CN104398935A - Hemorrhoid eliminating tablet and preparation method thereof - Google Patents

Hemorrhoid eliminating tablet and preparation method thereof Download PDF

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Publication number
CN104398935A
CN104398935A CN201410760593.1A CN201410760593A CN104398935A CN 104398935 A CN104398935 A CN 104398935A CN 201410760593 A CN201410760593 A CN 201410760593A CN 104398935 A CN104398935 A CN 104398935A
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China
Prior art keywords
eliminating tablet
hemorrhoid
carbon dioxide
ground
extract
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CN201410760593.1A
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Chinese (zh)
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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 CN201410760593.1A priority Critical patent/CN104398935A/en
Publication of CN104398935A publication Critical patent/CN104398935A/en
Withdrawn legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/489Sophora, e.g. necklacepod or mamani
    • 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)
    • A61K36/74Rubiaceae (Madder 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)
    • A61K36/185Magnoliopsida (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)
    • A61K36/902Sparganiaceae (Bur-reed family)
    • 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
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The invention discloses a hemorrhoid eliminating tablet and a preparation method thereof. The hemorrhoid eliminating tablet is characterized by being prepared from 10 g of burdock, 50 g of semen coicis, 200 g of sophora flower bud, 250 g of radix rubiae, 250 g of fruit of trifoliate orange, and 250 g of rhizoma sparganii, and prepared by the following steps: using a carbon dioxide supercritical extraction method to extract the raw materials, drying under reduced pressure, using a high-powered nano-scale impact mill to crush the dried materials to form nanometer dry paste, and adding functional auxiliary materials to the dry paste, so as to prepare the hemorrhoid eliminating tablet. The disintegration time of the hemorrhoid eliminating tablet is remarkably shortened; the curative effect is obviously better than that of the hemorrhoid eliminating tablet sold in the market, so that the hemorrhoid eliminating tablet can achieve a positive effect.

