CN1429625A - Medicine for treating chronic hepatitis B - Google Patents
Medicine for treating chronic hepatitis B Download PDFInfo
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- CN1429625A CN1429625A CN 03102080 CN03102080A CN1429625A CN 1429625 A CN1429625 A CN 1429625A CN 03102080 CN03102080 CN 03102080 CN 03102080 A CN03102080 A CN 03102080A CN 1429625 A CN1429625 A CN 1429625A
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Abstract
A medicine in the form of injection for treating chronic hepatitis B contains the mycob acterium of cow, hepatitis B vaccine and diluent chosen from one of distilled water, water for injection and physiologic saline. Its advantages are high curative effect, low cost, and low toxic by-effect.
Description
Invention field
The present invention relates to field of medicaments, more particularly, relate to the medicine that is used for the treatment of chronic hepatitis B.
Background technology
Chronic hepatitis B is a kind of disease that heals than refractory, and sickness rate is higher, in China more than 3,000 ten thousand patients is arranged approximately, and great majority are rural patient.Owing to still lack medicine and the Therapeutic Method that thoroughly to cure hepatitis B at present, therefore to such an extent as to most humans protracted course of disease usually increases the weight of, gradually disability, a part of patient is wherein finally developed into hepatitis interstitialis chronica or hepatocarcinoma, seriously influences the people's life and health.
Want thoroughly to cure chronic hepatitis B, most importantly to thoroughly remove the intravital hepatitis B virus of patient, in order to reach this purpose, generally can start with from following two aspects, be directly to eliminate or the inhibition hepatitis B virus on the one hand, be the specific immunity that improves human body on the other hand, allow this specific immunity eliminate or suppress hepatitis B virus.Can utterly destroy at present that the medicine and the method for hepatitis B virus also do not have in the body, and the medicine that can suppress the hepatitis B virus breeding It is generally accepted comparatively effectively have only interferon, lamivudine, kurarinone and vidarabine phosphate these are several.But the price of these medicines is all very expensive, and bigger side effect or toxicity is generally all arranged, unsuitable prolonged application.Wherein, interferon is an injection, and the next day injects once, injects at least 6 months.At once effective percentage (refer to e antigen is turned out cloudy, transaminase normal again) only is about 40%.And side effect is bigger.Lamivudine is an oral tablet, and general every day, a slice need be taken 1.5-2 at least continuously.The effective percentage at once in 1 year only is about 20%, though better to the curative effect of HBV-DNA, may virus variation take place about 1 year and produce drug resistance taking medicine.It is oral more than 90 days that kurarinone generally needs injection earlier to change into after 90 days again, so half a year at least course of treatment, effective percentage also only has an appointment 40% at once.Vidarabine phosphate is an injection, is generally intramuscular injection every day once, and 30 days is a course of treatment, because of its toxic action is too big, at the most can only be with two courses of treatment, though can obtain about 40% temporary transient curative effect, but because of the course of treatment too short, so great majority recurrence after the drug withdrawal is present less independent use.
In sum, all are all very expensive to the price of the effective medicine of inhibition hepatitis B virus at present, are difficult to extensive use, particularly are difficult in vast rural area and use.And the toxic and side effects of these medicines is big, and curative effect is undesirable, recurrence easily after the drug withdrawal.Therefore press at present and seek a kind of cheap, curative effect is desirable and toxic and side effects is little medicine that is used for the treatment of chronic hepatitis B.
Summary of the invention
The objective of the invention is to develop a kind of shortcoming that can overcome said medicine, and cheap, curative effect is better and toxic and side effects is little, is suitable for generally promoting, the medicine that is used for the treatment of chronic hepatitis B that uses in vast rural area particularly suits.
