CN106729447B - Pharmaceutical composition for treating hyperplasia of mammary glands and preparation method, preparation and application thereof - Google Patents

Pharmaceutical composition for treating hyperplasia of mammary glands and preparation method, preparation and application thereof Download PDF

Info

Publication number
CN106729447B
CN106729447B CN201710088298.XA CN201710088298A CN106729447B CN 106729447 B CN106729447 B CN 106729447B CN 201710088298 A CN201710088298 A CN 201710088298A CN 106729447 B CN106729447 B CN 106729447B
Authority
CN
China
Prior art keywords
parts
hyperplasia
treating
pharmaceutical composition
mammary glands
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.)
Active
Application number
CN201710088298.XA
Other languages
Chinese (zh)
Other versions
CN106729447A (en
Inventor
郝振平
徐溧
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.)
KUNMING SINOWAY NATURAL PHARMACEUTICALS CO Ltd
Original Assignee
KUNMING SINOWAY NATURAL PHARMACEUTICALS CO Ltd
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 KUNMING SINOWAY NATURAL PHARMACEUTICALS CO Ltd filed Critical KUNMING SINOWAY NATURAL PHARMACEUTICALS CO Ltd
Priority to CN201710088298.XA priority Critical patent/CN106729447B/en
Publication of CN106729447A publication Critical patent/CN106729447A/en
Application granted granted Critical
Publication of CN106729447B publication Critical patent/CN106729447B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/63Arthropods
    • 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)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/233Bupleurum
    • 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
    • A61K36/536Prunella or Brunella (selfheal)
    • 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)
    • A61K36/65Paeoniaceae (Peony family), e.g. Chinese peony
    • 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)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • 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
    • 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
    • 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
    • A61K2236/10Preparation or pretreatment of starting material
    • A61K2236/15Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH

Landscapes

  • 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)
  • Insects & Arthropods (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

The invention discloses a pharmaceutical composition for treating hyperplasia of mammary glands and a preparation method, a preparation and application thereof. The pharmaceutical composition for treating hyperplasia of mammary glands comprises 50-150 parts by weight of periplaneta americana, 60-200 parts by weight of moutan bark, 90-250 parts by weight of selfheal, 30-150 parts by weight of radix bupleuri, 60-150 parts by weight of rhizoma sparganii and 60-150 parts by weight of curcuma zedoary, and is prepared through the steps of pretreatment, extraction and post-treatment. The preparation is prepared into tablets, capsules, granules, pills and mixture by adding pharmaceutically acceptable auxiliary materials into the pharmaceutical composition for treating the hyperplasia of mammary glands. The application is the application of the pharmaceutical composition for treating the hyperplasia of mammary glands in preparing the drugs for preventing/treating the hyperplasia of mammary glands. The composition provided by the invention can effectively improve the curative effect on hyperplasia of mammary glands, is convenient to use, small in toxic and side effects, good in safety, economical and practical, and worthy of clinical popularization and application.

