CN105396050A - Ping xiao tablet (tablet for restraining cancer) and preparation method thereof - Google Patents

Ping xiao tablet (tablet for restraining cancer) and preparation method thereof Download PDF

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Publication number
CN105396050A
CN105396050A CN201510842248.7A CN201510842248A CN105396050A CN 105396050 A CN105396050 A CN 105396050A CN 201510842248 A CN201510842248 A CN 201510842248A CN 105396050 A CN105396050 A CN 105396050A
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tablet
carbon dioxide
ground
pressure
extracting solution
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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 CN201510842248.7A priority Critical patent/CN105396050A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • 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
    • 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)
    • A61K36/56Loganiaceae (Logania family), e.g. trumpetflower or pinkroot
    • 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
    • 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)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/752Citrus, e.g. lime, orange or lemon
    • 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)
    • A61K36/899Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A61K36/8994Coix (Job's tears)
    • 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)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9066Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • 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
    • A61K2236/37Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction

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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)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a ping xiao tablet (a tablet for restraining cancer) and a preparation method thereof. The ping xiao tablet and the preparation method are characterized in that 20g of great burdock achene, 29g of coix seed, 58g of turmeric root-tuber, 58g of hairyvein agrimonia herbs, 50g of alum, 90g of fructus aurantii and 30g of strychni semen are taken to be extracted through a carbon dioxide supercritical extraction method; pressure-reduction drying is performed; a high-energy nano impact mill is used for grinding the raw materials into nano dry paste, and functional accessories are added to be produced into the ping xiao tablet. The ping xiao tablet has the advantages that disintegration time is shortened remarkably, the curative effect is obviously better than that of a market ping xiao tablet, and a positive effect is achieved.

