CN108272847A - Fuxuekang granules and its preparation process - Google Patents

Fuxuekang granules and its preparation process Download PDF

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Publication number
CN108272847A
CN108272847A CN201810263553.4A CN201810263553A CN108272847A CN 108272847 A CN108272847 A CN 108272847A CN 201810263553 A CN201810263553 A CN 201810263553A CN 108272847 A CN108272847 A CN 108272847A
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parts
filler
fuxuekang
microcrystalline cellulose
alpha
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CN108272847B (en
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曾胜
曾佐达
梁烽焱
张�浩
陈尚杰
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Guangxi Yili Guixi Pharmaceutical Co Ltd
GUANGDONG YILI GROUP PHARMACEUTICAL CO Ltd
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Guangxi Yili Guixi Pharmaceutical Co Ltd
GUANGDONG YILI GROUP PHARMACEUTICAL CO Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/10Preparation or pretreatment of starting material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH

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Abstract

The present invention discloses a kind of Fuxuekang granules and its preparation process.The Fuxuekang granules include that following parts by weight prepare raw material:500~2000 parts of blumea riparia, 75~300 parts of filler and appropriate flavoring agent.Preferably, the filler is alpha lactose and microcrystalline cellulose with 1:3.5~4.5 weight ratio composition, it is highly preferred that the filler is alpha lactose and microcrystalline cellulose with 1:4.25 weight ratio composition.Further, the flavoring agent is sucrose, xylitol, sorbierite, maltitol or mannitol.The present invention uses distinctive formula and preparation process, and the Fuxuekang granules of acquisition is made to have high active constituent content, preferable bioavilability and bin stability.

Description

Fuxuekang granules and its preparation process
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of Fuxuekang granules and its preparation process.
Background technology
Fuxuekang granules are gynecological drugs made of being developed by Zhuang traditional herbal medicine blumea riparia, have taken in national drug prison It superintends and directs in country of management board standard for traditional Chinese medicines compilation (terrestrial reference rises national standard part).The granule is the single preparation of blumea riparia. Blumea riparia is the drying herb of feverfew blumea riparia, mainly originates in Guangxi, Yunnan, has promoting blood circulation and removing blood stasis, hemostasis The effect of menstruation regulating is used for congestion blood block, and menorrhalgia, menstrual period are long, the diseases such as post partum lochiorrhea.Clinical research shows this medicine Unique functional component can promote uterine myometrium, make vessel sealing, accelerate endometrium and fall off;Vagina after reduction medical abortion Amount of bleeding, shortening are bled the duration, and clinical application obtains good effect.
Studies have shown that the active ingredient that blumea riparia plays anastalsis is mainly water soluble ingredient such as protocatechuic acid, green Ortho acid etc..Therefore, the preparation process of traditional Fuxuekang granules is:Blumea riparia is added water to cook, thick paste is condensed into, adding can The auxiliary materials such as soluble starch, sucrose, granulation, drying form.The granule is extracted using extraction process by water, is decocted at high temperature It boils and is easy to cause active ingredient protocatechuic acid and chlorogenic acid decomposition, and aggravate the loss of volatile effective component.Further, since Herba Blumeae Balsamiferae extract is mainly water-soluble substances, is had using soluble starch as granule made of filler larger Hygroscopicity, make granule in long term storage be easy the moisture absorption, grow bacterium, finally examine the microbial limit of granule Look into against regulation, stability reduction.Based on this, it is necessary to be improved, carry to the preparation process of traditional Fuxuekang granules The quality standard of high product improves drug effect, benefits the common people to ensure the quality monitoring of product.
Invention content
A kind of Fuxuekang granules and its preparation process, gained are provided the purpose of the present invention is overcome the deficiencies in the prior art Fuxuekang granules active constituent contents it is high, impurity is few, and particle is uniform, is not easy the moisture absorption, stability is good, is suitable for industrial production.