Description

Pharmaceutical composition for treating hyperplasia of mammary glands and preparation method, preparation and application thereof
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a pharmaceutical composition for treating hyperplasia of mammary glands, and a preparation method, a preparation and application thereof.
Background
The hyperplasia of mammary glands is a common disease and a frequently encountered disease of clinical women, the occurrence and the development of the disease are related to endocrine disorder of patients, and benign hyperplasia of mammary glands, particularly the occurrence of atypical mammary glands epithelia, can increase the risk of generating breast cancer. The hyperplasia of mammary glands takes breast lumps and pain as two main symptoms, belongs to the pathological changes of mammary gland with poor structure, and mainly comprises simple hyperplasia of mammary glands and cystic hyperplasia of mammary glands. In China, cystic changes are rare, and gland hyperplasia is the main factor, so the cystic changes are mostly called as 'hyperplasia of mammary glands', and the hyperplasia of mammary glands in the theory of traditional Chinese medicine belongs to the 'nodules of breast'. The mammary gland hyperplasia accounts for more than 70% of all mammary gland diseases, the peak age of the disease is 25-45 years old, and the incidence rate of women over 30 years old reaches more than 90%. Because the disease has long course of disease, is easy to recur and seriously harms the physical and mental health of women, the current pure western medicines have no ideal treatment method, mainly take hormone treatment as the main treatment, but easily recur after long-term application, have large adverse reaction and can cause a plurality of complications, so the traditional Chinese medicine is the main means for clinically treating the hyperplasia of mammary glands. The traditional medicine considers that the occurrence of hyperplasia of mammary glands is related to factors such as emotional discomfort, stagnation of liver qi, deficiency of liver and kidney, disharmony of Chong and conception vessels, and phlegm-blood stasis.
Periplaneta americana is an insect of the genus Periplaneta of the family Periplaneta of the order Periplaneta of the class Insecta, commonly called Blatta seu periplaneta, the largest volume insect of the family Blattadae, native to south America. Periplaneta americana is a traditional Chinese medicinal material, and is recorded in Shen nong's herbal Jing, which is called salty and cold in taste. Mainly has the effects of blood stasis, hard mass, cold and heat, mass breaking, throat and throat contraction, internal cold and no seed, and is used for treating infantile malnutrition, furuncle, carbuncle, tonsillitis, innominate toxic swelling, syphilis, venomous snake bite, centipede bite and the like.
With the continuous development of modern science, the research on the chemical components and the pharmacological action of the periplaneta americana is increasingly deep. The periplaneta americana is reported to contain proteins, peptides, amino acids, chitin, mucoglycine, nucleosides, fatty acids, enols, olefine acids, alkanes, polyols, macrolides, enzymes and abundant minerals and trace elements. According to the research conditions of the existing products and related pharmacological activities in China, the biological activities of the medicinal components in the periplaneta americana mainly comprise: has good muscle tissue repair activity on various wound surfaces and body ulcers; has effects in tonifying heart, increasing blood pressure, and improving blood circulation; has antibacterial and antiviral activity; has antitumor and immunity enhancing effects.
Disclosure of Invention
The first purpose of the invention is to provide a pharmaceutical composition for treating hyperplasia of mammary glands; the second purpose is to provide a preparation method of the pharmaceutical composition for treating the hyperplasia of mammary glands; the third purpose is to provide the preparation of the pharmaceutical composition for treating the hyperplasia of mammary glands; the fourth purpose is to provide the application of the pharmaceutical composition for treating the hyperplasia of mammary glands.
The first purpose of the invention is realized in such a way that the pharmaceutical composition for treating the hyperplasia of mammary glands comprises 50-150 parts by weight of periplaneta americana, 60-200 parts by weight of moutan bark, 90-250 parts by weight of selfheal, 30-150 parts by weight of radix bupleuri, 60-150 parts by weight of rhizoma sparganii and 60-150 parts by weight of curcuma zedoary, and is prepared through the steps of pretreatment, extraction and post-treatment.
The second purpose of the invention is realized by the following steps of pretreatment, extraction and post-treatment, and the method specifically comprises the following steps:
