CN108272847B - Fuxuekang granule and its preparation process - Google Patents

Fuxuekang granule and its preparation process Download PDF

Info

Publication number
CN108272847B
CN108272847B CN201810263553.4A CN201810263553A CN108272847B CN 108272847 B CN108272847 B CN 108272847B CN 201810263553 A CN201810263553 A CN 201810263553A CN 108272847 B CN108272847 B CN 108272847B
Authority
CN
China
Prior art keywords
granules
fuxuekang
lactose
microcrystalline cellulose
parts
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CN201810263553.4A
Other languages
Chinese (zh)
Other versions
CN108272847A (en
Inventor
曾胜
曾佐达
梁烽焱
张�浩
陈尚杰
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Yili Pharmaceutical Nanning Co Ltd
Yili Pharmaceutical Co ltd
Original Assignee
Yili Pharmaceutical Nanning Co Ltd
Yili Pharmaceutical Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Yili Pharmaceutical Nanning Co Ltd, Yili Pharmaceutical Co ltd filed Critical Yili Pharmaceutical Nanning Co Ltd
Priority to CN201810263553.4A priority Critical patent/CN108272847B/en
Publication of CN108272847A publication Critical patent/CN108272847A/en
Application granted granted Critical
Publication of CN108272847B publication Critical patent/CN108272847B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a Fuxuekang granule and a preparation process thereof. The Fuxuekang granules comprise the following preparation raw materials in parts by weight: 500-2000 parts of blumea riparia, 75-300 parts of a filling agent and a proper amount of a flavoring agent. Preferably, the filler is composed of alpha-lactose and microcrystalline cellulose in a weight ratio of 1: 3.5-4.5, and more preferably, the filler is composed of alpha-lactose and microcrystalline cellulose in a weight ratio of 1: 4.25. Further, the flavoring agent is sucrose, xylitol, sorbitol, maltitol or mannitol. The invention adopts a specific formula and a preparation process, so that the obtained Fuxuekang granules have high content of effective components, better bioavailability and storage stability.

