CN1977864A

CN1977864A - Novel medicine for preventing early cervical cancer rubra Nocardia preparation and use

Info

Publication number: CN1977864A
Application number: CNA2005101276039A
Authority: CN
Inventors: 李丰才
Original assignee: Individual
Current assignee: Individual
Priority date: 2005-12-06
Filing date: 2005-12-06
Publication date: 2007-06-13

Abstract

The present invention relates to a new medicine-red noeardicin capable of preventing early cervical carcinoma and curing human papillomavirus (HPV). Said invention also provides its preparation method.

Description

A kind of new drug-nocardia rubra preparation and application that prevents early cervical Ca

The object of the present invention is to provide a kind of new drug that prevents early cervical Ca, its Main Ingredients and Appearance is nocardia rubracell wall and pharmaceutically acceptable carrier, be used for the treatment of the early stage cervix uteri Ca that infects initiation because of human papillomavirus's (HPV virus), specifically, the present invention is to provide nocardia rubra preparation and the application that anti-human papilloma virus (anti-HPV) infects.

The main component of described anti human papillomavirus medicine is nocardia rubracell wall and pharmaceutically acceptable carrier.

Described carrier comprises excipient, based on dextran.In the present invention, described medicine is a local application, comprises freeze dried powder, lotion, liniment, ointment, plaster, gel, oil preparation, paste, ointment, aerosol etc., is preferably lotion, liniment and freeze dried powder.

Described medicine is the cell wall product that contains the described nocardia rubra of 0.0015-2 milligram (actinomycetes) in per 1 milliliter or the every gram medicine.

Red promise blocking agent is used for anti-HPV viral infection, and its control effect and mechanism is a science.Both, also be fit to the immunoregulatory characteristic of red promise blocking agent, thereby verified the drug action that red promise blocking agent has the immunity regulated and removes HPV virus at viral pathogenesis.

In numerous trouble HPV viral infection persons, most people can be within a certain period of time, by self good immunocompetence, the infection of removing HPV virus fully.But an a minority is also arranged,, cause long-term infection of HPV virus and cause further pathological changes because of the autoimmune ability is low.So the power of patient's autoimmune ability becomes the key factor of infection.Or say it, can regulate the human body immunity becomes the key that remove HPV virus.

Research practice for many years proves that red promise blocking agent is a nonspecific immunity regulator, has more significantly immunological enhancement with the mucosa system especially on human body skin.

After red promise blocking agent effect lesion, the immune system of human activin is transferred a large amount of macrophages and natural killer cell (NK cell) and is assembled to lesion rapidly, the ability that sick cell was killed and engulfed to obvious activating macrophage and NK cell.Induce simultaneously to produce cytotoxic T lymphocyte and a large amount of cytokine, specific killing and removing virus infected cell, and significantly strengthen the humoral immunization ability.

Have research to think: effective activated CTL has important effect in removing the squamous epithelial cancer infringement that HPV infects and the HPV viral infection causes.

The disappearing to exist with the neutrality antibody of anti-HPV-16 of CIN is associated, and this antibody can be by the HPV that suppresses to duplicate infection cell again, reduces virus load and stops the relevant cervix uteri infringement of HPV to further develop.

There are some researches show that 87% the cervical cancer of having an appointment all occurs in transitional zone (being cervix uteri squama post intersection).And detect to find the HPV Lang Gehan Schwann Cells content height of patient of turning out cloudy than HPV persistent infection person.The zone Lang Gehan Schwann Cells concentration affects HPV gradient of infection so divide a word with a hyphen at the end of a line, and red promise blocking agent helps increment of Lang Gehan Schwann Cells and activation.

Though the effect of virus is not directly killed, removed in red promise blocking agent self, the mechanism of action that virus was killed, removed to red promise blocking agent transfer enhancing human autoimmune function still is science, definite.This indirect immunoregulation effect and the control effect and mechanism that produces have illustrated the reason of red promise blocking agent safety.

The present invention adopts following method to identify the effect that the cell wall product of described red promise card infects treatment human papillomavirus (HPV virus).

