EP0951291A1 - Cancer treatment drug - Google Patents

Cancer treatment drug

Info

Publication number
EP0951291A1
EP0951291A1 EP97948892A EP97948892A EP0951291A1 EP 0951291 A1 EP0951291 A1 EP 0951291A1 EP 97948892 A EP97948892 A EP 97948892A EP 97948892 A EP97948892 A EP 97948892A EP 0951291 A1 EP0951291 A1 EP 0951291A1
Authority
EP
European Patent Office
Prior art keywords
cancer
medicament
drakocephalum
kotshyi
boss
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP97948892A
Other languages
German (de)
French (fr)
Inventor
Mohammad Ismail Zolfaghari
Pirus Salehian
Abolghassem Pakdaman
Parwin Pharmaceutical Research Center NUHNEJAD
Mahmud Pharmaceutical Research Center NAJAFI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pharmaceutical Research Center
Original Assignee
Pharmaceutical Research Center
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pharmaceutical Research Center filed Critical Pharmaceutical Research Center
Publication of EP0951291A1 publication Critical patent/EP0951291A1/en
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the invention relates to a medicament for cancer therapy, which is based on biology.
  • Cancer is a disease in which body cells grow uncontrollably.
  • Various therapies are known to prevent or at least limit such cell growth.
  • One of the most frequently used therapies at the moment is the so-called chemotherapy, which triggers considerable side effects, but without leading to lasting success.
  • the object of the invention is a pharmaceutical or pharmaceutical
  • the anti-cancer agent according to the invention is a medicament which contains two plant substances with a cytotoxic effect and which can be administered orally and / or rectally and / or parenterally.
  • This combination anti-cancer preparation preferably contains extracts from two plants, namely Peganum harmala L. and Drakocephalum Kotshyi Boss, which contain anti-cancer substances. Such plants are native to Iran.
  • the ingredients or contents of the plant extracts to be used according to the invention were first prepared as alcoholic and aqueous extracts or solutions. Granules are produced from the resulting mixture. The extracts and granules obtained in this way were processed into tablets and other pharmaceutical forms of administration so that they could be administered to patients.
  • the drug according to the invention shows u. a. cytotoxic, anti-phlogistic, anti-inflammatory, analgesic, antibacterial and anti-viral effects.
  • the biological anti-cancer agent according to the invention acts as a mitotic inhibitor and interferes with the itosis phase in the cell division of cancerous cells.
  • the biological anti-cancer agent according to the invention binds to the deoxiribonucleic acid (DNA) chain after administration and thereby prevents the formation of ribonucleic acid (RNA). On this basis, it affects the amino acids of cancer-affected cells and thus prevents cancer cell growth.
  • DNA deoxiribonucleic acid
  • RNA ribonucleic acid
  • the molecular structure of the biological anti-cancer agent or preparation according to the invention is designed so that the agent functions as a physiological and body-compatible agent in the body. It has been shown that the medicament or preparation according to the invention produces positive therapeutic effects in various cancer tumors, for example mom carcinoma, carcino e of the gastrointestinal tract, brain tumors and others.
  • a particular advantage of the invention is that the positive therapeutic effect against the cancer cells is achieved without any notable side effects.
  • the medicament or preparation according to the invention has no negative side effects on the blood picture and the natural blood components when administered.
  • the medicament or preparation according to the invention can be administered as a mono- and / or combination therapy preparation with other biological substances and anti-tumor agents which have been produced on a biological and / or conventional basis.
  • the medicament or preparation according to the invention has a synergistic effect in combination with oral oxygen therapy, whereby the anti-cancer effect is enhanced.
  • the agent or preparation according to the invention has a relaxation and relaxation effect, especially with smooth muscles.
  • the medicament or preparation according to the invention has immunostimulating and immunomodulating effects. These properties have been studied and confirmed in animals whose immune system has been paralyzed by diethylbenzan traces (DMBA) as a carcinogenic and immunosuppressive agent. After treatment with the biological anti-cancer agent according to the invention, an immune stimulation and immune modulation was determined and documented in these animals. These positive effects on the human immune system have also been demonstrated. A decrease in tumor markers could also be detected in cancer patients treated with the medicament or preparation according to the invention.
  • DMBA diethylbenzan traces
  • LD 50 lethal dose
  • the cancer-inhibiting effect of the medicament or preparation according to the invention has been confirmed and documented by various cell examinations and effects on cancer cells of humans and monkeys.
  • the extract obtained and produced according to the invention from two special plants and its fractions have been allowed to act on cancer cells and control cells.
  • the course of this action was checked by an electronic microscope. Ultrastructural damage to the cancer cells was shown in comparison with healthy control cells.