The inventor notices that Hepatitis B virus vaccine is a kind of vaccine that is used to prevent hepatitis B, and this vaccine can stimulate body to produce the immunity of anti-hepatitis B virus after inoculation, thereby plays the prevention hepatitis B.But still have no talent up to now and can successfully Hepatitis B virus vaccine be used for the treatment of hepatitis B.The inventor carrying out finding after the deep research to Hepatitis B virus vaccine, can obtain significantly the inhibition effect to hepatitis B virus when medicine that can raise immunity with Hepatitis B virus vaccine and some is used.For example, the inventor once attempted Hepatitis B virus vaccine is added the treatment that bacillus calmette-guerin vaccine is used for chronic hepatitis B, had obtained effective percentage at once and had reached effect more than 50% and low price.In a single day but bacillus calmette-guerin vaccine can only be used for intradermal injection, if inject subcutaneous or muscle, cold pus infections just takes place probably.Promptly enable to inject exactly Intradermal and also will produce an aphtha, continue several weeks after knot one little scar, if at this moment protect badly also suppurative infection can take place.Therefore this method also is difficult to be accepted by patient and doctor.The inventor has carried out the research that Hepatitis B virus vaccine adds mycobacterium vaccine [trade name: microcaloire (Vaccae)] again on the basis of above-mentioned result of study.The no pathogenicity of mycobacterium vaccae vaccine own, its preparation is more without any side effects.Since the effect that mycobacterium vaccine has stronger raising immunity, the therefore domestic and international complementary therapy that is applied to tuberculotherapy more widely.But still have no talent up to now used as the assistant medicament of treatment hepatitis B.The inventor considers, mycobacterium vaccine is very similar to the effect and the bacillus calmette-guerin vaccine of immunity, some index more is better than bacillus calmette-guerin vaccine, and can be used for intramuscular injection, without any side effects, therefore replacing bacillus calmette-guerin vaccine to cooperate with Hepatitis B virus vaccine with it, be used for the treatment of chronic hepatitis B, is fully possible in theory.For this reason, the inventor is mixed with therapeutic adjuvant Hepatitis B virus vaccine with mycobacterium vaccine and Hepatitis B virus vaccine by different proportion, be used for clinical trial, found that, with mycobacterium vaccine and Hepatitis B virus vaccine in the scope of safe level by 1: mass ratio (0.4-4.5) cooperates, make the treatment that injection is used for chronic hepatitis B with any in distilled water, water for injection and the normal saline as diluent, all can obtain better therapeutic effect and without any toxic and side effects.Because this achievement in research, thereby finished the present invention.
Technical scheme of the present invention is as follows:
(1) a kind of medicine that is used for the treatment of chronic hepatitis B, it is characterized in that, wherein contain mycobacterium vaccine and Hepatitis B virus vaccine as effective ingredient, diluent is any in distilled water, water for injection and the normal saline, mycobacterium vaccine: the mass ratio of Hepatitis B virus vaccine is 1: (0.4-4.5), and the total concentration of effective ingredient in this medicine is in the scope of 3 μ g/ml to 3mg/ml.
As above-mentioned (1) described medicine, it is characterized in that (2) this medicine is an injection.
The present invention is described below in more detail.Hepatitis B virus vaccine has only preventive effect to hepatitis B virus and the effect not killing or suppress when using separately.And mycobacterium vaccine has only the effect of enhancing immunity when using separately, and it had not both been killed or inhibitory action hepatitis B virus, did not also have preventive effect.But the function that just has killing or suppress hepatitis B virus when the two is used than cooperation by certain mass, this is a kind of function of new generation.About the mass ratio of mycobacterium vaccine and Hepatitis B virus vaccine, when with the consumption of mycobacterium vaccine during as 1 mass parts, the consumption of Hepatitis B virus vaccine should be in the scope of 0.4-4.5 mass parts.That is to say that the consumption of Hepatitis B virus vaccine should be 0.4 times to 4.5 times of mycobacterium vaccine.If this multiple is lower than 0.4 times, then may not have the effect of killing or suppressing hepatitis B virus, if and this multiple