CN105380993A - Yindanxintai dispersible tablet and preparation method thereof - Google Patents

Yindanxintai dispersible tablet and preparation method thereof Download PDF

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Publication number
CN105380993A
CN105380993A CN201510798951.2A CN201510798951A CN105380993A CN 105380993 A CN105380993 A CN 105380993A CN 201510798951 A CN201510798951 A CN 201510798951A CN 105380993 A CN105380993 A CN 105380993A
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extract
chinese medicine
disintegrating agent
salvia miltiorrhiza
folium ginkgo
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马玉国
张昕
任萃文
江延辉
马凌风
王海涛
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Harbin Shengji Pharmaceutical Co Ltd
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Harbin Shengji 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
    • A61K36/16Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • 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)
    • A61K36/42Cucurbitaceae (Cucumber family)
    • A61K36/424Gynostemma
    • 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)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537Salvia (sage)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • 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
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • 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
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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Abstract

The invention provides a Yindanxintai dispersible tablet and a preparation method thereof. The Yindanxintai dispersible tablet is prepared from raw materials and auxiliary materials in percent by weight, wherein the raw materials include 10-50% of traditional Chinese medicine extracts; the auxiliary materials include 10-70% of filling agents, 5-40% of internally-added disintegrating agents, 5-10% of externally-added disintegrating agents, 0.1-10% of flavoring agents, 0.05-1% of lubricating agents, 0.5-15% of flow aids and a right amount of wetting agents; and the traditional Chinese medicine extracts include the following raw materials in parts by weight: 30-40 parts of ginkgo leaf, 40-50 parts of salvia yunnanensis, 20-30 parts of gynostemma pentaphylla and 3-5 parts of natural borneol. The preparation method comprises the following steps: 1, raw material pretreatment; 2, extraction; and 3, preparation. The Yindanxintai dispersible tablet has the effects of promoting blood circulation to remove blood stasis as well as promoting coronary circulation and relieving pain and is good in solubility and dispersibility, high in dissolution rate, high in effect taking speed, good in bioavailability, fast in body distribution, stable in quality, good in taste and convenient to take.