Description

Fuxuekang granule and its preparation process
Technical Field
The invention belongs to the technical field of medicinal preparations, and particularly relates to a Fuxuekang granule and a preparation process thereof.
Background
Fuxuekang granules are gynecological medicines developed from the Zhuang nationality Chinese herbal medicine blumea riparia, and are received in the national Chinese patent medicine standard compilation (the landmark rising national standard part) of the State drug administration. The granule is a single preparation of blumea riparia. The blumea riparia is dry whole plant of blumea riparia of Compositae, is mainly produced in Guangxi and Yunnan, has effects of promoting blood circulation for removing blood stasis, stopping bleeding and regulating menstruation, and can be used for treating blood stasis, menorrhagia, menostaxis, puerperal lochiorrhea, etc. Clinical research shows that the unique functional components of the medicine can promote the contraction of uterine smooth muscle, close blood vessels and accelerate the shedding of endometrium; reduce the vaginal bleeding amount after drug flow, shorten the bleeding duration time and obtain good effect in clinical application.
Research shows that the effective components of blumea riparia with hemostatic effect are mainly water soluble components such as protocatechuic acid, chlorogenic acid, etc. Therefore, the traditional preparation process of the Fuxuekang granules comprises the following steps: decocting herba Blumeae Balsamiferae in water, concentrating into soft extract, adding adjuvants such as soluble starch and sucrose, granulating, and drying. The granule is extracted by water extraction process, and decocting at high temperature easily causes decomposition of protocatechuic acid and chlorogenic acid as effective components, and aggravates volatile effective component loss. In addition, because the blumea riparia extract is mainly a water-soluble substance, the granules prepared by using soluble starch as a filler have higher hygroscopicity, so that the granules are easy to absorb moisture and breed bacteria in the long-term storage process, and finally, the microbial limit inspection of the granules is not in line with the regulations, and the stability is reduced. Therefore, the preparation process of the traditional Fuxuekang granules needs to be improved, the quality standard of the product is improved, the monitoring quality of the product is ensured, the drug effect is improved, and the common people are benefited.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provide the Fuxuekang granules and the preparation process thereof, and the obtained Fuxuekang granules have the advantages of high content of effective components, less impurities, uniform granules, difficult moisture absorption and good stability, and are suitable for industrial production.
The invention realizes the above purposes by the following technical scheme:
the Fuxuekang granules comprise the following preparation raw materials in parts by weight:
500-2000 parts of blumea riparia
75-300 parts of filler
And a proper amount of flavoring agent.
Preferably, the Fuxuekang granules comprise the following preparation raw materials in parts by weight:
1000 parts of blumea riparia
150 parts of filler
And a proper amount of flavoring agent.
Further, the filler is one or a mixture of dextrin, soluble starch, microcrystalline cellulose, pregelatinized starch, alpha-lactose and mannitol.
Preferably, the filler is composed of alpha-lactose and microcrystalline cellulose in a weight ratio of 1: 3.5-4.5.
More preferably, the filler is composed of alpha-lactose and microcrystalline cellulose in a weight ratio of 1: 4.25.
Further, the flavoring agent is sucrose, xylitol, sorbitol, maltitol or mannitol.
In the above formula, the preparation of the granule can be carried out by selecting sugar or non-sugar flavoring agent according to different conditions of patients, so as to meet different market demands.
The effective component of the Fuxuekang granules is a water-soluble extract of blumea riparia, the content is high, the selection of auxiliary materials of the granules is strictly required, and particularly, the selection of a filling agent has great influence on the formability, uniformity and solubility of the granules. Mannitol or microcrystalline cellulose is selected as a filler, so that the granules are easy to pelletize, the hardness of the granules is proper, but the uniformity of the granules is poor, and more fine powder exists. Dextrin is selected as a filling agent, so that the soft material has strong viscosity, is difficult to disperse, is difficult to pelletize, and has hard particle hardness. Alpha-lactose was chosen as filler, which is easy to granulate, but the granules are slightly agglomerated. For this reason, the present inventors tried to use a combination of two or more fillers for the preparation of granules, and as a result, found that, using a combination of soluble starch and mannitol, there still occurred phenomena of strong soft material viscosity, difficulty in granulation, and harder granules; the combination of soluble starch and microcrystalline cellulose is used, so that the granulation is easy, but the granules have a slightly caking phenomenon; the combination of mannitol and microcrystalline cellulose is used, so that the granulation is easy, the granules have no caking phenomenon, but the granules are hard, and the dissolution performance is poor; the combination of dextrin and mannitol is used, so that the granulation is difficult and the granules are hard; the combination of dextrin and microcrystalline cellulose is used, so that the granulation is difficult, the granule hardness is proper, and the granules are slightly agglomerated; the combination of alpha-lactose and mannitol is used, so that the granulation is difficult, the granule hardness is proper, and the granules are slightly agglomerated; the combination of alpha-lactose and soluble starch is used, so that the granulation is difficult, the granule hardness is proper, and the granules are slightly caked; the combination of alpha-lactose and dextrin is used, so that the granulation is difficult, and the hardness of the granules is soft; using a combination of alpha-lactose and microcrystalline cellulose, granulation is easy, the granules are suitably hard, free of caking, but slightly non-uniform in particle size.