Landscapes

  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Botany (AREA)
  • Mycology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The invention relates to a cancer treatment drug containing two biological plant active ingredients having a cytotoxic action and carcinolytic properties, namely extracts from the plants Peganum Harmala L. and Drakocephalum Kotshyi Boss.

Description

Arzneimittel für Krebs-TherapieMedicines for cancer therapy
Die Erfindung betrifft ein Arzneimittel für die Krebs-Therapie, das auf biologischer Basis beruht.The invention relates to a medicament for cancer therapy, which is based on biology.
Krebs ist eine Krankheit, bei der Körperzellen unkontrolliert wachsen. Um ein derartiges Zellwachstum zu verhindern oder zumindest einzuschränken, sind verschiedene Therapien bekannt. Eine der derzeit am häufigsten angewendeten Therapien ist die sogenannte Chemothera- pie, die erhebliche Nebenwirkungen auslöst, ohne jedoch zu nachhaltigen Erfolgen zu führen.Cancer is a disease in which body cells grow uncontrollably. Various therapies are known to prevent or at least limit such cell growth. One of the most frequently used therapies at the moment is the so-called chemotherapy, which triggers considerable side effects, but without leading to lasting success.
Auch Versuche mit biologischen Krebs-Therapien allein haben bisher keine nachhaltigen Erfolge ergeben, weil die sich im menschlichen Körper bildenden Krebszellen auch mit diesen Therapien nicht wirksam abgetötet werden konnten.Even experiments with biological cancer therapies alone have so far not shown any lasting success because the cancer cells that form in the human body could not be effectively killed with these therapies either.
Aufgabe der Erfindung ist es, ein Arzneimittel oder pharmazeutischesThe object of the invention is a pharmaceutical or pharmaceutical
Präparat zu schaffen, welches anti-krebs bzw. zytostatische Wirkungen hat, mit dessen Hilfe Krebszellen wirksam abgetötet oder zumindest beeinträchtigt werden können.To create a preparation that has anti-cancer or cytostatic effects, with the help of which cancer cells can be effectively killed or at least impaired.
Diese Aufgabe wird erfindungsgemäß mit einem Arzneimittel gelöst, welches die Merkmale des Patentanspruches 1 aufweist.According to the invention, this object is achieved with a medicament which has the features of patent claim 1.
Vorteilhafte Ausgestaltungen und Weiterbildungen der Erfindung sind Gegenstand der Unteransprüche.Advantageous refinements and developments of the invention are the subject of the dependent claims.
Das erfindungsgemäße Anti-Krebs-Mittel ist ein Arzneimittel, das zwei pflanzliche Substanzen mit zytotoxischer Wirkung enthält und das oral und/oder rektal und/oder parenteral verabreicht werden kann. Dieses Kombinations-Anti-Krebs-Präparat enthält vorzugsweise Extrakte von zwei Pflanzen, nämlich Peganum harmala L. und Drakocephalum Kotshyi Boss, die krebshemmend wirksame Stoffe enthalten. Derartige Pflanzen sind im Iran beheimatet.The anti-cancer agent according to the invention is a medicament which contains two plant substances with a cytotoxic effect and which can be administered orally and / or rectally and / or parenterally. This combination anti-cancer preparation preferably contains extracts from two plants, namely Peganum harmala L. and Drakocephalum Kotshyi Boss, which contain anti-cancer substances. Such plants are native to Iran.
Phytochemische Untersuchungen dieser Pflanzen bestätigen u. a. das Vorhandensein von Wirkstoffen wie Alkaloide, Flavqnoidejannin, Saponine, Steroide, Proteine, Li p de, Carbohydrate, ätherische Öle, Mineralien, Aminosäuren u. a..Phytochemical studies of these plants confirm u. a. the presence of active ingredients such as alkaloids, flavqnoidejannin, saponins, steroids, proteins, lipid, carbohydrates, essential oils, minerals, amino acids and the like. a ..
Die Inhaltsstoffe bzw. Gehalte der erfindungsgemäß zu verwendenden Pflanzenextrakte wurden zunächst als alkoholische und wässerige Extrakte bzw. Lösungen vorbereitet. Aus dem daraus gebildeten Gemisch werden Granulate hergestellt. Die so gewonnenen Extrakte und Granulate wurden zu Tabletten und anderen medikamentösen Darreichungsformen verarbeitet, um sie Patienten verabreichen zu können.The ingredients or contents of the plant extracts to be used according to the invention were first prepared as alcoholic and aqueous extracts or solutions. Granules are produced from the resulting mixture. The extracts and granules obtained in this way were processed into tablets and other pharmaceutical forms of administration so that they could be administered to patients.