Description

Safe dispersible tablet of a kind of lunar caustic heart and preparation method thereof
Technical field
the present invention relates to pharmaceutical field, particularly relate to safe dispersible tablet of a kind of lunar caustic heart and preparation method thereof.
Background technology
because coronary atherosclerosis causes myocardial ischemia, anoxia and the heart disease caused is called coronary heart disease.Because of coronary insufficiency in coronary heart disease, cardiac muscle temporary transient ischemia sharply and the clinical syndrome caused by anoxia are called angina pectoris.This disease belongs to the traditional Chinese medical science " precordial pain with cold limbs ", " obstruction of qi in the chest and cardialgia " category.
angina pectoris (obstruction of qi in the chest and cardialgia) is the commonly encountered diseases of serious harm people ' s health.In the last few years, coronary heart disease, malignant tumor, cerebrovascular were considered to the large cause of death of the mankind three.The traditional Chinese medical science thinks that the pathogenic characteristic of obstruction of qi in the chest and cardialgia should belong to deficiency in origin and excess in superficiality, and void is the deficiency of vital energy, yang deficiency, deficiency of both QI and YIN then; Actually turbid, the cold coagulation of the stagnation of QI, blood stasis, expectorant.
ischemia resisting is treated, and conventional Western medicine medicine has: 1. nitrate esters: nitroglycerin, single nitro Soquad etc.2. beta-blocker: metoprolol, bisoprolol etc.3. calcium ion antagonist: Nifedipine sustained-release/controlled release tablet, amlodipine etc.4. morphine sulfate: with mitigation symptoms, ensures patient comfort.
modern pharmacological research shows, Chinese medicine has pharmacodynamics effect widely, as antiplatelet sticks gathering, inhibition thrombosis, blood vessel dilating, improves vascular endothelial function, regulates inflammatory reaction, promotes heart muscle capillary regeneration and increase myocardial tissue perfusion etc., many pathology links of angina pectoris can be acted on.
Summary of the invention
the object of this invention is to provide one and effectively can treat coronary heart disease, there is blood circulation promoting and blood stasis dispelling, safe dispersible tablet of the lunar caustic heart of coronary circulation-promoting pain-relieving and preparation method thereof.
object of the present invention is achieved through the following technical solutions:
the safe dispersible tablet of a kind of lunar caustic heart, by weight percentage, it is formed by following raw materials according and auxiliaries, and raw material is:
chinese medicine extract 10-50%;
adjuvant is:
filler 10-70%
inside with disintegrating agent 5-40%
additional disintegrating agent 5-10%
correctives 0.1-10%
lubricant 0.05-1%
fluidizer 0.5-15%
wetting agent is appropriate;
in described Chinese medicine extract, raw materials by weight portion, Folium Ginkgo 30-40 part, Salvia miltiorrhiza Bge 40-50 part, Herb Gynostemmae Pentaphylli 20-30 part, natural Broneolum Syntheticum 3-5 part.
the safe dispersible tablet of described a kind of lunar caustic heart, by weight percentage, it is formed by following raw materials according and auxiliaries, and raw material is:
chinese medicine extract 30-40%;
adjuvant is:
filler 30-50%
inside with disintegrating agent 10-20%
additional disintegrating agent 7-9%
correctives 3-5%
lubricant 0.1-0.5%
fluidizer 0.5-2%
wetting agent is appropriate;
in described Chinese medicine extract, raw materials by weight portion, Folium Ginkgo 33-37 part, Salvia miltiorrhiza Bge 44-46 part, Herb Gynostemmae Pentaphylli 24-36 part, natural Broneolum Syntheticum 4-5 part.
the safe dispersible tablet of described a kind of lunar caustic heart, by weight percentage, it is formed by following raw materials according and auxiliaries, and raw material is:
chinese medicine extract 30%;
adjuvant is:
filler 43%
inside with disintegrating agent 15%
additional disintegrating agent 8%
correctives 3.4%
lubricant 0.1%
fluidizer 0.5%
wetting agent is appropriate;
in described Chinese medicine extract, raw materials by weight portion, Folium Ginkgo 35 parts, Salvia miltiorrhiza Bge 45 parts, Herb Gynostemmae Pentaphylli 25 parts, natural Broneolum Syntheticum 5 parts.