A. pretreatment: grinding and sieving the American cockroach raw material in the formula ratio to obtain a material a for later use; meanwhile, the raw materials of the formula, namely the tree peony bark, the common selfheal fruit-spike, the Chinese thorowax root, the common burreed rhizome and the zedoary are respectively cut into slices or segments and mixed to obtain a material b for later use;
B. extraction:
1) adding an ethanol solution into the material a for extraction and concentration to obtain an extract c;
2) adding an ethanol solution into the material b for extraction and concentration to obtain an extract d;
C. and (3) post-treatment: and respectively crushing and sieving the extract c and the extract d, and uniformly mixing to obtain the target pharmaceutical composition for treating the hyperplasia of mammary glands.
The third purpose of the invention is realized by adding pharmaceutically acceptable auxiliary materials into the pharmaceutical composition for treating the hyperplasia of mammary glands to prepare tablets, capsules, granules, pills and mixture.
The fourth purpose of the invention is realized by the application of the pharmaceutical composition for treating the hyperplasia of mammary glands in the preparation of the drugs for preventing/treating the hyperplasia of mammary glands.
The preparation method of the pharmaceutical composition for treating hyperplasia of mammary glands provided by the invention is simple and feasible, and the effect of the periplaneta americana extract is fully exerted.
The composition provided by the invention can effectively improve the curative effect on hyperplasia of mammary glands, is convenient to use, small in toxic and side effects, good in safety, economical and practical, and worthy of clinical popularization and application.
Detailed Description
The present invention is further illustrated by the following examples, which are not intended to be limiting in any way, and any modifications or alterations based on the teachings of the present invention are intended to fall within the scope of the present invention.
The pharmaceutical composition for treating hyperplasia of mammary glands comprises 50-150 parts by weight of periplaneta americana, 60-200 parts by weight of moutan bark, 90-250 parts by weight of selfheal, 30-150 parts by weight of radix bupleuri, 60-150 parts by weight of rhizoma sparganii and 60-150 parts by weight of curcuma zedoary, and is prepared through the steps of pretreatment, extraction and post-treatment.
The pharmaceutical composition for treating hyperplasia of mammary glands comprises 80-120 parts by weight of periplaneta americana, 100-150 parts by weight of moutan bark, 150-200 parts by weight of selfheal, 80-110 parts by weight of radix bupleuri, 80-120 parts by weight of rhizoma sparganii and 80-120 parts by weight of curcuma zedoary, and is prepared through the steps of pretreatment, extraction and post-treatment.
The pharmaceutical composition for treating hyperplasia of mammary glands comprises 100 parts by weight of periplaneta americana, 100 parts by weight of moutan bark, 180 parts by weight of selfheal, 80 parts by weight of radix bupleuri, 90 parts by weight of rhizoma sparganii and 90 parts by weight of curcuma zedoary, and is prepared by the steps of pretreatment, extraction and post-treatment.
The pharmaceutical composition for treating hyperplasia of mammary glands comprises 100 parts by weight of periplaneta americana, 120 parts by weight of moutan bark, 150 parts by weight of selfheal, 100 parts by weight of radix bupleuri, 80 parts by weight of rhizoma sparganii and 80 parts by weight of curcuma zedoary, and is prepared through the steps of pretreatment, extraction and post-treatment.
The preparation method of the pharmaceutical composition for treating the hyperplasia of mammary glands comprises the steps of pretreatment, extraction and post-treatment, and specifically comprises the following steps:
A. pretreatment: grinding and sieving the American cockroach raw material in the formula ratio to obtain a material a for later use; meanwhile, the raw materials of the formula, namely the tree peony bark, the common selfheal fruit-spike, the Chinese thorowax root, the common burreed rhizome and the zedoary are respectively cut into slices or segments and mixed to obtain a material b for later use;
B. extraction:
1) adding an ethanol solution into the material a for extraction and concentration to obtain an extract c;
2) adding an ethanol solution into the material b for extraction and concentration to obtain an extract d;
C. and (3) post-treatment: and respectively crushing and sieving the extract c and the extract d, and uniformly mixing to obtain the target pharmaceutical composition for treating the hyperplasia of mammary glands.
And the crushing and sieving in the step A is crushing and sieving by a 24-mesh sieve.
The extraction step in the step B is as follows:
1) adding an ethanol solution with the volume percentage concentration of 90-95% and the feed liquid volume ratio of 1: 3-5 into the material a, and soaking for 3-5 hours at normal temperature to obtain a material e; performing reflux extraction on the material e for 4 times at the temperature of 70-85 ℃, and concentrating to obtain an extract c;
2) and adding 70-90% ethanol solution with the volume percentage concentration of 1: 3-10 into the material b, soaking and extracting for 3-5 h, and then performing reflux extraction and concentration at the temperature of 70-85 ℃ to obtain an extract d.
And C, crushing and sieving, namely crushing and sieving by using a 100-mesh sieve.
The preparation of the pharmaceutical composition for treating the hyperplasia of mammary glands is prepared by adding pharmaceutically acceptable auxiliary materials into the pharmaceutical composition for treating the hyperplasia of mammary glands to prepare tablets, capsules, granules, pills and mixtures.
The application of the pharmaceutical composition for treating the hyperplasia of mammary glands provided by the invention is the application of the pharmaceutical composition for treating the hyperplasia of mammary glands in preparing a medicament for preventing/treating the hyperplasia of mammary glands.
The specific operation method of the invention comprises the following steps:
the preparation method of the periplaneta americana extract comprises the following steps:
a. crushing: crushing the dried periplaneta americana body, and sieving the crushed periplaneta americana body with a 24-mesh sieve to prepare coarse periplaneta americana powder;
b. soaking: soaking the periplaneta americana coarse powder obtained in the step a in 90-95% ethanol, and hermetically storing the ethanol until the liquid level of the ethanol is 5-10 cm higher than the liquid level of the coarse powder to obtain a coarse powder mixed solution;
c. extraction: c, performing reflux extraction on the coarse powder mixed solution obtained in the step b for 4 times at the temperature of 70-85 ℃, and adding 92% ethanol with the concentration being 5 times of the weight of the coarse powder when performing first extraction on the coarse powder mixed solution, wherein the extraction time is 5 hours; adding 92% ethanol with 5 times of the weight of the coarse powder for each extraction, wherein the extraction time is 4 hours; mixing extractive solutions, and filtering to obtain ethanol extractive solution;
d. primary concentration: c, concentrating the ethanol extract obtained in the step c under reduced pressure under the conditions of vacuum degree of-0.05 to-0.06 MPa and temperature of 50 to 60 ℃ until the specific gravity is 1.05 to 1.15 to obtain an ethanol concentrated solution;
e. degreasing: d, adding purified water which is 8 times of the weight of the ethanol concentrated solution into the ethanol concentrated solution obtained in the step d, heating to 85-95 ℃ while stirring, stirring for 40 minutes at the stirring speed of 40 revolutions per minute, and then keeping the temperature and standing for 4 hours to separate oil from water;
f. secondary concentration: and e, discharging the lower-layer water liquid obtained in the step e, filtering the lower-layer water liquid by using filter paper, concentrating the filtrate under reduced pressure at the temperature of 60-80 ℃ and the vacuum degree of-0.05-0.06 MPa until the specific gravity is 1.25-1.35, and obtaining the periplaneta americana extract.
The preparation method of the extracts of the tree peony bark, the common selfheal fruit-spike, the Chinese thorowax root, the common burreed rhizome and the zedoary five-flavor plant medicine comprises the following steps:
a. pretreatment: collecting cortex moutan, Prunellae Spica, bupleuri radix, rhizoma Sparganii, and Curcumae rhizoma, removing impurities, and slicing or cutting;
b. extraction: taking cut medicinal decoction pieces of the a, extracting the medicinal decoction pieces for 2-4 times by using 70-90% ethanol, adding 6-8 times of 70-90% ethanol for the first time, soaking the medicinal decoction pieces for half an hour at normal temperature, and then heating and refluxing the medicinal decoction pieces for extraction for 2-3 hours; and then adding 70-90% ethanol in an amount which is 3-5 times that of the raw materials each time, and heating and refluxing for extraction for 1-2 hours. Collecting extractive solutions, mixing, and filtering to obtain ethanol extractive solution.
c. Concentration: and c, concentrating the ethanol extract obtained in the step b under reduced pressure under the conditions of vacuum degree of-0.05 to-0.06 MPa and temperature of 50 to 60 ℃ until the specific gravity is 1.2 to 1.3 to obtain the five-herb extract.
The invention is further illustrated by the following specific examples:
example 1
The formula is 100 parts of periplaneta americana; 60 parts of tree peony bark; 200 parts of selfheal; 80 parts of radix bupleuri; 150 parts of rhizoma sparganii; 60 parts of curcuma zedoary.