Finally, the inventor discovers through a large number of experiments that the mixture of alpha-lactose and microcrystalline cellulose in a weight ratio of 1: 3.5-4.5 is used as a filler, so that the viscosity of the blumea riparia thick paste is obviously improved, granulation is easy, the prepared particles are good in appearance and shape, moderate in particle hardness, uniform in particle size and good in solubility, the change of the moisture content is measured to be minimum after three months of a moisture absorption test, and particularly the combination effect of the alpha-lactose-microcrystalline cellulose (1:4.25) is best.
In addition, the invention also provides a preparation method of the Fuxuekang granules, which comprises the following steps:
(1) cleaning herba Blumeae Balsamiferae, air drying, pulverizing into coarse powder, and introducing into a container with density of 1.29kg/m3Pressurizing to 5-10 MP at normal temperature, puffing for 4-6 min, releasing pressure instantaneously, and replacing gas to 1.98kg/m3Pressurizing the carbon dioxide to 6-12 MP at normal temperature, carrying out puffing treatment for 4-6 min, and releasing pressure instantly to obtain a material A;
(2) mixing the material A with a mixed solvent, adding a proper amount of zinc sulfate, and exposing the mixture to a high-voltage pulse electromagnetic field at normal temperature for treatment for 6-12 min to obtain a blumea riparia extract; wherein the field intensity of the pulse electromagnetic field is controlled to be 15-20 kv/cm, and the frequency is 10-20 Hz;
(3) and (3) filtering the blumea riparia extract treated in the step (2), combining the filtrates, concentrating the filtrate to a thick paste with the relative density of 1.36-1.38 at the temperature of 60 ℃, adding a filling agent and a proper amount of flavoring agent according to the prescription amount, uniformly mixing, granulating, drying and sieving to obtain the blumea riparia extract.
Further, the mixed solvent in the step (2) of the preparation method is purified water and acetic acid, and the volume ratio of the purified water to the acetic acid is 1: 0.08-0.1.
Further, the material-liquid ratio of the material A and the mixed solvent in the step (2) of the preparation method is 1: 20-35 g/mL.
Further, the adding amount of the zinc sulfate in the step (2) of the preparation method is 0.1-0.4% (w/w) of the weight of the material A.
Compared with the traditional preparation process of the Fuxuekang granules, the preparation method firstly carries out puffing treatment on the blumea riparia, and then carries out extraction in a pulse electromagnetic field, so that the content of protocatechuic acid and chlorogenic acid in the extract can be obviously improved, the stability of the extract is improved, the protocatechuic acid and chlorogenic acid are prevented from being degraded in the process of decocting with water, and the reduction of volatile active ingredients is avoided.
Specifically, through adopting air and carbon dioxide gas of different molecular mass, handle yunnanguien blumea balsamifera coarse powder rich in fibre cell under different pressure, make the high pressure of gas molecule gather in traditional chinese medicine is internal, subtracts external pressure in the twinkling of an eye, utilizes the molecular kinetic energy of yunnanguien blumea balsamifera intracellular high-pressure gas release production, breaks up the medicinal material tissue, makes the medicinal material structure loose, inside the solvent deepened into the medicinal material with higher speed, increases the contact surface area of medicinal material and solvent by a wide margin. Furthermore, the invention puts the processed medicinal materials into a pulse electromagnetic field for extraction treatment, and promotes the dissolution of bioactive substances under the action of mixed solvent, wherein a certain amount of zinc sulfate is added into the material A before extraction to interact with acetic acid in the mixed solvent, so that water molecules can be promoted to be decomposed into a large number of particles with higher reaction activity, and the existence of the active particles improves the damage rate of the pulse electromagnetic field to cell walls, thereby improving the extraction rate of active ingredients.
Compared with the prior art, the invention has the advantages that:
(1) the invention adopts a specific formula and a preparation process, so that the obtained Fuxuekang granules have high content of effective components and better bioavailability, and have the advantages of small volume, good preservation property, convenient taking, deep action and the like.
(2) The granule prescription of the invention obviously improves the viscosity of the blumea riparia thick paste, not only the granulation is easy, but also the prepared granules have good appearance and shape, moderate granule hardness and better solubility, and the change of the water content is minimum after the moisture absorption test for three months, and the stability is good.
(3) By adopting the preparation process, the contents of protocatechuic acid and chlorogenic acid which are effective components of blumea riparia (Bl.) DC can be greatly improved, wherein the contents of protocatechuic acid are more than 3 times higher than those specified in Chinese pharmacopoeia.
Detailed Description
The present invention will be further described below by way of specific embodiments, but the present invention is not limited to only the following examples.
EXAMPLE 1 preparation of a Thick extract of Blumeae Balsamiferae