Description

A kind of pile eliminating tablet and preparation method thereof
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of pile eliminating tablet and preparation method thereof.
Background technology
Pile eliminating tablet heat clearing away, removing heat from blood, hemostasis, circulation of qi promoting dissipating blood stasis.For internal hemorrhoid, external hemorrhoid, mixed hemorrhoid, mixed hemorrhoids thrombosis.Commercially available pile eliminating tablet 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 pile eliminating tablet that a kind of disintegration rate is fast, curative effect is high and preparation method thereof.
Invention embodiment is as follows:
Get Fructus Arctii 10g, Semen Coicis 50g, Flos Sophorae Immaturus 200g, Radix Rubiae 250g, Fructus Aurantii 250g, Rhizoma Sparganii 250g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 20 ~ 40Mpa, extraction temperature 20 ~ 40 DEG C, separator pressure 15 ~ 25Mpa, separator temperature 40 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 20 ~ 40L 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 fructose 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, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional leucine 7 ~ 9g, granulate, be pressed into 1000, obtained pile eliminating tablet.
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 Arctium laPPa L..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 Coix lacryma-jobi L.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.
The Flos Sophorae Immaturus: China's coastal port one ministerial standard.This product is the dry flower and alabastrum of leguminous plant Chinese scholartree Sophora japonica L..Summer, the flowers are in blossom put or alabastrum is formed time gather, dry in time, except debranching, stalk and impurity.The former practises title " Flos Sophorae ", and the latter practises title " Flos Sophorae Immaturus ".
Radix Rubiae: China's coastal port one ministerial standard.This product is the dry root and rhizome of Maguireothamnus speciosus Radix Rubiae Rubia cordifolia L..Spring, Qiu Erji excavate, removing silt, dry.
Fructus Aurantii: China's coastal port one ministerial standard.This product is the dry immature fruit of rutaceae Citrus aurantium Linn. Citrus aurantium L. and variety thereof.July gathers when peel is still green, is two halves from middle part crosscut, dries or cold drying.
Rhizoma Sparganii: China's coastal port one ministerial standard.This product is the dry tuber of Sparganiaceae plant rhizoma scirpi Sparganium stoloniferumBuch-Ham..Spring winter to next year excavates, and clean, crust of pruning, dries.
Fructose: 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.
Hypromellose: Chinese Pharmacopoeia version two ministerial standard in 2010.
Micropowder silica gel: Chinese Pharmacopoeia version two ministerial standard in 2010.
Leucine: Chinese Pharmacopoeia version two ministerial standard in 2010.
Raw material used by above pile eliminating tablet 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 10g, Semen Coicis 50g, Flos Sophorae Immaturus 200g, Radix Rubiae 250g, Fructus Aurantii 250g, Rhizoma Sparganii 250g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 20Mpa, extraction temperature 20 DEG C, separator pressure 15Mpa, separator temperature 40 DEG C, disengaging time 2 hours, carbon dioxide flow 20L per hour, obtains extracting solution; Get extracting solution 60 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add fructose 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, crospolyvinylpyrrolidone 35g, cross-linking sodium carboxymethyl cellulose 35g, hypromellose 25g, micropowder silica gel 15g, mix homogeneously, with 50% ethanol wet granulation, 60 DEG C of dryings, additional leucine 7g, granulate, is pressed into 1000, obtained pile eliminating tablet.
Specific embodiments of the invention 2
Get Fructus Arctii 10g, Semen Coicis 50g, Flos Sophorae Immaturus 200g, Radix Rubiae 250g, Fructus Aurantii 250g, Rhizoma Sparganii 250g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 40Mpa, extraction temperature 40 DEG C, separator pressure 25Mpa, separator temperature 60 DEG C, disengaging time 4 hours, carbon dioxide flow 40L per hour, obtains extracting solution; Get extracting solution 80 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add fructose 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, crospolyvinylpyrrolidone 45g, cross-linking sodium carboxymethyl cellulose 45g, hypromellose 35g, micropowder silica gel 25g, mix homogeneously, with 70% ethanol wet granulation, 80 DEG C of dryings, additional leucine 9g, granulate, is pressed into 1000, obtained pile eliminating tablet.
Specific embodiments of the invention 3
Get Fructus Arctii 10g, Semen Coicis 50g, Flos Sophorae Immaturus 200g, Radix Rubiae 250g, Fructus Aurantii 250g, Rhizoma Sparganii 250g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 30Mpa, extraction temperature 30 DEG C, separator pressure 20Mpa, separator temperature 50 DEG C, disengaging time 3 hours, carbon dioxide flow 30L per hour, obtains extracting solution; Get extracting solution 70 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add fructose 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, crospolyvinylpyrrolidone 40g, cross-linking sodium carboxymethyl cellulose 40g, hypromellose 30g, micropowder silica gel 20g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional leucine 8g, granulate, is pressed into 1000, obtained pile eliminating tablet.
Above embodiment illustrates, adopts the extreme condition of embodiment of the present invention and optimal conditions all can make pile eliminating tablet.Actual effect of the present invention is investigated below with the pile eliminating tablet that embodiment 3 is obtained:
(1) embodiment 3 pile eliminating tablet and commercially available pile eliminating tablet contrast disintegration
1 disintegration time mensuration method
Measure by Chinese Pharmacopoeia version annex Ⅻ A in 2010.
Contrast 2 disintegrations
Table 1 embodiment 3 pile eliminating tablet and commercially available pile eliminating tablet contrast table disintegration
The above results shows, pile eliminating tablet prepared by the present invention has the remarkable advantages such as disintegration rate is fast, bioavailability is high relative to commercially available pile eliminating tablet.
(2) embodiment 3 pile eliminating tablet and commercially available pile eliminating tablet treat internal hemorrhoid, external hemorrhoid, mixed hemorrhoid, mixed hemorrhoids thrombus disease clinical observation on the therapeutic effect
1 case scenario
Statistics outpatient service and inpatient, observe internal hemorrhoid, external hemorrhoid, mixed hemorrhoid altogether, mixed hemorrhoids thrombus disease case 120 example, 39 years old mean age.Patient is divided into two groups, test group takes embodiment 3 pile eliminating tablet, and matched group takes commercially available pile eliminating tablet.
2 efficacy assessment standards
According to new Chinese medicine 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 pile eliminating tablet and commercially available pile eliminating tablet clinical efficacy contrast table
Above-mentioned clinical observation on the therapeutic effect result shows, pile eliminating tablet prepared by the present invention is treating internal hemorrhoid, external hemorrhoid, mixed hemorrhoid, evident in efficacy higher than commercially available pile eliminating tablet during mixed hemorrhoids thrombus disease, p < 0.05.

Claims (3)

1. treat an internal hemorrhoid, external hemorrhoid, mixed hemorrhoid, the Chinese medicine of mixed hemorrhoids thrombus disease, it is characterized in that getting Fructus Arctii 10g, Semen Coicis 50g, Flos Sophorae Immaturus 200g, Radix Rubiae 250g, Fructus Aurantii 250g, Rhizoma Sparganii 250g, be ground into 60 order coarse powder, adopt carbon dioxide supercritical extraction method to extract, extracting pressure 20 ~ 40Mpa, extraction temperature 20 ~ 40 DEG C, separator pressure 15 ~ 25Mpa, separator temperature 40 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 20 ~ 40L 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 fructose 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, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional leucine 7 ~ 9g, granulate, tabletting, obtained pile eliminating tablet.
2. the preparation method of Chinese medicine according to claim 1, is characterized in that getting Fructus Arctii 10g, Semen Coicis 50g, Flos Sophorae Immaturus 200g, Radix Rubiae 250g, Fructus Aurantii 250g, Rhizoma Sparganii 250g, is ground into 60 order coarse powder, adopts carbon dioxide supercritical extraction method to extract, extracting pressure 20 ~ 40Mpa, extraction temperature 20 ~ 40 DEG C, separator pressure 15 ~ 25Mpa, separator temperature 40 ~ 60 DEG C, disengaging time 2 ~ 4 hours, carbon dioxide flow 20 ~ 40L 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 fructose 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, crospolyvinylpyrrolidone 35 ~ 45g, cross-linking sodium carboxymethyl cellulose 35 ~ 45g, hypromellose 25 ~ 35g, micropowder silica gel 15 ~ 25g, mix homogeneously, with 50 ~ 70% ethanol wet granulations, 60 DEG C ~ 80 DEG C dryings, additional leucine 7 ~ 9g, granulate, tabletting, obtained pile eliminating tablet.
3. the preparation method of Chinese medicine according to claim 1, gets Fructus Arctii 10g, Semen Coicis 50g, Flos Sophorae Immaturus 200g, Radix Rubiae 250g, Fructus Aurantii 250g, Rhizoma Sparganii 250g, 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 20Mpa, separator temperature 50 DEG C, disengaging time 3 hours, carbon dioxide flow 30L per hour, obtains extracting solution; Get extracting solution 70 DEG C of drying under reduced pressure, get dry extract; Get dry cream and add fructose 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, crospolyvinylpyrrolidone 40g, cross-linking sodium carboxymethyl cellulose 40g, hypromellose 30g, micropowder silica gel 20g, mix homogeneously, with 60% ethanol wet granulation, 70 DEG C of dryings, additional leucine 8g, granulate, tabletting, obtained pile eliminating tablet.
CN201410760593.1A 2014-12-13 2014-12-13 Hemorrhoid eliminating tablet and preparation method thereof Withdrawn CN104398935A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201410760593.1A CN104398935A (en) 2014-12-13 2014-12-13 Hemorrhoid eliminating tablet and preparation method thereof

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Application Number Priority Date Filing Date Title
CN201410760593.1A CN104398935A (en) 2014-12-13 2014-12-13 Hemorrhoid eliminating tablet and preparation method thereof

Publications (1)

Publication Number Publication Date
CN104398935A true CN104398935A (en) 2015-03-11

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Country Status (1)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3145287A1 (en) 2023-01-31 2024-08-02 Le Rouge Français Particular process for preparing an extract of at least one plant belonging to the Rubiaceae family.

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR3145287A1 (en) 2023-01-31 2024-08-02 Le Rouge Français Particular process for preparing an extract of at least one plant belonging to the Rubiaceae family.

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Application publication date: 20150311