(1) The preparation method and the steps of the periplaneta americana extract are as described above for standby.
(2) The preparation method of the extracts of the tree peony bark, the common selfheal fruit-spike, the Chinese thorowax root, the common burreed rhizome and the zedoary five-flavor plant medicine comprises the following steps:
a. pretreatment: collecting cortex moutan, Prunellae Spica, bupleuri radix, rhizoma Sparganii, and Curcumae rhizoma, removing impurities, and slicing or cutting;
b. extraction: b, taking cut medicinal decoction pieces of the a, extracting the medicinal decoction pieces for 2 times by using 70% ethanol, adding 70% ethanol in an amount which is 6 times that of the medicinal decoction pieces for the first time, soaking the medicinal decoction pieces for half an hour at normal temperature, and then heating and extracting the medicinal decoction pieces for 2 hours under reflux; then, 3 times of 70% ethanol is added each time, and the mixture is heated and refluxed for extraction for 1 hour. Collecting extractive solutions, mixing, and filtering to obtain ethanol extractive solution.
c. Concentration: and c, concentrating the ethanol extract obtained in the step b under reduced pressure under the conditions of vacuum degree of-0.05 to-0.06 MPa and temperature of 50 to 60 ℃ until the specific gravity is 1.2 to obtain the five-herb extract.
(3) And (3) patent medicine preparation:
weighing the periplaneta Americana extract and the five-herb plant extract according to the mass part ratio of the medicinal materials, uniformly mixing and drying to obtain the pharmaceutical composition for treating the hyperplasia of mammary glands.
Example 2
The formula is 100 parts of periplaneta americana; 150 parts of moutan bark; 90 parts of selfheal; 30 parts of radix bupleuri; 60 parts of rhizoma sparganii; and 120 parts of curcuma zedoary.
(1) The preparation method and the steps of the periplaneta americana extract are as described above for standby.
(2) Preparation method of extracts of moutan bark, selfheal, radix bupleuri, rhizoma sparganii and curcuma zedoary
a. Pretreatment: collecting cortex moutan, Prunellae Spica, bupleuri radix, rhizoma Sparganii, and Curcumae rhizoma, removing impurities, and slicing or cutting;
b. extraction: b, taking cut medicinal decoction pieces of the a, extracting the medicinal decoction pieces for 3 times by using 80% ethanol, adding 8 times of 80% ethanol for the first time, soaking the decoction pieces for half an hour at normal temperature, and then heating and extracting the decoction pieces for 3 hours under reflux; then, 5 times of 80% ethanol is added each time, and the mixture is heated and refluxed for extraction for 2 hours. Collecting extractive solutions, mixing, and filtering to obtain ethanol extractive solution.
c. Concentration: and c, concentrating the ethanol extract obtained in the step b under reduced pressure under the conditions of vacuum degree of-0.05 to-0.06 MPa and temperature of 50 to 60 ℃ until the specific gravity is 1.25 to obtain the five-herb extract.
(3) And (3) patent medicine preparation:
weighing the periplaneta Americana extract and the five-herb plant extract according to the mass part ratio of the medicinal materials, uniformly mixing and drying to obtain the pharmaceutical composition for treating the hyperplasia of mammary glands.
Example 3
The formula is 100 parts of periplaneta americana; 200 parts of moutan bark; 150 parts of selfheal; 250 parts of bupleurum; 120 parts of rhizoma sparganii; 150 parts of curcuma zedoary.
(1) The preparation method and the steps of the periplaneta americana extract are as described above for standby.
(2) The preparation method of the extracts of the tree peony bark, the common selfheal fruit-spike, the Chinese thorowax root, the common burreed rhizome and the zedoary five-flavor plant medicine comprises the following steps:
a. pretreatment: collecting cortex moutan, Prunellae Spica, bupleuri radix, rhizoma Sparganii, and Curcumae rhizoma, removing impurities, and slicing or cutting;
b. extraction: taking cut medicinal decoction pieces of a, extracting the medicinal decoction pieces with 90% ethanol for 4 times, adding 7 times of 90% ethanol for the first time, soaking at normal temperature for half an hour, and then heating and extracting under reflux for 3 hours; then, 90% ethanol in an amount of 4 times the amount of the extract was added thereto, and the mixture was heated under reflux for 2 hours. Collecting extractive solutions, mixing, and filtering to obtain ethanol extractive solution.
c. Concentration: and c, concentrating the ethanol extract obtained in the step b under reduced pressure under the conditions of vacuum degree of-0.05 to-0.06 MPa and temperature of 50 to 60 ℃ until the specific gravity is 1.3 to obtain the five-herb extract.
(3) And (3) patent medicine preparation:
weighing the periplaneta Americana extract and the five-herb plant extract according to the mass part ratio of the medicinal materials, uniformly mixing and drying to obtain the pharmaceutical composition for treating the hyperplasia of mammary glands.
Example 4
The formula is 100 parts of periplaneta americana; 120 parts of moutan bark; 150 parts of selfheal; 100 parts of bupleurum; 80 parts of rhizoma sparganii; and 80 parts of curcuma zedoary.
(1) The preparation method and the steps of the periplaneta americana extract are as described above for standby.
(2) The preparation method of the extracts of the tree peony bark, the common selfheal fruit-spike, the Chinese thorowax root, the common burreed rhizome and the zedoary five-flavor plant medicine comprises the following steps:
a. pretreatment: collecting cortex moutan, Prunellae Spica, bupleuri radix, rhizoma Sparganii, and Curcumae rhizoma, removing impurities, and slicing or cutting;
b. extraction: b, taking cut medicinal decoction pieces of the a, extracting the medicinal decoction pieces for 3 times by using 80% ethanol, adding 7 times of 90% ethanol for the first time, soaking the decoction pieces for half an hour at normal temperature, and then heating and extracting the decoction pieces for 2 hours under reflux; then, 90% ethanol in an amount of 4 times the amount of the extract was added thereto, and the mixture was heated under reflux for 1 hour. Collecting extractive solutions, mixing, and filtering to obtain ethanol extractive solution.
c. Concentration: and c, concentrating the ethanol extract obtained in the step b under reduced pressure under the conditions of vacuum degree of-0.05 to-0.06 MPa and temperature of 50 to 60 ℃ until the specific gravity is 1.23 to obtain the five-herb extract.
(3) And (3) patent medicine preparation:
weighing the periplaneta Americana extract and the five-herb plant extract according to the mass part ratio of the medicinal materials, uniformly mixing and drying to obtain the pharmaceutical composition for treating the hyperplasia of mammary glands.
Example 5
Case data: 130 patients with hyperplasia of mammary glands are randomly divided into 70 treatment groups and 60 control groups, wherein the treatment groups are 26-47 years old, the average age is 32.46 years old, the shortest disease course is 5 months, and the longest disease course is 7 years. Patients all feel breast pain, and may be aggravated after great mood swings or after fatigue and before menstruation, and palpate masses of varying sizes.
The treatment method comprises the following steps: the treatment group administers tablets prepared from the pharmaceutical composition for treating hyperplasia of mammary glands provided by the invention, and the tablets are orally taken 3 times a day and 3 times a day. The control group takes the tablets for eliminating nodules of breast, and the tablets are orally taken 5 to 6 tablets at a time and 3 times a day. 1 treatment course in 1 month in two groups, continuously treating for 3 treatment courses, stopping administration in menstrual period, advising patients to keep good mood during administration, avoiding mental irritation and overwork, avoiding taking pungent, greasy and irritant substances, rechecking for 1 time every month, and making visit for 3 months after stopping administration.
The curative effect standard is as follows: refer to the diagnosis, syndrome differentiation and efficacy evaluation criteria of mammary gland hyperplasia discussed and revised by the society for mastopathy professional committee of Chinese medical and pharmaceutical sciences. The breast lump symptom and pain disappear to be cured; the breast lumps are obviously improved into obvious effect, and are all improved into effective effect, and no obvious improvement or aggravation is ineffective.
The treatment effect is as follows: the treatment group is cured by 52 cases (74.3%), 10 cases with obvious effect (14.3%), 5 cases with effect (7.1%), 3 cases with no effect (4.3%) and the total effective rate is 95.7%. The control group cured 38 cases (63.3%), significant 8 cases (13.3%), significant 7 cases (11.7%), ineffective 7 cases (11.7%) and total effective rate 88.3%. The cure rate and the total effective rate of the treatment group are higher than those of the control group, and in the cure cases, the treatment group recurs 2 times (recurrence rate is 3.9%) and the control group recurs 3 times (recurrence rate is 7.9%) after 3 months. Therefore, the curative effect of the treatment group is obviously better than that of the control group, and the relapse rate of the treatment group is obviously lower than that of the control group.
The results show that the composition can not only obviously improve the curative effect, but also has low recurrence rate, less toxic and side effects, good safety, economy and practicality, and is worthy of clinical popularization and application.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims (9)

