CN104435435B - A kind of Chinese medicinal granule for the treatment of dysmenorrhes and preparation method thereof - Google Patents

A kind of Chinese medicinal granule for the treatment of dysmenorrhes and preparation method thereof Download PDF

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CN104435435B
CN104435435B CN201410782659.7A CN201410782659A CN104435435B CN 104435435 B CN104435435 B CN 104435435B CN 201410782659 A CN201410782659 A CN 201410782659A CN 104435435 B CN104435435 B CN 104435435B
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adjuvant
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chinese medicine
weight ratio
chinese medicinal
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CN104435435A (en
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肖军平
吴永忠
康兴东
杨伟庆
陈金德
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JIANGXI PUZHENG PHARMACEUTICAL CO Ltd
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SHANDONG JINGYUTANG PHARMACEUTICAL Co Ltd
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    • 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)
    • A61K36/66—Papaveraceae (Poppy family), e.g. bloodroot
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/24—Mucus; Mucous glands; Bursa; Synovial fluid; Arthral fluid; Excreta; Spinal fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K36/537—Salvia (sage)
    • A—HUMAN NECESSITIES
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/00—Isolation 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
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/00—Isolation 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
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation 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
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps

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Abstract

The present invention relates to a kind of compound Chinese medicinal preparation for the treatment of primary dysmenorrhea and preparation method thereof.It is made up of Chinese medicine extract and adjuvant.The weight ratio of described Chinese medicine extract and adjuvant is 10:1.0 ~ 1.6; Described Chinese medicine extract by weight portion is: Rhizoma Corydalis 10 parts, Radix Salviae Miltiorrhizae 10 parts, Oletum Trogopterori 10 parts and Pollen Typhae 10 parts are made.Described adjuvant is preferably hydroxypropyl emthylcellulose, pregelatinized Starch and Aspartame, and the weight ratio of three is 1:0.2 ~ 0.8:0.02.The present invention gropes by lot of experiments research the preferred plan obtaining supplementary product kind, proportioning and consumption, adopt above-mentioned adjuvant to overcome Chinese medicinal granule affects medicine stability problem due to hygroscopicity, Chinese medicinal granule of the present invention greatly improves the stability of dysmenorrhes granule.

