CN1167446C - Chinese medicine gel for treating cervicitis and cervical erosion, and preparing method thereof - Google Patents

Chinese medicine gel for treating cervicitis and cervical erosion, and preparing method thereof Download PDF

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Publication number
CN1167446C
CN1167446C CNB011265612A CN01126561A CN1167446C CN 1167446 C CN1167446 C CN 1167446C CN B011265612 A CNB011265612 A CN B011265612A CN 01126561 A CN01126561 A CN 01126561A CN 1167446 C CN1167446 C CN 1167446C
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China
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gel
chinese medicine
cervicitis
catechu
cervical erosion
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CN1401344A (en
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怡 冯
冯怡
徐德生
李媛
付荣杰
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Guangxi Huahong Pharmaceutical Co., Ltd.
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Shanghai University of Traditional Chinese Medicine
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Abstract

The present invention relates to a traditional Chinese medicine gel for treating cervicitis and cervical erosion and a preparing method thereof. The gel is composed of components of the following percentage by weight: 5 to 50% flavescent sophora roots total extracts, 3 to 25 % Nauclea gambir total extracts, 20 to 60 % acid solvent, 10 to 50 % polar solvent and 0.5 to 10% macromolecule adhere materials. The gel used as a preparation for vaginas of women is firstly put forward by the present invention and can be directly used for a position catching a disease. The present invention has the advantages of strong pertinence, small interference for the internal environment of an organism and quick doing execution, and thus, the present invention can well exert therapeutic effect. The present invention also provides a preparing method for the gel and solves the imcompatible problem that tannin in Nauclea gambir is matched with alkaloid in flavescent sophora root. The made gel can be completely gel, cream bodies are exquisite and lucidus.

