carried rare extractum or the rare extractum of water extract-alcohol precipitation sprays into one-step-granulating method as binding agent, open turnover wind, control with-0.02~-negative pressure of 0.05MPa seethes with excitement evenly powder in the granulator jar, add the thermal control temperature of charge then at 30~50 ℃, carry out one-step palletizing, the granulation time is 3~5 hours;
(3) granule that one-step palletizing is made carries out granulate, adds other adjuvants, makes the oral medicinal herb preparation.
Comprise at the adjuvant described in the step (3): micropowder silica gel, dextrin, starch, one or more compositionss in the microcrystalline Cellulose.
In the step (3), described oral medicinal herb preparation is granule, tablet or capsule.
After step (2) was finished, the granule water content that one-step palletizing is made was controlled at below 5%.
Innovative point of the present invention is to adopt the wet granulation in the former preparation process of fluid bed boiling granulating (one-step palletizing) replacement.The fluid bed boiling granulating claims one-step palletizing again, be the material adjuvant to be carried out (spraying) granulation, airpillow-dry, mixing once finish in airtight container, also be that said at ordinary times preparation granule will have three steps, in hermetic container, once finish, make one-step method granulate.One-step method granulator is external product, begins to introduce China at the beginning of 70, nearly uses in the pharmaceutical factory about 30 years, begins mass production to the beginning of the nineties, and this equipment generally is used in the Factory Building of newly-built " GMP " standard and goes.
One-step method granulator is to utilize clean thermal current to be fluidized state (negative pressure) blowing from the bottom to boil at the material of hermetic container and adjuvant.The material adjuvant is done waving up and down of random complexity in container, and mixing reaches uniform state in waving.Spray into binding agent or liquid extract then and make the moistening coagulation of granular material,, form the cellular granule again through hot-air dry.It is the wet-mixed during tradition is granulated, and multiple tracks granulation process such as stirring granulation, drying are incorporated in the same operation container to be finished.
The technical characterstic of one-step palletizing: this technology is the novel granulation technique of finishing in one step of mixing, granulation, drying process, the adjuvant amount be can obviously reduce, process time and heated time shortened, the even particle size of making, improve particulate flowability and compressibility, the production efficiency height is convenient to automatic control; Because pelletization is finished in airtight granulator, and production process is difficult for contaminated, end product quality obtains better guarantee simultaneously.Be used at present the preparation of chemical medicine granule more.
Adsorptivity when considering preparation of granules, granule size and uniformity and particulate flowability, easy pressure property, the present invention adopts marumerization, realize that extracting solution extractum system grain forming one goes on foot and finishes, enhancing productivity, reducing energy resource consumption, improving and comparatively remarkable advantages is all arranged aspect the product quality.
The consumption of the Chinese medicine composition of the control menoxenia that the present invention makes and the course of treatment can be done suitably to adjust according to the light and heavy degree of dosage form, patient's age, disease, but be generally oral 2-3 time of every day, each 1 bag (granule), every bag 10 gram, with 3 months be a course of treatment, can use continuously 2 courses of treatment or the longer time.
The present invention has following beneficial effect:
A. original production process need be condensed into the thick extractum of relative density about 1.3 to Chinese medicine extraction liquid, or put in the baking oven and dry with higher temperature, general temperature is more than 60 ℃, drying needs about 8 hours, the dry extract that obtains need through after pulverizing again with other mixing of materials, after wet granulation carries out oven heat drying, granulate again as tabletting or fill granule, capsular material.The present invention adopts the fluid bed boiling granulating, Chinese medicine extraction liquid only need be concentrated into rare extractum of relative density about 1.1, concentrated heated time shortens greatly, rare extractum promptly can carry out (spraying) with adjuvant and other material and granulate, a dry step of the extractum system of realization grain forming finishes, Production Time is several hrs and temperature low (generally being no more than 4 hours) only, and less technological process and time, lower technology consume energy, and increase work efficiency greatly.
B. former explained hereafter Chinese medicine extraction is condensed into thick extractum, and heated time was long when extractum concentrated, and oven drying again after making granule, baking temperature be generally all more than 60 ℃, and twice heated time is long, temperature is high, and consuming time longer, and it is higher to consume energy.And the present invention adopts the fluid bed boiling granulating system granule and baking temperature can be controlled at below 60 ℃, and consuming time shorter, and it is lower to consume energy.
