CN104383251A - Koji capsule and preparation method thereof - Google Patents

Koji capsule and preparation method thereof Download PDF

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Publication number
CN104383251A
CN104383251A CN201410703481.2A CN201410703481A CN104383251A CN 104383251 A CN104383251 A CN 104383251A CN 201410703481 A CN201410703481 A CN 201410703481A CN 104383251 A CN104383251 A CN 104383251A
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radix
carbon dioxide
capsule
heart
ground
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不公告发明人
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Heilongjiang Jiangheng Pharmaceutical Co Ltd
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Heilongjiang Jiangheng Pharmaceutical Co Ltd
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Priority to CN201410703481.2A priority Critical patent/CN104383251A/en
Publication of CN104383251A publication Critical patent/CN104383251A/en
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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)
    • 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)
    • A61K36/25Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258Panax (ginseng)
    • 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
    • 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)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/734Crataegus (hawthorn)
    • 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)
    • A61K36/78Saururaceae (Lizard's-tail family)
    • 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)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8968Ophiopogon (Lilyturf)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • 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
    • A61K2236/37Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
    • 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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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a koji capsule and a preparation method thereof. The preparation method of the koji capsule is characterized by taking 80g of houttuynia cordata, 27g of benzoin, 150g of pseudo-ginseng, 80g of ginseng, 80g of radix ophiopogonis, 120g of salviae miltiorrhizae and 230g of hawthorn, extracting by adopting a carbon dioxide supercritical extraction method, carrying out reduced pressure drying, smashing to nano dry paste by adopting a high-energy nano impact mill, adding a functional auxiliary material, and preparing the koji capsule. The preparation method of the koji capsule has the advantages that disintegration time is obviously shortened, curative effect is obvious better than that of commercially available koji capsules, and a positive effect is obtained.

Description

A kind of Kang Er heart-soothing capsule and preparation method thereof
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of Kang Er heart-soothing capsule and preparation method thereof.
Background technology
Kang Er heart-soothing capsule benefiting QI for activating blood circulation, enriching yin and nourishing kidney, increase coronary flow, blood fat reducing.Be used for the treatment of coronary heart disease, angina pectoris, the diseases such as sensation of oppression over the chest with shortness of breath.Commercially available Kang Er heart-soothing capsule is due to prescription and technological reason, and curative effect is not satisfactory, and preparation adopts traditional handicraft preparation, there is the deficiencies such as prolonged disintegration, curative effect are low.
Summary of the invention
The present invention, for overcoming above-mentioned deficiency, provides Kang Er heart-soothing capsule that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Herba Houttuyniae 80g, Benzoinum 27g, Radix Notoginseng 150g, Radix Ginseng 80g, Radix Ophiopogonis 80g, Radix Salviae Miltiorrhizae 120g, Fructus Crataegi 230g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 30 ~ 40Mpa, extraction temperature 30 ~ 40 DEG C, separator pressure 10 ~ 20Mpa, separator temperature 50 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 40 ~ 50L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add aspartame 150 ~ 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 45 ~ 55g, crospolyvinylpyrrolidone 45 ~ 55g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, granulate, incapsulates, obtained Kang Er heart-soothing capsule 1000.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
Herba Houttuyniae: China's coastal port one ministerial standard.This product is the fresh herb of saururaceae plant houttuynia cordata Houttuynia cordata Thunb. or dry aerial parts, fresh goods all can be tapped the whole year; Tap when the luxuriant spica of dry product stem and leaf in summer is many, removing impurity, dries.
Benzoinum: China's coastal port one ministerial standard.This product is Styracaceae plant styrax tonkinensis Craib ex Hart Styrax tonkinensis(Pierre) dry resin of Craib ex Hart..Trunk, through naturally damaging or isolating trunk in summer, Qiu Erji, is collected the resin flowed out, is dried in the shade.
Radix Notoginseng: China's coastal port one ministerial standard.This product is the dry root and rhizome of panax araliaceae plant Punax notoginseng (Burk.) F.H.Chen.Autumn excavates before the flowers are in blossom, cleans, and separately main root, a root and rhizome, dry.Supporting root is practised and is claimed " rib ", and rhizome is practised and claimed " clip ".
Radix Ginseng: China's coastal port one ministerial standard.This product is the dry root and rhizome of Araliaceae Radix Ginseng Panax ginseng C.A.Mey..Excavate more than autumn, clean through drying or drying.Cultivation also known as " Park Ginseng "; Sowing under mountain forest wild state self-sow also known as " Panax Ginseng ", practise and claim " seed sea ".
Radix Ophiopogonis: China's coastal port one ministerial standard.This product is liliaceous plant Ophiopogon Radix Ophiopogonis japonicus(Thunb.) dried root of Ker-Gawl..Summer excavates, and cleans, is repeatedly exposed to the sun, banks up. and to very likely in, removing fibrous root, dry.
Radix Salviae Miltiorrhizae: China's coastal port one ministerial standard.This product is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae Salvia miltiorrhiza Bge..Spring, Qiu Erji excavate, removing silt, dry.
Fructus Crataegi: China's coastal port one ministerial standard.This product is the dry mature fruit of rosaceous plant Fructus Pyri Pashiae Crataegus Pinnatifida Bge. var.major. N.E.Br. or crataegus pin natifida var. Major Crataegus pinnatifida Bge..Gather during fruit maturation in autumn.Section, dry.
Aspartame: Chinese Pharmacopoeia version two ministerial standard in 2010.
Microcrystalline Cellulose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Crospolyvinylpyrrolidone: Chinese Pharmacopoeia version two ministerial standard in 2010.
Cross-linking sodium carboxymethyl cellulose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Carboxymethyl starch sodium: Chinese Pharmacopoeia version two ministerial standard in 2010.
Magnesium stearate: Chinese Pharmacopoeia version two ministerial standard in 2010.
Raw material used by above Kang Er heart-soothing capsule all can be bought from pharmaceuticals and obtain, and all can be used to implement the present invention program as long as meet national standard.
In foregoing invention scheme, term used is pharmacy proprietary term, as " decompression " etc. all defers to Chinese Pharmacopoeia regulation and pharmaceutical practice of being correlated with.
Unit g in the present invention also can be other weight portion, does not affect the enforcement of the present invention program.
Equipment Market described in the present invention program all has sale, is not limited to typical production producer, as long as technical specification can reach requirement, all can be used to realize the present invention.
 
