CN100381166C - Suppository for treating chronic cervicitis - Google Patents

Suppository for treating chronic cervicitis Download PDF

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CN100381166C
CN100381166C CNB2004101044357A CN200410104435A CN100381166C CN 100381166 C CN100381166 C CN 100381166C CN B2004101044357 A CNB2004101044357 A CN B2004101044357A CN 200410104435 A CN200410104435 A CN 200410104435A CN 100381166 C CN100381166 C CN 100381166C
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radix
herba
fructus
rhizoma
suppository
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CN1663596A (en
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赵恒�
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XI'AN HENGTONG GUANGHUE PHARMACEUTICAL CO Ltd
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Abstract

The present invention belongs to a suppository for treating chronic cervicitis which is characterized in that its main component includes Alpha-mannan peptides 20-40%, and Chinese traditional medicine with broadspectrum antibiotic action 60-80%. The main components also includes Alpha-mannan peptides 20-40%, Chinese traditional medicine with broadspectrum antibiotic action 30-60%, and Chinese traditional medicine with the anti vagina trichomonad 10-30%. The main component further includes Alpha-mannan peptides 20-40%, Chinese traditional medicine with broadspectrum antibiotic action 20-40%, Chinese traditional medicine with the anti vagina trichomonad 10-20%, and Chinese traditional medicine of reducing fever dehumidification detoxifcation kind 10-30%. The suppository for treating chronic cervicitis adopts the suppository synthesized by biological preparation and Chinese traditional medicine, and can be reasonably prescribed according to the pathogeny and pathological change of the chronic cervicitis, and can curing dialectically and reach the effect of seeking both temporary and permanent solution; and this suppository is used in vagina and can be absorbed by mucous membrane with direct acting and remarkable curative effect, and can be put by the patient conveniently, safely without toxic side reaction.

Description

A kind of suppository for the treatment of chronic cervicitis
Affiliated technical field
The invention belongs to a kind of suppository for the treatment of chronic cervicitis, particularly about a kind of suppository of the treatment chronic cervicitis that is mixed and made into biological preparation and Chinese medicine.
Background technology
Chronic cervicitis is a female reproductive system common inflammation disease the most, mostly is the acute cervicitis treatment and does not thoroughly change.There are a large amount of antibacterials in normal women vagina and the cervix uteri, because the squamous epithelial cancer layer of ectocervical is thicker, resistance is strong, generally is difficult for causing infection, and cervical canal mucosa columnar epithelium layer is thinner, vulnerable, when damage took place, pathogen seized the opportunity to worm one's way into the part that the cervical mucosa columnar epithelium is covered, add that the cervical mucosa pleat is many, pathogen is hiding herein, infects to be difficult for thoroughly removing, and often forms chronic cervicitis.
The pathogenic factor of chronic cervicitis has some: 1. mechanical injuries: the damage that childbirth, uteroventral operation or sexual life cause, changed the physiological condition of reproductive tract, and weakened partial defense function, increased the chance and the condition that infect; 2. acute cervicitis changes: acute stage hide antibacterial in cervix gland or mucosal fold thoroughly do not remove and cause that pathogen is mainly staphylococcus, streptococcus, escherichia coli and anaerobe; 3. virus or chlamydia infection: the generation of chronic cervicitis and human papillomavirus, herpes simplex virus and chlamydia infection are closely related; 4. special infection: tuberculous cervicitis, cervix uteri gonorrhea, parasitic cervicitis etc.Motherland's traditional medicine is then thought chronic cervicitis always by stopping in the turbid damp, damp and hot stasis of blood knot, and conception vessel is solid, due to dai channel is failed to keep an appointment.
The pathological change of chronic cervicitis: chronic cervicitis is that the cervix uteri squamous epithelial cancer strips off because of inflammation, is substituted by the neck tube columnar epithelium.Can be divided into following several according to the histopathology form: 1. cervical erosion: be meant red sick damage the on cervix uteri surface, for squamous epithelial cancer comes off, the columnar epithelium area of coverage.Multinuclear leucocyte and plasmocyte infiltrating, vasodilation hyperemia, cervix uteri proliferation of fibrous tissue are arranged under the visible mucosa under the mirror.2. cervical polyp: since the stimulation of inflammation, the neck tube mucosal hyperplasia, outstanding from basal layer to the cervix uteri collar extension, form polyp.Polyp matter is soft and crisp, and is easily hemorrhage.See polyp surface coverage one deck columnar epithelium under the mirror, the center is a connective tissue, companion's hyperemia, edema and inflammatory cell infiltration.3. Nabothcyst: in the inflammation repair process, newborn squamous epithelial cancer covers cervix uteri glandular tube mouth or stretches into glandular tube, and the mouth of pipe is stopped up.Connective tissue proliferation cicatrization around the glandular tube, the compressing glandular tube narrows down glandular tube even stops up, the fully drain and form Nabothcyst of glandular secretion thing.See under the mirror that endocervix organizes body of gland to enlarge unusually, intracavity is full of mucus, and the body of gland epithelial cell is low column or has been pressed into flat.4. cervical hypertrophy: because of the inflammation long-time stimulus, cervical tissue hyperemia, edema, a matter and glandular hyperplasia, fibrous connective tissue is hypertrophy also, cause cervix uteri to increase and quality hard.
Summary of the invention
The purpose of this invention is to provide a kind of suppository for the treatment of chronic cervicitis, its adopts biological preparation and the synthetic suppository of the Chinese medicine cause of disease, the pathological change at chronic cervicitis, reasonable formula, and dialectical executing controlled, and reaches the effect for the treatment of both the principal and secondary aspects of a disease; This medicine adopts vagina administration simultaneously, has mucosa absorption, effect is direct, evident in efficacy, characteristics such as patient can place voluntarily, makes things convenient for, safety, no toxicity.
Technical scheme of the present invention is: design a kind of suppository for the treatment of chronic cervicitis, it is characterized in that: its Main Ingredients and Appearance includes the Chinese medicine 60-80% of α-mannatide 20-40%, broad-spectrum antibacterial action.
Described Main Ingredients and Appearance also includes the Chinese medicine 10-30% of α-mannatide 20-40%, the Chinese medicine 30-60% of broad-spectrum antibacterial action, anti-trichomonas vaginitis.
Described Main Ingredients and Appearance also includes Chinese medicine 10-20%, the removing damp-heat detoxifcation class Chinese medicine 10-30% of α-mannatide 20-40%, the Chinese medicine 20-40% of broad-spectrum antibacterial action, anti-trichomonas vaginitis.
Described Main Ingredients and Appearance also includes Chinese medicine 10-20%, removing damp-heat detoxifcation class Chinese medicine 10-20%, the spleen strengthening and damp drying class Chinese medicine 10-30% of α-mannatide 10-30%, the Chinese medicine 20-40% of broad-spectrum antibacterial action, anti-trichomonas vaginitis.
Described Main Ingredients and Appearance also includes Chinese medicine 5-20%, removing damp-heat detoxifcation class Chinese medicine 5-30%, the spleen strengthening and damp drying class Chinese medicine 10-30%, the QI invigorating invigorating middle warmer class Chinese medicine 5-20% of α-mannatide 10-30%, the Chinese medicine 10-30% of broad-spectrum antibacterial action, anti-trichomonas vaginitis.
The Chinese medicine of described broad-spectrum antibacterial action has: Flos Lonicerae, Radix Isatidis, Fructus Forsythiae, Folium Isatidis, Indigo Naturalis, Rhizoma Coptidis, Radix Scutellariae, Cortex Phellodendri, Caulis Fibraureae, Herba Andrographis, Herba Violae, Herba Taraxaci, Herba Patriniae, Rhizoma Paridis, Radix Gentianae, Radix Sophorae Tonkinensis, the Rhizoma Anemarrhenae, Cortex Magnoliae Officinalis, Cortex Moutan, the Radix Paeoniae Alba, Spica Prunellae, Fructus Trichosanthis, Calculus Bovis, Bulbus Allii, Fructus Chebulae; The Chinese medicine of described anti-trichomonas vaginitis has: Fructus Cnidii, Radix Sophorae Flavescentis, the Radix Pulsatillae, melia, bud of Herba Agrimoniae, Herba Menthae, Bulbus Allii, very light blue, Semen Raphani, Olibanum, Folium Persicae, Fructus Gleditsia; Described removing damp-heat detoxifcation class Chinese medicine has: Radix Gentianae, Radix Scutellariae, Rhizoma Imperatae, the Radix Rehmanniae, Gypsum Fibrosum, the Rhizoma Anemarrhenae, LIUYI SAN, Folium Isatidis, Cortex Moutan, Radix Paeoniae Rubra, Herba Plantaginis, Cortex Sclerotii Poriae, raw pearl barley, the Fructus Kochiae, Herba Hedyotidis Diffusae; Described the spleen strengthening and damp drying class Chinese medicine has: Rhizoma Atractylodis, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri tangerinae, the Rhizoma Pinelliae, Poria, Rhizoma Alismatis, Polyporus, Talcum, Semen Plantaginis; Described QI invigorating invigorating middle warmer class Chinese medicine has: Radix Codonopsis, Rhizomadioscoreae, the Radix Astragali, Radix Ginseng, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Rehmanniae Preparata.
Composition is α-mannatide 300g, Flos Lonicerae 30g, Radix Isatidis 50g, Fructus Forsythiae 30g, Folium Isatidis 25g, Indigo Naturalis 30g, Rhizoma Coptidis 30g, Radix Scutellariae 30g, Cortex Phellodendri 30g, Caulis Fibraureae 25g, Herba Andrographis 30g, Herba Violae 30g, Herba Taraxaci 25g, Herba Patriniae 30g, Rhizoma Paridis 25g, Radix Gentianae 20g, Radix Sophorae Tonkinensis 30g, Rhizoma Anemarrhenae 10g, Cortex Magnoliae Officinalis 30g, Cortex Moutan 30g, Radix Paeoniae Alba 20g, Spica Prunellae 30g, Fructus Trichosanthis 30g, Calculus Bovis 20g, Bulbus Allii 30g, Fructus Chebulae 30g among the described medicament 1000g.