(1) 1000g of blumea riparia is cleaned, dried, crushed into coarse powder and then introduced into the coarse powder with the density of 1.29kg/m3Pressurizing to 8MP at normal temperature, puffing for 5min, releasing pressure instantaneously, and replacing gas to density of 1.98kg/m3Pressurizing to 10MP at normal temperature, puffing for 5min, and releasing pressure instantly to obtain material A;
(2) adding a mixed solvent into the material A according to a material-liquid ratio of 1:25g/mL, uniformly mixing, wherein the mixed solvent is composed of purified water and acetic acid according to a volume ratio of 1:0.1, then adding a proper amount of zinc sulfate, the adding amount of the zinc sulfate is 0.4% (w/w) of the weight of the material A, and then exposing the material A to a high-voltage pulse electromagnetic field for treatment for 10min under a normal temperature condition to obtain a blumea riparia extract; wherein the field intensity of the pulse electromagnetic field is controlled at 20kv/cm, and the frequency is 20 Hz;
(3) and (3) filtering the blumea riparia extract treated in the step (2), combining the filtrates, and concentrating the filtrate to a thick paste with the relative density of 1.36-1.38 at 60 ℃ to obtain the blumea riparia extract.
Comparative example 1 preparation of a thick paste of Blumea blumea balsamifera
(1) 1000g of blumea riparia is taken, cleaned, dried and crushed into coarse powder for standby;
(2) adding a mixed solvent into the coarse powder according to the material-liquid ratio of 1:25g/mL, uniformly mixing, wherein the mixed solvent is composed of purified water and acetic acid according to the volume ratio of 1:0.1, then adding a proper amount of zinc sulfate, the adding amount of the zinc sulfate is 0.4% (w/w) of the weight of the material A, and then exposing the mixture to a high-voltage pulse electromagnetic field for treatment for 10min under the normal temperature condition to obtain the blumea riparia extract; wherein the field intensity of the pulse electromagnetic field is controlled at 20kv/cm, and the frequency is 20 Hz;
(3) and (3) filtering the blumea riparia extract treated in the step (2), combining the filtrates, and concentrating the filtrate to a thick paste with the relative density of 1.36-1.38 at 60 ℃ to obtain the blumea riparia extract.
Comparative example 1 a blumea riparia thick paste was prepared as compared to example 1, except that no puffing pre-treatment was performed, and the remaining steps were the same as in example 1.
Comparative example 2 preparation of Yunnan Gui blumea balsamifera thick paste
(1) 1000g of blumea riparia is cleaned, dried, crushed into coarse powder and then introduced into the coarse powder with the density of 1.29kg/m3Pressurizing to 8MP at normal temperature, puffing for 5min, releasing pressure instantaneously, and replacing gas to density of 1.98kg/m3Pressurizing to 10MP at normal temperature, puffing for 5min, and releasing pressure instantly to obtain material A;
(2) decocting the material A in water twice, wherein the first time is 1.5 hours, the second time is 1 hour, merging decoction, filtering, concentrating the filtrate to obtain clear paste with the relative density of 1.08(60 ℃), standing for 8 hours, filtering, and concentrating the filtrate to obtain thick paste with the relative density of 1.36-1.38 (60 ℃).
Comparative example 2 the preparation of a blumea riparia thick paste was compared with example 1 except that the extraction was performed by water decoction and the rest of the procedure was the same as in example 1.
Comparative example 3 preparation of Yunnan Gui blumea balsamifera thick paste
(1) 1000g of blumea riparia is cleaned, dried, crushed into coarse powder and then introduced into the coarse powder with the density of 1.29kg/m3Pressurizing to 8MP at normal temperature, puffing for 5min, releasing pressure instantaneously, and replacing gas to density of 1.98kg/m3Pressurizing to 10MP at normal temperature, and puffingTreating for 5min, and releasing pressure instantly to obtain material A;
(2) adding purified water into the material A according to the material-liquid ratio of 1:25g/mL, uniformly mixing, and then exposing the mixture to a high-voltage pulse electromagnetic field at normal temperature for 10min to obtain a blumea riparia extract; wherein the field intensity of the pulse electromagnetic field is controlled at 20kv/cm, and the frequency is 20 Hz;
(3) and (3) filtering the blumea riparia extract treated in the step (2), combining the filtrates, and concentrating the filtrate to a thick paste with the relative density of 1.36-1.38 at 60 ℃ to obtain the blumea riparia extract.
Comparative example 3 a thick extract of blumea riparia was prepared in comparison with example 1, except that the extraction solvent was purified water only, acetic acid was not included, and zinc sulfate was not added, and the rest of the procedure was the same as in example 1.
Comparative example 4 preparation of Yunnan Gui blumea balsamifera Thick paste
1000g of blumea riparia (Bl.) DC is taken, water is added for decoction twice, the first time lasts for 1.5 hours, the second time lasts for 1 hour, decoction liquid is combined, filtration is carried out, filtrate is concentrated to clear paste with the relative density of 1.08(60 ℃), standing is carried out for 8 hours, filtration is carried out, and filtrate is concentrated to thick paste with the relative density of 1.36-1.38 (60 ℃).
Comparative example 4 the process for preparing the thick paste of blumea riparia is the process for preparing pharmacopoeia.
Example 2 detection of active ingredients in a thick extract of Blumeae Balsamiferae
Drying the thick paste of blumea riparia prepared in example 1 and comparative examples 1-4 to obtain dry powder, and performing high performance liquid chromatography to obtain protocatechuic acid (C)7H6O4) And chlorogenic acid (C)16H18O9) The content was measured and the results are shown in Table 1.
TABLE 1 content determination of protocatechuic acid and chlorogenic acid
Figure BDA0001609696750000051
Figure BDA0001609696750000061