Four detailed description of the invention
Specific embodiments of the invention 1
Get Herba Houttuyniae 80g, Benzoinum 27g, Radix Notoginseng 150g, Radix Ginseng 80g, Radix Ophiopogonis 80g, Radix Salviae Miltiorrhizae 120g, Fructus Crataegi 230g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 30Mpa, extraction temperature 30 DEG C, separator pressure 10Mpa, separator temperature 50 DEG C, disengaging time 2 hours, carbon dioxide flow 40L per hour, obtains extracting solution; Get extracting solution 60 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add aspartame 150g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 45g, crospolyvinylpyrrolidone 45g, cross-linking sodium carboxymethyl cellulose 35g, mix homogeneously, with 50% ethanol wet granulation, 60 DEG C of dryings, additional carboxymethyl starch sodium 7g, magnesium stearate 1g, granulate, incapsulates, obtained Kang Er heart-soothing capsule 1000.
Specific embodiments of the invention 2
Get Herba Houttuyniae 80g, Benzoinum 27g, Radix Notoginseng 150g, Radix Ginseng 80g, Radix Ophiopogonis 80g, Radix Salviae Miltiorrhizae 120g, Fructus Crataegi 230g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 40Mpa, extraction temperature 40 DEG C, separator pressure 20Mpa, separator temperature 60 DEG C, disengaging time 4 hours, carbon dioxide flow 50L per hour, obtains extracting solution; Get extracting solution 80 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add aspartame 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 55g, crospolyvinylpyrrolidone 55g, cross-linking sodium carboxymethyl cellulose 45g, mix homogeneously, with 70% ethanol wet granulation, 80 DEG C of dryings, additional carboxymethyl starch sodium 9g, magnesium stearate 3g, granulate, incapsulates, obtained Kang Er heart-soothing capsule 1000.
Specific embodiments of the invention 3
Get Herba Houttuyniae 80g, Benzoinum 27g, Radix Notoginseng 150g, Radix Ginseng 80g, Radix Ophiopogonis 80g, Radix Salviae Miltiorrhizae 120g, Fructus Crataegi 230g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 35Mpa, extraction temperature 35 DEG C, separator pressure 15Mpa, separator temperature 55 DEG C, disengaging time 3 hours, carbon dioxide flow 45L per hour, obtains extracting solution; Get extracting solution 70 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add aspartame 175g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 50g, crospolyvinylpyrrolidone 50g, cross-linking sodium carboxymethyl cellulose 40g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional carboxymethyl starch sodium 8g, magnesium stearate 2g, granulate, incapsulates, obtained Kang Er heart-soothing capsule 1000.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make Kang Er heart-soothing capsule.Actual effect of the present invention is investigated below with the Kang Er heart-soothing capsule that embodiment 3 is obtained:
(1) embodiment 3 Kang Er heart-soothing capsule and contrast disintegration of commercially available Kang Er heart-soothing capsule
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
Table 1 embodiment 3 Kang Er heart-soothing capsule and commercially available Kang Er heart-soothing capsule contrast table disintegration
The above results shows, Kang Er heart-soothing capsule prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available Kang Er heart-soothing capsule.
(2) embodiment 3 Kang Er heart-soothing capsule and commercially available Kang Er heart-soothing capsule treatment coronary heart disease, angina pectoris, sensation of oppression over the chest with shortness of breath Disease Clinical observation of curative effect
1 case scenario
Statistics outpatient service and inpatient, observe coronary heart disease, angina pectoris altogether, sensation of oppression over the chest with shortness of breath disease case 138 example, 59 years old mean age.Patient is divided into two groups, test group takes embodiment 3 Kang Er heart-soothing capsule, and matched group takes commercially available Kang Er heart-soothing capsule.
2 efficacy assessment standards
According to new Chinese medicine treatment angina pectoris guideline of clinical investigations tcm syndrome curative effect determinate standard:
Effective: tcm clinical practice symptom, sign are obviously improved, syndrome integral reduces >=70%.
Effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integral reduces >=30%.
Invalid: tcm clinical practice symptom, sign are all not improved or increase the weight of, syndrome integral reduces < 30%.
Increase the weight of: tcm clinical practice symptom, sign all have and increase the weight of, syndrome integral reduces < 0.
Computing formula: [before (before treatment the rear integration of integration-treatment) ÷ treatment integration] × 100%.
3 clinical observation result
Table 2 embodiment 3 Kang Er heart-soothing capsule and commercially available Kang Er heart-soothing capsule clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, Kang Er heart-soothing capsule prepared by the present invention is treating coronary heart disease, angina pectoris, during sensation of oppression over the chest with shortness of breath disease, evident in efficacy higher than commercially available Kang Er heart-soothing capsule, p < 0.05.