C. the traditional processing technology extract dry after pulverize with other mixing of materials, granulation, granulate after granule carry out the tabletting operation, mobile unstable but because its granularity of material is inhomogeneous, can cause the weight differential wave amplitude of tablet in the tabletting process bigger.The present invention adopts fluid bed boiling granulating resulting granules, its even particle size degree improves, flow stability is improved, compressibility is good, press tablet no matter significantly improve in hardness, fineness, wearability, and the tablet weight variation wave amplitude is less, and all there is remarkable advantages aspects such as the remarkable shortening of disintegration time.
D. former technology to Chinese medicine extraction, concentrate, dry, system granule, dry whole process operation are many, long flow path, production time are long.The present invention adopts the fluid bed boiling granulating, its extract dry, mixing, grain forming are finished in airtight facility for granulating simultaneously, and the time is short, than traditional production technology need concentrate through the long-time heat of extractum, granulate, a plurality of operations such as dry, mixing or pulverizing, production process is not vulnerable to pollute, end product quality control is more secure, more meets the GMP production requirement.
The specific embodiment
The invention will be further elaborated by the following examples:
The one-step method granulator that following examples adopted is that the model that Huafa Pharmaceutical Mating Development Co., Shanghai produces is the boiling granulating machine of FL-5.
Embodiment 1
With Herba Leonuri 24g, Rhizoma Cyperi 12g, Fructus Liquidambaris 12g, Rhizoma Chuanxiong 12g, Semen Vaccariae 12g, Caulis Spatholobi 12g water boiling and extraction 2 times, extracting amount of water for the first time is 10 times of doses, extraction time is 2 hours; Amount of water is 7 times of doses for the second time, and extraction time is 2 hours; Filter, merging filtrate is condensed into relative density and is 1.05 water and carries rare extractum; In one-step-granulating method, put into dextrin or starch etc. as substrate, above-mentioned water is carried rare extractum spray into one-step-granulating method as binding agent, open turnover wind, control seethes with excitement evenly powder with the negative pressure of-0.02MPa in the granulator jar, add the thermal control temperature of charge then at 30 ℃, carry out one-step palletizing, the granulation time is 5 hours; The granule that one-step palletizing is made carries out granulate, adds the appropriate amount of auxiliary materials micropowder silica gel, dextrin, and starch, microcrystalline Cellulose, compacting is in flakes.
Embodiment 2
With Herba Leonuri 5g, Rhizoma Cyperi 5g, Fructus Liquidambaris 5g, Rhizoma Chuanxiong 2g, Semen Vaccariae 3g, Caulis Spatholobi 5g be with water boiling and extraction 2 times, and extract amount of water for the first time and be dose 6 times, extraction time is 0.5 hour; Extract for the second time amount of water and be dose 4 times, extraction time is 0.5 hour; Filter, merging filtrate is condensed into relative density and is 1.18 water and carries rare extractum; In one-step-granulating method, put into dextrin or starch etc. as substrate, above-mentioned water is carried rare extractum spray into one-step-granulating method as binding agent, open turnover wind, control seethes with excitement evenly powder with the negative pressure of-0.05MPa in the granulator jar, add the thermal control temperature of charge then at 50 ℃, carry out one-step palletizing, the granulation time is 3 hours; The granule that one-step palletizing is made carries out granulate, adds the appropriate amount of auxiliary materials micropowder silica gel, dextrin, fill capsule.
Embodiment 3
With Herba Leonuri 35g, Rhizoma Cyperi 20g, Fructus Liquidambaris 20g, Rhizoma Chuanxiong 20g, Semen Vaccariae 20g, Caulis Spatholobi 20g be with water boiling and extraction 2 times, and extract amount of water for the first time and be dose 15 times, extraction time is 3 hours; Extract for the second time amount of water and be dose 10 times, extraction time is 3 hours; Add the ethanol precipitate with ethanol, regulating alcoholic degree is 30%, filters, and it is 1.05 the rare extractum of water extract-alcohol precipitation that concentrated alcohol deposit fluid becomes relative density; In one-step-granulating method, put into dextrin or starch etc. as substrate, the rare extractum of above-mentioned water extract-alcohol precipitation is sprayed into one-step-granulating method as binding agent, open turnover wind, control seethes with excitement evenly powder with the negative pressure of-0.03MPa in the granulator jar, add the thermal control temperature of charge then at 40 ℃, carry out one-step palletizing, the granulation time is 4 hours; The granule that one-step palletizing is made carries out granulate, adds the appropriate amount of auxiliary materials micropowder silica gel, dextrin, and starch, granule is made in pack.