Composition is α-mannatide 300g among the described medicament 1000g; Flos Lonicerae 20g; Radix Isatidis 40g; Fructus Forsythiae 20g; Folium Isatidis 15g; Indigo Naturalis 20g; Rhizoma Coptidis 20g; Radix Scutellariae 20g; Cortex Phellodendri 20g; Caulis Fibraureae 15g; Herba Andrographis 20g; Herba Violae 20g; Herba Taraxaci 15g; Herba Patriniae 20g; Rhizoma Paridis 15g; Radix Gentianae 10g; Radix Sophorae Tonkinensis 20g; Rhizoma Anemarrhenae 10g; Cortex Magnoliae Officinalis 20g; Cortex Moutan 20g; Radix Paeoniae Alba 10g; Spica Prunellae 20g; Fructus Trichosanthis 20g; Calculus Bovis 10g; Fructus Chebulae 20g; Fructus Cnidii 20g; Radix Sophorae Flavescentis 20g; Radix Pulsatillae 20g; melia 20g; bud of Herba Agrimoniae 20g; Herba Menthae 20g; Bulbus Allii 40g; very light blue 20g; Semen Raphani 20g; Olibanum 20g; Folium Persicae 20g; Fructus Gleditsia 20g.
Composition is α-mannatide 300g among the described medicament 1000g; Flos Lonicerae 20g; Radix Isatidis 20g; Fructus Forsythiae 10g; Folium Isatidis 10g; Indigo Naturalis 10g; Rhizoma Coptidis 10g; Radix Scutellariae 15g; Cortex Phellodendri 10g; Caulis Fibraureae 10g; Herba Andrographis 10g; Herba Violae 15g; Herba Taraxaci 5g; Herba Patriniae 10g; Rhizoma Paridis 15g; Radix Gentianae 10g; Radix Sophorae Tonkinensis 15g; Rhizoma Anemarrhenae 5g; Cortex Magnoliae Officinalis 10g; Cortex Moutan 15g; Radix Paeoniae Alba 10g; Spica Prunellae 10g; Fructus Trichosanthis 15g; Calculus Bovis 10g; Fructus Chebulae 10g; Fructus Cnidii 10g; Radix Sophorae Flavescentis 15g; Radix Pulsatillae 10g; melia 15g; bud of Herba Agrimoniae 15g; Herba Menthae 10g; Bulbus Allii 20g; very light blue 10g; Semen Raphani 15g; Olibanum 10g; Folium Persicae 10g; Fructus Gleditsia 10g; Radix Gentianae 10g; Radix Scutellariae 20g; Rhizoma Imperatae 20g; Radix Rehmanniae 20g; Gypsum Fibrosum 20g; Rhizoma Anemarrhenae 10g; LIUYI SAN 20g; Folium Isatidis 20g; Cortex Moutan 20g; Radix Paeoniae Rubra 20g; Herba Plantaginis 10g; Cortex Sclerotii Poriae 20g; raw pearl barley 20g; Fructus Kochiae 20g; Herba Hedyotidis Diffusae 20g.
Composition is α-mannatide 230g among the described medicament 1000g; Flos Lonicerae 20g; Radix Isatidis 20g; Fructus Forsythiae 10g; Folium Isatidis 10g; Indigo Naturalis 10g; Rhizoma Coptidis 10g; Radix Scutellariae 15g; Cortex Phellodendri 10g; Caulis Fibraureae 10g; Herba Andrographis 10g; Herba Violae 15g; Herba Taraxaci 5g; Herba Patriniae 10g; Rhizoma Paridis 15g; Radix Gentianae 10g; Radix Sophorae Tonkinensis 15g; Rhizoma Anemarrhenae 5g; Cortex Magnoliae Officinalis 10g; Cortex Moutan 15g; Radix Paeoniae Alba 10g; Spica Prunellae 10g; Fructus Trichosanthis 15g; Calculus Bovis 10g; Fructus Chebulae 10g; Fructus Cnidii 10g; Radix Sophorae Flavescentis 15g; Radix Pulsatillae 10g; melia 15g; bud of Herba Agrimoniae 15g; Herba Menthae 10g; Bulbus Allii 20g; very light blue 10g; Semen Raphani 15g; Olibanum 10g; Folium Persicae 10g; Fructus Gleditsia 10g; Radix Gentianae 5g; Radix Scutellariae 10g; Rhizoma Imperatae 15g; Radix Rehmanniae 10g; Gypsum Fibrosum 15g; Rhizoma Anemarrhenae 5g; LIUYI SAN 10g; Folium Isatidis 15g; Cortex Moutan 10g; Radix Paeoniae Rubra 10g; Herba Plantaginis 10g; Cortex Sclerotii Poriae 15g; raw pearl barley 10g; Fructus Kochiae 10g; Herba Hedyotidis Diffusae 15g; Rhizoma Atractylodis 20g; Rhizoma Atractylodis Macrocephalae 20g; Pericarpium Citri tangerinae 20g; Rhizoma Pinelliae 15g; Poria 25g; Rhizoma Alismatis 20g; Polyporus 20g; Talcum 15g; Semen Plantaginis 20g.
Composition is α-mannatide 215g among the described medicament 1000g; Flos Lonicerae 15g; Radix Isatidis 15g; Fructus Forsythiae 10g; Folium Isatidis 10g; Indigo Naturalis 10g; Rhizoma Coptidis 5g; Radix Scutellariae 10g; Cortex Phellodendri 5g; Caulis Fibraureae 10g; Herba Andrographis 10g; Herba Violae 10g; Herba Taraxaci 5g; Herba Patriniae 10g; Rhizoma Paridis 5g; Radix Gentianae 10g; Radix Sophorae Tonkinensis 5g; Rhizoma Anemarrhenae 5g; Cortex Magnoliae Officinalis 10g; Cortex Moutan 10g; Radix Paeoniae Alba 10g; Spica Prunellae 10g; Fructus Trichosanthis 15g; Calculus Bovis 10g; Fructus Chebulae 10g; Fructus Cnidii 10g; Radix Sophorae Flavescentis 5g; Radix Pulsatillae 5g; melia 10g; bud of Herba Agrimoniae 5g; Herba Menthae 10g; Bulbus Allii 10g; very light blue 10g; Semen Raphani 15g; Olibanum 10g; Folium Persicae 10g; Fructus Gleditsia 10g; Radix Gentianae 5g; Radix Scutellariae 10g; Rhizoma Imperatae 15g; Radix Rehmanniae 10g; Gypsum Fibrosum 15g; Rhizoma Anemarrhenae 5g; LIUYI SAN 10g; Folium Isatidis 15g; Cortex Moutan 10g; Radix Paeoniae Rubra 10g; Herba Plantaginis 10g; Cortex Sclerotii Poriae 15g; raw pearl barley 10g; Fructus Kochiae 10g; Herba Hedyotidis Diffusae 15g; Rhizoma Atractylodis 20g; Rhizoma Atractylodis Macrocephalae 20g; Pericarpium Citri tangerinae 20g; Rhizoma Pinelliae 15g; Poria 25g; Rhizoma Alismatis 20g; Polyporus 20g; Talcum 15g; Semen Plantaginis 20g; Radix Codonopsis 20g; Rhizomadioscoreae 15g; Radix Astragali 10g; Radix Ginseng 15g; Radix Glycyrrhizae 20g; Radix Angelicae Sinensis 10g; Radix Rehmanniae Preparata 20g.
Characteristics of the present invention are: α-mannatide improves the premunition of body by regulating body's immunity, improves environment in the vagina part, makes it to be in physiological equilibrium's state; Herba Taraxaci, Flos Lonicerae have the effect of broad ectrum antibiotic, and staphylococcus aureus, streptococcus, escherichia coli, anaerobe are all had strong inhibitory action; Fructus Cnidii, Fel Sus domestica have splitting action to multiple pathogen such as infusorian, so have stronger broad-spectrum antiseptic and the effect of antiinflammatory antiseptical.Be equipped with the effect that Galla Chinensis has removing damp-heat detoxifcation, putrefaction-removing granulation-promoting, astringing to arrest bleeding, detumescence; The Radix Astragali, the invigorating middle warmer of Radix Codonopsis QI invigorating; The Rhizoma Atractylodis the spleen strengthening and damp drying.Full side plays invigorate the spleen and warm the kidney altogether, yang invigorating dehumidifying, leukorrhagia stopping, the effect of removing damp-heat detoxifcation, putrefaction-removing granulation-promoting, astringing to arrest bleeding detumescence.
Through collection a large amount of medication patient medical record data further investigations, conclude and sum up, confirm that this Chinese medicine and western medicine compound suppository has: anti-inflammation, it is anticorrosion to stop blooding, heat clearing away, detoxifcation, detumescence, leukorrhagia stopping, Thyme Extract; Can obviously improve intravaginal environment and vagina cleanness degree; Come the resistance against diseases of enhancing body by regulating body's immunological function, have tangible after effect; Promote regeneration and restoration, quicken the healing of cervical erosion face; Recover the function of cervix uteri squamous epithelial cancer regeneration, increase resistance pathogen.
The specific embodiment
Because the present invention is carried recoverable space craft (spacecraft or retrievable satellite) with the Alpha-hemolytic streptococcus strain, utilize the comprehensive function of factors such as little in the space (zero) gravity, cosmic ray, alternating magnetic field, fine vacuum, hyperpyrexia deep cooling, make the dna double chain structure fracture of bacterial strain, genome is reset, thereby produces new bacterial strain.After returning ground, bacterial strain through space treatment is cultivated and screened, by studying contents such as its morphological characteristic, cultural characteristic, biochemical reactions, metabolite, hereditary character and protein expression, hereditary stability, pilot scale production target, optimize the stable strain of plus variant, inherited character wherein, the medicine of the ulcerative colitis that after cultivation and fermentation, obtains medical treatment.This strain in China Committee for Culture Collection of Microorganisms's common micro-organisms center preservation, is numbered CGMCCNo.1082.