described filler is the mixing of one or more in pregelatinized Starch, mannitol, microcrystalline Cellulose, sucrose, lactose, sodium chloride, calcium sulfate;
with the mixing of one or more that disintegrating agent or additional disintegrating agent are in low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone in described;
described correctives is the mixing of one or more in aspartame, steviosin, citric acid, flavoring orange essence, orange flavor, flavoring pineapple essence;
described lubricant is one or both the mixing in magnesium stearate, sodium lauryl sulphate; Described fluidizer is silicon dioxide;
described wetting agent is one or both the mixing in water, alcoholic solution.
the safe dispersible tablet of described a kind of lunar caustic heart, its preparation method comprises the following steps:
step 1, pretreatment of raw material: by weight, choose the Folium Ginkgo of high-quality, Salvia miltiorrhiza Bge, Herb Gynostemmae Pentaphylli, cleans and remove impurity;
step 2, extraction:
a, get Folium Ginkgo, Salvia miltiorrhiza Bge, Herb Gynostemmae Pentaphylli;
b, Folium Ginkgo are with 70% alcohol reflux secondary, and each 2 hours, filter, filtrate recycling ethanol, when being concentrated into 20 DEG C, relative density was the clear paste of 1.20 ~ 1.25, and spraying dry, obtains dried powder;
c, Salvia miltiorrhiza Bge decoct with water three times, 3 hours first times, second time 2 hours, 1 hour third time, filter, merging filtrate, when being concentrated into 40 DEG C, relative density is 1.2, adds ethanol and makes alcohol content reach 75%, stirring makes precipitation, get supernatant and reclaim ethanol, when being concentrated into 20 DEG C, relative density is the clear paste of 1.20 ~ 1.25, spraying dry, obtains dried powder;
d, Herb Gynostemmae Pentaphylli are with 75% alcohol reflux secondary, and each 2 hours, filter, filtrate recycling ethanol, when being concentrated into 20 DEG C, relative density was the clear paste of 1.20 ~ 1.25, and spraying dry, obtains dried powder, obtains extract powder;
e, obtained Chinese medicine extract: Folium Ginkgo extract, Salvia miltiorrhiza Bge extract, Herb Gynostemmae Pentaphylli extract, for subsequent use;
step 3, preparation
a, by weight percentage, choose raw material and the adjuvant of high-quality: Chinese medicine extract, filler, in disintegrating agent, additional disintegrating agent, correctives, lubricant, fluidizer, wetting agent, for subsequent use;
b, the Folium Ginkgo extract by Chinese medicine extract, Salvia miltiorrhiza Bge extract, Herb Gynostemmae Pentaphylli extract pulverized 80 mesh sieves, and 80 mesh sieves pulverized by Borneolum Syntheticum, and 80 mesh sieves crossed by other adjuvants, for subsequent use;
c, by the correctives beyond Folium Ginkgo extract, Salvia miltiorrhiza Bge extract, Herb Gynostemmae Pentaphylli extract, 2/3 Borneolum Syntheticum powder, filler, essence, in disintegrating agent be placed in three-dimensional motion mixer mixing 45 minutes;
d, the material mixed is put in fluidised bed granulator, spray into wetting agent, adopt fluidized bed granulation technology to granulate, dry, setup parameter: air inducing frequency 30-50Hz, feed flow frequency 25-80Hz, atomizing pressure 0.18-0.2HZ, inlet temperature 45-80 DEG C;
e, granulate adopt oscillating granulator granulate, and sieve number is 18 orders;
after f, granulate, add additional disintegrating agent, 1/3 Borneolum Syntheticum powder, lubricant, fluidizer and essence and put three-dimensional motion mixer and mix 30 minutes;
g, employing rotary tablet press, Hardness Control is at 5-9kg/cm 2 between, dispersing uniformity disperseed in 1.5-2.5 minute, tabletting speed controlling 15-30r/min.
in medicine, Folium Ginkgo, has blood circulation promoting and blood stasis dispelling, and removing obstruction in the collateral to relieve pain is astringed the lung and relievingd asthma, and changes effect of turbid blood fat reducing, for obstruction of collaterals by blood stasis, obstruction of qi in the chest and cardialgia, apoplectic hemiplegia, cough and asthma due to lung deficiency, hyperlipemia, Salvia miltiorrhiza Bge, blood circulation promoting and blood stasis dispelling, cooling blood for hemostasis, tranquilizing by nourishing the heart, removing toxic substances and promoting subsidence of swelling, main menoxenia, dysmenorrhea, amenorrhea, lochia is suffered from abdominal pain, thoracic obstruction