Object above that the invention is realized by the following technical scheme:
A kind of Fuxuekang granules, including following parts by weight prepare raw material:
500~2000 parts of blumea riparia
75~300 parts of filler
Appropriate flavoring agent.
Preferably, the Fuxuekang granules, including following parts by weight prepare raw material:
1000 parts of blumea riparia
150 parts of filler
Appropriate flavoring agent.
Further, the filler be dextrin, soluble starch, microcrystalline cellulose, pregelatinized starch, alpha-lactose, Or mixtures thereof one kind in mannitol.
Preferably, the filler is alpha-lactose and microcrystalline cellulose with 1:3.5~4.5 weight ratio composition.
It is highly preferred that the filler is alpha-lactose and microcrystalline cellulose with 1:4.25 weight ratio composition.
Further, the flavoring agent is sucrose, xylitol, sorbierite, maltitol or mannitol.
In above-mentioned prescription, the flavoring agent of carbohydrate or non-carbohydrate can be selected to carry out granule according to the different situations of patient It prepares, to meet the different market demands.
The active ingredient of Fuxuekang granules of the present invention is the water-soluble extractive of blumea riparia, and content is larger, to particle The selection of agent auxiliary material has mouldability, the uniformity, dissolubility of the selection to granule of more strict requirements, especially filler With large effect, the present inventor has found in early-stage study, selects soluble starch as filler, is being added without lubricant Under the premise of disintegrant, viscosity is strong when softwood processed, and hardly possible dispersion, pelletization is more difficult, and pellet hardness is partially soft, there is knot Block.It selects mannitol or microcrystalline cellulose as filler, is easy to pelletize, pellet hardness is suitable, but granulation uniformity is poor, deposits In more fine powder.Select dextrin as filler, viscosity is strong when softwood processed, and hardly possible dispersion, pelletization is more difficult, and particle Hardness is partially hard.It selects alpha-lactose as filler, is easy to pelletize, but particle slightly lumps.For this purpose, the present inventor attempts to use two The filler combination of kind or more is used to prepare granule, as a result, it has been found that, using the combination of soluble starch and mannitol, still go out Existing softwood viscosity is strong, and granulation is difficult, the harder phenomenon of particle;Using the combination of soluble starch and microcrystalline cellulose, granulation is held Easily, but particle slightly has caking phenomenon;Using the combination of mannitol and microcrystalline cellulose, granulation is easy, particle without caking phenomenon, but Particle is partially hard, and solubility property is deteriorated;Using the combination of dextrin and mannitol, granulation is difficult, and particle is partially hard;Use dextrin and crystallite The combination of cellulose, granulation is difficult, and pellet hardness is suitable, but slightly lumps;Using the combination of alpha-lactose and mannitol, granulation is tired Difficulty, pellet hardness is suitable, but slightly lumps;Using the combination of alpha-lactose and soluble starch, granulation is difficult, and pellet hardness is suitable Preferably, it but slightly lumps;Using the combination of alpha-lactose and dextrin, granulation is difficult, and pellet hardness is partially soft;It is fine using alpha-lactose and crystallite The combination of element is tieed up, granulation is easy, and pellet hardness is suitable, no caking, but granularity is slightly uneven.
Finally, the present inventor is by largely testing discovery, using alpha-lactose and microcrystalline cellulose with 1:3.5~4.5 The mixture of weight ratio composition improves significantly to the viscosity of blumea riparia thick paste as filler, and not only granulation is easy, And particle appearance shape obtained is good, and pellet hardness was moderate, and epigranular, solubility is preferable, through fuchsin(e)test three months It is minimum that moisture content change is measured afterwards, especially alpha-lactose-microcrystalline cellulose (1:4.25) combined effect it is best.
In addition, the present invention also provides a kind of preparation methods of the Fuxuekang granules comprising following steps:
(1) blumea riparia is cleaned, is dried, be ground into coarse powder, it is 1.29kg/m to then pass to density3Air, 5~10MP, 4~6min of expanding treatment are forced under normal temperature condition, then gas displacement is by abrupt release pressure at density 1.98kg/m3Carbon dioxide, 6~12MP, 4~6min of expanding treatment are forced under normal temperature condition, abrupt release pressure obtains Material A;
(2) above-mentioned material A is mixed with mixed solvent, suitable zinc sulfate is added, be exposed to height under normal temperature condition It presses and handles 6~12min in pulse electromagnetic field, obtain Herba Blumeae Balsamiferae extract;Wherein, the control of pulse electromagnetic field field strength 15~ 20kv/cm, frequency are 10~20Hz;
(3) it will be filtered through step (2) treated Herba Blumeae Balsamiferae extract, merging filtrate, filtrate is concentrated at 60 DEG C The filler of recipe quantity and suitable flavoring agent is added in the thick paste that relative density is 1.36~1.38, and mixing is pelletized, dry, mistake Sieve to get.
Further, the mixed solvent in above-mentioned preparation method step (2) is purified water and acetic acid with 1:0.08~0.1 Volume ratio forms.
Further, the solid-liquid ratio of the material A described in above-mentioned preparation method step (2) and mixed solvent is 1:20~ 35g/mL。
Further, the zinc sulfate addition described in above-mentioned preparation method step (2) be material A weight 0.1~ 0.4% (w/w).
Compared with traditional Fuxuekang granules preparation process, the present invention carries out expanding treatment to blumea riparia first, so It is placed in pulse electromagnetic field and extracts, be remarkably improved the content of extract protocatechuic acid and chlorogenic acid, it is steady to improve it It is qualitative, it degrades during avoiding protocatechuic acid and chlorogenic acid water from decocting, and avoid the reduction of volatile active.
Specifically, by using the air and carbon dioxide gas of different molecular quality, at various pressures to being rich in The blumea riparia coarse powder of fibrocyte is handled, and gas molecule high pressure is made to accumulate in Chinese medicine body, the extraneous pressure of moment subduction Power, the molecular kinetic energy generated using the intracellular high pressure gas release of blumea riparia, is smashed medicinal material tissue, medicinal material structure is made to dredge Pine accelerates solvent to go deep into inside medicinal material, the contact surface area of medicinal material and solvent is significantly increased.Further, the present invention will be handled Medicinal material afterwards, which is placed in pulse electromagnetic field, extracts processing, under the action of mixed solvent, promotes the molten of bioactive substance Go out, it should be noted that a certain amount of zinc sulfate is added into material A before extraction, with the acetic acid phase interaction in mixed solvent With water-molecule dissociation being promoted at a large amount of particles having compared with high reaction activity, the presence of these active particles improves arteries and veins The destructive rate for rushing Electromagnetic Field on Cell wall, to improve the recovery rate of active constituent, facts proved that, blumea riparia of the present invention is thick The content of protocatechuic acid in cream is high 3 times or more than as defined in Chinese Pharmacopoeia.
Compared with prior art, advantage of the invention is that:
(1) present invention uses distinctive formula and preparation process, and the Fuxuekang granules of acquisition is made to have high active ingredient Content and preferable bioavilability have many advantages, such as that small, keeping quality is good, convenient to take, effect is goed deep into.
(2) granule prescription of the present invention is used, is improved significantly to the viscosity of blumea riparia thick paste, not only granulation is held Easily, and particle appearance shape obtained is good, and pellet hardness is moderate, and solubility is preferable, is measured after three months through fuchsin(e)test Moisture content change is minimum, good stability.
(3) preparation process using the present invention can greatly improve blumea riparia active ingredient protocatechuic acid and chlorogenic acid Content, the content of protocatechuic acid is high 3 times or more than as defined in Chinese Pharmacopoeia.
Specific implementation mode
The present invention is further described below by way of specific implementation mode, but the present invention is not limited only to following embodiment.
It is prepared by 1 blumea riparia thick paste of embodiment
(1) it takes 1000g blumea riparias to clean, dries, be ground into coarse powder, it is 1.29kg/m to then pass to density3Sky Gas is forced into 8MP, expanding treatment 5min under normal temperature condition, then gas displacement is by abrupt release pressure at density 1.98kg/m3Carbon dioxide, 10MP, expanding treatment 5min are forced under normal temperature condition, abrupt release pressure obtains material A;
(2) above-mentioned material A is pressed 1:Mixed solvent, mixing is added in the solid-liquid ratio of 25g/mL, and the mixed solvent is Purified water is with acetic acid with 1:0.1 volume ratio composition, is then added suitable zinc sulfate, and the zinc sulfate addition is material 0.4% (w/w) of A weight, is then exposed in high-voltage pulse electromagnetic field under normal temperature condition and handles 10min, obtains Yunnan osmanthus Ai Na Fragrant extract;Wherein, the control of pulse electromagnetic field field strength is in 20kv/cm, frequency 20Hz;
(3) it will be filtered through step (2) treated Herba Blumeae Balsamiferae extract, merging filtrate, filtrate is concentrated at 60 DEG C Relative density be 1.36~1.38 thick paste to get.
It is prepared by 1 blumea riparia thick paste of comparative example
(1) it takes 1000g blumea riparias to clean, dries, be ground into coarse powder, it is spare;
(2) above-mentioned coarse powder is pressed 1:Mixed solvent, mixing is added in the solid-liquid ratio of 25g/mL, and the mixed solvent is pure Change water with acetic acid with 1:0.1 volume ratio composition, is then added suitable zinc sulfate, and the zinc sulfate addition is material A 0.4% (w/w) of weight, is then exposed in high-voltage pulse electromagnetic field under normal temperature condition and handles 10min, obtain blumea riparia Extract;Wherein, the control of pulse electromagnetic field field strength is in 20kv/cm, frequency 20Hz;
(3) it will be filtered through step (2) treated Herba Blumeae Balsamiferae extract, merging filtrate, filtrate is concentrated at 60 DEG C Relative density be 1.36~1.38 thick paste to get.
1 blumea riparia thick paste of comparative example is prepared compared with embodiment 1, difference lies in, extrusion pretreatment is not carried out, Remaining step is same as Example 1.
It is prepared by 2 blumea riparia thick paste of comparative example
(1) it takes 1000g blumea riparias to clean, dries, be ground into coarse powder, it is 1.29kg/m to then pass to density3Sky Gas is forced into 8MP, expanding treatment 5min under normal temperature condition, then gas displacement is by abrupt release pressure at density 1.98kg/m3Carbon dioxide, 10MP, expanding treatment 5min are forced under normal temperature condition, abrupt release pressure obtains material A;
(2) it by above-mentioned material A, adds water to cook secondary, 1.5 hours first times, second 1 hour, collecting decoction, filter It crosses, filtrate is concentrated into the clear cream that relative density is 1.08 (60 DEG C), stands 8 hours, and filtration, filtrate is concentrated into relative density and is The thick paste of 1.36~1.38 (60 DEG C) to get.
2 blumea riparia thick paste of comparative example is prepared compared with embodiment 1, difference lies in, it is extracted using water boiling method, Remaining step is same as Example 1.
It is prepared by 3 blumea riparia thick paste of comparative example
(1) it takes 1000g blumea riparias to clean, dries, be ground into coarse powder, it is 1.29kg/m to then pass to density3Sky Gas is forced into 8MP, expanding treatment 5min under normal temperature condition, then gas displacement is by abrupt release pressure at density 1.98kg/m3Carbon dioxide, 10MP, expanding treatment 5min are forced under normal temperature condition, abrupt release pressure obtains material A;
(2) above-mentioned material A is pressed 1:Purified water is added in the solid-liquid ratio of 25g/mL, and mixing is then sudden and violent under normal temperature condition It is exposed in high-voltage pulse electromagnetic field and handles 10min, obtain Herba Blumeae Balsamiferae extract;Wherein, pulse electromagnetic field field strength control exists 20kv/cm, frequency 20Hz;
(3) it will be filtered through step (2) treated Herba Blumeae Balsamiferae extract, merging filtrate, filtrate is concentrated at 60 DEG C Relative density be 1.36~1.38 thick paste to get.
3 blumea riparia thick paste of comparative example is prepared compared with embodiment 1, and difference lies in Extraction solvent is only purified water, no Containing acetic acid, and that zinc sulfate is not added, remaining step is same as Example 1.
It is prepared by 4 blumea riparia thick paste of comparative example
1000g blumea riparias are taken, are added water to cook secondary, 1.5 hours first times, second 1 hour, collecting decoction, filter It crosses, filtrate is concentrated into the clear cream that relative density is 1.08 (60 DEG C), stands 8 hours, and filtration, filtrate is concentrated into relative density and is The thick paste of 1.36~1.38 (60 DEG C).
4 blumea riparia thick paste preparation process of comparative example is pharmacopeia preparation process.
Effective substance in 2 blumea riparia thick paste of embodiment
Blumea riparia thick paste made from embodiment 1 and comparative example 1-4 is dried, dried powder is obtained, using efficient Liquid chromatography is to protocatechuic acid (C7H6O4) and chlorogenic acid (C16H18O9) content detection is carried out, the results are shown in Table 1.
1 protocatechuic acid of table and chlorogenic acid content testing result
States Pharmacopoeia specifications, every gram of (C containing protocatechuic acid of medicinal extract that blumea riparia obtains after water boiling and extraction7H6O4) many In 0.12mg, the results show that active ingredient original catechu in blumea riparia thick paste can be effectively improved using extraction process of the present invention The content of acid and chlorogenic acid, wherein every gram of 0.43mg containing protocatechuic acid of medicinal extract, significantly larger than 0.12mg.It achieves unexpected Technique effect.
The pairs of granule of group of the different fillers of embodiment 3 influences
Investigating the pairs of granule of group of different fillers respectively influences, and is specifically shown in shown in the following table 2 and table 3.
Granule composition of the table 2 containing different fillers
Group Blumea riparia Filler Flavoring agent
1 1000 parts 150 parts of soluble starch Appropriate sucrose
2 1000 parts 150 parts of mannitol Appropriate sucrose
3 1000 parts 150 parts of microcrystalline cellulose Appropriate sucrose
4 1000 parts 150 parts of dextrin Appropriate sucrose
5 1000 parts 150 parts of alpha-lactose Appropriate sucrose
6 1000 parts Soluble starch and mannitol (1:1) 150 parts Appropriate sucrose
7 1000 parts Soluble starch and microcrystalline cellulose (1:1) 150 parts Appropriate sucrose
8 1000 parts Mannitol and microcrystalline cellulose (1:1) 150 parts Appropriate sucrose
9 1000 parts Dextrin and mannitol (1:1) 150 parts Appropriate sucrose
10 1000 parts Dextrin and microcrystalline cellulose (1:1) 150 parts Appropriate sucrose
11 1000 parts Alpha-lactose and mannitol (1:1) 150 parts Appropriate sucrose
12 1000 parts Alpha-lactose and soluble starch (1:1) 150 parts Appropriate sucrose
13 1000 parts Alpha-lactose and dextrin (1:1) 150 parts Appropriate sucrose
14 1000 parts Alpha-lactose and microcrystalline cellulose (1:1) 150 parts Appropriate sucrose
Preparation method:
(1) preparation of blumea riparia thick paste is with embodiment 1, obtain relative density at 60 DEG C be 1.36~1.38 it is thick Cream.
(2) filler of recipe quantity and suitable flavoring agent are added into the thick paste of step (1), mixing is pelletized, dry, Sieving to get.
Influence of the different fillers of table 3 to granule
As can be seen from Table 3, when filler is alpha-lactose and microcrystalline cellulose combines, not only granulation is easy, and is made The particle appearance obtained is good, and in yellowish-brown to sepia, pellet hardness is suitable, no caking, but granularity is slightly uneven, is tried through moisture absorption The moisture content change measured after testing 3 months is smaller.
The composition and ratio of the different alpha-lactoses of embodiment 4 and microcrystalline cellulose influences granule
Investigating the composition and ratio of same alpha-lactose and microcrystalline cellulose respectively influences granule, is specifically shown in 5 institute of the following table 4 and table Show.
Granule composition of the table 4 containing different alpha-lactoses and microcrystalline cellulose composition and ratio
Group Blumea riparia Filler Flavoring agent
1 1000 parts Alpha-lactose and microcrystalline cellulose (1:1) 150 parts Appropriate sucrose
2 1000 parts Alpha-lactose and microcrystalline cellulose (1:2) 150 parts Appropriate sucrose
3 1000 parts Alpha-lactose and microcrystalline cellulose (1:3) 150 parts Appropriate sucrose
4 1000 parts Alpha-lactose and microcrystalline cellulose (1:3.5) 150 parts Appropriate sucrose
5 1000 parts Alpha-lactose and microcrystalline cellulose (1:4.25) 150 parts Appropriate sucrose
6 1000 parts Alpha-lactose and microcrystalline cellulose (1:4.5) 150 parts Appropriate sucrose
7 1000 parts Alpha-lactose and microcrystalline cellulose (1:5) 150 parts Appropriate sucrose
8 1000 parts Alpha-lactose and microcrystalline cellulose (1:6) 150 parts Appropriate sucrose
9 1000 parts Alpha-lactose and microcrystalline cellulose (2:1) 150 parts Appropriate sucrose
10 1000 parts Alpha-lactose and microcrystalline cellulose (2.5:1) 150 parts Appropriate sucrose
11 1000 parts Alpha-lactose and microcrystalline cellulose (3:1) 150 parts Appropriate sucrose
Preparation method:
(1) preparation of blumea riparia thick paste is with embodiment 1, obtain relative density at 60 DEG C be 1.36~1.38 it is thick Cream.
(2) filler of recipe quantity and suitable flavoring agent are added into the thick paste of step (1), mixing is pelletized, dry, Sieving to get.
The influence of table 5 different alpha-lactoses and microcrystalline cellulose composition and ratio to granule
As can be seen from Table 5, when filler is alpha-lactose and microcrystalline cellulose with 1:3.5~4.5 weight ratio composition When, not only granulation is easy, and particle appearance obtained is good, and in yellowish-brown to sepia, pellet hardness is suitable, no caking, grain Degree is uniform, and the moisture content change measured after 3 months through fuchsin(e)test is minimum, and solubility property in water is good, in 1.5 minutes Dissolving dispersion finishes.
It the above is only the preferred embodiment of the present invention, it is noted that above-mentioned preferred embodiment is not construed as pair The limitation of the present invention, protection scope of the present invention should be subject to claim limited range.For the art For those of ordinary skill, without departing from the spirit and scope of the present invention, several improvements and modifications can also be made, these change Protection scope of the present invention is also should be regarded as into retouching.

Claims (10)

1. a kind of Fuxuekang granules, which is characterized in that prepare raw material including following parts by weight:
500~2000 parts of blumea riparia
75~300 parts of filler
Appropriate flavoring agent.
2. Fuxuekang granules according to claim 1, which is characterized in that prepare raw material including following parts by weight:
1000 parts of blumea riparia
150 parts of filler
Appropriate flavoring agent.
3. Fuxuekang granules according to claim 1 or 2, which is characterized in that the filler is dextrin, soluble shallow lake Or mixtures thereof one kind in powder, microcrystalline cellulose, pregelatinized starch, alpha-lactose, mannitol.
4. Fuxuekang granules according to claim 3, which is characterized in that the filler is alpha-lactose and microcrystalline cellulose Element is with 1:3.5~4.5 weight ratio composition.
5. Fuxuekang granules according to claim 4, which is characterized in that the filler is alpha-lactose and microcrystalline cellulose Element is with 1:4.25 weight ratio composition.
6. Fuxuekang granules according to claim 1 or 2, which is characterized in that the flavoring agent be sucrose, xylitol, Sorbierite, maltitol or mannitol.
7. according to the preparation method of any Fuxuekang granules of claim 1-6, which is characterized in that include the following steps:
(1) blumea riparia is cleaned, is dried, be ground into coarse powder, it is 1.29kg/m to then pass to density3Air, in room temperature item 5~10MP, 4~6min of expanding treatment are forced under part, then gas displacement is 1.98kg/ at density by abrupt release pressure m3Carbon dioxide, 6~12MP, 4~6min of expanding treatment are forced under normal temperature condition, abrupt release pressure obtains material A;
(2) above-mentioned material A is mixed with mixed solvent, suitable zinc sulfate is added, be exposed to high-tension pulse under normal temperature condition 6~12min of processing in electromagnetic field is rushed, Herba Blumeae Balsamiferae extract is obtained;Wherein, the control of pulse electromagnetic field field strength is in 15~20kv/ Cm, frequency are 10~20Hz;
(3) it will be filtered through step (2) treated Herba Blumeae Balsamiferae extract, merging filtrate, filtrate is concentrated at 60 DEG C relatively The filler of recipe quantity and suitable flavoring agent is added in the thick paste that density is 1.36~1.38, and mixing is pelletized, dry, sieving, To obtain the final product.
8. the preparation method of Fuxuekang granules according to claim 7, which is characterized in that the mixed solvent is purifying Water and acetic acid are with 1:0.08~0.1 volume ratio composition.
9. the preparation method of Fuxuekang granules according to claim 7, which is characterized in that the material A and mixing is molten The solid-liquid ratio of matchmaker is 1:20~35g/mL.
10. the preparation method of Fuxuekang granules according to claim 7, which is characterized in that the zinc sulfate addition For 0.1~0.4%w/w of material A weight.
CN201810263553.4A 2018-03-27 2018-03-27 Fuxuekang granule and its preparation process Active CN108272847B (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115252703A (en) * 2022-08-23 2022-11-01 一力制药股份有限公司 Children's Yinlian granules and preparation method thereof
CN116135218A (en) * 2023-04-20 2023-05-19 北京东升制药有限公司 Eight-ingredient dysmenorrhea granule and preparation method thereof

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1626179A (en) * 2003-12-12 2005-06-15 北京博尔达生物技术开发有限公司 Solid preparation of 'Fuxiekang' and preparation method
CN104127465A (en) * 2014-07-15 2014-11-05 贵州大学 Blumea balsamifera controlled release preparation and preparation method thereof
CN107823400A (en) * 2017-11-23 2018-03-23 广东三蓝药业股份有限公司 A kind of QI invigorating, which rises, falls into ball and preparation method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1626179A (en) * 2003-12-12 2005-06-15 北京博尔达生物技术开发有限公司 Solid preparation of 'Fuxiekang' and preparation method
CN104127465A (en) * 2014-07-15 2014-11-05 贵州大学 Blumea balsamifera controlled release preparation and preparation method thereof
CN107823400A (en) * 2017-11-23 2018-03-23 广东三蓝药业股份有限公司 A kind of QI invigorating, which rises, falls into ball and preparation method thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115252703A (en) * 2022-08-23 2022-11-01 一力制药股份有限公司 Children's Yinlian granules and preparation method thereof
CN115252703B (en) * 2022-08-23 2023-08-18 一力制药股份有限公司 Children's Yinlian granule and preparation method thereof
CN116135218A (en) * 2023-04-20 2023-05-19 北京东升制药有限公司 Eight-ingredient dysmenorrhea granule and preparation method thereof

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