Particularly described Alpha-hemolytic streptococcus D33 bacterial strain behind ground screening, separation and the purification, selects higher, the secreted mannan peptide content of fermentation unit higher high yield, quality strains T33 strain through space treatment mutation.By Institute of Microorganism, Academia Sinica whole-cell protein SDS-polyacrylamide gel (SDS-PAGE) analysis of T33 bacterial strain and D33 bacterial strain and the genomic DNA restricted enzyme cutting analysis (RFLP/PFGE) of bacterial strain are compared, can prove that its gene of T33 bacterial strain that space mutagenesis and ground filter out has variation.This mutant strain is stable in heredity, stronger production adaptability is arranged, the mannan peptide content that is produced by its fermentation improves, content of peptides improves 3 to 5 times than national standard (80%), institute for drug control, Xi'an sample presentation is measured and is reached 271.6%, and fermentation content on average exceeds more than three times than matched group product content.This strain is through the spaceship-carried space flight of Shenzhou series of spacecraft, and further screening and culturing breeding forms stable hereditary property, the tangible high-yield highly-effective strain of variation features to strain by BeiJing ZhongKe Institute of Micro-biology of institute and biology department of Northwest University.The mannan peptide content of α in the every fermentation unit of this strain-space flight strain production has improved more than several times.(the material 1 of seeing Appendix: science and technology bureau Shaanxi Province, Shaanxi Province scientific and technological achievement assay certificate material
Adnexa material 2: the mannatide that the space flight strain is produced is produced bacterial strain and is carried notarization through " No. three, divine boat " airship.
Adnexa material 3: the mannatide that the space flight strain is produced is produced bacterial strain and is returned ground screening report through the lift-launch of " No. three, divine boat " airship
Adnexa material 4: Microbe Inst., Chinese Academy of Sciences produces the form Physiology and biochemistry probation report book of bacterial strain and ground contrast bacterium about the mannatide that " No. three, divine boat " airship carries the production of space flight strain
Adnexa material 5: Microbe Inst., Chinese Academy of Sciences produces SDS-PAGE and the RFLP/PFGE Analysis and Identification statement of bacterial strain and ground contrast bacterium about the mannatide that " No. three, divine boat " airship carries the production of space flight strain
Adnexa material 6: the mannatide oral liquid examining report that institute for drug control, Shaanxi Province " No. three, divine boat " space flight strain is produced
Adnexa material 7: scientific and technological novelty assessment report copy
Adnexa material 8: notice is accepted in China Committee for Culture Collection of Microorganisms's common micro-organisms center preservation culture presevation)
Strain improvement of the present invention: on the basis of Alpha-hemolytic streptococcus growth rhythm, selected than the proper growth strain in period, adopt the plate growth bacterium colony, immerse methods such as the bacteria suspension in other material, germ-carrying sand, carry " No. three, divine boat " spacecraft on March 25th, 2002.Carried out 6 days 0 18 hours flying at space track (200 kilometers of perigee altitudes, 350 kilometers of altitude of the apogees) at rail.The specific condition of space mainly is presented as special environments such as microgravity, fine vacuum, high radiation, alternating magnetic field.The strain of outer-space flight be placed in one with the diverse environment of tellurian ecological environment in, the electronics, proton and the mental retardation heavy particle that mainly comprise coming self-magnetic field to capture; Cosmic ray such as proton, particle and heavier high energy heavy particle from the milky way galaxy; From the proton of sun magnetic storm and heavy particle etc.These particles act on the dna double chain structure in the microbial cell nuclear, can cause double-strand break.Microgravity, high vacuum environment can make the base sequence of DNA recombinate, promptly genomic reorganization and variation.The new bacterial strain that the variation back produces, variation in various degree all can take place in its morphological characteristic, cultural characteristic, biochemical reactions, metabolite, hereditary character and protein expression, pilot scale production target etc.After ground is returned in spacecraft, through further screening, only optimize wherein 0.2% plus variant and the stable bacterial strain of inherited character, make the production strain through cultivation.This strain that after spaceship-carried mutation, selects December in 2003 29 days by China Committee for Culture Collection of Microorganisms's common micro-organisms center preservation, be numbered CGMCCNo.1082.
Experiment and middle trial production result show, stable on inherited character through the novel space strain behind the space mutagenesis, stronger production adaptability is arranged, the mannan peptide content that is produced by its fermentation improves, content of peptides improves 3 to 5 times than national standard (80%), institute for drug control, Xi'an sample presentation is measured and is reached 271.6%, and fermentation content on average exceeds more than three times than matched group product content, and fermentation period shortens greatly.
Preparation method:
The space flight strain is produced the preparation process of mannatide:
The mannatide of space flight strain of the present invention production is by following method preparation: the space strain preparation--purify, and final production goes out mannatide by one grade fermemtation--second order fermentation-----fermentation liquid.
The space strain preparation:
With through the Alpha-hemolytic streptococcus of space mutagenesis breeding meticulous selection-breeding as producing strain.
A. inclined-plane seed culture medium: Carnis Bovis seu Bubali cream 0.5%, yeast extract 0.6%, peptone 0.5%, glucose 0.4%, sodium chloride 0.5%, agar 3%, sheep blood 8%; PH 7.4.
121 ℃ of inclined-plane seed culture medium sterilising temps, 30 minutes time, steam pressure 0.12Mpa.
Unpacking strain cryovial with aseptic broth bouillon dilution, inserts the blood inclined-plane under aseptic condition, the rearmounted 38 ℃ of constant temperature culture of inoculation 30 hours.
B. meat soup seed culture medium: Carnis Bovis seu Bubali cream 0.5%, yeast extract 0.6%, peptone 0.5%, glucose 0.4%, sodium chloride 0.5%; PH 7.4.
121 ℃ of meat soup seed culture medium sterilising temps, 30 minutes time, steam pressure 0.12Mpa.
With cultured slant strains under aseptic condition by 9% inoculum concentration, insert in the meat soup seed culture medium 38 ℃ of constant temperature culture 30 hours.
Sweat:
Fermentation medium: Carnis Bovis seu Bubali cream 0.4%, yeast extract 0.5%, peptone 0.5%, glucose 0.4%, sodium chloride 0.5%.
121 ℃ of fermentation medium sterilising temps, 30 minutes time, steam pressure 0.12Mpa.
A. one grade fermemtation jar: with good meat soup strain under aseptic condition by 10% inoculum concentration, insert first class seed pot, 29 ℃ of constant temperature culture 30 hours, tank pressure was no more than 0.02Mpa, ventilation is advisable can stir culture fluid, fully stirs continuously.
B. second order fermentation jar: with the one grade fermemtation culture fluid under aseptic condition by 20% inoculum concentration, insert fermentation tank, 29 ℃ of constant temperature culture 70 hours, tank pressure is 0.02Mpa not, jar is put in deactivation.Deactivation is adopted to heat and is made the fermentation liquid temperature reach 100 ℃, is incubated 60 minutes, and cooling is left standstill.
Leaching process:
A, fermentation liquid concentrate, and make concentrated solution volume and fermentating liquid volume ratio be controlled at 1: 15-1: 20 or be determined by circumstances.
The concentrated solution of b, fermentation liquid adds 80-99% ethanol, and the volume ratio is controlled at 1: 1.5-1: 5.5 or be determined by circumstances.Fully stir leave standstill after, centrifugal removal supernatant, the precipitation dissolved in distilled water, accent pH5.0 obtains lysate and lysate is left standstill.
C, the more centrifugal removal impurity of lysate is obtained supernatant, accurately measure the clear liquid volume, calculate required amount of alcohol by the supernatant stereometer, adjust pH slowly joins ethanol in the supernatant, and fully stirs, and leaves standstill the centrifugal removal supernatant in back and obtains precipitate.
D, precipitate reuse dissolved in distilled water are transferred pH, and centrifugal, supernatant adds ethanol precipitation again.Such technology repeatable operation to intermediate detection qualified till, the precipitate that obtains is the mannatide crude product that the space flight strain is produced.Vacuum drying 3-8 hour, promptly obtain the mannan peptide product that the space flight strain is produced.
The check of the product that said method obtains:
[character] this product is white or little yellow amorphous powder; Odorless, tasteless.
This product is easily molten in water, and is insoluble in ethanol, chloroform and acetone.
Specific optical rotation: get this product, accurate claim surely, be dissolved in water and be diluted to the solution that contains 10mg among every 1ml approximately, measure (two appendix vI of Chinese Pharmacopoeia version in 2000 E) in accordance with the law, specific optical rotation is+70 ℃ to+80 ℃.
[discriminating] 1, get this product 10mg, add water 0.5ml and make dissolving, add a-naphthols alcoholic solution (5-100) 1ml, shake up, slowly add sulphuric acid 0.5ml along tube wall, after several minutes, the interface is aubergine.
2, get this product, add water and make the solution that contains 1mg among every 1ml, get about 10ul point on filter paper, dry, fix with dehydrated alcohol, put high salpeter solution (get periodic acid 1.2g, add water 30ml dissolving after.Add 0.2mol/L sodium acetate solution 1.5ml and ethanol 100ml, mixing promptly.Put the dark place and preserve, can use the several months) the middle immersion 5 minutes, take out, wash with 70% alcoholic solution, (get potassium iodide 5g, sodium thiosulfate 5g adds water 100ml and makes dissolving to put reducing solution, add ethanol 150ml, 2mol/L hydrochloric acid solution 2.5ml again, with adding, face the time spent and join with stirring) the middle immersion 5 minutes, take out, wash with 70% alcoholic solution, put in the pinkish red industry sulphuric acid test solution and soaked about 30 minutes, take out, (get sodium pyrosulfite 0.4g with sodium metabisulfite solution, add hydrochloric acid 1ml, being dissolved in water makes into 100ml, promptly), and flushing, dry, the place should be aubergine at the filter paper point sample.