Description

A kind of Chinese medicine gel and preparation method for the treatment of cervicitis and cervical erosion
Technical field
The present invention relates to treat the Chinese medicine preparation and the preparation method of cervicitis and cervical erosion, be specifically related to treat the gel and the preparation method of cervicitis and cervical erosion.
Background technology
Chronic cervicitis disease and cervical erosion are married woman's frequently-occurring disease, commonly encountered diseases.At present, Therapeutic Method has oral drugs and external treatment (physiotherapy, pharmacotherapy).Though physiotherapy such as pressing, wherein freezing in the external treatment, laser, electricity can make that inflammatory tissue comes off, cervical mucosa is newborn repairs, but side effect such as hemorrhage, that water sample oozes out are arranged, also can shrink and make narrow, the adhesion of cervical canal because of scar tissue, to bring the childbirth difficulty to the married women of not educating, and treatment must be carried out in hospital.Pharmacotherapy in the external treatment is because of directly acting on disease sites, and is with strong points, organismic internal environment disturbed little, and it is fast to prove effective, and belongs to the non-invasive treatment method and clinical rather well received and pay attention to.After in " the Jiangsu traditional Chinese medical science " 1992 (11) 8-9 pages or leaves, reporting cervix uteri I number of making, the administration of II powder transvaginal as Huang Yongcheng with Chinese medicines such as Indigo Naturalis, catechu, Cortex Phellodendris, 62 routine patients, cure rate 88.7%, produce effects example 6.4%, improvement rate 4.9%, total effective rate are 98.6%.Yang Xiaohui etc. are at " Chinese Pharmaceutical Journal " 1,997 32 (8): report is made gynecological's antiinflammatory vaginal suppository with Chinese medicines such as Olibanum, Myrrha, catechu and is treated the cervicitis patient among the 496-498, and its total effective rate is 98.6%.Fan Yingchang is at " Chinese experimental pharmacology of Chinese medical formulae magazine " 19973 (5): after the Chinese medicine vagina effervescence that report is made up of Fructus Cnidii, Radix Sophorae Flavescentis etc. among the 35-38 acts on rat uterus neck inflammatory model, its covering epithelium serviceability rate is obvious, interior inflammatory cell of matter and edema degree all obviously were lighter than matched group between mucosa reached down, and the vagina epithelium estrogen receptor obviously reduces than other groups.In a word, the clinical report of Chinese medicine external curing chronic cervicitis disease and cervical erosion is more, and the dosage form of application has fumigation and washing agent, powder, suppository, unguentum, paste etc.From clinical practice, these dosage forms all have weak point separately.As type of effervescent suppository characteristics such as the medicine spreading area is big are arranged, but, make said preparation that sense of discomfort be arranged in use because of mucosa there being certain stimulation.
Summary of the invention
The technical problem of the desired solution of the present invention provides a kind of bioavailability height, long, the malicious little treatment cervicitis of effect and the new medicine gel of cervical erosion paid of drug treating time.
The Chinese medicine gel of treatment cervicitis disclosed by the invention and cervical erosion is a 5-50% Radix Sophorae Flavescentis total extract by percentage by weight, 3-25% catechu total extract, the 20-60% acid flux material, 10-50% polar solvent and 0.5-10% macromolecule adhesion material are formed, Radix Sophorae Flavescentis total alkaloids content 〉=92% in the Radix Sophorae Flavescentis total extract wherein, tannin, catechin and epicatechin total content 〉=85% in the catechu total extract.
Radix Sophorae Flavescentis total extract of the present invention is the commercially available prod, Radix Sophorae Flavescentis total alkaloids content 〉=92%.
Catechu total extract of the present invention is the extractum after purified, tannin, catechin and epicatechin total content 〉=85%.
Acid flux material of the present invention is meant hydrochloric acid, 0.5-1N acetic acid and the 0.5-1N nitric acid of 0.5-1N.
Polar solvent of the present invention is meant the aqueous solution of concentration (w/w) for the glycerol of 20-80% and 20-80% propylene glycol.
Macromolecule adhesion material of the present invention is meant HPMC (RT15000), CMC-Na and Carbom (acrylic polymer polymer).
Another technical problem to be solved by this invention provides the preparation method of the Chinese medicine gel of above-mentioned treatment cervicitis and cervical erosion.
The preparation method of the Chinese medicine gel of treatment cervicitis disclosed by the invention and cervical erosion comprises the following steps:
(1) preparation of catechu total extract
Catechu extracted 5 hours with the organic solvent Soxhlet, and extracting solution concentrates the recovery solvent and gets extractum, and 70 ℃ of vacuum dryings promptly get Catechu extract; Tannin, catechin and epicatechin total content 〉=85% in the Catechu extract;
(2) preparation of gel
By recipe quantity the Radix Sophorae Flavescentis total alkaloids extract is dissolved in the acid flux material, adds the gelling of macromolecule adhesion material swelling, standby; The catechu total extract is dissolved with polar solvent, under agitation dropwise join in the above-mentioned gel object, stir promptly.
Organic solvent described in the preparation method of the present invention can be ethyl acetate, acetone, 30% methanol and ethanol etc.
The present invention treats and adopts Radix Sophorae Flavescentis and catechu compatible in the prescription of Chinese medicine gel of cervicitis and cervical erosion, and wherein Radix Sophorae Flavescentis has heat clearing and damp drying, parasite killing, diuresis; Catechu has the effect of removing dampness promoting tissue regeneration and ulcer healing.Bibliographical information and effect experiment prove: Radix Sophorae Flavescentis ethanol extract, matrine, Radix Sophorae Flavescentis total alkaloids have antibiotic, the anti-trichomonal effect in inside and outside preferably.Clinical report, treatment cervical erosions such as catechu have curative effect preferably.Being used of Radix Sophorae Flavescentis and catechu total extract will be played effect antibiotic, promoting tissue regeneration and ulcer healing.