Das erfindungsgemäße Arzneimittel zeigt u. a. zytotoxische, anti- phlogistische, ant inflammatorische, analgetische, antibakterielle und antivirale Wirkungen.The drug according to the invention shows u. a. cytotoxic, anti-phlogistic, anti-inflammatory, analgesic, antibacterial and anti-viral effects.
Das erfindungsgemäße biologische Anti-Krebs-Mittel wirkt als mitoser Hemmstoff und greift hemmend in der itosen Phase in die Zellteilung von krebsbefallenen Zellen ein.The biological anti-cancer agent according to the invention acts as a mitotic inhibitor and interferes with the itosis phase in the cell division of cancerous cells.
Das erfindungsgemäße biologische Anti-Krebs-Mittel verbindet sich nach Verabreichung mit der Desoxiribonucleinsäure-{DNA}-Kette und verhindert dadurch die Bildung von Ribonucleinsäure-(RNA). Auf dieser Basis beeinträchtigt sie die Aminosäuren der von Krebs befallenen Zellen und verhindert damit das Krebszellenwachstu .The biological anti-cancer agent according to the invention binds to the deoxiribonucleic acid (DNA) chain after administration and thereby prevents the formation of ribonucleic acid (RNA). On this basis, it affects the amino acids of cancer-affected cells and thus prevents cancer cell growth.
Die molekulare Baustruktur des erfindungsgemäßen biologischen Anti- Krebs-Mittels oder -Präparates ist so gestaltet, daß das Mittel als physiologisches und körperverträgliches Mittel im Körper funktioniert. Es hat sich gezeigt, daß das erfindungsgemäße Arzneimittel oder Präparat positive Therapieeffekte bei verschiedenen Krebstumoren, beispielsweise Mama Carcinom, Carcino e des gastrointestinalen Traktes, Hirntumoren u. a. hervorruft.The molecular structure of the biological anti-cancer agent or preparation according to the invention is designed so that the agent functions as a physiological and body-compatible agent in the body. It has been shown that the medicament or preparation according to the invention produces positive therapeutic effects in various cancer tumors, for example mom carcinoma, carcino e of the gastrointestinal tract, brain tumors and others.
Ein besonderer Vorteil der Erfindung ist, daß der positive Therapieeffekt gegen die Krebszellen ohne nennenswerte Nebenwirkungen erzielt wird.A particular advantage of the invention is that the positive therapeutic effect against the cancer cells is achieved without any notable side effects.
Insbesondere hat das erfindungsgemäße Arzneimittel oder Präparat bei Verabreichung keine negativen Nebenwirkungen auf das Blutbild und die natürlichen Blutkomponenten.In particular, the medicament or preparation according to the invention has no negative side effects on the blood picture and the natural blood components when administered.
Das erfindungsgemäße Arzneimittel oder Präparat kann als Mono- und/oder Kombinations-Therapie-Präparat mit anderen Biostoffen und Anti-Tumor-Mitteln, die auf biologischer und/oder konventioneller Basis hergestellt worden sind, verabreicht werden.The medicament or preparation according to the invention can be administered as a mono- and / or combination therapy preparation with other biological substances and anti-tumor agents which have been produced on a biological and / or conventional basis.
Das erfindungsgemäße Arzneimittel oder Präparat wirkt in Kombination mit oraler Oxygen-Therapie synergisch, wodurch der Effekt der AntiKrebs-Wirkung verstärkt wird.The medicament or preparation according to the invention has a synergistic effect in combination with oral oxygen therapy, whereby the anti-cancer effect is enhanced.
Es hat sich gezeigt, daß das erfindungsgemäße Mittel oder Präparat einen Entspannungs- und Entkrampfungs-Effekt hat, besonders bei glatten Muskulaturen.It has been shown that the agent or preparation according to the invention has a relaxation and relaxation effect, especially with smooth muscles.