angor, arthralgia, colic, metrorrhagia, spits blood, epistaxis, hemoptysis, numbness of extremities due to deficiency of blood, insomnia, forgetful, palpitation with fear, palpitation with a distress feeling, acute mastitis, skin ulcer swells, Herb Gynostemmae Pentaphylli, replenishing QI to invigorate the spleen, preventing phlegm from forming and stopping coughing, heat-clearing and toxic substances removing; Cure mainly: body void is weak, nephrasthenia emission, leukopenia, hyperlipemia, viral hepatitis, chronic gastroenteritis, chronic tracheitis; Borneolum Syntheticum, delicate fragrance a surname is loose, has refreshment of having one's ideas straightened out, and the loose poison of heat clearing away, effect of improving acuity of vision and removing nebula, cures mainly calentura unconsciousness due to high fever, apoplexy syncope due to accumulation of phlegm infantile convulsion, and heat-damp in summer hoodwinks key clearly, and sore throat is deaf, and aphtha tooth swells, carbuncle sore infantile malnutrition hemorrhoid, conjunctival congestion and swelling pain, pterygium.
beneficial effect of the present invention: the safe dispersible tablet of a kind of lunar caustic heart of the present invention, have blood circulation promoting and blood stasis dispelling, effect of coronary circulation-promoting pain-relieving, for the thoracic obstruction that blood stasis impatency causes, disease is seen uncomfortable in chest, chest pain, cardiopalmus; Coronary heart disease, angina pectoris belongs to above-mentioned patient; Its dissolubility, favorable dispersibility, dissolution is high, rapid-action, bioavailability is good, and distribution in vivo is rapid, steady quality, mouthfeel is good, taking convenience, can swallow, chew, containing sucking or taking with after aqueous dispersion, be more suitable for old man and the patient of difficulty of swallowing, there is medicine stability good, packaging, transport, the advantages such as storage is convenient, its preparation method is simple, is applicable to commercial production.
the present invention is through two groups of clinical verifications, wherein one group is treatment group, edible the present invention, eat the present invention every day once, it within 7 days, is a course for the treatment of, another group matched group takes blood circulation and channel invigorating ball, taking every day once, 7 days is a course for the treatment of, every group selection outpatient 120 example, wherein male 60 example, women 60 example, max age 70 years old, minimal ages 25 years old, clinical manifestation is sclerosis of blood vessels, yellow tuberosity, hypertension, angina pectoris, weak, shortness of breath and palpitation, feel run-down, and table one is for taking the contrasting data after the course for the treatment of:
table 1 is taken front and back and is compared (unit: people) two groups of courses for the treatment of
the effective percentage for the treatment of group and matched group has notable difference, is not difficult to find out the significant curative effect in clinical practice of the present invention.
Detailed description of the invention
embodiment 1
the safe dispersible tablet of a kind of lunar caustic heart, by weight percentage, it is formed by following raw materials according and auxiliaries, and raw material is:
chinese medicine extract 10-50%;
adjuvant is:
filler 10-70%
inside with disintegrating agent 5-40%
additional disintegrating agent 5-10%
correctives 0.1-10%
lubricant 0.05-1%
fluidizer 0.5-15%
wetting agent is appropriate;
in described Chinese medicine extract, raw materials by weight portion, Folium Ginkgo 30-40 part, Salvia miltiorrhiza Bge 40-50 part, Herb Gynostemmae Pentaphylli 20-30 part, natural Broneolum Syntheticum 3-5 part.
embodiment 2
the safe dispersible tablet of a kind of lunar caustic heart, by weight percentage, it is formed by following raw materials according and auxiliaries, and raw material is:
chinese medicine extract 30-40%;
adjuvant is:
filler 30-50%
inside with disintegrating agent 10-20%
additional disintegrating agent 7-9%
correctives 3-5%
lubricant 0.1-0.5%
fluidizer 0.5-2%
wetting agent is appropriate;
in described Chinese medicine extract, raw materials by weight portion, Folium Ginkgo 33-37 part, Salvia miltiorrhiza Bge 44-46 part, Herb Gynostemmae Pentaphylli 24-36 part, natural Broneolum Syntheticum 4-5 part.
embodiment 3