The pharmacopoeia stipulates that one gram of extract obtained by decocting blumea riparia (Bl.) DC with water and extracting contains protocatechuic acid (C)7H6O4) The extraction process can effectively improve the content of active ingredients protocatechuic acid and chlorogenic acid in the Yunnan and Guangxi blumea balsamifera thick paste, wherein the content of protocatechuic acid in each gram of the extract is 0.43mg which is far higher than 0.12 mg. Unexpected technical effects are achieved.
Example 3 composition of different fillers impact on granules
The effect of the composition of the different fillers on the granules was examined separately and is shown in tables 2 and 3 below.
TABLE 2 formulation of granules with different fillers
Group of Blumea riparia (Bl.) DC Filler Flavoring agent
1 1000 portions 150 parts of soluble starch Proper amount of sucrose
2 1000 portions Mannitol 150 parts Proper amount of sucrose
3 1000 portions Microcrystalline cellulose 150 parts Proper amount of sucrose
4 1000 portions Dextrin 150 parts Proper amount of sucrose
5 1000 portions 150 parts of alpha-lactose Proper amount of sucrose
6 1000 portions Soluble starch and mannitol (1:1)150 parts Proper amount of sucrose
7 1000 portions Soluble starch and microcrystalline cellulose (1:1)150 parts Proper amount of sucrose
8 1000 portions Mannitol and microcrystalline cellulose (1:1)150 parts Proper amount of sucrose
9 1000 portions Dextrin and mannitol (1:1)150 parts Proper amount of sucrose
10 1000 portions Dextrin and microcrystalline cellulose (1:1)150 parts Proper amount of sucrose
11 1000 portions 150 portions of alpha-lactose and mannitol (1:1) Proper amount of sucrose
12 1000 portions 150 portions of alpha-lactose and soluble starch (1:1) Proper amount of sucrose
13 1000 portions 150 portions of alpha-lactose and dextrin (1:1) Proper amount of sucrose
14 1000 portions 150 portions of alpha-lactose and microcrystalline cellulose (1:1) Proper amount of sucrose
The preparation method comprises the following steps:
(1) the preparation of the blumea riparia thick paste is the same as that in example 1, and the thick paste with the relative density of 1.36-1.38 at 60 ℃ is obtained.
(2) Adding the filling agent and the flavoring agent into the thick paste obtained in the step (1), uniformly mixing, granulating, drying and sieving to obtain the traditional Chinese medicine composition.
TABLE 3 Effect of different fillers on granules
Figure BDA0001609696750000062
Figure BDA0001609696750000071
As can be seen from table 3 above, when the filler is a combination of α -lactose and microcrystalline cellulose, not only granulation is easy, but also the prepared granules have good appearance, are yellowish brown to tan, have suitable granule hardness, do not cake, but have slightly non-uniform particle size, and have small change in moisture content measured after 3 months of moisture absorption test.
Example 4 different compositional ratios of alpha-lactose and microcrystalline cellulose have an effect on the granules
The effect of the same composition ratio of alpha-lactose and microcrystalline cellulose on granules was examined, and is shown in tables 4 and 5 below.
TABLE 4 formulation composition of granules containing different composition ratios of alpha-lactose and microcrystalline cellulose
Group of Blumea riparia (Bl.) DC Filler Flavoring agent
1 1000 portions 150 portions of alpha-lactose and microcrystalline cellulose (1:1) Proper amount of sucrose
2 1000 portions 150 portions of alpha-lactose and microcrystalline cellulose (1:2) Proper amount of sucrose
3 1000 portions 150 portions of alpha-lactose and microcrystalline cellulose (1:3) Proper amount of sucrose
4 1000 portions 150 parts of alpha-lactose and microcrystalline cellulose (1:3.5) Proper amount of sucrose
5 1000 portions 150 parts of alpha-lactose and microcrystalline cellulose (1:4.25) Proper amount of sucrose
6 1000 portions 150 parts of alpha-lactose and microcrystalline cellulose (1:4.5) Proper amount of sucrose
7 1000 portions 150 parts of alpha-lactose and microcrystalline cellulose (1:5) Proper amount of sucrose
8 1000 portions 150 portions of alpha-lactose and microcrystalline cellulose (1:6) Cane sugarMeasurement of
9 1000 portions 150 portions of alpha-lactose and microcrystalline cellulose (2:1) Proper amount of sucrose
10 1000 portions 150 parts of alpha-lactose and microcrystalline cellulose (2.5:1) Proper amount of sucrose
11 1000 portions 150 portions of alpha-lactose and microcrystalline cellulose (3:1) Proper amount of sucrose
The preparation method comprises the following steps:
(1) the preparation of the blumea riparia thick paste is the same as that in example 1, and the thick paste with the relative density of 1.36-1.38 at 60 ℃ is obtained.
(2) Adding the filling agent and the flavoring agent into the thick paste obtained in the step (1), uniformly mixing, granulating, drying and sieving to obtain the traditional Chinese medicine composition.
TABLE 5 Effect of different alpha-lactose and microcrystalline cellulose compositional ratios on granules
Figure BDA0001609696750000081
As can be seen from table 5 above, when the filler is composed of α -lactose and microcrystalline cellulose in a weight ratio of 1: 3.5-4.5, granulation is easy, and the prepared granules have good appearance, are yellowish brown to tan, have suitable hardness, no agglomeration, uniform particle size, minimal change in moisture content after 3 months of moisture absorption test, and good solubility in water, and are completely dissolved and dispersed within 1.5 minutes.
The above is only a preferred embodiment of the present invention, and it should be noted that the above preferred embodiment should not be considered as limiting the present invention, and the protection scope of the present invention should be subject to the scope defined by the claims. It will be apparent to those skilled in the art that various modifications and adaptations can be made without departing from the spirit and scope of the invention, and these modifications and adaptations should be considered within the scope of the invention.

Claims (4)

1. The Fuxuekang granules are characterized by being prepared from the following preparation raw materials in parts by weight:
1000 parts of blumea riparia;
150 parts of a filler;
a proper amount of flavoring agent;
the filler is composed of alpha-lactose and microcrystalline cellulose in a weight ratio of 1: 3.5-4.5;
the preparation method of the Fuxuekang granules comprises the following steps:
(1) cleaning herba Blumeae Balsamiferae, air drying, pulverizing into coarse powder, and introducing into a container with density of 1.29kg/m3Pressurizing to 5-10 MP at normal temperature, puffing for 4-6 min, releasing pressure instantaneously, and replacing gas to 1.98kg/m3Pressurizing the carbon dioxide to 6-12 MP at normal temperature, carrying out puffing treatment for 4-6 min, and releasing pressure instantly to obtain a material A;
(2) mixing the material A with a mixed solvent, adding zinc sulfate, and exposing to a high-voltage pulse electromagnetic field at normal temperature for treatment for 6-12 min to obtain a blumea riparia extract; wherein the field intensity of the pulse electromagnetic field is controlled to be 15-20 kv/cm, and the frequency is 10-20 Hz;
(3) filtering the blumea riparia extract treated in the step (2), combining the filtrates, concentrating the filtrate to a thick paste with the relative density of 1.36-1.38 at the temperature of 60 ℃, adding a filling agent and a proper amount of flavoring agent according to the prescription amount, uniformly mixing, granulating, drying and sieving to obtain the blumea riparia extract;
the mixed solvent is composed of purified water and acetic acid in a volume ratio of 1: 0.08-0.1;
the material-liquid ratio of the material A to the mixed solvent is 1: 20-35 g/mL.
2. The fuxuekang granules of claim 1, wherein the filler is a-lactose and microcrystalline cellulose in a weight ratio of 1: 4.25.
3. The fuxuekang granules of claim 1, wherein the flavoring agent is sucrose, xylitol, sorbitol, maltitol or mannitol.
4. The Fuxuekang granule according to claim 1, wherein the zinc sulfate is added in an amount of 0.1-0.4% w/w based on the weight of the material A.
CN201810263553.4A 2018-03-27 2018-03-27 Fuxuekang granule and its preparation process Active CN108272847B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201810263553.4A CN108272847B (en) 2018-03-27 2018-03-27 Fuxuekang granule and its preparation process