3, get test sample and reference substance is an amount of, add respectively the chlorination sodium injection make contain 1mg among every 1ml solution as need testing solution and reference substance solution, press the test of mannatide immunogenicity determining method, test sample and contrast QC should all not have haemolysis to be taken place.
[inspection] 1, acidity: get this product, add water and make the solution that contains IOmg among every 1ml, measure (two appendix VIH of Chinese Pharmacopoeia version in 2000) in accordance with the law, pH value should be 3.0-5.0.
2, trap: get this product, add water and make the solution that contains 0.4mg among every 1ml, according to spectrophotography (two appendix VI of Chinese Pharmacopoeia version in 2000 A), wavelength place at 260nm, its trap must not be greater than 0.25, and at the wavelength place of 280nm, its trap must not be greater than 0.20.
3, total nitrogen: get this product, measure according to N2 method (two appendix VII of Chinese Pharmacopoeia version in 2000 D, second method).Press dry product and calculate, contain total nitrogen and should be 0.8-2.0%.
4, immunogenicity: get test sample and reference substance is an amount of, add the chlorination sodium injection respectively and make the solution that contains 10mg among every 1ml, make 1: 2,1: 4,1: 8,1: 16,1: 32,1: 64,1: 128,1: 256 diluent as need testing solution and reference substance solution with phosphate buffer respectively again, check in accordance with the law (attached mannatide immunogenicity determining method) that the least concentration of the insoluble blood vessel of test sample should be higher than more than a times of reference substance respective concentration.
5, loss on drying is got this product, is dried to constant weight at 105 ℃, subtracts weight loss and must not cross 5.0% (two appendix VIII of Chinese Pharmacopoeia version in 2000 L).
6, heavy metal is got this product, at 1.0g, checks that in accordance with the law (Chinese Pharmacopoeia version VIII in 2000 H) contains heavy metal and must not cross 20/1000000ths.
7, the undue toxicity gets this product, adds the chlorination sodium injection and makes the solution that contains 0.5mg among every 1ml, checks (Chinese Pharmacopoeia version appendix in 2000 XI C) in accordance with the law.Press the intravenous injection administration, should (injection) up to specification.
[assay]
1. the preparation of reference substance solution
Precision takes by weighing through 105 ℃ of D-mannose reference substance 0.1g that are dried to constant weight and puts in the 100ml measuring bottle, is dissolved in water and is diluted to scale.Shake up; Precision is measured 5ml, puts in the measuring bottle of 100ml, adds water to scale, shakes up.Contain mannose 50ug among every 1ml.
2. need testing solution is equipped with
It is an amount of to get this product, and accurate the title decides, and is dissolved in water and makes the solution that contains 40ug among every 1ml.
3. the preparation of standard curve
Precision takes by weighing reference substance solution 0,0.2,0.4,0.6,0.8,1.0ml, puts respectively in the tool plug test tube, respectively adds water to 1.0ml, adds 3% phenol solution 1.0ml again, shakes up, and pours sulphuric acid 4.5ml, shakes up, and is positioned over room temperature, is blank with 0 pipe.Measure trap according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2000 A) at the wavelength place of 490nm.To corresponding trap, calculate regression equation with mannose ug number.
4. algoscopy
Precision is measured need testing solution 1.0ml, and from " adding 3% phenol solution 1.0ml again ", operation is in accordance with the law measured trap, by the content of regression equation calculation mannose under the sighting target directrix curve preparation.
Mannatide immunogenicity determining method (complement combined techniques);
1, test solution
A. phthalate buffer (pH7.2).
Get sodium chloride 8.5g, sodium hydrogen phosphate 0.565g and potassium dihydrogen phosphate 0.135g, add water to 1000ml and make its dissolving, add 10% Adlerika 1ml, shake up.
B.1% sheep erythrocyte suspension
The preparation of sheeps blood erythrocyte: (get glucose 20.5g, sodium citrate 8.0g, sodium chloride 4.2g in filling equivalent A Shi liquid by sheep jugular vein sterile blood sampling, citric acid 5.5g, add water to 1000ml and make dissolving, 100 ℃ the sterilization 30 minutes) sterile chamber in, 4 ℃ of preservations.
The preparation of 1% sheeps blood erythrocyte suspension: it is an amount of to get above-mentioned sheeps blood erythrocyte, and with sodium chloride injection washing three times, each centrifugal 5 minutes (2000 rev/mins), sheeps blood erythrocyte is amassed in pressure, makes 1% sheeps blood erythrocyte suspension with sodium chloride injection.Get suspension, make need testing solution for 20 times with the sodium chloride injection dilution, other gets 20 times of equivalent suspension thin ups as blank solution, according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2000 A), wavelength place at 541nm measures, its trap should be 0.65-0.70, should regulate the concentration of 1% sheep erythrocyte suspension as overrun.
C. hemolysin and sensitization sheeps blood erythrocyte
The preparation of hemolysin: get above-mentioned hematocrit sheeps blood erythrocyte, make 25% sheeps blood erythrocyte suspension with sodium chloride injection. get 1 of rabbit, the above-mentioned sheeps blood erythrocyte suspension of intravenous injection, once a day, totally seven times, first three time 3ml, three 5ml in back, last is injected blood sampling in back seven days.Separation of serum, 56 ℃ of deactivations in .30 minute, packing is preserved below 0 ℃.
The mensuration of amboceptor unit: it is an amount of to get hemolysin, add phosphate buffer and make 1: 1000,1: 2000,1: 3000,1: 4000,1: 5000,1: 6000,1: 7000,1: 8000,1: 9000,1: 10000 diluent respectively, respectively getting 0.1ml puts in the test tube, add 1% Sanguis caprae seu ovis cell suspension 0.1ml, shake up, add dilution factor and be 1: 30 guinea pig serum (complement) 0.2ml and phosphate buffer 0.2ml, shake up, 37 ℃ of insulations 30 minutes, the high dilution of complete hemolysis pipe is 1 unit hemolysin.
The preparation of sensitization sheeps blood erythrocyte: before facing usefulness, the sheeps blood erythrocyte suspension with 2% mixes with 2 unit haemolysis rope equal-volumes, and 37 ℃ are incubated 15 minutes promptly.
Complement: get three above Cavia porcelluss, the heart blood sampling, centrifugalize serum is preserved below 0 ℃.
The mensuration of complement unit: it is an amount of to get complement, add phosphate buffer, make 1: 40,1: 60,1: 80,1: 100,1: 120,1: 140,1: 160,1: 180 diluent respectively, respectively get 0.2ml and put in the test tube, add the 0.2ml phosphate buffer, shake up, 37 ℃ of insulations are after 30 minutes, add sensitization sheeps blood erythrocyte 0.2ml respectively, shake up, 37 ℃ are incubated 30 minutes again.The high dilution of complete hemolysis pipe is the complement of 1 unit.
Antibody: it is an amount of to get the mannatide reference substance, add the chlorination sodium injection and make the reference substance solution immunizing rabbit that contains 10mg among every 1ml, the next day adopt ear vein injection reference substance solution once.Inject for the first time 0.2ml, for the second time respectively inject 0.5ml to the 5th time, respectively inject 1.0ml the 6th time to the tenth time, the tenth once respectively injects 2.0ml to the 15 time, and last is injected blood sampling in back three days, centrifugalize serum, 56 ℃ of deactivations in following 30 minutes, (before facing usefulness, needing 56 ℃ of deactivations once more in 30 minutes) preserved in packing below 0 ℃.
The mensuration of antibody unit: it is an amount of to get antibody, add phosphate buffer and make 1: 2,1: 4,1: 8,1: 16,1: 32.1: 64,1: 128 diluent respectively, respectively getting 0.1ml puts in the test tube, add mannatide reference substance solution 0.1ml and the 2 complement 0.2m of unit], shake up, place more than 4 hours in 4-8 ℃, put 37 ℃ of insulations 30 minutes, the high dilution of insoluble blood vessel is 1 unit antibody.Establish antigen simultaneously and (do not add antibody, replace with the 0.1ml phosphate buffer), antibody (do not add antigen, replace with the 0.1ml phosphate buffer), complement (do not add antigen, antibody, replace with the 0.2ml phosphate buffer) control tube, more than three kinds of control tube haemolysis entirely; The sensitization sheeps blood erythrocyte that other establishes (do not add antigen, antibody and complement, replace with the 0.4ml phosphate buffer) control tube is haemolysis not.
2, immunogenicity determining method
It is an amount of to get rapid glycopeptide reference substance of manna and test sample, and the regulation under the photograph medicine item is made the reference substance solution and the need testing solution of variable concentrations, respectively gets 0.1ml and puts in the test tube, adds 2 antibody 0.1ml of unit and the 2 complement 0.2ml of unit.Shake up, more than 4 hours, put 37 ℃ of insulations 30 minutes in 4-8 ℃ of placement, add sensitization sheeps blood erythrocyte 0.2ml, shake up, 37 ℃ are incubated 30 minutes again.Observe the haemolysis situation of each pipe, the least concentration of insoluble blood vessel is represented the immunogenicity of mannatide.Establish antigen simultaneously and (do not add antibody, replace with the 0.1ml phosphate buffer), antibody (do not add antigen, replace with the 0.1ml phosphate buffer), complement (do not add antigen, antibody, replace) control tube with the 0.2ml phosphate buffer, more than three kinds of control tube haemolysis entirely: the sensitization sheeps blood erythrocyte that other establishes (do not add antigen, antibody and complement, replace with the 0.4ml phosphate buffer) control tube is haemolysis not.
Embodiment 1 gets Herba Taraxaci 150g, Flos Lonicerae 150g, Fructus Cnidii 120g, Fel Sus domestica 120g, Galla Chinensis 120g, Radix Astragali 150g, Radix Codonopsis 150g, Rhizoma Atractylodis 120g.