Description

A kind of Chinese medicinal granule for the treatment of dysmenorrhes and preparation method thereof
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of compound Chinese medicinal preparation for the treatment of primary dysmenorrhea and preparation method thereof.
Background technology
Dysmenorrhea refers to that women occurs that before and after menstrual period or its periodically hypogastralgia is main symptom, uncomfortable with other, so that affects the gynaecopathia of work and life.China's menalgia sickness rate is 33.19%, is commonly encountered diseases and the frequently-occurring disease of gynecological.Dysmenorrhea is divided into constitutional and Secondary cases two class, and primary dysmenorrhea refers to the dysmenorrhea of genitals without organic disease, is mainly in juvenile era.Its pathomechanism may be relevant with endometrial prostaglandin, and in dysmenorrhea patient uterine inner membrance and blood, Prostaglandin is higher than normal women.Dysmenorrhea occurs together nausea,vomiting,diarrhea, dizziness, the symptom such as weak often, and severe patient can have pale complexion, be in a cold sweat, and has had a strong impact on work and the quality of life of patient, must active treatment.But the treatment at present to primary dysmenorrhea, adopt non_steroidal anti_inflammatory drug, gonadal hormone, pain relieving spasmolytic, prostaglandin inhibitor treatment, clinical effectiveness is not obvious, has certain toxic and side effects to patient more.But often receive good effect with treatment by Chinese herbs.
Dysmenorrhes ball records for " Drug Standard of Ministry of Public Health of the Peoples Republic of China " Traditional Chinese medicine historical preparation first, and medicine consists of Rhizoma Corydalis, Oletum Trogopterori, Radix Salviae Miltiorrhizae and Pollen Typhae, effect blood-activating and qi-promoting, menstruction regulating and pain relieving, less and power is special, and curative effect certainly.But this product is concentrated pill, holding time its disintegration slightly long easily changes and transfinites, and taking dose is bigger than normal, once needs to take 50.
Patent CN1548125 discloses a kind of improvement dosage form of dysmenorrhes ball, it is by changing system into granule by pill, improve the stability of medicine to a certain extent and decrease dosage, but its preparation recipe is simple, the hygroscopicity problems of granule cannot be overcome completely, thus cause the unstability of granule.
Summary of the invention
An object of the present invention is to provide a kind of Chinese medicinal granule for the treatment of dysmenorrhes, it is made up of Chinese medicine extract and adjuvant.The weight ratio of described Chinese medicine extract and adjuvant is 10:1.0 ~ 1.6; Described Chinese medicine extract by weight portion is: Rhizoma Corydalis 10 parts, Radix Salviae Miltiorrhizae 10 parts, Oletum Trogopterori 10 parts and Pollen Typhae 10 parts are made.
Described adjuvant is selected from starch, pregelatinized Starch, starch slurry, beta-schardinger dextrin-, carbomer, microcrystalline Cellulose, hydroxypropyl emthylcellulose, low-substituted hydroxypropyl cellulose, carboxymethylcellulose calcium, Polyethylene Glycol (PEG), sodium carboxymethyl cellulose, methylcellulose, ethyl cellulose, mannitol, sodium lauryl sulphate, cross-linking sodium carboxymethyl cellulose, lactose, polyvinylpyrrolidone (PVP), crospolyvinylpyrrolidone, magnesium stearate, Pulvis Talci, micropowder silica gel, aspartame, orange flavor, sodium bicarbonate, one or more in sodium carbonate.The adjuvant used of above-mentioned preparation and preparation method all can adopt the adjuvant of its routine and preparation method to obtain.
In embodiments of the invention, the weight ratio of described Chinese medicine extract and adjuvant is preferably 10:1.3; Described adjuvant is preferably hydroxypropyl emthylcellulose, pregelatinized Starch and Aspartame, and the weight ratio of three is 1:0.2 ~ 0.8:0.02.
Further, the weight ratio of described hydroxypropyl emthylcellulose, pregelatinized Starch and Aspartame is preferably 1:0.4:0.02.
Another object of the present invention is to provide a kind of method preparing described Chinese medicinal granule, and concrete steps are as follows:
(1) after above-mentioned four taste Chinese medicines being pulverized by proportioning, extract twice at 80 DEG C with the ethanol of 80% of 10 times amount and 8 times amount respectively, extraction time is 2h at every turn, filter and merging filtrate, decompression recycling ethanol obtains extractum, adopts the water of 8 times amount again to extract filtering residue, and the time is 2h, the extractum of reclaim under reduced pressure, merges alcohol and mentions the water extracted immersing paste;
(2) get extractum, mix with the adjuvant of corresponding weight portion, add 60% appropriate amount of ethanol and granulate, dry, to obtain final product.
The present invention gropes by lot of experiments research the preferred plan obtaining supplementary product kind, proportioning and consumption, adopt above-mentioned adjuvant to overcome Chinese medicinal granule affects medicine stability problem due to hygroscopicity, Chinese medicinal granule of the present invention greatly improves the stability of dysmenorrhes granule.
Detailed description of the invention
Further will describe the present invention in detail below.It is pointed out that following explanation is only illustrating the technical scheme that application claims is protected, any restriction not to these technical schemes.The content that protection scope of the present invention is recorded with appended claims is as the criterion.
Embodiment 1
Get 1000g Rhizoma Corydalis, 1000g Oletum Trogopterori, 1000g Radix Salviae Miltiorrhizae and 1000g Pollen Typhae, 80% ethanol of 1.5L extracts 2h at 80 DEG C, filter, 80% ethanol adding 1.2L extracts 2h at 80 DEG C, filter merging filtrate, reclaim under reduced pressure obtains the extractum of relative density 1.25-1.30 (50 DEG C), 1.2L water extraction 2h is added in filtering residue, filter, reclaim under reduced pressure obtains the extractum of relative density 1.25-1.30 (50 DEG C), merge extractum, get 300g extractum, 30g auxiliary materials and mixing (hydroxypropyl emthylcellulose in adjuvant, the weight ratio 1:0.2:0.02 of pregelatinized Starch and Aspartame), add appropriate 60% alcohol granulation, dry, obtain.
Embodiment 2-5
Except following table parameter, other preparation methoies are all identical with embodiment 1
The study on the stability of dysmenorrhes granule prepared by embodiment 6 embodiment 1-3
Investigate correlated samples stability according to the stability guideline of Chinese Pharmacopoeia 2010 editions two annex, investigate the placement medicine stability of 60 days under placing 36 months, 25 DEG C and relative humidity 75% condition at 25 DEG C respectively.HPLC method is adopted to measure the content of tetrahydropalmatine and salvianolic acid B in Chinese medicinal granule.
In addition, for embodying the superiority of capsule of the present invention, ad hoc fixed following comparative example:
Comparative example 1: do not add any adjuvant, other are with embodiment 3;
Comparative example 2: preparation method and supplementary product consumption are with patent CN1548125, and other are with embodiment 3;
Comparative example 3: Chinese medicine extract and supplementary product consumption are than being 10:2.0, and other are with embodiment 3;
The weight ratio of comparative example 4: three kinds of adjuvants is 10:0.1:0.02, and other are with embodiment 3;
The weight ratio of comparative example 5: three kinds of adjuvants is 10:1.2:0.02, and other are with embodiment 3;
Place each group Effective Component of Chinese Medicine content (n=10) after 36 months for 25 DEG C
Place under 25 DEG C and relative humidity 75% condition and respectively organize Effective Component of Chinese Medicine content (n=10) afterwards in 60 days
In addition, get sample after above-mentioned test, require to carry out detection disintegration with reference to Chinese Pharmacopoeia 2010 editions annex XIIA, result is as follows:
Place 36 months for 25 DEG C
Disintegration (min)
Embodiment 1 19.5
Embodiment 2 21.8
Embodiment 3 14.5
Comparative example 1 43.8
Comparative example 2 35.2
Comparative example 3 31.4
Comparative example 4 32.8
Comparative example 5 30.5
Place 60 days under 25 DEG C and relative humidity 75% condition
Disintegration (min)
Embodiment 1 25.4
Embodiment 2 26.3
Embodiment 3 16.9
Comparative example 1 58.5
Comparative example 2 43.3
Comparative example 3 35.9
Comparative example 4 34.5
Comparative example 5 32.8
Content of the present invention merely illustrates some claimed specific embodiments; one of them or more described technical characteristic can be combined with arbitrary one or more technical scheme in technical scheme; these technical schemes obtained through combination also in the application's protection domain, just as these technical schemes obtained through combination in the disclosure of invention concrete record.