the safe dispersible tablet of a kind of lunar caustic heart, by weight percentage, it is formed by following raw materials according and auxiliaries, and raw material is:
chinese medicine extract 30%;
adjuvant is:
filler 43%
inside with disintegrating agent 15%
additional disintegrating agent 8%
correctives 3.4%
lubricant 0.1%
fluidizer 0.5%
wetting agent is appropriate;
in described Chinese medicine extract, raw materials by weight portion, Folium Ginkgo 35 parts, Salvia miltiorrhiza Bge 45 parts, Herb Gynostemmae Pentaphylli 25 parts, natural Broneolum Syntheticum 5 parts.
embodiment 4
described filler is the mixing of one or more in pregelatinized Starch, mannitol, microcrystalline Cellulose, sucrose, lactose, sodium chloride, calcium sulfate;
embodiment 5
with the mixing of one or more that disintegrating agent or additional disintegrating agent are in low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone in described;
embodiment 6
described correctives is the mixing of one or more in aspartame, steviosin, citric acid, flavoring orange essence, orange flavor, flavoring pineapple essence;
embodiment 7
described lubricant is one or both the mixing in magnesium stearate, sodium lauryl sulphate; Described fluidizer is silicon dioxide;
embodiment 8
described wetting agent is one or both the mixing in water, alcoholic solution.
embodiment 9
the safe dispersible tablet of described a kind of lunar caustic heart, its preparation method comprises the following steps:
step 1, pretreatment of raw material: by weight, choose the Folium Ginkgo of high-quality, Salvia miltiorrhiza Bge, Herb Gynostemmae Pentaphylli, natural Broneolum Syntheticum, cleans and remove impurity;
step 2, extraction:
a, get Folium Ginkgo, Salvia miltiorrhiza Bge, Herb Gynostemmae Pentaphylli;
b, Folium Ginkgo are with 70% alcohol reflux secondary, and each 2 hours, filter, filtrate recycling ethanol, when being concentrated into 20 DEG C, relative density was the clear paste of 1.20 ~ 1.25, and spraying dry, obtains dried powder;
c, Salvia miltiorrhiza Bge decoct with water three times, 3 hours first times, second time 2 hours, 1 hour third time, filter, merging filtrate, when being concentrated into 40 DEG C, relative density is 1.2, adds ethanol and makes alcohol content reach 75%, stirring makes precipitation, get supernatant and reclaim ethanol, when being concentrated into 20 DEG C, relative density is the clear paste of 1.20 ~ 1.25, spraying dry, obtains dried powder;
d, Herb Gynostemmae Pentaphylli are with 75% alcohol reflux secondary, and each 2 hours, filter, filtrate recycling ethanol, when being concentrated into 20 DEG C, relative density was the clear paste of 1.20 ~ 1.25, and spraying dry, obtains dried powder, obtains extract powder;
e, obtained Chinese medicine extract: Folium Ginkgo extract, Salvia miltiorrhiza Bge extract, Herb Gynostemmae Pentaphylli extract, for subsequent use;
step 3, preparation
a, by weight percentage, choose raw material and the adjuvant of high-quality: Chinese medicine extract, filler, in disintegrating agent, additional disintegrating agent, correctives, lubricant, fluidizer, wetting agent, for subsequent use;
b, the Folium Ginkgo extract by Chinese medicine extract, Salvia miltiorrhiza Bge extract, Herb Gynostemmae Pentaphylli extract pulverized 80 mesh sieves, and 80 mesh sieves pulverized by Borneolum Syntheticum, and 80 mesh sieves crossed by other adjuvants, for subsequent use;
c, by the correctives beyond Folium Ginkgo extract, Salvia miltiorrhiza Bge extract, Herb Gynostemmae Pentaphylli extract, 2/3 Borneolum Syntheticum powder, filler, essence, in disintegrating agent be placed in three-dimensional motion mixer mixing 45 minutes;
d, the material mixed is put in fluidised bed granulator, spray into wetting agent, adopt fluidized bed granulation technology to granulate, dry, setup parameter: air inducing frequency 30-50Hz, feed flow frequency 25-80Hz, atomizing pressure 0.18-0.2HZ, inlet temperature 45-80 DEG C;
e, granulate adopt oscillating granulator granulate, and sieve number is 18 orders;
after f, granulate, add additional disintegrating agent, 1/3 Borneolum Syntheticum powder, lubricant, fluidizer and essence and put three-dimensional motion mixer and mix 30 minutes;
g, employing rotary tablet press, Hardness Control is at 5-9kg/cm 2 between, dispersing uniformity disperseed in 1.5-2.5 minute, tabletting speed controlling 15-30r/min.