Twice → collecting decoction of above decocting for Chinese herbal medicine → concentrate → filter → add above-mentioned α-mannatide 100g and medicinal liquid mixing → insulation are irritated mould, make every piece heavy 5g of suppository → quality inspection warehouse-in altogether.
Concrete production process is pressed preparation technology's (Chinese Pharmacopoeia Commission compiles, and Chemical Industry Press publishes) of 2000 editions suppositorys of Pharmacopoeia of People's Republic of China
Other embodiment is just different with Chinese medicine ingredients with embodiment 1, and other production process is identical.
Contain α-mannatide 300g, Flos Lonicerae 30g, Radix Isatidis 50g, Fructus Forsythiae 30g, Folium Isatidis 25g, Indigo Naturalis 30g, Rhizoma Coptidis 30g, Radix Scutellariae 30g, Cortex Phellodendri 30g, Caulis Fibraureae 25g, Herba Andrographis 30g, Herba Violae 30g, Herba Taraxaci 25g, Herba Patriniae 30g, Rhizoma Paridis 25g, Radix Gentianae 20g, Radix Sophorae Tonkinensis 30g, Rhizoma Anemarrhenae 10g, Cortex Magnoliae Officinalis 30g, Cortex Moutan 30g, Radix Paeoniae Alba 20g, Spica Prunellae 30g, Fructus Trichosanthis 30g, Calculus Bovis 20g, Bulbus Allii 30g, Fructus Chebulae 30g among the medicine 1000g of embodiment 2.
Contain α-mannatide 300g, Flos Lonicerae 20g, Radix Isatidis 40g, Fructus Forsythiae 20g, Folium Isatidis 15g, Indigo Naturalis 20g, Rhizoma Coptidis 20g, Radix Scutellariae 20g, Cortex Phellodendri 20g, Caulis Fibraureae 15g, Herba Andrographis 20g, Herba Violae 20g, Herba Taraxaci 15 among the medicine 1000g of embodiment 3
G, Herba Patriniae 20g, Rhizoma Paridis 15g, Radix Gentianae 10g, Radix Sophorae Tonkinensis 20g, Rhizoma Anemarrhenae 10g, Cortex Magnoliae Officinalis 20g, Cortex Moutan 20g, Radix Paeoniae Alba 10g, Spica Prunellae 20g, Fructus Trichosanthis 20g, Calculus Bovis 10g, Fructus Chebulae 20g, Fructus Cnidii 20g, Radix Sophorae Flavescentis 20g, Radix Pulsatillae 20g, melia 20g, bud of Herba Agrimoniae 20g, Herba Menthae 20g, Bulbus Allii 40g, very light blue 20g, Semen Raphani 20g, Olibanum 20g, Folium Persicae 20g, Fructus Gleditsia 20g.
Contain α-mannatide 300g among the medicine 1000g of embodiment 4; Flos Lonicerae 20g; Radix Isatidis 20g; Fructus Forsythiae 10g; Folium Isatidis 10g; Indigo Naturalis 10g; Rhizoma Coptidis 10g; Radix Scutellariae 15g; Cortex Phellodendri 10g; Caulis Fibraureae 10g; Herba Andrographis 10g; Herba Violae 15g; Herba Taraxaci 5g; Herba Patriniae 10g; Rhizoma Paridis 15g; Radix Gentianae 10g; Radix Sophorae Tonkinensis 15g; Rhizoma Anemarrhenae 5g; Cortex Magnoliae Officinalis 10g; Cortex Moutan 15g; Radix Paeoniae Alba 10g; Spica Prunellae 10g; Fructus Trichosanthis 15g; Calculus Bovis 10g; Fructus Chebulae 10g; Fructus Cnidii 10g; Radix Sophorae Flavescentis 15g; Radix Pulsatillae 10g; melia 15g; bud of Herba Agrimoniae 15g; Herba Menthae 10g; Bulbus Allii 20g; very light blue 10g; Semen Raphani 15g; Olibanum 10g; Folium Persicae 10g; Fructus Gleditsia 10g; Radix Gentianae 10g; Radix Scutellariae 20g; Rhizoma Imperatae 20g; Radix Rehmanniae 20g; Gypsum Fibrosum 20g; Rhizoma Anemarrhenae 10g; LIUYI SAN 20g; Folium Isatidis 20g; Cortex Moutan 20g; Radix Paeoniae Rubra 20g; Herba Plantaginis 10g; Cortex Sclerotii Poriae 20g; raw pearl barley 20g; Fructus Kochiae 20g; Herba Hedyotidis Diffusae 20g.
Contain α-mannatide 230g among the medicine 1000g of embodiment 5; Flos Lonicerae 20g; Radix Isatidis 20g; Fructus Forsythiae 10g; Folium Isatidis 10g; Indigo Naturalis 10g; Rhizoma Coptidis 10g; Radix Scutellariae 15g; Cortex Phellodendri 10g; Caulis Fibraureae 10g; Herba Andrographis 10g; Herba Violae 15g; Herba Taraxaci 5g; Herba Patriniae 10g; Rhizoma Paridis 15g; Radix Gentianae 10g; Radix Sophorae Tonkinensis 15g; Rhizoma Anemarrhenae 5g; Cortex Magnoliae Officinalis 10g; Cortex Moutan 15g; Radix Paeoniae Alba 10g; Spica Prunellae 10g; Fructus Trichosanthis 15g; Calculus Bovis 10g; Fructus Chebulae 10g; Fructus Cnidii 10g; Radix Sophorae Flavescentis 15g; Radix Pulsatillae 10g; melia 15g; bud of Herba Agrimoniae 15g; Herba Menthae 10g; Bulbus Allii 20g; very light blue 10g; Semen Raphani 15g; Olibanum 10g; Folium Persicae 10g; Fructus Gleditsia 10g; Radix Gentianae 5g; Radix Scutellariae 10g; Rhizoma Imperatae 15g; Radix Rehmanniae 10g; Gypsum Fibrosum 15g; Rhizoma Anemarrhenae 5g; LIUYI SAN 10g; Folium Isatidis 15g; Cortex Moutan 10g; Radix Paeoniae Rubra 10g; Herba Plantaginis 10g; Cortex Sclerotii Poriae 15g; raw pearl barley 10g; Fructus Kochiae 10g; Herba Hedyotidis Diffusae 15g; Rhizoma Atractylodis 20g; Rhizoma Atractylodis Macrocephalae 20g; Pericarpium Citri tangerinae 20g; Rhizoma Pinelliae 15g; Poria 25g; Rhizoma Alismatis 20g; Polyporus 20g; Talcum 15g; Semen Plantaginis 20g.
Composition is α-mannatide 215g among the medicine 1000g of embodiment 6; Flos Lonicerae 15g; Radix Isatidis 15g; Fructus Forsythiae 10g; Folium Isatidis 10g; Indigo Naturalis 10g; Rhizoma Coptidis 5g; Radix Scutellariae 10g; Cortex Phellodendri 5g; Caulis Fibraureae 10g; Herba Andrographis 10g; Herba Violae 10g; Herba Taraxaci 5g; Herba Patriniae 10g; Rhizoma Paridis 5g; Radix Gentianae 10g; Radix Sophorae Tonkinensis 5g; Rhizoma Anemarrhenae 5g; Cortex Magnoliae Officinalis 10g; Cortex Moutan 10g; Radix Paeoniae Alba 10g; Spica Prunellae 10g; Fructus Trichosanthis 15g; Calculus Bovis 10g; Fructus Chebulae 10g; Fructus Cnidii 10g; Radix Sophorae Flavescentis 5g; Radix Pulsatillae 5g; melia 10g; bud of Herba Agrimoniae 5g; Herba Menthae 10g; Bulbus Allii 10g; very light blue 10g; Semen Raphani 15g; Olibanum 10g; Folium Persicae 10g; Fructus Gleditsia 10g; Radix Gentianae 5g; Radix Scutellariae 10g; Rhizoma Imperatae 15g; Radix Rehmanniae 10g; Gypsum Fibrosum 15g; Rhizoma Anemarrhenae 5g; LIUYI SAN 10g; Folium Isatidis 15g; Cortex Moutan 10g; Radix Paeoniae Rubra 10g; Herba Plantaginis 10g; Cortex Sclerotii Poriae 15g; raw pearl barley 10g; Fructus Kochiae 10g; Herba Hedyotidis Diffusae 15g; Rhizoma Atractylodis 20g; Rhizoma Atractylodis Macrocephalae 20g; Pericarpium Citri tangerinae 20g; Rhizoma Pinelliae 15g; Poria 25g; Rhizoma Alismatis 20g; Polyporus 20g; Talcum 15g; Semen Plantaginis 20g; Radix Codonopsis 20g; Rhizomadioscoreae 15g; Radix Astragali 10g; Radix Ginseng 15g; Radix Glycyrrhizae 20g; Radix Angelicae Sinensis 10g; Radix Rehmanniae Preparata 20g.
The toxicological study of treatment chronic cervicitis suppository of the present invention: 1. acute toxicity test: Female rabbits abdominal cavity heeling-in 50g, do not see after 24 hours that dead and any untoward reaction takes place; 2. Female rabbits local application, every day three times, each 5g, hepatic and renal function, hemogram and all no abnormal variation of each organs and tissues are checked in logotype 2 months; 3. the Cavia porcellus hypersensitive test is negative; 4. the deadly test of teratogenesis is all negative.
The animal pharmacodynamic study
Experiment one: five kinds of suppositorys of the present invention are to the influence of cervicitis rat natural immunity function
Summary: [purpose] inquires into the therapeutical effect of five kinds of suppositorys of the present invention to the cervicitis experimental rat.[method] is divided into modeling group, five kinds of suppository groups of the present invention, α-mannatide group, GONGJINGNING SHUANJI group, normal control group with rat.All laboratory animal is carried out the mensuration of pathological examination, erythrocyte immune adhesion function, T lymphocyte activation rate and phagocyte phagocytic function.Mucosal ulcer appears in the visible down a large amount of cell infiltration of [result] pathological examination, modeling group cervical mucosa; Five kinds of suppository treatment groups of the present invention, normal control group pathological change are not obvious.Erythrocyte immune adhesion function, phagocyte phagocytic function, the modeling group is starkly lower than the normal control group; Five kinds of suppository treatment groups of the present invention are apparently higher than the modeling group, and no significant difference between the normal control group.[conclusion] five kinds of suppositorys of the present invention all can improve cervicitis experimental rat erythrocyte immune adhesion function and phagocyte phagocytic function, thereby corresponding pathological change is improved.