Embodiment 4
With Herba Leonuri 24g, Rhizoma Cyperi 12g water boiling and extraction 2 times, extracting amount of water for the first time is 10 times of doses, extraction time is 2 hours; Amount of water is 7 times of doses for the second time, and extraction time is 2 hours; Filter, merging filtrate is condensed into relative density and is 1.1 water and carries rare extractum; In one-step-granulating method, put into dextrin or starch etc. as substrate, above-mentioned water is carried rare extractum spray into one-step-granulating method as binding agent, open turnover wind, control seethes with excitement evenly powder with the negative pressure of-0.04MPa in the granulator jar, add the thermal control temperature of charge then at 40 ℃, carry out one-step palletizing, the granulation time is 4 hours; The granule that one-step palletizing is made carries out granulate, adds the appropriate amount of auxiliary materials micropowder silica gel, dextrin, and microcrystalline Cellulose, granule is made in pack.
Embodiment 5
With Herba Leonuri 24g, Rhizoma Cyperi 12g, Fructus Liquidambaris 12g be with water boiling and extraction 2 times, and extract amount of water for the first time and be dose 6 times, extraction time is 0.5 hour; Extract for the second time amount of water and be dose 4 times, extraction time is 0.5 hour; Filter, merging filtrate is condensed into relative density and is 1.1 water and carries rare extractum; In one-step-granulating method, put into dextrin or starch etc. as substrate, above-mentioned water is carried rare extractum spray into one-step-granulating method as binding agent, open turnover wind, control seethes with excitement evenly powder with the negative pressure of-0.04MPa in the granulator jar, add the thermal control temperature of charge then at 40 ℃, carry out one-step palletizing, the granulation time is 4 hours; The granule that one-step palletizing is made carries out granulate, adds the appropriate amount of auxiliary materials dextrin, starch, and microcrystalline Cellulose, granule is made in pack.
Embodiment 6
With Herba Leonuri 24g, Rhizoma Cyperi 12g, Fructus Liquidambaris 12g, Rhizoma Chuanxiong 12g be with water boiling and extraction 2 times, and extract amount of water for the first time and be dose 15 times, extraction time is 3 hours; Extract for the second time amount of water and be dose 10 times, extraction time is 3 hours; Add the ethanol precipitate with ethanol, regulating alcoholic degree is 90%, filters, and it is 1.18 the rare extractum of water extract-alcohol precipitation that concentrated alcohol deposit fluid becomes relative density; In one-step-granulating method, put into dextrin or starch etc. as substrate, the rare extractum of above-mentioned water extract-alcohol precipitation is sprayed into one-step-granulating method as binding agent, open turnover wind, control seethes with excitement evenly powder with the negative pressure of-0.03MPa in the granulator jar, add the thermal control temperature of charge then at 40 ℃, carry out one-step palletizing, the granulation time is 4 hours; The granule that one-step palletizing is made carries out granulate, adds the appropriate amount of auxiliary materials micropowder silica gel, dextrin, and microcrystalline Cellulose, granule is made in pack.
Embodiment 7
With Herba Leonuri 24g, Rhizoma Cyperi 12g, Fructus Liquidambaris 12g, Rhizoma Chuanxiong 12g, Semen Vaccariae 12g water boiling and extraction 2 times, extracting amount of water for the first time is 10 times of doses, extraction time is 2 hours; Amount of water is 7 times of doses for the second time, and extraction time is 2 hours; Add the ethanol precipitate with ethanol, regulating alcoholic degree is 60%, filters, and it is 1.1 the rare extractum of water extract-alcohol precipitation that concentrated alcohol deposit fluid becomes relative density; In one-step-granulating method, put into dextrin or starch etc. as substrate, the rare extractum of above-mentioned water extract-alcohol precipitation is sprayed into one-step-granulating method as binding agent, open turnover wind, control seethes with excitement evenly powder with the negative pressure of-0.03MPa in the granulator jar, add the thermal control temperature of charge then at 40 ℃, carry out one-step palletizing, the granulation time is 4 hours; The granule that one-step palletizing is made carries out granulate, adds the appropriate amount of auxiliary materials micropowder silica gel, starch, and microcrystalline Cellulose, compacting is in flakes.