Claims (5)

1. the safe dispersible tablet of the lunar caustic heart, it is characterized in that: by weight percentage, it is formed by following raw materials according and auxiliaries, and raw material is:
Chinese medicine extract 10-50%;
Adjuvant is:
Filler 10-70%
Inside with disintegrating agent 5-40%
Additional disintegrating agent 5-10%
Correctives 0.1-10%
Lubricant 0.05-1%
Fluidizer 0.5-15%
Wetting agent is appropriate;
In described Chinese medicine extract, raw materials by weight portion, Folium Ginkgo 30-40 part, Salvia miltiorrhiza Bge 40-50 part, Herb Gynostemmae Pentaphylli 20-30 part, natural Broneolum Syntheticum 3-5 part.
2. the safe dispersible tablet of a kind of lunar caustic heart according to claim 1, it is characterized in that: by weight percentage, it is formed by following raw materials according and auxiliaries, and raw material is:
Chinese medicine extract 30-40%;
Adjuvant is:
Filler 30-50%
Inside with disintegrating agent 10-20%
Additional disintegrating agent 7-9%
Correctives 3-5%
Lubricant 0.1-0.5%
Fluidizer 0.5-2%
Wetting agent is appropriate;
In described Chinese medicine extract, raw materials by weight portion, Folium Ginkgo 33-37 part, Salvia miltiorrhiza Bge 44-46 part, Herb Gynostemmae Pentaphylli 24-36 part, natural Broneolum Syntheticum 4-5 part.
3. the safe dispersible tablet of a kind of lunar caustic heart according to claim 1, it is characterized in that: by weight percentage, it is formed by following raw materials according and auxiliaries, and raw material is:
Chinese medicine extract 30%;
Adjuvant is:
Filler 43%
Inside with disintegrating agent 15%
Additional disintegrating agent 8%
Correctives 3.4%
Lubricant 0.1%
Fluidizer 0.5%
Wetting agent is appropriate;
In described Chinese medicine extract, raw materials by weight portion, Folium Ginkgo 35 parts, Salvia miltiorrhiza Bge 45 parts, Herb Gynostemmae Pentaphylli 25 parts, natural Broneolum Syntheticum 5 parts.
4. the safe dispersible tablet of a kind of lunar caustic heart according to claim 1-3 any one, is characterized in that: described filler is the mixing of one or more in pregelatinized Starch, mannitol, microcrystalline Cellulose, sucrose, lactose, sodium chloride, calcium sulfate;
With the mixing of one or more that disintegrating agent or additional disintegrating agent are in low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone in described;
Described correctives is the mixing of one or more in aspartame, steviosin, citric acid, flavoring orange essence, orange flavor, flavoring pineapple essence;
Described lubricant is one or both the mixing in magnesium stearate, sodium lauryl sulphate; Described fluidizer is silicon dioxide;
Described wetting agent is one or both the mixing in water, alcoholic solution.
5. the safe dispersible tablet of a kind of lunar caustic heart according to claim 1-4 any one, is characterized in that: its preparation method comprises the following steps:
Step 1, pretreatment of raw material: by weight, choose the Folium Ginkgo of high-quality, Salvia miltiorrhiza Bge, Herb Gynostemmae Pentaphylli, natural Broneolum Syntheticum, cleans and remove impurity;
Step 2, extraction:
A, get Folium Ginkgo, Salvia miltiorrhiza Bge, Herb Gynostemmae Pentaphylli;
B, Folium Ginkgo are with 70% alcohol reflux secondary, and each 2 hours, filter, filtrate recycling ethanol, when being concentrated into 20 DEG C, relative density was the clear paste of 1.20 ~ 1.25, and spraying dry, obtains dried powder;
C, Salvia miltiorrhiza Bge decoct with water three times, 3 hours first times, second time 2 hours, 1 hour third time, filter, merging filtrate, when being concentrated into 40 DEG C, relative density is 1.2, adds ethanol and makes alcohol content reach 75%, stirring makes precipitation, get supernatant and reclaim ethanol, when being concentrated into 20 DEG C, relative density is the clear paste of 1.20 ~ 1.25, spraying dry, obtains dried powder;
D, Herb Gynostemmae Pentaphylli are with 75% alcohol reflux secondary, and each 2 hours, filter, filtrate recycling ethanol, when being concentrated into 20 DEG C, relative density was the clear paste of 1.20 ~ 1.25, and spraying dry, obtains dried powder, obtains extract powder;
E, obtained Chinese medicine extract: Folium Ginkgo extract, Salvia miltiorrhiza Bge extract, Herb Gynostemmae Pentaphylli extract, for subsequent use;
Step 3, preparation
A, by weight percentage, choose raw material and the adjuvant of high-quality: Chinese medicine extract, filler, in disintegrating agent, additional disintegrating agent, correctives, lubricant, fluidizer, wetting agent, for subsequent use;
B, the Folium Ginkgo extract by Chinese medicine extract, Salvia miltiorrhiza Bge extract, Herb Gynostemmae Pentaphylli extract pulverized 80 mesh sieves, and 80 mesh sieves pulverized by Borneolum Syntheticum, and 80 mesh sieves crossed by other adjuvants, for subsequent use;
C, by the correctives beyond Folium Ginkgo extract, Salvia miltiorrhiza Bge extract, Herb Gynostemmae Pentaphylli extract, 2/3 Borneolum Syntheticum powder, filler, essence, in disintegrating agent be placed in three-dimensional motion mixer mixing 45 minutes;
D, the material mixed is put in fluidised bed granulator, spray into wetting agent, adopt fluidized bed granulation technology to granulate, dry, setup parameter: air inducing frequency 30-50Hz, feed flow frequency 25-80Hz, atomizing pressure 0.18-0.2HZ, inlet temperature 45-80 DEG C;
E, granulate adopt oscillating granulator granulate, and sieve number is 18 orders;
After f, granulate, add additional disintegrating agent, 1/3 Borneolum Syntheticum powder, lubricant, fluidizer and essence and put three-dimensional motion mixer and mix 30 minutes;
G, employing rotary tablet press, Hardness Control is at 5-9kg/cm 2between, dispersing uniformity disperseed in 1.5-2.5 minute, tabletting speed controlling 15-30r/min.
CN201510798951.2A 2015-11-19 2015-11-19 Yindanxintai dispersible tablet and preparation method thereof Withdrawn CN105380993A (en)