Cervicitis is a modal illness in the female sex organ inflammation.This inflammation is except that outside the Pass having with infection such as wound, various antibacterial, virus, chlamydia, and is also closely related with body's immunological function.The nonspecific immunity of body (claiming the natural immunity again) is in the generation of disease, the development of the state of an illness and the generally attention that the effect in the prognosis process more and more is subjected to people.Immune adherence is the autarcetic aspect of reaction body, and wherein the erythrocyte immune adhesion function shows important function.CR1 on the erythrocyte membrane has the ability that adheres to C3b, C4b, and the mensuration of its power can be used as one of index of molecule erythrocyte immune adhesion function power.The phagocyte phagocytic function also plays an important role in the body natural immunity.This research has been observed cervicitis rat erythrocyte immune adhesion function, phagocyte phagocytic function, T lymphocyte activation level and suppository of the present invention to its regulating action.
1 materials and methods
1.1 main agents, medicine
Liquid phenol: Tianjin Chemical Reagents Factory No.1, Tianjin Q/HG3524-91.
Radix Acaciae senegalis: Guangdong city chemical glass instrument plant, UK import packing, lot number 930118.
ConA (concanavalin A, Con A): Sigma company.
3-(4,5-dimethyl-2-thiazole)-2,5 diphenyl bromination tetrazoliums (MTT): the same.
Lyophilizing zymosan reagent: immunity teaching and research room of Xi'an Jiaotong University Medical College.
GONGJINGNING SHUANJI: Jiangsu TCM Hospital.
α-mannatide suppository: Xi'an Hengtongguanghua Pharmaceutical Co., Ltd.
Five kinds of suppositorys of the present invention: Xi'an Hengtongguanghua Pharmaceutical Co., Ltd.
1.2 animal and grouping
Select 117 of healthy, female, unpregnancy wistar rat for use, body weight 151-225g (Xi'an Jiaotong University Medical College's Experimental Animal Center provides).Animal is divided into 9 groups at random by body weight, every group 13: the normal control group, model group, first kind of suppository group of the present invention, described second kind of suppository group, the third suppository group of the present invention, the 4th kind of suppository group of the present invention, the 5th kind of suppository group of the present invention, α-mannatide group, GONGJINGNING SHUANJI group.
1.3 modeling method and experimental technique
Except that the normal control group, make the cervicitis model with 25% phenol rubber cement for all the other 4 groups,, enter the vagina deep and inject phenol rubber cement, every 1.5ml, 3 days 1 time, totally 3 times with taper venotomy pin.Beginning administration in the 3rd day after the modeling, α-mannatide group α-mannatide powder 10mg, Radix Acaciae senegalis 8g, distilled water 15ml is made into rubber cement; The GONGJINGNING SHUANJI group is with the peaceful bolt 5g of cervix uteri, Radix Acaciae senegalis 8g, and distilled water 15ml is made into rubber cement; Five kinds of suppository groups of the present invention are used five kinds of each 5g of suppository of the present invention respectively, Radix Acaciae senegalis 8g, and distilled water 15ml is made into rubber cement; Normal control group, model group after modeling the 3rd day are used Radix Acaciae senegalis, and distilled water is made into rubber cement; Each group is all used taper venotomy pin, and heading vagina deep is injected respectively, and every day 1 time, each every 1.5ml uses 10 days continuously.
1.4 the assay method of experimental index
The mensuration of red blood cell cr1 molecular immune adhesion function: the anticoagulation of experimental rat to be measured is centrifugal, be made into 1.25 * 10/mL red cell suspension, lyophilizing zymosan reagent is made into 1 * 10 8/ mL uses liquid, and both take out an amount of back and mix 37 ℃ of incubation 30min, sampling dyeing microscopic examination.
The T lymphocyte activity is measured: adopt the MTT detection method, with the aseptic respectively spleen of getting of each group rat, grind and separate, make the mononuclearcell suspension, adjusting cell concentration is 1 * 10 7/ mL adds the ConA that whole mass concentration is 8mg/L respectively, and blank well adds RPMI1640,5%CO 2, cultivate 72h for 37 ℃, 4h before stopping cultivating, the centrifugal 15min of 1500r/min abandons supernatant, and every hole adds hydrochloric acid isopropyl alcohol 100 μ L dissolved particles, surveys the OD value in 570nm.And calculate its activation rate.
The detection of neutrophilic granulocyte phagocytic function: with the anticoagulation of experimental rat to be measured, centrifugal sucking-off leukocytic cream is suitably got 0.5mL after the dilution, adds staphylococcus bacterium liquid 0.1mL (10 6CFU/mL), 37 ℃ of incubation 45min behind the mixing, sampling dyeing microscopic examination.
2 results
After the animal modeling, modeling treated animal great majority (8) vagina collar extension has the yellow secretions of dense thick summary.Only indivedual after five kinds of suppositorys treatment of the present invention (1-2 only) animal vagina collar extension has a small amount of secretions, all the other all dry, cleanings.α-mannatide group and GONGJINGNING SHUANJI group all half (6) animal vagina collar extension have secretions.Each treated animal is put to death in the treatment back, sees the visible a large amount of cell infiltration of modeling treated animal vagina and cervical mucosa under the pathological examination, mirror, little vasodilation, hyperemia, edema, and mucosal ulcer appears in minority.α-mannatide group and the above-mentioned pathological change of GONGJINGNING SHUANJI group alleviate, and five kinds of suppository groups of the present invention all obviously alleviate, near normal group.
The mensuration of red blood cell cr1 molecular immune adhesion function, T lymphocyte activity are measured, the mensuration of neutrophilic granulocyte phagocytic function, the results are shown in Table 1,2,3.Statistical procedures adopts variance analysis, the q check.
Table 1 is respectively organized mensuration (%, the X ± s) of experimental rat red blood cell cr1 molecular immune adhesion function
Figure C20041010443500171
Figure C20041010443500181
Annotate: matched group and model group be * * P<0.01 relatively, and model group and suppository group of the present invention be * * P<0.01 relatively, and model group and α-mannatide group and GONGJINGNING SHUANJI group be * P<0.05 relatively, and matched group and suppository group of the present invention be P>0.05 relatively.
Above experimental data shows: the normal control rats of cervicitis rat red blood cell cr1 molecular immune adhesion rate obviously reduces, and statistics has significant difference; After using five kinds of suppositorys treatment of the present invention, red blood cell cr1 molecular immune adhesion rate all returns to normal level again, and along with the reinforcement of filling a prescription, curative effect is more and more sure; Through the rat of α-mannatide and GONGJINGNING SHUANJI treatment, its red blood cell cr1 molecular immune adhesion rate raises, but fails to return to normal level.Illustrate that five kinds of suppositorys of the present invention descend to cervicitis erythrocyte immune adhesion function curative effect is preferably arranged, though and α-mannatide and GONGJINGNING SHUANJI have certain therapeutic effect, evident in efficacyly be lower than five kinds of suppositorys of the present invention.
Table 2 is respectively organized mensuration (%, the X ± s) of experimental rat neutrophilic granulocyte phagocytic function
Annotate: matched group and model group be * * P<0.01 relatively, and model group and suppository group of the present invention be * * P<0.01 relatively, and model group and α-mannatide group and GONGJINGNING SHUANJI group be P>0.05 relatively, and matched group and suppository group of the present invention be P>0.05 relatively.
Above experimental data shows: the normal rat of the phagocytic function of cervicitis rat neutrophilic granulocyte obviously reduces, and statistics has significant difference; After using five kinds of suppositorys treatment of the present invention, the phagocytic function of neutrophilic granulocyte all returns to normal level, and along with the reinforcement of filling a prescription, curative effect is more and more sure, with the matched group there was no significant difference; Through the rat of α-mannatide and GONGJINGNING SHUANJI treatment, its neutral granulocytic phagocytic function changes little.Illustrate that reduction has curative effect preferably to five kinds of suppositorys of the present invention to cervicitis neutrophilic granulocyte phagocytic function, α-mannatide and GONGJINGNING SHUANJI then do not have the obvious treatment effect.
Table 3 is respectively organized mensuration (%, the X ± s) of experimental rat T lymphocyte activity
Figure C20041010443500191
Annotate: matched group and model group be * * P<0.01 relatively, and model group and suppository group of the present invention be * * P<0.01 relatively, and model group and α-mannatide group and GONGJINGNING SHUANJI group be * P<0.05 relatively, and matched group and suppository group of the present invention be P>0.05 relatively.
Above experimental data shows: the normal rat of cervicitis rat T lymphocyte activation rate obviously reduces, and significant difference is arranged; After using five kinds of suppositorys treatment of the present invention, T lymphocyte activation rate significantly raises again, returns to normal level; Through the rat of α-mannatide and GONGJINGNING SHUANJI treatment, its T lymphocyte activation rate raises to some extent, but for returning to normal level.Illustrate that five kinds of suppositorys of the present invention have stronger activation to the cellular immune function of cervicitis rat T cell mediated, α-mannatide and GONGJINGNING SHUANJI have certain activation to the T lymphocyte, but evident in efficacyly are lower than five kinds of suppositorys of the present invention.