Embodiment 8
With Rhizoma Cyperi 6g, Fructus Liquidambaris 6g, Rhizoma Chuanxiong 3g, Semen Vaccariae 5g, Caulis Spatholobi 9g water boiling and extraction 2 times, extracting amount of water for the first time is 10 times of doses, extraction time is 2 hours; Amount of water is 7 times of doses for the second time, and extraction time is 2 hours; Add the ethanol precipitate with ethanol, regulating alcoholic degree is 60%, filters, and it is 1.1 the rare extractum of water extract-alcohol precipitation that concentrated alcohol deposit fluid becomes relative density; In one-step-granulating method, put into dextrin or starch etc. as substrate, the rare extractum of above-mentioned water extract-alcohol precipitation is sprayed into one-step-granulating method as binding agent, open turnover wind, control seethes with excitement evenly powder with the negative pressure of-0.03MPa in the granulator jar, add the thermal control temperature of charge then at 40 ℃, carry out one-step palletizing, the granulation time is 4 hours; The granule that one-step palletizing is made carries out granulate, adds the appropriate amount of auxiliary materials dextrin, microcrystalline Cellulose, and compacting is in flakes.
Embodiment 9
With Fructus Liquidambaris 6g, Rhizoma Chuanxiong 3g, Semen Vaccariae 5g, Caulis Spatholobi 9g water boiling and extraction 2 times, extracting amount of water for the first time is 10 times of doses, extraction time is 2 hours; Amount of water is 7 times of doses for the second time, and extraction time is 2 hours; Add the ethanol precipitate with ethanol, regulating alcoholic degree is 60%, filters, and it is 1.1 the rare extractum of water extract-alcohol precipitation that concentrated alcohol deposit fluid becomes relative density; In one-step-granulating method, put into dextrin or starch etc. as substrate, the rare extractum of above-mentioned water extract-alcohol precipitation is sprayed into one-step-granulating method as binding agent, open turnover wind, control seethes with excitement evenly powder with the negative pressure of-0.03MPa in the granulator jar, add the thermal control temperature of charge then at 40 ℃, carry out one-step palletizing, the granulation time is 4 hours; The granule that one-step palletizing is made carries out granulate, adds the appropriate amount of auxiliary materials micropowder silica gel, dextrin, and microcrystalline Cellulose, compacting is in flakes.
Embodiment 10
With Herba Leonuri 30g, Rhizoma Chuanxiong 18g, Semen Vaccariae 18g, Caulis Spatholobi 15g be with water boiling and extraction 2 times, and extract amount of water for the first time and be dose 15 times, extraction time is 3 hours; Extract for the second time amount of water and be dose 10 times, extraction time is 3 hours; Add the ethanol precipitate with ethanol, regulating alcoholic degree is 30%, filters, and it is 1.05 the rare extractum of water extract-alcohol precipitation that concentrated alcohol deposit fluid becomes relative density; In one-step-granulating method, put into dextrin or starch etc. as substrate, the rare extractum of above-mentioned water extract-alcohol precipitation is sprayed into one-step-granulating method as binding agent, open turnover wind, control seethes with excitement evenly powder with the negative pressure of-0.02MPa in the granulator jar, add the thermal control temperature of charge then at 30 ℃, carry out one-step palletizing, the granulation time is 5 hours; The granule that one-step palletizing is made carries out granulate, adds the appropriate amount of auxiliary materials micropowder silica gel, dextrin, starch, fill capsule.
Below by test the example beneficial effect of the present invention is further elaborated:
The Chinese medicine composition that the present invention relates to carried out mass effect comparative study to traditional handicraft (employing wet granulation technology) and the product that adopts the fluid bed boiling granulating in research process, result of study sees the following form:
Table 1
Adopting process Traditional handicraft Fluid bed boiling granulating (one-step method)
Abstraction process Extracting solution is condensed into relative density about 1.3 Extracting solution is condensed into relative density
Thick extractum, and need heated drying become the dry extract solid, to carry out pulverizer again and pulverize 1.1 about rare extractum, drying-free, pulverizing.
Granulation process Wet method is made granulation again through oven drying One step of the drying of granulating simultaneously finishes
Granulate the production time 5~10 hours 3~5 hours
The production temperature More than 60 ℃ Be no more than 60 ℃
Particle appearance Inhomogeneous, mobile poor Uniform particles, good fluidity
The tabletting process Compressibility is general Compressibility is good
Tablet weight variation Wave amplitude is big Wave amplitude is little
The disintegration of tablet time limit 40~50 minutes 15~20 minutes
Water content About 6% About 4%
Tablet hardness Less than 5Kg Greater than 4Kg
The tablet wearability Generally Good
The tablet friability Bump extruding cracky Bump pushes not cracky

Claims (4)

1, a kind of preparation method of preventing and treating the Chinese medicine composition of menoxenia, this Chinese medicine composition is mainly by being selected from two kinds of following weight portion, and three kinds, four kinds, the water extract of five kinds or six kinds crude drug or water extracting alcohol hypostasis are formed: Herba Leonuri 5-35 part, Rhizoma Cyperi 5-20 part, Fructus Liquidambaris 5-20 part, Rhizoma Chuanxiong 2-20 part, Semen Vaccariae 3-20 part, Caulis Spatholobi 5-20 part is characterized in that, this method may further comprise the steps:
(1) with described bulk drugs with water boiling and extraction 2 times, the 6-15 that extracts amount of water for the first time and be dose doubly, extraction time is 0.5-3 hour; The 4-10 that extracts for the second time amount of water and be dose doubly, extraction time is 0.5-3 hour; Filter, merging filtrate is condensed into relative density and is 1.05~1.18 water and carries rare extractum, perhaps adds the ethanol precipitate with ethanol, and adjustings alcoholic degree is 30%-90%, filtration, and it is 1.05~1.18 the rare extractum of water extract-alcohol precipitation that concentrated alcohol deposit fluid becomes relative density;
(2) adopt the fluid bed one-step palletizing: in one-step-granulating method, put into dextrin or starch as substrate, above-mentioned water is carried rare extractum or the rare extractum of water extract-alcohol precipitation sprays into one-step-granulating method as binding agent, open turnover wind, control with-0.02~-negative pressure of 0.05MPa seethes with excitement evenly powder in the granulator jar, add the thermal control temperature of charge then at 30~50 ℃, carry out one-step palletizing, the granulation time is 3~5 hours;
(3) granule that one-step palletizing is made carries out granulate, adds other adjuvants, makes the oral medicinal herb preparation.
2, the preparation method of the Chinese medicine composition of control menoxenia as claimed in claim 1 is characterized in that, comprises at the adjuvant described in the step (3): micropowder silica gel, dextrin, starch, one or more compositionss in the microcrystalline Cellulose.
3, the preparation method of the Chinese medicine composition of control menoxenia as claimed in claim 1 is characterized in that, in the step (3), described oral medicinal herb preparation is granule, tablet or capsule.
4, the preparation method of the Chinese medicine composition of control menoxenia as claimed in claim 1 is characterized in that, after step (2) was finished, the granule water content that one-step palletizing is made was controlled at below 5%.
CNA2008100430146A 2008-01-08 2008-01-08 Method for preparing Chinese medicinal composition for preventing and treating menoxenia Pending CN101480458A (en)

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CN2010105902193A Division CN102028843B (en) 2008-01-08 2008-01-08 Method for preparing Chinese medicinal composition for preventing and treating menoxenia
CN2010105900728A Division CN102008545A (en) 2008-01-08 2008-01-08 Preparation method of traditional Chinese medicine composition for preventing and treating irregular menstruation
CN2010105904409A Division CN102028844A (en) 2008-01-08 2008-01-08 Method for preparing Chinese medicinal composite for preventing and treating abnormal menstruation

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103349707A (en) * 2013-07-23 2013-10-16 宁波立华制药有限公司 Method for preparing eight-treasure granules
CN106265077A (en) * 2015-05-30 2017-01-04 天士力制药集团股份有限公司 A kind of Chinese medical concrete aerosol dispersion technique and preparation thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103349707A (en) * 2013-07-23 2013-10-16 宁波立华制药有限公司 Method for preparing eight-treasure granules
CN106265077A (en) * 2015-05-30 2017-01-04 天士力制药集团股份有限公司 A kind of Chinese medical concrete aerosol dispersion technique and preparation thereof

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