Mucosa delivery is meant that medicine closely contacts with the biological mucosa surface, enters the administering mode of blood circulation by this place's epithelial cell.The position of mucosa delivery can be oral cavity, nasal cavity, eye, vagina, rectum etc., and dosage form can be tablet, membrane, stick, powder, ointment etc. as required.Mucosa delivery both can produce local action, can produce general action again.Mucosa delivery except have can avoid first pass effect, blood drug level steadily, the characteristics of transdermal administration such as long action time, application be convenient, also because there is not the such keratinization of skin in mucosa, and blood capillary is abundant under the mucosa, making mucosa delivery have that dosage is little, bioavailability is high and characteristics such as action time is fast, is one of more novel form of Recent study.
Along with pharmaceutical polymers research and deepening continuously of using, the foreign biomolecule adhesion preparation has been made into multiple dosage form, adhere to specific regions such as human oral cavity, nasal cavity, gastrointestinal tract, vagina, carry medicine, reach the purpose of whole body or topical therapeutic by the transhipment of mucosa.In the pharmaceutical preparation, the bioadhesion effect refers to that some polymeric material has the adhesion strength of long period to the body tissue mucosa, but body tissue mucosa secreting mucus, polymer contacts with mucosa, absorb the moisture in the mucus, in mucomembranous surface generation swelling, rely on mechanical bond power, static pressure gravitation, Van der Waals force or hydrogen bond, covalent bond effect and mucosa to combine, thereby biologic adhesion preparation in prolong drug effect, control drug release, alleviate poisonous side effect of medicine, improving aspect such as bioavailability has remarkable advantages.
The present invention proposes gel first as the woman vagina preparation, employed macromolecular material has the adhesion strength of long period to the body tissue mucosa, in mucomembranous surface generation swelling, rely on mechanical bond power, static pressure gravitation, Van der Waals force or hydrogen bond, covalent bond effect and mucosa to combine, thereby can prolong drug than other external preparation such as suppository etc. action time, can directly act on disease sites, with strong points, disturb little to organismic internal environment, it is fast to prove effective, thereby brings into play curative effect better.
The present invention treats the Chinese medicine gel of cervicitis and cervical erosion and compares with other vaginal suppositories or vagina effervescent suppository, no foreign body sensation, and nonirritant can improve patient's compliance.
The Chinese medicine gel that the present invention treats cervicitis and cervical erosion contains Radix Sophorae Flavescentis total alkaloids and Catechu extract simultaneously, in preparation process if directly both mixing will be produced precipitation, in the inventive method Radix Sophorae Flavescentis total alkaloids is dissolved with acid flux material, the catechu total extract dissolves with polar solvent, then catechu total extract solution is splashed in the gelled fluid of Radix Sophorae Flavescentis total alkaloids, solved the tannin in the catechu and the problem of the alkaloid incompatibility in the Radix Sophorae Flavescentis, the gel gelling of making is complete, mastic is fine and smooth, gloss.
The Chinese medicine gel for the treatment of cervicitis and cervical erosion with the present invention is carried out relevant pharmacodynamics test proof and had (1) antibacterial action: having proved has bacteriostasis preferably to staphylococcus, escherichia coli, Candida albicans, first streptococcus.(2) itching-relieving action: can significantly improve the Cavia porcellus itch-threshold that histamine phosphate causes.(3) to the influence of experimental rat cervicitis pathomorphology: can effectively improve rat experiment cervix uteri inflammation and rotten to the corn pathomorphism due to chemical (phenol rubber cement), bacillary (the golden Portugal bacterium).
The Chinese medicine gel of treatment cervicitis disclosed by the invention and cervical erosion, evident in efficacy, the bioavailability height has been given full play to unique curative effect of Chinese medicine, has played positive facilitation to starting Chinese medicine vagina administration novel form.
The specific embodiment
The preparation of embodiment 1 catechu total extract
Catechu extracted 5 hours with the ethyl acetate Soxhlet, and extracting solution concentrates the recovery solvent and gets extractum, and 70 ℃ of vacuum dryings promptly get Catechu extract; Extracting yield is 40%, and tannin, catechin and epicatechin total content are 87.5% in the Catechu extract.
Embodiment 2
Prescription: Radix Sophorae Flavescentis total extract 27g (Radix Sophorae Flavescentis total alkaloids content is 92%)
Catechu total extract 15g
0.8NHCL 30ml
30% glycerol 25g
HPMC 3g
By recipe quantity the Radix Sophorae Flavescentis total alkaloids extract is dissolved among the 0.8NHCL, adds the gelling of HPMC swelling, it is standby to get sample 1; Make the catechu total extract by embodiment 1 method, get sample 2, under agitation sample 2 is dropwise joined in the sample 1, stir promptly with 30% glycerol stirring and dissolving.The every gram of the gel that makes contains Radix Sophorae Flavescentis total alkaloids 0.25g, contains catechu total extract 0.13g.
Embodiment 3
Prescription: Radix Sophorae Flavescentis total extract 23g (Radix Sophorae Flavescentis total alkaloids content is 94%)
Catechu total extract 20g
0.8NHAC 25ml
50% propylene glycol 30g
Carbom 2g
Preparation method is with embodiment 1, and the every gram of the gel that makes contains Radix Sophorae Flavescentis total alkaloids 0.22g, contains catechu total extract 0.17g.