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201810263553.4A CN108272847B (en) 2018-03-27 2018-03-27 Fuxuekang granule and its preparation process

Publications (2)

Publication Number Publication Date
CN108272847A CN108272847A (en) 2018-07-13
CN108272847B true CN108272847B (en) 2020-12-18

Family

ID=62810748

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201810263553.4A Active CN108272847B (en) 2018-03-27 2018-03-27 Fuxuekang granule and its preparation process

Country Status (1)

Country Link
CN (1) CN108272847B (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CN116135218B (en) * 2023-04-20 2023-07-04 北京东升制药有限公司 Eight-ingredient dysmenorrhea granule and preparation method thereof

Family Cites Families (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

Also Published As

Publication number Publication date
CN108272847A (en) 2018-07-13

Similar Documents

Publication Publication Date Title
CN101429254B (en) Bletilla striata polysaccharide, preparation method and new uses thereof
CN108186690A (en) A kind of Chinese medicine processing method
CN108272847B (en) Fuxuekang granule and its preparation process
CN1813782B (en) Composition of ginkgo leaf extract and dipyridamole, medicine containing same and preparing method thereof
CN1965836A (en) Oral solid formulation and its preparation method
CN109805147A (en) A kind of red medlar polysaccharide chewable tablet and its preparation process
WO2018099493A1 (en) Tropaeolum majus granules and preparation method therefor
CN111991358A (en) Pseudo-ginseng powder formula particle and preparation method thereof
CN115300470B (en) Spica Prunellae tablet and preparation method thereof
CN108553485B (en) Preparation method of deer blood tablets
CN110801499A (en) Health food for dispelling effects of alcohol and protecting liver and preparation method thereof
CN100556426C (en) Anti-bone regeneration preparation and the method for making and the detection method of treatment orthopaedic disease
CN111920916B (en) Preparation method of children's favorite effervescent tablets
CN109771631B (en) Agastache rugosus, ginger and jujube composition and preparation method thereof
CN110179035B (en) Composition for warming middle-jiao and dispelling cold and preparation method thereof
CN114014951A (en) Production process of alcohol-free instant pectin
CN112656866A (en) Peach red four-ingredient particle and preparation method thereof
CN101095538A (en) Waxberry beverage particles and preparing process thereof
CN111110642A (en) Anoectochilus roxburghii polysaccharide dispersible tablet and preparation method thereof
CN114366770A (en) Preparation method of Qiqing Baidu granules
CN110881657A (en) Composition with function of dispelling effects of alcohol and preparation method and application thereof
CN115645490B (en) Tablet for pharyngitis and preparation method thereof
CN109965049A (en) A kind of preparation method of the separation and Extraction effective component from green tea
CN111658723B (en) Anti-inflammatory diuretic capsule and preparation method thereof
CN110583947B (en) Method for preparing dogwood solid beverage and prepared solid beverage

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
CB02 Change of applicant information
CB02 Change of applicant information

Address after: 526200 Fengshan Road, Dongcheng District, Sihui City, Guangdong, Zhaoqing

Applicant after: Yili Pharmaceutical Co.,Ltd.

Applicant after: Yili Pharmaceutical (Nanning) Co., Ltd

Address before: 526200 Fengshan Road, Dongcheng District, Sihui City, Guangdong, Zhaoqing

Applicant before: GUANGDONG YILI GROUP PHARMACEUTICAL Co.,Ltd.

Applicant before: GUANGXI YILI GUIXI PHARMACEUTICAL Co.,Ltd.

GR01 Patent grant
GR01 Patent grant