Known, the detection method of HPV virus in this area has following several usually:

1, cytologic slide detection method:

The pap staining detection method also is referred to as to be coated with chip detection method.Exactly the cervical secretions of gathering being coated on the sheet glass, using microscopic examination, mainly is to check whether physaliphore or keratinocyte, recall rate 70-76% are arranged.

2, immunohistochemistry detection method:

Behind the HPV immune animal, the polyclonal antibody of generation is looked into and is organized HPV antigen, adopts the PAP Faxian to show virus protein, with proof virus antigen is arranged.When HPV albumen is positive, occur pink weak positive reaction in the epithelial cell, it is positive to see brown granular shape calmness in physaliphore nuclear.But verification and measurement ratio hangs down 40-60%, and sensitivity is not high, can not typing

3, TCT method (the ultra-thin cytology's detection method of membrane liquid base)

Take special-purpose brush in the sampling of cervix uteri place, utilize cell-preservation liquid to isolate then and gathered impurity in the sample, form ultrafine cell smear clearly, can detect whether HPV virus is arranged, can also determine type.Also be called TCT.Recall rate 70-95%.

4, HPV viral DNA detection method:

(1) polymerase chain reaction PCR:

Get secretions with the cotton rod that scraper plate or normal saline soak into from vagina and cervix uteri collar extension, the DNA that methods such as process is centrifugal, washing are extracted HPV through pcr amplification and gel electrophoresis, observes the contrast of electrophoresis and sample and can make diagnosis.Though easy, can not locate, do not know whether virus has activity.

(2) DNA hybrid method PCK:

HPV-DNA molecular hybridization, CP-14 immune hybrid method.Can see that with 400 times of fluorescence microscopies 3 above phosphor dots are positive.Can typing, nucleic acid hybridization can detect the HPV-DNA sequence, and PCR detects visible specificity HPV-DNA amplification region band, but loaded down with trivial details, expensive.Need certain device and condition.

Because the present invention adopts the nocardia rubra preparation, treat human papillomavirus's (HPV virus) by cervical canal mode such as inject and infect, obtained better therapeutic effect.Preliminary test, all effective in cure to the high-risk or low danger virus of HPV.

Thereby proof adopts the nocardia rubracell wall preparation can effectively treat the HPV viral infection, thereby reaches the purpose of prevention cervical cancer.And the disease that causes because of HPV virus for effective treatment provides brand-new Therapeutic Method.For conquering first cancer-cervical cancer comprehensively, the mankind brought new hope.

The present invention is directed to bringing out of cervical cancer mainly is this important step of HPV viral infection.On the anti-HPV viral infection of red promise blocking agent, carried out a large amount of tests, and tentatively summed up a whole set of Therapeutic Method, obtained excellent curative, explored the new approach of an anti-HPV viral infection at anti-HPV viral infection.

Adopt red promise blocking agent to carry out anti-HPV viral infection, following several distinguishing feature arranged:

1, safety is good: in therapeutic process, do not find toxic and side effects, and uncomfortable sensation.

2, correspondence is good: local disease is treated by local application, has avoided the somatic reaction of systemic administration.

3, with strong points: disease shows epidermis and mucosa, and the invention medicine has good enhance immunity effect at epidermis and mucosa place, and is therefore with strong points.

4, non-specific: as to find in the treatment that various infection all has good antagonism to this Therapeutic Method to HPV virus.

5, effectiveness is good: in the treatment case, effective percentage reaches 87.5%, and cure rate reaches 62.5%.

6, easy to use, be beneficial to popularization.Only need simple disposable easy medical apparatus to get final product during treatment.

Find early that 7, early treatment is the optimal treatment policy of prevention cervical cancer.

8, put prevention first: do the prevention cervical cancer from anti-HPV viral infection.

Implement example

In following embodiment, the present invention at first adopts the method for the above-mentioned HPV viral infection of making a definite diagnosis, and the patient is made a definite diagnosis, and adopts the nocardia rubra preparation to inject the neck tube position of being put in prison at HPV viral infection person then.

Comprehensive Treatment, with 22 days be a treatment cycle, women's intermenstrual period should be discontinued medication, one-period can be cured, and can cooperate operative treatment simultaneously to severe the infected.