1. The pharmaceutical composition for treating the hyperplasia of mammary glands is characterized by comprising 50-150 parts of periplaneta americana, 60-200 parts of tree peony bark, 90-250 parts of selfheal, 30-150 parts of radix bupleuri, 60-150 parts of rhizoma sparganii and 60-150 parts of curcuma zedoary by weight, and is prepared through the steps of pretreatment, extraction and post-treatment, and the pharmaceutical composition for treating the hyperplasia of mammary glands specifically comprises the following components:
A. pretreatment: grinding and sieving the American cockroach raw material in the formula ratio to obtain a material a for later use; meanwhile, the raw materials of the formula, namely the tree peony bark, the common selfheal fruit-spike, the Chinese thorowax root, the common burreed rhizome and the zedoary are respectively cut into slices or segments and mixed to obtain a material b for later use;
B. extraction:
1) adding an ethanol solution into the material a for extraction and concentration to obtain an extract c;
2) adding an ethanol solution into the material b for extraction and concentration to obtain an extract d;
C. and (3) post-treatment: and respectively crushing and sieving the extract c and the extract d, and uniformly mixing to obtain the target pharmaceutical composition for treating the hyperplasia of mammary glands.
2. The pharmaceutical composition for treating the hyperplasia of mammary glands according to claim 1, wherein the pharmaceutical composition for treating the hyperplasia of mammary glands is prepared from 80-120 parts by weight of periplaneta americana, 100-150 parts by weight of moutan bark, 150-200 parts by weight of selfheal, 80-110 parts by weight of radix bupleuri, 80-120 parts by weight of rhizoma sparganii and 80-120 parts by weight of curcuma zedoary through the steps of pretreatment, extraction and post-treatment.
3. The pharmaceutical composition for treating hyperplasia of mammary glands according to claim 1, wherein the pharmaceutical composition for treating hyperplasia of mammary glands is prepared from the following raw materials, by weight, 100 parts of periplaneta americana, 100 parts of moutan bark, 180 parts of selfheal, 80 parts of radix bupleuri, 90 parts of rhizoma sparganii and 90 parts of curcuma zedoary, and is prepared through the steps of pretreatment, extraction and post-treatment.
4. The pharmaceutical composition for treating hyperplasia of mammary glands according to claim 1, wherein the pharmaceutical composition for treating hyperplasia of mammary glands is prepared from the following raw materials, by weight, 100 parts of periplaneta americana, 120 parts of moutan bark, 150 parts of selfheal, 100 parts of radix bupleuri, 80 parts of rhizoma sparganii and 80 parts of curcuma zedoary, and is prepared through the steps of pretreatment, extraction and post-treatment.
5. The pharmaceutical composition for treating mammary gland hyperplasia according to claim 1, wherein the pulverizing and sieving in step A is pulverizing and sieving with 24 mesh sieve.
6. The pharmaceutical composition for treating mammary gland hyperplasia according to claim 1, wherein the extraction step in step B is as follows:
1) adding an ethanol solution with the volume percentage concentration of 90-95% and the feed liquid volume ratio of 1: 3-5 into the material a, and soaking for 3-5 hours at normal temperature to obtain a material e; performing reflux extraction on the material e for 4 times at the temperature of 70-85 ℃, and concentrating to obtain an extract c;
2) and adding 70-90% ethanol solution with the volume percentage concentration of 1: 3-10 into the material b, soaking and extracting for 3-5 h, and then performing reflux extraction and concentration at the temperature of 70-85 ℃ to obtain an extract d.
7. The pharmaceutical composition for treating mammary gland hyperplasia according to claim 1, wherein the pulverizing and sieving in step C is pulverizing and sieving with 100 mesh sieve.
8. A preparation of the pharmaceutical composition for treating the hyperplasia of mammary glands according to any one of claims 1 to 7, wherein pharmaceutically acceptable auxiliary materials are added into the pharmaceutical composition for treating the hyperplasia of mammary glands to prepare tablets, capsules, granules, pills and mixtures.
9. The application of the pharmaceutical composition for treating hyperplasia of mammary glands according to any one of claims 1 to 7, which is characterized in that the pharmaceutical composition for treating hyperplasia of mammary glands is applied to the preparation of medicines for preventing/treating hyperplasia of mammary glands.
CN201710088298.XA 2017-02-17 2017-02-17 Pharmaceutical composition for treating hyperplasia of mammary glands and preparation method, preparation and application thereof Active CN106729447B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201710088298.XA CN106729447B (en) 2017-02-17 2017-02-17 Pharmaceutical composition for treating hyperplasia of mammary glands and preparation method, preparation and application thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201710088298.XA CN106729447B (en) 2017-02-17 2017-02-17 Pharmaceutical composition for treating hyperplasia of mammary glands and preparation method, preparation and application thereof