Das erfindungsgemäße Arzneimittel bzw. Präparat hat immunstimulierende und immunmodulierende Wirkungen. Diese Eigenschaften wurden bei Tieren, deren Immunsystem durch Di ethylbenzantracen (DMBA) als kanzerogenes und immunsuppresives Mittel lahmgelegt wurde, untersucht und bestätigt. Bei diesen Tieren wurde nach Behandlung mit dem erfindungsgemäßen biologischen Anti-Krebs-Mittel eine Immunstimulation und Immunmodulation festgestellt und dokumentiert. Diese positiven Wirkungen auf das Immunsystem des Menschen wurden ebenfalls nachgewiesen. Auch konnte bei mit dem erfindungsgemäßen Arzneimittel oder Präparat behandelten Krebspatienten ein Rückgang der Tu ormarker nachgewiesen werden.The medicament or preparation according to the invention has immunostimulating and immunomodulating effects. These properties have been studied and confirmed in animals whose immune system has been paralyzed by diethylbenzan traces (DMBA) as a carcinogenic and immunosuppressive agent. After treatment with the biological anti-cancer agent according to the invention, an immune stimulation and immune modulation was determined and documented in these animals. These positive effects on the human immune system have also been demonstrated. A decrease in tumor markers could also be detected in cancer patients treated with the medicament or preparation according to the invention.
Pharmakodynamische Untersuchungen mit dem erfindungsgemäßen Arzneimittel oder Präparat zeigten eine Letaldosis (LD 50) von 657,5 mg/kg Körpergewicht bei untersuchten Mäusen.Pharmacodynamic studies with the medicament or preparation according to the invention showed a lethal dose (LD 50) of 657.5 mg / kg body weight in the examined mice.
Pharmakodynamische Vergleichsuntersuchungen mit anderen Anti-Tumor- Mitteln wie Vincristin, Vinblastin und Chlorambucil zeigten, daß das erfindungsgemäße Arzneimittel bzw. Präparat eine optimale Verträglichkeit hat, während die vorbekannten Krebsbehandlungsmittel erhebliche Nebenwirkungen hervorrufen, die bei Anwendung des erfindungsgemäßen Arzneimittels nicht auftraten.Comparative pharmacodynamic studies with other anti-tumor agents such as vincristine, vinblastine and chlorambucil showed that the medicament or preparation according to the invention has an optimal tolerance, while the previously known cancer treatment agents cause considerable side effects which did not occur when the medicament according to the invention was used.
Die krebshemmende Wirkung des erfindungsgemäßen Arzneimittels oder Präparates wurde durch verschiedene Zelluntersuchungen und Einwirkungen auf Krebszellen von Menschen und Affen bestätigt und dokumentiert.The cancer-inhibiting effect of the medicament or preparation according to the invention has been confirmed and documented by various cell examinations and effects on cancer cells of humans and monkeys.
Der gemäß der Erfindung aus zwei speziellen Pflanzen gewonnene und hergestellte Extrakt und seine Fraktionen sind auf Krebszellen und Kontrollzellen einwirken gelassen worden. Der Verlauf dieser Einwirkung wurde durch ein elektronisches Mikroskop kontrolliert. Es zeigte sich eine ultrastrukturelle Schädigung der Krebszellen im Vergleich mit gesunden Kontrollzellen.The extract obtained and produced according to the invention from two special plants and its fractions have been allowed to act on cancer cells and control cells. The course of this action was checked by an electronic microscope. Ultrastructural damage to the cancer cells was shown in comparison with healthy control cells.
Bei klinischen Studien zeigte sich bei Anwendung des erfindungsge- mäßen Mittels bei Krebspatienten zum Teil eine volle Remission sowie eine Lebensverlängerung und eine Verbesserung der Lebensqualität.In clinical studies, when the agent according to the invention was used in cancer patients, full remission as well as an extension of life and an improvement in quality of life were shown in some cases.
Nachfolgend wird die Erfindung anhand eines tabellarisch aufgeführten praktischen Ausführungsbeispieles eines krebshemmenden Arzneimittels weiter erläutert. Bestandteil mg/Tablette %The invention is explained in more detail below on the basis of a practical exemplary embodiment of a cancer-inhibiting medicament which is listed in tabular form. Component mg / tablet%
Peganum harmala L. 142,7 23,8Peganum harmala L. 142.7 23.8
Drakocephalum K. B. 19,6 3,3Drakocephalum K.B. 19.6 3.3
Zucker-Puder 15,7 2,6Sugar powder 15.7 2.6
Calzium-Carbonat 43,6 7,3Calcium carbonate 43.6 7.3
Polyvinylpirolidon (PVP) 12,5 2,0Polyvinylpyrolidone (PVP) 12.5 2.0
Stärke 166,5 27,8Strength 166.5 27.8
Lactose 156,0 26,0Lactose 156.0 26.0
Carboxymethylcellulose (CMC) 10,0 1,6Carboxymethyl cellulose (CMC) 10.0 1.6
Microcristallincellulose (MCC) 24,0 4,0Microcrystalline cellulose (MCC) 24.0 4.0
Aerosyl 9,4 1,6Aerosyl 9.4 1.6
600,0 mg 100,0 % 600.0 mg 100.0%