3 discuss
Five kinds of suppositorys of the present invention have heat clearing and damp drying, removing toxic substances and promoting subsidence of swelling, the effect of putrefaction-removing granulation-promoting.Can obviously improve the pathological change of cervicitis experimental rat.Erythrocyte has many important immune correlation functions as the maximum hemocyte of body quantity, participates in the body natural immunity at many levels.Mainly show on the red blood cell cr1 molecular immune adhesion function.Five kinds of suppositorys of the present invention can strengthen the erythrocyte immune adhesion function of cervicitis rat, and the symptom of its cervicitis and corresponding pathological change are had clear improvement.The neutrophilic granulocyte phagocytic function plays an important role in sterilization, bacteriolyze and reset procedure, is the autarcetic ingredient of body.Cervicitis experimental rat neutrophilic granulocyte phagocytic function reduces, and five kinds of suppositorys of the present invention can improve the phagocytic function of cervicitis experimental rat neutrophilic granulocyte, to inflammation excessively, sustained response has and suppresses and therapeutical effect.The cellular immune function of T cell mediated is autarcetic ingredient, cervicitis experimental rat T lymphocyte activation rate obviously descends, five kinds of suppositorys of the present invention can improve cervicitis experimental rat T lymphocyte activation rate, recover cell immune function of human body.
This research has been inquired into five kinds of suppositorys of the present invention by improving cervicitis experimental rat erythrocyte immune adhesion function from the immunology angle, improve the neutrophilic granulocyte phagocytic function, activate the cellular immune function of T cell mediated, reach effective control, stop inflammatory reaction, make corresponding pathological change be improved significantly.
Experiment two: five kinds of suppositorys of the present invention are to the influence of test rat cervicitis pathomorphology
Summary adopts the vagina deep to inject the phenol rubber cement, sets up rat cervix uteri inflammatory model, and observes the influence of five kinds of suppositorys of the present invention to the cervical tissue form.The result shows: the local squamous epithelial cancer serviceability rate of five kinds of suppository treated animal cervix uteri of the present invention is apparently higher than α-mannatide and GONGJINGNING SHUANJI group; Interior inflammatory cell of matter and edema degree all obviously were lighter than α-mannatide and GONGJINGNING SHUANJI group between mucosa reached down.
1 materials and methods
1.1 main agents, medicine
Liquid phenol: Tianjin Chemical Reagents Factory No.1, Tianjin Q/HG3524-91.
Radix Acaciae senegalis: Guangdong city chemical glass instrument plant, UK import packing, lot number 930118.
GONGJINGNING SHUANJI: Jiangsu TCM Hospital.
α-mannatide suppository: Xi'an Hengtongguanghua Pharmaceutical Co., Ltd.
Five kinds of suppositorys of the present invention: Xi'an Hengtongguanghua Pharmaceutical Co., Ltd.
1.2 animal and grouping
Select 126 of healthy, female, unpregnancy wistar rat for use, body weight 150-200g (Xi'an Jiaotong University Medical College's Experimental Animal Center provides).Animal is divided into 9 groups at random by body weight, every group 14: the normal control group, model group, first kind of suppository group of the present invention, second kind of suppository group of the present invention, the third suppository group of the present invention, the 4th kind of suppository group of the present invention, the 5th kind of suppository group of the present invention, α-mannatide group, GONGJINGNING SHUANJI group.
1.3 modeling method and experimental technique
Except that the normal control group, make the cervicitis model with 25% phenol rubber cement for all the other 4 groups,, enter the vagina deep and inject phenol rubber cement, every 1.5ml, 3 days 1 time, totally 3 times with taper venotomy pin.Beginning administration in the 3rd day after the modeling, α-mannatide group α-mannatide powder 10mg, Radix Acaciae senegalis 8g, distilled water 15ml is made into rubber cement; The GONGJINGNING SHUANJI group is with the peaceful bolt 5g of cervix uteri, Radix Acaciae senegalis 8g, and distilled water 15ml is made into rubber cement; Five kinds of suppository groups of the present invention are used five kinds of each 5g of suppository of the present invention respectively, Radix Acaciae senegalis 8g, and distilled water 15ml is made into rubber cement; Normal control group, model group after modeling the 3rd day are used Radix Acaciae senegalis, and distilled water is made into rubber cement; Each group is all used taper venotomy pin, and heading vagina deep is injected respectively, and every day 1 time, each every 1.5ml uses 10 days continuously.
1.4 observation item and method
Each treated animal is put to death in treatment after 10 days continuously, and take out behind the dissection uterus and observe, and the record finding of naked eye.The vagina of drawing materials is organized to uterus subangle place, put in 20% neutral formalin fixing, to organize after 3 days from the center line longitudinal incision, do the routine paraffin wax section, HE dyeing, mirror observe down vagina to uterine cancer cell morphological change and mucosa, mucosa down between the morphologic inflammation of matter change degree, according to evaluation criteria evaluation inflammation degree.
Mucosa: 1. the only local layer 2-3 that surpasses of squamous epithelial cancer level slightly thickens and is "+", obviously thickens to be " ++ ", thickens extensively and make that mucosa is uneven is " +++"; 2. as seen some place's columnar epithelium has hypertrophy and squama trend occurs for "+", and obviously squama turns to " ++ ", and the squamaization zone extensively even reach uterine cavity and be " +++"; 3. rarely seen few regional squamous epithelial cancer occurs rotten to the corn, and is replaced by "+" by adjacent posts columnar epithelium hypertrophy, and it is " ++ " that the columnar epithelium hypertrophy obviously substitutes squamous epithelial cancer, and the squamous epithelial cancer sheet comes off and is replaced by " +++" by columnar epithelium; 4. rarely seen few zone is rotten to the corn, and to break through basement membrane be "+", and visible obviously mucous epithelium degeneration necrosis be " ++ ", and mucosal ulcer is " +++" with infection.
Cell infiltration: shallow-layer has a small amount of cell infiltration for "+" under 5. rarely seen mucosa and the mucosa, and mucosa and mucosa all have the moderate cell infiltration to be " ++ " in the matter between down, mucosa down and between in the matter deep layer see that all a large amount of extensively cell infiltration are " +++"; 6. matter fibroblast proliferation between: the slightly normal matched group of rarely seen fibroblast increases and is "+" in the matter, fibroblast proliferation obviously and have a small amount of collagenous fiber bundle to be " ++ ", fibroblast proliferation forms " +++" with a large amount of collagenous fiber bundles.
Each inflammation of comprehensive vagina changes degree, with vagina and the overall inflammation change of cervix uteri degree be divided into 4 grades as follows: normal: a small amount of cell infiltration of rarely seen shallow-layer in six; Slightly: in six more than two "+"; Moderate: more than two "+", two have " ++ " in six; Severe: one has " +++" in six, and two have " ++ ", and three have "+"; Or three have " +++".
Observe cell infiltration situation under the mucosa with ordinary optical microscope, and count the cell infiltration degree down in 40 * 10 times of mirrors, and be unit are, evenly count 6 unit are inflammatory cell numbers at random with each eyepiece micrometer net with eyepiece micrometer net.Get average, each group inflammatory cell number is taken statistics to learn handle.
1.4 the statistical method experimental result adopts variance analysis, statistical methods such as Ridit check are handled.
2 results
2.1 gross examination of skeletal muscle
As seen modeling treated animal great majority (9 example) vagina collar extension has dense condensed secretions, animal to flock together, lack moving, perpendicular hair after the modeling; Only indivedual (1-2 example) the vagina collar extensions of five kinds of suppository groups of the present invention have outside a small amount of secretions, and all the other are all dry, and cleaning and animal appearance and normal control group do not have obvious difference; α-mannatide group and GONGJINGNING SHUANJI group nearly half (each 6 example) vagina collar extension has secretions, and outward appearance slightly is better than the modeling group.
2.2 tectology is observed
Modeling group vaginal mucosa squamous epithelial cancer level thickens, and as seen cervix uteri squama post intersection has the columnar epithelium squamous metaplasia, and the visible epithelial erosion in place is arranged, and has rotten to the corn position columnar epithelium to substitute the trend of squamous epithelial cancer.As seen the minority case has mucosal ulcer, tela submucosa telangiectasis hyperemia, interstitial edema.From mucosa between all visible a large amount of cell infiltration of matter, and visible interstitial fibers hamartoplasia.Five kinds of suppository groups of the present invention and modeling group corresponding site are relatively; pathological changes is all obviously slight; it is also obviously light than other group that its inflammation changes degree; its squamous epithelial cancer form is similar to the normal control group; under the mucosa cell infiltration than the modeling group obviously reduce,, organizational structure and normal control group no significant difference.The inflammation of α-mannatide group and GONGJINGNING SHUANJI group alleviates to some extent, but still overweights five kinds of suppository groups of the present invention.(seeing Table 1,2)
Table 1 is respectively organized the inflammation of uterus degree relatively
Figure C20041010443500221
Figure C20041010443500231
Table 2 is respectively organized cervical mucous membrane inflammatory cell number relatively
Figure C20041010443500232
Annotate: with normal group than * * P<0.01; Compare with the modeling group: ◇ ◇P<0.01
3 discuss
This experimental histology checks that the covering epithelium serviceability rate that confirms five kinds of suppository groups of the present invention is all apparently higher than α-mannatide group and GONGJINGNING SHUANJI group, two kinds of epithelial migration portions of squama post intersection are clear, its morphosis, squamous epithelial cancer level all more approach the normal control group.At squama post intersection, do not see obvious height squama sign is arranged, submucosal gland body hypertrophy is also slight than α-mannatide group and GONGJINGNING SHUANJI group, and interior cell infiltration of matter and edema degree all obviously were lighter than the modeling group between mucosa reached down, also slightly were lighter than α-mannatide group and GONGJINGNING SHUANJI group.Its overall inflammation changes all slight than the modeling group, and more approaches matched group.Prompting: five kinds of suppositorys of the present invention all have ideal therapeutical effect to the damage and the inflammation of the cervical mucosa that laboratory animal caused.