Claims (8)

1, a kind of Chinese medicine gel for the treatment of cervicitis and cervical erosion, it is characterized in that this gel is a 5-50% Radix Sophorae Flavescentis total extract by percentage by weight, 3-25% catechu total extract, the 20-60% acid flux material, 10-50% polar solvent and 0.5-10% macromolecule adhesion material are formed.
2, the Chinese medicine gel of a kind of treatment cervicitis as claimed in claim 1 and cervical erosion is characterized in that Radix Sophorae Flavescentis total alkaloids content is no less than 92% in the wherein said Radix Sophorae Flavescentis total extract.
3, a kind of Chinese medicine gel for the treatment of cervicitis and cervical erosion according to claim 1 is characterized in that tannin, catechin and epicatechin total content are no less than 85% in the wherein said catechu total extract.
4, a kind of Chinese medicine gel for the treatment of cervicitis and cervical erosion according to claim 1 is characterized in that wherein said acid flux material is the centinormal 1 hydrochloric acid of 0.5-1, the centinormal 1 acetic acid of 0.5-1 and the centinormal 1 nitric acid of 0.5-1.
5, a kind of Chinese medicine gel for the treatment of cervicitis and cervical erosion according to claim 1 is characterized in that wherein said polar solvent is meant that weight concentration is the glycerol of 20-80% and the aqueous solution of 20-80% propylene glycol.
6, a kind of Chinese medicine gel for the treatment of cervicitis and cervical erosion according to claim 1 is characterized in that wherein said macromolecule adhesion material is hydroxypropyl methylcellulose, sodium carboxymethyl cellulose and carbomer.
7, the preparation method of the Chinese medicine gel of a kind of treatment cervicitis as claimed in claim 1 and cervical erosion is characterized in that the preparation method of this gel comprises the following steps:
(1) preparation of catechu total extract
Catechu extracted 5 hours with the organic solvent Soxhlet, and extracting solution concentrates the recovery solvent and gets extractum, and 70 ℃ of vacuum dryings promptly get Catechu extract; Tannin, catechin and epicatechin total content are not less than 85% in the Catechu extract;
(2) preparation of gel
By recipe quantity the Radix Sophorae Flavescentis total alkaloids extract is dissolved in the acid flux material, adds the gelling of macromolecule adhesion material swelling, standby; The catechu total extract is dissolved with polar solvent, under agitation dropwise join in the above-mentioned gel object, stir promptly.
8, the preparation method of the Chinese medicine gel of a kind of treatment cervicitis as claimed in claim 7 and cervical erosion is characterized in that wherein said organic solvent is ethyl acetate, acetone, 30% methanol and ethanol.
CNB011265612A 2001-08-28 2001-08-28 Chinese medicine gel for treating cervicitis and cervical erosion, and preparing method thereof Expired - Fee Related CN1167446C (en)

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Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102526170B (en) * 2011-12-31 2015-04-29 许学志 Catechu extract composition for resisting tubercle bacillus, preparation method of catechu extract composition, pharmaceutical preparation containing catechu extract composition, and application of catechu extract composition
CN104510767A (en) * 2013-10-08 2015-04-15 广西壮族自治区花红药业股份有限公司 Gel preparation for treating cervicitis and cervical erosion and preparation method thereof
CN110433284A (en) * 2019-08-07 2019-11-12 广东圆康再生医学科技开发有限公司 A kind of composition that treating cervicitis, gelling agent and preparation method thereof
CN110354182A (en) * 2019-08-12 2019-10-22 南京依美生物科技有限公司 It is a kind of to treat gynaecology's reparation gel and preparation method thereof that cervical squamous intraepithelial turns up

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