Claims

Patentansprüche claims
1. Arzneimittel für die Krebs-Therapie, d a d u r c h g e k e n n z e i c h n e t, daß es zwei biologische pflanzliche Wirkstoffe mit zytotoxischer1. Medicines for cancer therapy, d a d u r c h g e k e n n z e i c h n e t that there are two biological herbal active substances with cytotoxic
Wirkung, die somit krebszellentötende Eigenschaften aufweisen, enthält.Contains effects that have cancer cell-killing properties.
2. Arzneimittel nach Anspruch 1, dadurch gekennzeichnet, daß es als krebszellentötende Eigenschaften aufweisende Wirkstoffe Extrake der Pflanzen Peganum Harmala L. und Drakocephalum Kotshyi Boss enthält.2. Medicament according to claim 1, characterized in that it contains as extracts of the plants Peganum Harmala L. and Drakocephalum Kotshyi Boss as cancer cell-killing properties.
3. Arzneimittel nach Anspruch 1 oder 2, dadurch gekennzeichnet, daß es etwa 24 % Peganum Harmala L. und etwa 3 bis 4 % Drakocephalum3. Medicament according to claim 1 or 2, characterized in that it is about 24% Peganum Harmala L. and about 3 to 4% Drakocephalum
Kotshyi Boss, Rest Füllstoffe, enthält.Kotshyi Boss, rest of fillers, contains.
4. Arzneimittel nach Anspruch 3, dadurch gekennzeichnet, daß es 23,8 % Peganum Harmala L. und 3,3 % Drakocephalum Kotshyi Boss enthält. 4. Medicament according to claim 3, characterized in that it contains 23.8% Peganum Harmala L. and 3.3% Drakocephalum Kotshyi Boss.
EP97948892A 1997-11-06 1997-11-06 Cancer treatment drug Withdrawn EP0951291A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP1997/006155 WO1999024048A1 (en) 1997-11-06 1997-11-06 Cancer treatment drug

Publications (1)

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EP0951291A1 true EP0951291A1 (en) 1999-10-27

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EP (1) EP0951291A1 (en)
JP (1) JP2001514671A (en)
CA (1) CA2276276A1 (en)
WO (1) WO1999024048A1 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9447049B2 (en) 2010-03-01 2016-09-20 University Of Tennessee Research Foundation Compounds for treatment of cancer
US11084811B2 (en) 2010-03-01 2021-08-10 Oncternal Therapeutics, Inc. Compounds for treatment of cancer
KR101806255B1 (en) * 2010-08-24 2017-12-07 지티엑스, 인코포레이티드 Compounds for treatment of cancer
CN102286085B (en) * 2011-07-25 2014-06-11 新疆大学 Peganum harmala lipid transfer protein and preparation method and use thereof

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Publication number Priority date Publication date Assignee Title
CN1034135A (en) * 1987-10-27 1989-07-26 新疆医学院第二附属医院 The preparation method of peganum harmala seed extract
CN1047528C (en) * 1993-11-18 1999-12-22 王世渝 Pharmaceutics of common peganum herb and its preparation

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* Cited by examiner, † Cited by third party
Title
See references of WO9924048A1 *

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WO1999024048A1 (en) 1999-05-20
CA2276276A1 (en) 1999-05-20
JP2001514671A (en) 2001-09-11

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