Description

A kind of PINGXIAO PIAN and preparation method thereof
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of PINGXIAO PIAN and preparation method thereof.
Background technology
PINGXIAO PIAN blood circulation promoting and blood stasis dispelling, pain relieving eliminating stagnation, heat-clearing and toxic substances removing, strengthening vital QI to eliminate pathogenic factors.For tying caused tumor patient in the malicious stasis of blood, the effect that there is relief of symptoms, reduce tumor body, improve immunity of organisms, extend the survival of patients time.Commercially available PINGXIAO PIAN 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 PINGXIAO PIAN that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Fructus Arctii 20g, Semen Coicis 29g, Radix Curcumae 58g, Herba Agrimoniae 58g, Alumen 50g, Fructus Aurantii 90g, Semen Strychni 30g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 23 ~ 44Mpa, extraction temperature 22 ~ 45 DEG C, separator pressure 12 ~ 19Mpa, separator temperature 44 ~ 52 DEG C, disengaging time 2.2 ~ 3.5 hours, carbon dioxide flow 26 ~ 38L per hour, obtains extracting solution; Get extracting solution 65 ~ 78 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 80 ~ 120g, 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 35 ~ 45g, hyprolose 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, aluminium-magnesium silicate 15 ~ 25g, sodium chloride 5 ~ 15g, mannitol 4 ~ 6g, maltodextrin 4 ~ 6g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional sodium alginate 7 ~ 9g, boric acid 1 ~ 3g, granulate, tabletting, obtained PINGXIAO PIAN 800.
The raw material standards that above-mentioned embodiment is mentioned is as follows:
Fructus Arctii: China's coastal port one ministerial standard.This product is the dry mature fruit of feverfew Fructus Arctii ArctiumlaPPaL..To gather during fruit maturation in autumn infructescence, dry, lay fruit, removing impurity dries again.
Semen Coicis: China's coastal port one ministerial standard.This product is grass Semen Coicis Coixlacryma-jobiL.var.ma-yuen(ROman.) dry mature kernal of Stapf.Tap plant during fruit maturation in autumn, dry, lay fruit, then dry, except decapsidate, yellowish-brown seed coat and impurity, collect kernel.
Radix Curcumae: China's coastal port one ministerial standard.This product is the dried root of zingiberaceous plant RADIX CURCUMAE CurcumawenyujinY.H.ChenetC.Ling, Rhizoma Curcumae Longae CurcumalongaL., Guangxi zedoary CurcumakwaugsienisS.G.LeeetC.F.Liang or Rhizoma Curcumae Curcumapha-eocaulisVal..The above two practise title " RADIX CURCUMAE " and " Radix Curcuma " respectively, and all the other are practised by character difference and claim " osmanthus Radix Curcumae " or " green filament Radix Curcumae ".Winter, stem and leaf was excavated after withering, and removing silt and radicula, steam or boil to the saturating heart, dry.
Herba Agrimoniae: China's coastal port one ministerial standard.This product is the dry aerial parts of rosaceous plant Agrimony AgrimoniapilosaLedeb..Summer, autumn two tap when season, stem and leaf was luxuriant, removing impurity, dry.
Alumen: China's coastal port one ministerial standard.This product is that Sulfates mineral alunite is made through processing refinement.Main containing aqueous sulfuric acid aluminum potassium [KAl(SO4) 212H2O].
Fructus Aurantii: China's coastal port one ministerial standard.This product is the dry immature fruit of rutaceae Citrus aurantium Linn. CitrusaurantiumL. and variety thereof.July gathers when peel is still green, is two halves from middle part crosscut, dries or cold drying.
Semen Strychni: China's coastal port one ministerial standard.This product is the dry mature seed of loganiaceae plant Semen Strychni Strychnosnux-vomicaL..To gather winter mature fruit, take out seed, dry.
Citric acid: Chinese Pharmacopoeia version two ministerial standard in 2010.
Microcrystalline Cellulose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Hyprolose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Cross-linking sodium carboxymethyl cellulose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Aluminium-magnesium silicate: Chinese Pharmacopoeia version two ministerial standard in 2010.
Sodium chloride: Chinese Pharmacopoeia version two ministerial standard in 2010.
Mannitol: Chinese Pharmacopoeia version two ministerial standard in 2010.
Maltodextrin: Chinese Pharmacopoeia version two ministerial standard in 2010.
Sodium alginate: Chinese Pharmacopoeia version two ministerial standard in 2010.
Boric acid: Chinese Pharmacopoeia version two ministerial standard in 2010.
Raw material used by above PINGXIAO PIAN 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 Fructus Arctii 20g, Semen Coicis 29g, Radix Curcumae 58g, Herba Agrimoniae 58g, Alumen 50g, Fructus Aurantii 90g, Semen Strychni 30g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 23Mpa, extraction temperature 22 DEG C, separator pressure 12Mpa, separator temperature 44 DEG C, disengaging time 2.2 hours, carbon dioxide flow 26L per hour, obtains extracting solution; Get extracting solution 65 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 80g, 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 35g, hyprolose 35g, cross-linking sodium carboxymethyl cellulose 35g, aluminium-magnesium silicate 15g, sodium chloride 5g, mannitol 4g, maltodextrin 4g, mix homogeneously, with 50% ethanol wet granulation, 60 DEG C of dryings, additional sodium alginate 7g, boric acid 1g, granulate, tabletting, obtained PINGXIAO PIAN 800.
Specific embodiments of the invention 2
Get Fructus Arctii 20g, Semen Coicis 29g, Radix Curcumae 58g, Herba Agrimoniae 58g, Alumen 50g, Fructus Aurantii 90g, Semen Strychni 30g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 44Mpa, extraction temperature 45 DEG C, separator pressure 19Mpa, separator temperature 52 DEG C, disengaging time 3.5 hours, carbon dioxide flow 38L per hour, obtains extracting solution; Get extracting solution 78 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 120g, 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, hyprolose 45g, cross-linking sodium carboxymethyl cellulose 45g, aluminium-magnesium silicate 25g, sodium chloride 15g, mannitol 6g, maltodextrin 6g, mix homogeneously, with 70% ethanol wet granulation, 80 DEG C of dryings, additional sodium alginate 9g, boric acid 3g, granulate, tabletting, obtained PINGXIAO PIAN 800.
Specific embodiments of the invention 3
Get Fructus Arctii 20g, Semen Coicis 29g, Radix Curcumae 58g, Herba Agrimoniae 58g, Alumen 50g, Fructus Aurantii 90g, Semen Strychni 30g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 33Mpa, extraction temperature 34 DEG C, separator pressure 16Mpa, separator temperature 48 DEG C, disengaging time 3 hours, carbon dioxide flow 32L per hour, obtains extracting solution; Get extracting solution 71 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 100g, 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 40g, hyprolose 40g, cross-linking sodium carboxymethyl cellulose 40g, aluminium-magnesium silicate 20g, sodium chloride 10g, mannitol 5g, maltodextrin 5g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional sodium alginate 8g, boric acid 2g, granulate, tabletting, obtained PINGXIAO PIAN 800.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make PINGXIAO PIAN.
Actual effect of the present invention is investigated below with the PINGXIAO PIAN that embodiment 3 is obtained:
(1) embodiment 3 PINGXIAO PIAN and contrast disintegration of commercially available PINGXIAO PIAN
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
Table 1 embodiment 3 PINGXIAO PIAN and commercially available PINGXIAO PIAN contrast table disintegration
The above results shows, PINGXIAO PIAN prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available PINGXIAO PIAN.
(2) embodiment 3 PINGXIAO PIAN and commercially available PINGXIAO PIAN treat the tumor disease clinical observation on the therapeutic effect in the malicious stasis of blood caused by knot
1 case scenario
Statistics outpatient service and inpatient, observe tumor disease case 150 example in the malicious stasis of blood caused by knot, 55 years old mean age altogether.Patient is divided into two groups, test group takes embodiment 3 PINGXIAO PIAN, and matched group takes commercially available PINGXIAO PIAN.
2 efficacy assessment standards
According to new Chinese medicine treatment guideline of clinical investigations tcm syndrome curative effect determinate standard:
Clinical recovery: tcm clinical practice symptom, sign disappear or substantially disappear, syndrome integral reduces >=95%.
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%.
Computing formula: [before (before treatment the rear integration of integration-treatment) ÷ treatment integration] × 100%.
3 clinical observation result
Table 2 embodiment 3 PINGXIAO PIAN and commercially available PINGXIAO PIAN clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, when PINGXIAO PIAN prepared by the present invention ties caused tumor disease in the malicious stasis of blood for the treatment of, evident in efficacy higher than commercially available PINGXIAO PIAN, p < 0.05.

Claims (3)

1. treat a Chinese medicine for the tumor in the malicious stasis of blood caused by knot, it is characterized in that getting Fructus Arctii 20g, Semen Coicis 29g, Radix Curcumae 58g, Herba Agrimoniae 58g, Alumen 50g, Fructus Aurantii 90g, Semen Strychni 30g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 23 ~ 44Mpa, extraction temperature 22 ~ 45 DEG C, separator pressure 12 ~ 19Mpa, separator temperature 44 ~ 52 DEG C, disengaging time 2.2 ~ 3.5 hours, carbon dioxide flow 26 ~ 38L per hour, obtains extracting solution; Get extracting solution 65 ~ 78 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 80 ~ 120g, 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 35 ~ 45g, hyprolose 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, aluminium-magnesium silicate 15 ~ 25g, sodium chloride 5 ~ 15g, mannitol 4 ~ 6g, maltodextrin 4 ~ 6g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional sodium alginate 7 ~ 9g, boric acid 1 ~ 3g, granulate, suppresses to obtain PINGXIAO PIAN.
2. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Fructus Arctii 20g, Semen Coicis 29g, Radix Curcumae 58g, Herba Agrimoniae 58g, Alumen 50g, Fructus Aurantii 90g, Semen Strychni 30g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 23 ~ 44Mpa, extraction temperature 22 ~ 45 DEG C, separator pressure 12 ~ 19Mpa, separator temperature 44 ~ 52 DEG C, disengaging time 2.2 ~ 3.5 hours, carbon dioxide flow 26 ~ 38L per hour, obtains extracting solution; Get extracting solution 65 ~ 78 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 80 ~ 120g, 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 35 ~ 45g, hyprolose 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, aluminium-magnesium silicate 15 ~ 25g, sodium chloride 5 ~ 15g, mannitol 4 ~ 6g, maltodextrin 4 ~ 6g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional sodium alginate 7 ~ 9g, boric acid 1 ~ 3g, granulate, suppresses to obtain PINGXIAO PIAN.
3. the preparation method of Chinese medicine according to claim 1, gets Fructus Arctii 20g, Semen Coicis 29g, Radix Curcumae 58g, Herba Agrimoniae 58g, Alumen 50g, Fructus Aurantii 90g, Semen Strychni 30g, be ground into 60 order coarse powder, employing carbon dioxide supercritical extraction method is extracted, extracting pressure 33Mpa, extraction temperature 34 DEG C, separator pressure 16Mpa, separator temperature 48 DEG C, disengaging time 3 hours, carbon dioxide flow 32L per hour, obtains extracting solution; Get extracting solution 71 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add citric acid 100g, 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 40g, hyprolose 40g, cross-linking sodium carboxymethyl cellulose 40g, aluminium-magnesium silicate 20g, sodium chloride 10g, mannitol 5g, maltodextrin 5g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional sodium alginate 8g, boric acid 2g, granulate, tabletting, obtained PINGXIAO PIAN.
CN201510842248.7A 2015-11-29 2015-11-29 Ping xiao tablet (tablet for restraining cancer) and preparation method thereof Pending CN105396050A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024262570A1 (en) * 2023-06-20 2024-12-26 株式会社ファンケル Oral composition, method for masking bitterness in oral composition, and method for producing oral composition

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024262570A1 (en) * 2023-06-20 2024-12-26 株式会社ファンケル Oral composition, method for masking bitterness in oral composition, and method for producing oral composition

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Application publication date: 20160316