Claims (3)

1. treat a Chinese medicinal granule for dysmenorrhes, it is characterized in that, it is made up of Chinese medicine extract and adjuvant; The weight ratio of described Chinese medicine extract and adjuvant is 10:1.0 ~ 1.6; Described Chinese medicine extract by weight portion is: Rhizoma Corydalis 10 parts, Radix Salviae Miltiorrhizae 10 parts, Oletum Trogopterori 10 parts and Pollen Typhae 10 parts are made; Described adjuvant is hydroxypropyl emthylcellulose, pregelatinized Starch and Aspartame, and the weight ratio of three is 1:0.2 ~ 0.8:0.02, and concrete preparation method is as follows:
(1) after above-mentioned four taste Chinese medicines being pulverized by proportioning, extract twice at 80 DEG C with the ethanol of 80% of 10 times amount and 8 times amount respectively, extraction time is 2h at every turn, filter and merging filtrate, decompression recycling ethanol obtains extractum, adopts the water of 8 times amount again to extract filtering residue, and the time is 2h, reclaim under reduced pressure obtains extractum, merges alcohol and mentions the water extracted immersing paste;
(2) get extractum, mix with the adjuvant of corresponding weight portion, add 60% appropriate amount of ethanol and granulate, dry, to obtain final product.
2. Chinese medicinal granule according to claim 1, is characterized in that, the weight ratio of described hydroxypropyl emthylcellulose, pregelatinized Starch and Aspartame is preferably 1:0.4:0.02.
3. Chinese medicinal granule according to claim 1, is characterized in that, the weight ratio of described Chinese medicine extract and adjuvant is preferably 10:1.3.
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Publication number Priority date Publication date Assignee Title
CN105832922A (en) * 2016-06-10 2016-08-10 普正药业股份有限公司 Application of woman dysmenorrhea granules to medicines for improving blood rheology
CN106404974B (en) * 2016-08-30 2018-01-23 普正药业股份有限公司 A kind of method for building up of dysmenorrhes particle finger-print
CN116135218B (en) * 2023-04-20 2023-07-04 北京东升制药有限公司 Eight-ingredient dysmenorrhea granule and preparation method thereof

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1548125A (en) * 2003-05-11 2004-11-24 山东绿因药业有限公司 Dysmenorrhea treating granule and its prepn process

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1548125A (en) * 2003-05-11 2004-11-24 山东绿因药业有限公司 Dysmenorrhea treating granule and its prepn process

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
妇女痛经丸治疗原发性痛经的临床疗效观察;辛菊云;《社区医学杂志》;20121031;第10卷(第20期);第31-32页 *
妇女痛经丸质量控制标准鉴定研究;朱荣，朱斌;《临床合理用药》;20120229;第5卷(第2B期);第27-29页 *

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