Claims (3)

1. treat a coronary heart disease, angina pectoris, the Chinese medicine of sensation of oppression over the chest with shortness of breath, is characterized in that getting Herba Houttuyniae 80g, Benzoinum 27g, Radix Notoginseng 150g, Radix Ginseng 80g, Radix Ophiopogonis 80g, Radix Salviae Miltiorrhizae 120g, Fructus Crataegi 230g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 30 ~ 40Mpa, extraction temperature 30 ~ 40 DEG C, separator pressure 10 ~ 20Mpa, separator temperature 50 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 40 ~ 50L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add aspartame 150 ~ 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 45 ~ 55g, crospolyvinylpyrrolidone 45 ~ 55g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, granulate, incapsulates, obtained Kang Er heart-soothing capsule.
2. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Herba Houttuyniae 80g, Benzoinum 27g, Radix Notoginseng 150g, Radix Ginseng 80g, Radix Ophiopogonis 80g, Radix Salviae Miltiorrhizae 120g, Fructus Crataegi 230g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 30 ~ 40Mpa, extraction temperature 30 ~ 40 DEG C, separator pressure 10 ~ 20Mpa, separator temperature 50 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 40 ~ 50L per hour, obtains extracting solution; Get extracting solution 60 DEG C ~ 80 DEG C drying under reduced pressure, get dry extract; Get dry cream and add aspartame 150 ~ 200g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 45 ~ 55g, crospolyvinylpyrrolidone 45 ~ 55g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional carboxymethyl starch sodium 7 ~ 9g, magnesium stearate 1 ~ 3g, granulate, incapsulates, obtained Kang Er heart-soothing capsule.
3. the preparation method of Chinese medicine according to claim 1, gets Herba Houttuyniae 80g, Benzoinum 27g, Radix Notoginseng 150g, Radix Ginseng 80g, Radix Ophiopogonis 80g, Radix Salviae Miltiorrhizae 120g, Fructus Crataegi 230g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 35Mpa, extraction temperature 35 DEG C, separator pressure 15Mpa, separator temperature 55 DEG C, disengaging time 3 hours, carbon dioxide flow 45L per hour, obtains extracting solution; Get extracting solution 70 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add aspartame 175g, adopt the impact grinding of high energy nanometer to be ground into the mixing dried cream powder of particle diameter 200 ~ 300nm; Get mixing dried cream powder, microcrystalline Cellulose 50g, crospolyvinylpyrrolidone 50g, cross-linking sodium carboxymethyl cellulose 40g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional carboxymethyl starch sodium 8g, magnesium stearate 2g, granulate, incapsulates, obtained Kang Er heart-soothing capsule.
CN201410703481.2A 2014-11-30 2014-11-30 Koji capsule and preparation method thereof Withdrawn CN104383251A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105311281A (en) * 2015-11-20 2016-02-10 王立鑫 Health maintenance honeyed bolus for relieving dyspnea chest discomfort

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105311281A (en) * 2015-11-20 2016-02-10 王立鑫 Health maintenance honeyed bolus for relieving dyspnea chest discomfort

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