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Cited By (3)

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CN105999046A (en) * 2016-07-27 2016-10-12 浙江省磐安县外贸药业有限公司 Oxazepan capsule and preparation method thereof
CN106421449A (en) * 2016-07-06 2017-02-22 南方医科大学 Bamboo leaf flavone-containing traditional Chinese medicine composition having anti-oxidation function, and applications thereof
CN115531335A (en) * 2022-11-02 2022-12-30 合肥医工医药股份有限公司 Oseltamivir phosphate oral disintegrating tablet and preparation method thereof

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CN104383129A (en) * 2014-11-26 2015-03-04 黑龙江省智诚医药科技有限公司 Dispersible tablets containing herba eupatorii chinansis, elephantopus scaber and European verbena and preparation method of dispersible tablets

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CN1626132A (en) * 2003-12-11 2005-06-15 天津天士力制药股份有限公司 Medication for treating obstruction of qi in the chest
CN104383129A (en) * 2014-11-26 2015-03-04 黑龙江省智诚医药科技有限公司 Dispersible tablets containing herba eupatorii chinansis, elephantopus scaber and European verbena and preparation method of dispersible tablets

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106421449A (en) * 2016-07-06 2017-02-22 南方医科大学 Bamboo leaf flavone-containing traditional Chinese medicine composition having anti-oxidation function, and applications thereof
CN105999046A (en) * 2016-07-27 2016-10-12 浙江省磐安县外贸药业有限公司 Oxazepan capsule and preparation method thereof
CN115531335A (en) * 2022-11-02 2022-12-30 合肥医工医药股份有限公司 Oseltamivir phosphate oral disintegrating tablet and preparation method thereof
CN115531335B (en) * 2022-11-02 2024-01-30 合肥医工医药股份有限公司 Oselta phosphate Wei Kou disintegrating tablet and preparation method thereof

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