About the clinical trial of anti-HPV viral infection, select to have the women of HPV viral infection, the age, existing HPV low risk viral infection also had HPV high-risk-type viral infection between 25-45 year.Generally all after ischomenia, begin medication, recheck in the clean back of the menstruation second time.Requiring during the treatment does not have sexual life, as is difficult to avoid, and sex partner must be used condom.Adhere to treating 8 examples that have of full course of treatment on request.Wherein:

(1) use Drug therapy HPV of the present invention and infect 8 routine patients, wherein have 5 examples to turn out cloudy, 2 examples reduce by 1 type and infect.1 routine no change.

(2) for 1 routine no change case, analysis may be that viral infection is heavier, and administration time is short, and number of times is few, longer better effect should be arranged as bigger times of dosage.

(3) cure rate 62.5%, effective percentage 87.5%.

(4) one examples are the contrast case.

Treatment HPV infection experiment is catalog as a result

Sequence number	Age	The HPV infection type	Route of administration	Therapeutic Method	Natural law	The administration time section	Menstruation for the first time clean 3-7 days	Menstruation for the second time is clean
Sequence number	Age	The HPV infection type	Route of administration	Therapeutic Method	Natural law	The administration time section	Menstruation for the first time clean 3-7 days	Menstruation for the second time is clean	01	28	18	Cervical canal is injected	Continuously	22	5/3-27/3	Negative	Negative
02	39	31/33/56	Cervical canal is injected	Continuously	22	10/3-1/4	33/56	33/56	01	28	18	Cervical canal is injected	Continuously	22	5/3-27/3	Negative	Negative
02	39	31/33/56	Cervical canal is injected	Continuously	22	10/3-1/4	33/56	33/56	03	43	56	Cervical canal is injected	Continuously	22	15/3-7/4	Negative	Negative
04	36	66	Cervical canal is injected	Continuously	22	20/4-12/5	66	66	03	43	56	Cervical canal is injected	Continuously	22	15/3-7/4	Negative	Negative
04	36	66	Cervical canal is injected	Continuously	22	20/4-12/5	66	66	05	42	CP8304	Cervical canal is injected	Continuously	22	2/8-24/8	Negative	Negative
06	30	31/33/56	Cervical canal is injected	Continuously	22	10/8-1/9	31/33	31/33	05	42	CP8304	Cervical canal is injected	Continuously	22	2/8-24/8	Negative	Negative
06	30	31/33/56	Cervical canal is injected	Continuously	22	10/8-1/9	31/33	31/33	07	34	56	Cervical canal is injected	Continuously	22	15/8-6/9	Negative	Negative
08	27	42	Cervical canal is injected	Continuously	22	15/9-6/10	Negative	Negative	07	34	56	Cervical canal is injected	Continuously	22	15/8-6/9	Negative	Negative
08	27	42	Cervical canal is injected	Continuously	22	15/9-6/10	Negative	Negative	09	36	Contrast	Cervical canal is injected	Continuously	22	20/11-12/12	Negative	Negative

Claims

1. the nocardia rubra preparation reaches the application at anti-human papilloma virus (anti-HPV) prevention cervical cancer medicine.

2. preparation according to claim 1 and application is characterized in that described anti human papillomavirus medicine comprises nocardia rubra and pharmaceutically acceptable carrier.

3. nocardia rubra according to claim 2, the main component that it is characterized in that described medicine is a nocardia rubracell wall.

4. carrier according to claim 2 is characterized in that described carrier comprises excipient.

5. excipient according to claim 4 is characterized in that described excipient is a dextran.

6. application according to claim 1 is characterized in that described medicine is a local application.

7. local application according to claim 6 is characterized in that described local application is that medicine for external use comprises: liniment, lotion, freeze dried powder, ointment, ointment, plaster, gel, oil preparation, paste, aerosol etc.

8. local application according to claim 7 is characterized in that local application is the best with lotion, liniment and freeze dried powder.

9. according to the described nocardia rubracell wall of claim 3, it is characterized in that described medicine is the nocardia rubracell wall product that contains the 0.0015-2 milligram in per 1 milliliter or the every gram medicine.