The clinical efficacy checking of treatment chronic cervicitis suppository of the present invention: Zhang, 48 years old, severe cervical erosion 15 years was once used the Western medicine external repeatedly, and vaginal secretions reduces, but the cervical erosion face does not have improvement, often feels fatigue and weak, dim complexion.Adopt treatment chronic cervicitis suppository treatment of the present invention after 7 days, subjective symptoms takes a turn for the better, the mental status is good, have rosy cheeks, vaginal secretions reduces, colorless and odorless, the cervical erosion face is from the original 2/3 cervix uteri area that surpasses, narrow down to the present 1/3 cervix uteri area that is less than, rotten to the corn degree shoals, and the surface is near recovery from illness.Continue medication and check after one month, fully recover, follow up a case by regular visits to and do not have recurrence half a year.As seen suppository of the present invention has unique curative effect really to chronic cervicitis.
The clinical efficacy statistics of treatment chronic cervicitis suppository of the present invention: collect the case that 270 examples all meet " chronic cervicitis " diagnostic criteria in " disease clinical diagnosis and criterion of therapeutical effect ", be selected into case and be the married woman, wherein 20-30 year person's 87 examples account for 32.2%; 31-40 year person's 102 examples account for 37.8%; 41-50 year person's 62 examples account for 23%; Person's 19 examples more than 50 years old stand 7%.Simple rotten to the corn person's 197 examples of cervix uteri account for 72.9%; Cervical erosion and loose person's 51 examples account for 18.9%; Cervical erosion and polyp person 15 examples account for 5.6%; Those Pasteur's vesicle 7 examples account for 2.6%; Cervical erosion degree I degree 43 examples account for 15.9%; II degree 168 examples account for 62.2%; III degree 59 examples account for 21.9%.Criterion of therapeutical effect: recovery from illness: the cervical erosion face heals fully, smooth surface, and biopsy is no abnormal, and original subjective symptoms disappears; Showing (having) imitates: the cervical erosion reduction of area is little more than 1/2, and rotten to the corn degree shoals, and subjective symptoms alleviates; Invalid: the cervical erosion reduction of area is little not to reach 1/2 or local no change, and subjective symptoms does not alleviate.Therapeutic outcome: 270 routine patient's medications every day once, each 5g, logotype 7 days was a course of treatment.After finished a course of treatment, 247 examples of fully recovering accounted for 91.5%; Show (having) and imitate 18 examples, account for 6.7%; Invalid 5 examples account for 1.8%.The statistics total effective rate is 98.1%.

Claims (5)

1. suppository for the treatment of chronic cervicitis, it is characterized in that: raw material mainly comprises α-mannatide 300g among the medicament 1000g; Flos Lonicerae 20g-30g; Radix Isatidis 20g-50g; Fructus Forsythiae 10g-30g; Folium Isatidis 10g-25g; Indigo Naturalis 10g-30g; Rhizoma Coptidis 10g-30g; Radix Scutellariae 15g-30g; Cortex Phellodendri 10g-30g; Caulis Fibraureae 10g-25g; Herba Andrographis 10g-30g; Herba Violae 15-30g; Herba Taraxaci 5g-25g; Herba Patriniae 10g-30g; Rhizoma Paridis 15g-25g; Radix Gentianae 10g-20g; Radix Sophorae Tonkinensis 15g-30g; Rhizoma Anemarrhenae 5g-10g; Cortex Magnoliae Officinalis 10g-30g; Cortex Moutan 15g-30g; Radix Paeoniae Alba 10g-20g; Spica Prunellae 10g-30g; Fructus Trichosanthis 15g-30g; Calculus Bovis 10g-20g; Bulbus Allii 20g-30g; Fructus Chebulae 10g-30g.
2. a kind of suppository for the treatment of chronic cervicitis according to claim 1 is characterized in that: raw material is α-mannatide 300g, Flos Lonicerae 30g, Radix Isatidis 50g, Fructus Forsythiae 30g, Folium Isatidis 25g, Indigo Naturalis 30g, Rhizoma Coptidis 30g, Radix Scutellariae 30g, Cortex Phellodendri 30g, Caulis Fibraureae 25g, Herba Andrographis 30g, Herba Violae 30g, Herba Taraxaci 25g, Herba Patriniae 30g, Rhizoma Paridis 25g, Radix Gentianae 20g, Radix Sophorae Tonkinensis 30g, Rhizoma Anemarrhenae 10g, Cortex Magnoliae Officinalis 30g, Cortex Moutan 30g, Radix Paeoniae Alba 20g, Spica Prunellae 30g, Fructus Trichosanthis 30g, Calculus Bovis 20g, Bulbus Allii 30g, Fructus Chebulae 30g among the described medicament 1000g.
3. a kind of suppository for the treatment of chronic cervicitis according to claim 1 is characterized in that: raw material is α-mannatide 300g among the described medicament 1000g; Flos Lonicerae 20g; Radix Isatidis 40g; Fructus Forsythiae 20g; Folium Isatidis 15g; Indigo Naturalis 20g; Rhizoma Coptidis 20g; Radix Scutellariae 20g; Cortex Phellodendri 20g; Caulis Fibraureae 15g; Herba Andrographis 20g; Herba Violae 20g; Herba Taraxaci 15g; Herba Patriniae 20g; Rhizoma Paridis 15g; Radix Gentianae 10g; Radix Sophorae Tonkinensis 20g; Rhizoma Anemarrhenae 10g; Cortex Magnoliae Officinalis 20g; Cortex Moutan 20g; Radix Paeoniae Alba 10g; Spica Prunellae 20g; Fructus Trichosanthis 20g; Calculus Bovis 10g; Fructus Chebulae 20g; Fructus Cnidii 20g; Radix Sophorae Flavescentis 20g; Radix Pulsatillae 20g; melia 20g; bud of Herba Agrimoniae 20g; Herba Menthae 20g; Bulbus Allii 40g; very light blue 20g; Semen Raphani 20g; Olibanum 20g; Folium Persicae 20g; Fructus Gleditsia 20g.
4. a kind of suppository for the treatment of chronic cervicitis according to claim 1 is characterized in that: raw material is α-mannatide 300g among the described medicament 1000g; Flos Lonicerae 20g; Radix Isatidis 20g; Fructus Forsythiae 10g; Folium Isatidis 10g; Indigo Naturalis 10g; Rhizoma Coptidis 10g; Radix Scutellariae 15g; Cortex Phellodendri 10g; Caulis Fibraureae 10g; Herba Andrographis 10g; Herba Violae 15g; Herba Taraxaci 5g; Herba Patriniae 10g; Rhizoma Paridis 15g; Radix Gentianae 10g; Radix Sophorae Tonkinensis 15g; Rhizoma Anemarrhenae 5g; Cortex Magnoliae Officinalis 10g; Cortex Moutan 15g; Radix Paeoniae Alba 10g; Spica Prunellae 10g; Fructus Trichosanthis 15g; Calculus Bovis 10g; Fructus Chebulae 10g; Fructus Cnidii 10g; Radix Sophorae Flavescentis 15g; Radix Pulsatillae 10g; melia 15g; bud of Herba Agrimoniae 15g; Herba Menthae 10g; Bulbus Allii 20g; very light blue 10g; Semen Raphani 15g; Olibanum 10g; Folium Persicae 10g; Fructus Gleditsia 10g; Radix Gentianae 10g; Radix Scutellariae 20g; Rhizoma Imperatae 20g; Radix Rehmanniae 20g; Gypsum Fibrosum 20g; Rhizoma Anemarrhenae 10g; LIUYI SAN 20g; Folium Isatidis 20g; Cortex Moutan 20g; Radix Paeoniae Rubra 20g; Herba Plantaginis 10g; Cortex Sclerotii Poriae 20g; raw pearl barley 20g; Fructus Kochiae 20g; Herba Hedyotidis Diffusae 20g.
5. a kind of suppository for the treatment of chronic cervicitis according to claim 1 is characterized in that: raw material is α-mannatide 215g among the described medicament 1000g; Flos Lonicerae 15g; Radix Isatidis 15g; Fructus Forsythiae 10g; Folium Isatidis 10g; Indigo Naturalis 10g; Rhizoma Coptidis 5g; Radix Scutellariae 10g; Cortex Phellodendri 5g; Caulis Fibraureae 10g; Herba Andrographis 10g; Herba Violae 10g; Herba Taraxaci 5g; Herba Patriniae 10g; Rhizoma Paridis 5g; Radix Gentianae 10g; Radix Sophorae Tonkinensis 5g; Rhizoma Anemarrhenae 5g; Cortex Magnoliae Officinalis 10g; Cortex Moutan 10g; Radix Paeoniae Alba 10g; Spica Prunellae 10g; Fructus Trichosanthis 15g; Calculus Bovis 10g; Fructus Chebulae 10g; Fructus Cnidii 10g; Radix Sophorae Flavescentis 5g; Radix Pulsatillae 5g; melia 10g; bud of Herba Agrimoniae 5g; Herba Menthae 10g; Bulbus Allii 10g; very light blue 10g; Semen Raphani 15g; Olibanum 10g; Folium Persicae 10g; Fructus Gleditsia 10g; Radix Gentianae 5g; Radix Scutellariae 10g; Rhizoma Imperatae 15g; Radix Rehmanniae 10g; Gypsum Fibrosum 15g; Rhizoma Anemarrhenae 5g; LIUYI SAN 10g; Folium Isatidis 15g; Cortex Moutan 10g; Radix Paeoniae Rubra 10g; Herba Plantaginis 10g; Cortex Sclerotii Poriae 15g; raw pearl barley 10g; Fructus Kochiae 10g; Herba Hedyotidis Diffusae 15g; Rhizoma Atractylodis 20g; Rhizoma Atractylodis Macrocephalae 20g; Pericarpium Citri tangerinae 20g; Rhizoma Pinelliae 15g; Poria 25g; Rhizoma Alismatis 20g; Polyporus 20g; Talcum 15g; Semen Plantaginis 20g; Radix Codonopsis 20g; Rhizomadioscoreae 15g; Radix Astragali 10g; Radix Ginseng 15g; Radix Glycyrrhizae 20g; Radix Angelicae Sinensis 10g; Radix Rehmanniae Preparata 20g.
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