Publications (2)

Publication Number Publication Date
CN106729447A CN106729447A (en) 2017-05-31
CN106729447B true CN106729447B (en) 2020-06-16

Family

ID=58958853

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201710088298.XA Active CN106729447B (en) 2017-02-17 2017-02-17 Pharmaceutical composition for treating hyperplasia of mammary glands and preparation method, preparation and application thereof

Country Status (1)

Country Link
CN (1) CN106729447B (en)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103191369A (en) * 2013-04-08 2013-07-10 李学风 Chinese medicinal composition for treating mammary gland hyperplasia

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103191369A (en) * 2013-04-08 2013-07-10 李学风 Chinese medicinal composition for treating mammary gland hyperplasia

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
夏三莪饮治疗乳腺增生症200例;胡兴明,等;《山西中医》;20051031;第21卷(第5期);第20页左栏第1段,右栏第3段和最后1段,第21页左栏第1段 *

Also Published As

Publication number Publication date
CN106729447A (en) 2017-05-31

Similar Documents

Publication Publication Date Title
CN101632827B (en) Traditional Chinese medicine composition for treating psoriasis and preparation method thereof
CN101850032B (en) Anti-tumor traditional Chinese medicine composition and preparation method and application thereof
CN106334060B (en) Pharmaceutical composition for treating obesity type polycystic ovarian syndrome
CN104055935A (en) Traditional Chinese medicine composition for improving immunity in synergetic mode
CN106729447B (en) Pharmaceutical composition for treating hyperplasia of mammary glands and preparation method, preparation and application thereof
CN106038637A (en) Pharmaceutical composition for treating breast cancer
CN101357206A (en) Medicine for treating liver cancer and preparation method thereof
CN104056207B (en) Traditional Chinese medicine combination for treating stomach cancer and preparation method for same
CN100457147C (en) Chinese medicine composition for treating climacteric metancholia for women and preparing method thereof
CN110960651B (en) Traditional Chinese medicine preparation with mammary gland hyperplasia resisting effect and preparation method and application thereof
CN104138502A (en) Traditional Chinese medicine compound for treating ovarian tumors and preparation method and application thereof
CN116870076B (en) Anti-inflammatory analgesic traditional Chinese medicine composition and preparation method and application thereof
CN1163252C (en) Tianjian capsule and its preparing process
CN115364179B (en) Traditional Chinese medicine composition for reducing blood uric acid as well as preparation method and application thereof
CN102727834B (en) Traditional Chinese medicine composition for treating migraine, and preparation method and application thereof
CN1244340C (en) Chinese medicine for treating coronary heart disease and angina pectoris and its preparing process
CN102406790A (en) Traditional Chinese medicine capsule for treating hyperplasia of mammary glands and preparation method thereof
CN104274708A (en) Traditional Chinese medicine for treating hyperthyroidism
CN103462938B (en) Cataplasm and preparation method thereof
CN1063074C (en) Chinese herbs injection for treating oncoma (cancer) and preparation method
CN1189207C (en) Chinese medicinal composition for improving human immunity and its preparation method
CN103055018A (en) Freeze-dried fresh rehmannia for treating senile dementia
CN1114434C (en) Medical capsule for treating hepatitis and its preparing process
CN111759991A (en) Traditional Chinese medicine compound preparation for treating chronic liver diseases and preparation method and application thereof
CN117771166A (en) Traditional Chinese medicine ointment for treating targeted drug-related rash as well as preparation method and application thereof

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant