CN105288173A - Traditional Chinese medicine pellet preparation for regulating menstruation and removing freckles and preparation method thereof - Google Patents

Traditional Chinese medicine pellet preparation for regulating menstruation and removing freckles and preparation method thereof Download PDF

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CN105288173A
CN105288173A CN201410309888.7A CN201410309888A CN105288173A CN 105288173 A CN105288173 A CN 105288173A CN 201410309888 A CN201410309888 A CN 201410309888A CN 105288173 A CN105288173 A CN 105288173A
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CN105288173B (en
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易斌
安明榜
韩妮娜
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Beijing Silian Pharmaceutical Industry Co ltd
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Beijing Scrianen Pharmaceutical Co Ltd
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Abstract

The invention discloses a traditional Chinese medicine pellet preparation for regulating menstruation and removing freckles and a preparation method thereof and belongs to preparation technology of Chinese patent medicine. The traditional Chinese medicine pellet preparation is characterized in that the pellet preparation is a pellet composed of dry extract powder of active ingredient water extract, crude drug powder and microcrystalline cellulose, grain size of the pellet is smaller than 2.5mm, and a weight ratio of the dry extract powder and the crude drug powder to microcrystalline cellulose is 1 to (0.5-1.0). The inventor performs studying on production process, screening of excipient type and solvent amount proportion experimenting, so that the traditional Chinese medicine pellet preparation has the advantages of high medicine releasing speed, high bioavailability, little irritancy, accurate divided dose and convenience for administration and carrying. Through dosage form updating, high cost and safety risk of existing production processes are improved, requirements of enterprises on convenience and safety of production process are met, and a novel medicine preparation which is more convenient to take and cheaper in price is provided for patients.

Description

A kind of Chinese medicine pellet preparation of menstruation-regulating and speckle-dispelling and preparation method
Technical field
The invention belongs to the preparation technique field of Chinese patent medicine, particularly relate to a kind of Chinese medicine pellet preparation and preparation method of menstruation-regulating and speckle-dispelling.
Background technology
According to pathogenesis and the rule for the treatment of of Chinese medical discrimination, the composition mainly blood of menstruation.So, QI and blood be mutually grow with project interdependent, qi being the governor of blood, blood being the material foundation of QI, disorders of blood can and gas, disorder of QI can and blood, have extremely close relationship each other.So QI and blood is the basic substance of menstruation, not having QI and blood also would not have menorrhea, then must there is menoxenia in disorder of QI and blood.QI and blood be internal organs biochemical, kidney controlling essence storage among internal organs, poly-congenital essence and hide it; The spleen being the foundation of acquired constitution, source of generating QI and blood, can often abide by follow by hemopoietic again.So, essence can be biochemical, and blood also can change into essence, essence and blood sharing the same origin, mutually grow, and with the internal organs such as the heart, liver, spleen, stomach between make mutually and assist mutually, complement each other, function just can be made normal, QI and blood is vigorous, and it is strong to rush wantonly two arteries and veins functions, uterus " Tibetan is rushed down joint ", " store the degree of having that overflows ", menstruation also can be painless.If function is not normal, biochemical not enough, QI and blood is lost then punching times and is lost in nourishing, two arteries and veins functional disorders, the sea of blood can not completely be full of or blood stasis, phlegm-damp, the stagnation of QI on time, so that functional activity of QI being not smooth, as weak in liver temper, QI failing to control blood or heat chase after the absurd row of blood then can cause preceeded menorrhea, menorrhagia, menostaxis etc.; Gas, anemia are damaged, and deficiency of kidney-YIN, can not Rong Yan.Therefore menoxenia can derive mottle and dysmenorrhea etc.Modern medicine is then thought, menoxenia is mainly not normal relevant with endocrine dysfunction, hormone metabolism.
With the Chinese medicine that the Radix Astragali, Radix Rehmanniae Preparata, Herba Ecliptae, the Radix Paeoniae Alba, Radix Rehmanniae, Semen Cuscutae, Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, Radix Polygoni Multiflori, Rhizoma Gymnadeniae, Semen Persicae, Radix Bupleuri, Colla Corii Asini, Flos Carthami are made, there is nourishing blood for regulating menstruation, effect of dissolving stasis and dispelling spots, can be used for nutrient QI and blood being insufficient, qi depression to blood stasis, menorrhagia, chloasma etc.Concrete weight portion prescription is as follows:: Radix Astragali 35-45, Radix Rehmanniae Preparata 25-35, Herba Ecliptae 20-30, Radix Paeoniae Alba 20-30, Radix Rehmanniae 20-30, Semen Cuscutae 15-25, Fructus Ligustri Lucidi 15-25, Fructus Lycii 15-25, Radix Angelicae Sinensis 15-25, Radix Polygoni Multiflori 15-25, Rhizoma Gymnadeniae 15-25, Semen Persicae 10-20, Radix Bupleuri 10-20, Colla Corii Asini 4-8, Flos Carthami 4-8.With nourishing blood and invigorating qis such as the Radix Astragali, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Rehmanniae Preparata, Colla Corii Asini, Rhizoma Gymnadeniae, invigorating the spleen for eliminating dampness; The liver and kidney tonifying such as Semen Cuscutae, Fructus Ligustri Lucidi, Fructus Lycii, liver blood kidney essense is sufficient, the face skin care of self energy China, and god's peace gas is felt well; Radix Polygoni Multiflori and Radix Bupleuri share can dispersing the stagnated live-QI to relieve the stagnation of QI; Radix Rehmanniae and Herba Ecliptae share invigorating the liver and kidney clearly, clearing away heat and cooling blood; Semen Persicae and Flos Carthami share blood circulation promoting and blood stasis dispelling.All medicines share plays nourishing blood for regulating menstruation altogether, effect of dissolving stasis and dispelling spots.
This prescription Chinese patent medicine only has 2 kinds of dosage forms such as capsule and tablet on the market at present.Capsule is used by attached Xijing hospital of The Fourth Military Medical University, the routine patient of Tang Dou hospital more than 70,000, and prove that this prescription is the choice drug of menstruation-regulating and speckle-dispelling determined curative effect, total effective rate is: chloasma 94.6%, senile plaque 92%, menoxenia 96.4%, dysmenorrhea 96%, acne 76.5%.
Based on the Clinical Basis that this prescription is good, but due to capsule and tablet, not easily swallow, be easy to the moisture absorption, less stable, not easily preserve; In order to enrich dosage form kind, play the good efficacy of this medicine better, the present inventor studies further, changed into pellet, the curative effect of former preparation can not only be retained preferably, and swallow compared with capsule and tablet more convenient, carry, store also more convenient, and stability improves a lot.By the research of production technology, the screening of supplementary product kind and quantity of solvent Ratio Experiments, this Chinese medicine pellet is had, and drug release rate is fast, bioavailability is high, zest is little, divided dose is accurate, take, the advantage such as easy to carry.By the renewal of dosage form, the high cost improving existing production technology and security risks, meet the facilitation of enterprise's production technology, safe, take more convenient, that price is more cheap new pharmaceutical formulation for patient provides again.Meanwhile, we establish more perfect quality standard, effectively can control the quality of this kind.Through retrieval, said preparation still belongs to internal blank.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine pellet preparation and preparation method of menstruation-regulating and speckle-dispelling, said preparation is by the Radix Astragali, Radix Rehmanniae Preparata, Herba Ecliptae, the Radix Paeoniae Alba, Radix Rehmanniae, Semen Cuscutae, Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, Radix Polygoni Multiflori, Rhizoma Gymnadeniae, Semen Persicae, Radix Bupleuri, Colla Corii Asini, the Chinese medicine compositions such as Flos Carthami, there is nourishing blood for regulating menstruation, the function of dissolving stasis and dispelling spots, clinical efficacy is remarkable, so because capsule and tablet are swallowed comparatively difficult, be easy to the moisture absorption, less stable, be subject to a definite limitation clinically, in order to enrich dosage form kind, the curative effect of better this medicine of performance, the applicant studies further to it, develop the pellet of this Chinese patent medicine, not only remain the curative effect of this Chinese patent medicine preferably, and take, carry, preserve more convenient, stability also greatly improves.
Technical scheme of the present invention is as follows:
A kind of Chinese medicine pellet preparation of menstruation-regulating and speckle-dispelling, be made up of the effective ingredient of following weight portion: Radix Astragali 35-45, Radix Rehmanniae Preparata 25-35, Herba Ecliptae 20-30, Radix Paeoniae Alba 20-30, Radix Rehmanniae 20-30, Semen Cuscutae 15-25, Fructus Ligustri Lucidi 15-25, Fructus Lycii 15-25, Radix Angelicae Sinensis 15-25, Radix Polygoni Multiflori 15-25, Rhizoma Gymnadeniae 15-25, Semen Persicae 10-20, Radix Bupleuri 10-20, Colla Corii Asini 4-8, Flos Carthami 4-8, this Chinese medicine pellet preparation is by the dried cream powder of described effective ingredient water extract, crude drug powder and microcrystalline Cellulose are less than the micropill of 2.5mm by the particle diameter that following weight ratio forms: (effective ingredient dried cream powder+crude drug powder): microcrystalline Cellulose=1: 0.5-1.0.
This Chinese medicine pellet preparation is preparation like this: get Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Bupleuri, Colla Corii Asini, Rhizoma Gymnadeniae and Flos Carthami powder are broken into fine powder, the seven flavor medicine materials such as all the other Semen Cuscutae decoct with water secondary, add 8-12 times of water gaging at every turn, each decoction 2 hours, collecting decoction, filter, filtrate is concentrated into the thick paste that relative density is 1.30 ~ 1.35 (50 DEG C), drying under reduced pressure, pulverize, add above-mentioned crude drug powder and microcrystalline Cellulose, weight ratio (effective ingredient dried cream powder+crude drug powder): microcrystalline Cellulose=1: 0.5-1.0, mixing, with appropriate water pill, by weight (effective ingredient dried cream powder+crude drug powder+microcrystalline Cellulose): distilled water=1: 0.2-0.4, dry, obtain.
Preferred pellet method for making is: get Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Bupleuri, Colla Corii Asini, Rhizoma Gymnadeniae and Flos Carthami powder are broken into fine powder, the seven flavor medicine materials such as all the other Semen Cuscutae decoct with water secondary, add 10 times of water gagings at every turn, each decoction 2 hours, collecting decoction, filter, filtrate is concentrated into the thick paste that relative density is 1.30-1.35 (50 DEG C), drying under reduced pressure, pulverize, add above-mentioned crude drug powder and microcrystalline Cellulose, weight ratio (effective ingredient dried cream powder+crude drug powder): microcrystalline Cellulose=1: 0.5, mixing, with appropriate water pill, by weight (effective ingredient dried cream powder+crude drug powder+microcrystalline Cellulose): distilled water=1: 0.3, dry, obtain.
Present inventor has performed series of experiments, to prove present invention process reasonable, stable and controllable for quality, to guarantee the beneficial effect of medicine.
Experimental example 1: extraction process is investigated
1, the investigation of medical material flour extraction
By prescription optimum proportioning parts by weight, get Radix Paeoniae Alba 300g, Fructus Ligustri Lucidi 240g, Fructus Lycii 240g, Radix Angelicae Sinensis 240g, Rhizoma Gymnadeniae 240g, Radix Bupleuri 180g, Colla Corii Asini 72g, Flos Carthami 60g, nominal gets 3 parts, pulverize respectively, cross 100 mesh sieves, carry out flour extraction investigation, the results are shown in Table 1.
Table 1 flour extraction investigation table
Sample number into spectrum Medical material amount (g) Crude drug powder must measure (g) Flour extraction (%)
1 1572 1395 88.74
2 1572 1380 87.79
3 1572 1380 87.79
Above data show, the Radix Paeoniae Alba etc. eight herbal medicine is ground into fine powder, and flour extraction is all more than 85%.
2, the seven flavor medicine material amount of water such as the Radix Astragali is investigated
By prescription optimum proportioning parts by weight, get Radix Astragali 16g, Radix Rehmanniae Preparata 12g, Herba Ecliptae 10g, Radix Rehmanniae 10g, Semen Cuscutae 8g, Radix Polygoni Multiflori 8g, Semen Persicae 6g, nominal gets 3 increment product.8,10,12 times amount that add water respectively decoct secondary, each 2 hours, filter, merging filtrate, concentrated, drying under reduced pressure.Consider above medical material, the Radix Astragali is mainly containing saponin component, Semen Cuscutae is mainly containing flavone, coumarin, terpenoid compound, Herba Ecliptae is mainly containing tannin, amaroid, flavone, isoflavone aglycone and alkaloids composition, and Radix Polygoni Multiflori is mainly containing anthraquinone component, and Radix Rehmanniae is mainly containing iridoid glycoside constituents, Semen Persicae is mainly containing amygdaloside, sterol and steroline constituents, above composition is all dissolved in n-butyl alcohol, therefore with the total amount of n-butanol extract for index, carries out preferably amount of water.Measure n-butanol extract content in 3 extracts by the following method: take extract dried cream powder respectively and be about 3g, accurately weighed, put in the conical flask of 100ml, add the methanol 50ml that precision measures, close plug, weighed weight, left standstill after 1 hour, in water-bath, backflow is heated to boiling, and keeps micro-and boil 1 hour.After letting cool, take off conical flask, close plug, weighed weight, supply the weight of less loss with methanol, shake up, filter with dry filter.Precision measures subsequent filtrate 25ml, evaporate to dryness, residue 30ml water dissolution, with water saturated n-butanol extraction 4 times (30ml, 30ml, 20ml, 20m1), merge extractive liquid, put evaporate to dryness in the evaporating dish of dry weight, residue was in 105 DEG C of dryings 3 hours, in dislocation exsiccator, cool 30 minutes, rapid accurately weighed weight.Calculate the radiotherapy of n-butanol extract in test sample with drying bottle, the results are shown in Table 2.
Table 2 amount of water investigates result table
Sample number into spectrum Amount of water Paste volume (g) N-butanol extract amount (g/ part)
1 8 times amount 23.5 1.12
2 10 times amount 25.7 1.16
3 12 times amount 27.4 1.14
Table 2 result shows, 8,10, the 12 times amount n-butanol extract amount difference that add water are little, considers, therefore determine that optimum amount of water is 10 times amount from production is actual.
Experimental example 2 preparations shaping technical study
1, the selection of supplementary product kind
Respectively starch, dextrin and microcrystalline Cellulose are carried out preferably.To get it filled powder (comprising extract dried cream powder and crude drug powder) 150g by best prescription parts by weight, be divided into 3 parts, add appropriate amount of starch, dextrin and microcrystalline Cellulose respectively, add appropriate distilled water after mixing and prepare micropill respectively, the results are shown in Table 3.
The selection result table of table 3 supplementary product kind
Table 3 result shows, and microcrystalline Cellulose as the easier pill of adjuvant, therefore is determined with the excipient of microcrystalline Cellulose as micropill.
2, the selection of microcrystalline Cellulose consumption
To get it filled thing (comprising extract dried cream powder and crude drug powder) 300g by best prescription amount parts by weight, be divided into 3 parts, add appropriate microcrystalline Cellulose and distilled water pill, dry, using the moisture absorption of pill complexity and micropill as inspection target, the results are shown in Table 4.
Table 4 microcrystalline Cellulose consumption is preferably shown
Table 4 result shows, and adds microcrystalline Cellulose 0.5 times, namely can be made into molding good, the not easily micropill of the moisture absorption, therefore selects the microcrystalline Cellulose adding medicated powder 0.5-1.0 times amount.
3, the consumption of wetting agent is selected
This product selects distilled water cheap and easy to get to make wetting agent.Fixing micropill prescription medicated powder: adjuvant is 1: 0.5, and the water adding different proportion makes soft material, pill (hole diameter of sieve (perforated) plate is 1.0mm, and extruded velocity is 30rpm, round as a ball speed 50Hz, and the round as a ball time is 2min).Measure yield and the roundness of micropill, the results are shown in Table 5.
The calculating of yield: sieved by obtained micropill, with 16 ~ 40 order micropills compared with inventory, calculated yield, shows complexity prepared by micropill.
The calculating of roundness: roundness is one of important indicator of micropill, reflects the quality of micropill globulate, directly affects quality and the drug release feature of micropill.The roundness of micropill is evaluated with trait index, namely at random take out 20 micropills that sieve, (17 × 16) measure its maximum diameter and most path under an optical microscope, evaluate the roundness of micropill with the ratio of maximum diameter and most path, the two ratio is less, and roundness is better.
Table 5 wetting agent consumption is on the impact of micropill
Sample number into spectrum Distilled water (%) Yield (%) Roundness
1 20 75 0.75
2 30 81 0.86
3 40 74 0.75
Table 5 result shows, and when moisture content is low, extrudate intensity is high, and plasticity is poor, not globulate; During moisture content height, short cylindrical is rolled into spherical rear easily mutual bonding, and yield is reduced.Therefore determine that amount of water is 30%.
4, the selection of hole diameter of sieve (perforated) plate
This product preparations shaping technical study is investigated hole diameter of sieve (perforated) plate, fixing micropill prescription and other process conditions (add 0.5 times amount microcrystalline Cellulose, 30% water soft material, it is 30rpm that agent goes out speed, round as a ball speed 50Hz, the round as a ball time is 2min), prepare micropill with different holes diameter of sieve (perforated) plate, the results are shown in Table 6.
Table 6 hole diameter of sieve (perforated) plate Selection experiment result table
Table 6 result shows, and hole diameter of sieve (perforated) plate does not make significant difference to micropill molding, considers convenient and product appearance of taking medicine in addition, therefore selects hole diameter of sieve (perforated) plate to be that the product of 1.0mm is more satisfactory.
5, the selection of round as a ball speed
Fixing micropill prescription and other process conditions (add 0.5 times amount microcrystalline Cellulose, 30% water soft material, hole diameter of sieve (perforated) plate 1.0mm, it is 30rpm that agent goes out speed, and the round as a ball time is 2min), prepare micropill by different round as a ball speed, the results are shown in Table 7.
Table 7 round as a ball speed Selection experiment result table
Sample number into spectrum Round as a ball speed (Hz) Yield (%) Roundness
1 30 76 0.75
2 40 85 0.85
3 50 81 0.84
Table 7 result shows, and during round as a ball speed 40Hz, the roundness of micropill is high, and yield is also better, therefore selects round as a ball speed to be 40Hz.
6, the selection of round as a ball time
Fixing micropill prescription and other process conditions (add 0.5 times amount microcrystalline Cellulose, 30% water soft material, hole diameter of sieve (perforated) plate 1.0mm, it is 30rpm that agent goes out speed, and round as a ball speed is 40Hz), get micropill sample from the different round as a ball time, measure the roundness of micropill, the results are shown in Table 8.
Table 8 round as a ball selection of time result of the test table
The round as a ball time (min) Roundness
2 0.85
4 0.85
6 0.86
8 0.83
10 0.83
Table 8 result shows, and the round as a ball time, the roundness change of micropill was little, therefore selects the round as a ball time to be at least 2min more than after 2min.
Detailed description of the invention
The optimum implementation of this invention is: best effective ingredient composition is by weight: the Radix Astragali 40, Radix Rehmanniae Preparata 30, Herba Ecliptae 25, the Radix Paeoniae Alba 25, Radix Rehmanniae 25, Semen Cuscutae 20, Fructus Ligustri Lucidi 20, Fructus Lycii 20, Radix Angelicae Sinensis 20, Radix Polygoni Multiflori 20, Rhizoma Gymnadeniae 20, Semen Persicae 15, Radix Bupleuri 15, Colla Corii Asini 6, Flos Carthami 5.Get Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Bupleuri, Colla Corii Asini, Rhizoma Gymnadeniae and Flos Carthami by the parts by weight of effective ingredient to pulverize, cross 100 mesh sieves and namely obtain crude drug powder.The Radix Astragali, Semen Cuscutae, Herba Ecliptae, Radix Polygoni Multiflori, Radix Rehmanniae, Radix Rehmanniae Preparata and Semen Persicae is got by the parts by weight of effective ingredient, decoct with water secondary, each 2 hours, add 10 times of water gagings, collecting decoction at every turn, filter, filtrate is concentrated into the thick paste that relative density is 1.30 ~ 1.35 (50 DEG C), drying under reduced pressure, pulverizes, cross 100 mesh sieves, obtain effective ingredient dried cream powder.By (effective ingredient dried cream powder+crude drug powder): microcrystalline Cellulose=1: the weight ratio of 0.5, got the microcrystalline Cellulose of 100 mesh sieves, mix with above-mentioned crude drug powder and effective ingredient dried cream powder, by weight (effective ingredient dried cream powder+crude drug powder+microcrystalline Cellulose): distilled water=1: 0.3 adds distilled water obtained mixing soft material, use extrusion-spheronization micropill, hole diameter of sieve (perforated) plate is 1.0mm, extruded velocity is 30rpm, round as a ball speed 40Hz, the round as a ball time be the obtained micropill of 2min. in 60 DEG C of dryings 8 hours, get product micropill.
The above is only the preferred embodiment of the present invention; it should be pointed out that for those skilled in the art, under the prerequisite not departing from the technology of the present invention principle; can also make some improvement and modification, these improve and modification also should be considered as protection scope of the present invention.

Claims (7)

1. the Chinese medicine pellet preparation of a menstruation-regulating and speckle-dispelling, be made up of the effective ingredient of following weight portion: Radix Astragali 35-45, Radix Rehmanniae Preparata 25-35, Herba Ecliptae 20-30, Radix Paeoniae Alba 20-30, Radix Rehmanniae 20-30, Semen Cuscutae 15-25, Fructus Ligustri Lucidi 15-25, Fructus Lycii 15-25, Radix Angelicae Sinensis 15-25, Radix Polygoni Multiflori 15-25, Rhizoma Gymnadeniae 15-25, Semen Persicae 10-20, Radix Bupleuri 10-20, Colla Corii Asini 4-8, Flos Carthami 4-8, it is characterized in that: this Chinese medicine pellet preparation is by the dried cream powder of described effective ingredient water extract, crude drug powder and microcrystalline Cellulose are less than the micropill of 2.5mm by the particle diameter that following weight ratio forms: (effective ingredient dried cream powder+crude drug powder): microcrystalline Cellulose=1: 0.5-1.0.
2. the Chinese medicine pellet preparation of a kind of menstruation-regulating and speckle-dispelling according to claim 1, be made up of the effective ingredient of following weight portion: the Radix Astragali 40, Radix Rehmanniae Preparata 30, Herba Ecliptae 25, the Radix Paeoniae Alba 25, Radix Rehmanniae 25, Semen Cuscutae 20, Fructus Ligustri Lucidi 20, Fructus Lycii 20, Radix Angelicae Sinensis 20, Radix Polygoni Multiflori 20, Rhizoma Gymnadeniae 20, Semen Persicae 15, Radix Bupleuri 15, Colla Corii Asini 6, Flos Carthami 5, it is characterized in that: this Chinese medicine pellet preparation is by the dried cream powder of described effective ingredient water extract, crude drug powder and microcrystalline Cellulose are less than the micropill of 2.5mm by the particle diameter that following weight ratio forms: (effective ingredient dried cream powder+crude drug powder): microcrystalline Cellulose=1: 0.5-1.0.
3. the preparation method of the Chinese medicine pellet preparation of menstruation-regulating and speckle-dispelling according to claim 1 and 2, is characterized in that: comprise the steps:
(1) get the Radix Astragali, Semen Cuscutae, Herba Ecliptae, Radix Polygoni Multiflori, Radix Rehmanniae, Radix Rehmanniae Preparata and Semen Persicae by the parts by weight of effective ingredient, decoct with water, filtrate is filtered, and concentrated and blood pressure lowering drying obtains the dried cream powder of effective ingredient water extract;
(2) get Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Bupleuri, Colla Corii Asini, Rhizoma Gymnadeniae and Flos Carthami powder by the parts by weight of effective ingredient and be broken into crude drug powder;
(3) the crude drug powder that the dried cream powder obtained by step (1), step (2) obtain and microcrystalline Cellulose sieve respectively, by weight (effective ingredient dried cream powder+crude drug powder): microcrystalline Cellulose=1: 0.5-1.0 mixes, and by weight (effective ingredient dried cream powder+crude drug powder+microcrystalline Cellulose): distilled water=1: 0.2-0.4 adds distilled water obtained mixing soft material, finally extrude, round as a ball, dry, obtain the pellet preparations that particle diameter is less than 2.5mm.
4. the preparation method of the Chinese medicine pellet preparation of menstruation-regulating and speckle-dispelling according to claim 3, is characterized in that: preparation process is as follows:
(1) Radix Astragali, Semen Cuscutae, Herba Ecliptae, Radix Polygoni Multiflori, Radix Rehmanniae, Radix Rehmanniae Preparata and Semen Persicae is got by the parts by weight of effective ingredient, decoct with water 2 times, each 2 hours, each amount of water is the water of 8-12 times of weight, decocting liquid filters and merges, concentrating under reduced pressure, drying under reduced pressure, pulverizes the dried cream powder being worth effective ingredient water extract;
(2) get Fructus Ligustri Lucidi, Fructus Lycii, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Radix Bupleuri, Colla Corii Asini, Rhizoma Gymnadeniae and Flos Carthami powder by the total amount number of effective ingredient and be broken into crude drug powder;
(3) the crude drug powder that the dried cream powder obtained by step (1), step (2) obtain and microcrystalline Cellulose cross 100 mesh sieves respectively, by weight (effective ingredient dried cream powder+crude drug powder): microcrystalline Cellulose=1: 0.5-1.0 mixes, and by weight (effective ingredient dried cream powder+crude drug powder+microcrystalline Cellulose): distilled water=1: 0.2-0.4 adds distilled water obtained mixing soft material;
(4) with extrusion-spheronization pelletizing machine the mixing soft material that step (3) obtains is extruded, round as a ball; obtain the micropill that particle diameter is less than 2.5mm; micropill is as 60 DEG C of dryings in baking oven; finally cross sieve classification; obtain medical treatment nutrient QI and blood being insufficient; qi depression to blood stasis, menorrhagia, the pellet preparations of chloasma Chinese medicine.
5. the preparation method of the Chinese medicine pellet preparation of menstruation-regulating and speckle-dispelling according to claim 4, is characterized in that: the concentrating under reduced pressure described in step (1) is pressure 0.06mpa, concentrated under temperature 60 C condition.
6. the preparation method of the Chinese medicine pellet preparation of menstruation-regulating and speckle-dispelling according to claim 4, is characterized in that: the drying under reduced pressure described in step (1) is pressure-0.1mpa, and temperature is under 80 DEG C of conditions dry 8 hours.
7. the preparation method of the Chinese medicine pellet preparation of menstruation-regulating and speckle-dispelling according to claim 4; it is characterized in that: the granulation conditions of the extrusion-spheronization pelletizing machine described in step (4) is: hole diameter of sieve (perforated) plate is 1.0mm; round as a ball speed is 40Hz, and the round as a ball time is 2min.
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* Cited by examiner, † Cited by third party
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CN107050116A (en) * 2016-11-23 2017-08-18 广州康臣药物研究有限公司 It is a kind of to treat medicine pill of diabetic nephropathy and its preparation method and application
CN107823155A (en) * 2017-11-21 2018-03-23 荆晓玉 A kind of simple micropill and preparation method thereof

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