some side effect then might occur greater than 4.5 times, so the quality mixture ratio of Hepatitis B virus vaccine is chosen to be 0.4 to 4.5 times of mycobacterium vaccine.For example, in every 22.5 μ g/ml of positive usual amounts of mycobacterium vaccine, then the use level of Hepatitis B virus vaccine should be in the scope of 9 μ g/ml to 100 μ g/ml.In addition, the total concentration in this medicine about mycobacterium vaccine and Hepatitis B virus vaccine, the normal working concentration of considering mycobacterium vaccine is 22.5 μ g/ml, and the normal working concentration of Hepatitis B virus vaccine is 10 μ g/ml, so the two normal use total concentration when lumping together is 32.5 μ g/ml.But preliminary test according to the inventor, maintain 1 at mass ratio: under the condition (0.4-4.5) with mycobacterium vaccine and Hepatitis B virus vaccine, the total concentration of the two is as long as still can have certain therapeutic effect more than 3 μ g/ml, and, if necessary, can also supply the dosage of effective ingredient by the volume that increases injection solution, so the lower limit of the total concentration of effective ingredient in this medicine is chosen to be 3 μ g/ml.In addition, preliminary test according to the inventor, maintain 1 at mass ratio: under the condition (0.4-4.5) with mycobacterium vaccine and Hepatitis B virus vaccine, even the total concentration of the two reaches 3mg/ml, also still can keep the stable of solution, if and surpass 3mg/ml, the situation that solution can not lasting stability then might appear, so the higher limit of effective ingredient total concentration is chosen to be 3mg/ml.In the case, can as required it be diluted to desired concn during use.
Compare with the prior art in this area, medicine of the present invention has following beneficial effect: hepatitis B is had obvious treatment effect, little, the more difficult recurrence in back of toxic and side effects, and cheap, easy to use, be suitable for generally promoting, suit especially to use in vast rural area.
The specific embodiment
When reality is used, as long as with 1 of commercially available microcaloire (freeze dried white loose powder, every contains mycobacterium vaccine 22.5 μ g) shake up with 1ml water for injection or physiological saline solution, pressing the mixed of stipulating in the front technical scheme of the present invention (1) with commercially available Hepatitis B virus vaccine injection goods (two kinds of per ampoule 0.5ml and 1.0ml contain HbsAg5 μ g and 10 μ g respectively) then gets final product.Enumerate concrete application examples below effect of the present invention is described.
Application examples 1
1 microcaloire (containing mycobacterium vaccine 22.5 μ g) is equipped with Hepatitis B virus vaccine 10 μ g, 40 μ g and 60 μ g respectively as an intramuscular injection consumption, with it respectively as one group of treatment, treatment two groups and treat three groups, with use No. 1, Chinese medicine anti-hepatitis virus in contrast group carry out clinical trial.Now the result is summarized as follows:
(1) case: observed chronic hepatitis B 122 examples altogether, be divided into four groups at random.
Treat one group of 32 example, male 18 examples, women 14 examples, age 20-56 year;
Treat two group of 30 example, male 16 examples, women 14 examples, age 18-60 year;
Treat three group of 30 example, male 15 examples, women 15 examples, age 20-56 year;
Matched group 30 examples, male 17 examples, women 13 examples, age 18-58 year;
Four groups HBsAg, HBeAg, the HBV-DNA positive, Serum SA LT all raise, so four groups all have comparability.
(2) Therapeutic Method: each treatment is organized everyone and is used 1 of mycobacterium vaccine-Hepatitis B virus vaccine of the present invention, every contains mycobacterium vaccine 22.5 μ g, Hepatitis B virus vaccine dosage is then had nothing in common with each other, first group of 10 μ g, second group of 40 μ g, the 3rd group of 60 μ g, every first quarter moon intramuscular injection once, 6 totally months; No. 1, the hospital-made Chinese medicine anti-hepatitis virus in north, railroad suboffice Changzhi, The control group Zhengzhou, everyone each 5g takes after mixing it with water 6 totally months every day 3 times.
(3) detect: the ELISA test kit that the hepatitis B label all adopts the magnificent company in Luoyang to produce.The PCR kit for fluorescence quantitative that the HBV-DNA quantitative analysis adopts the multiple star company in Shanghai to produce.Liver function detects uses automatic biochemistry analyzer.The results are shown in Table 1.
Table 1
| Treat one group (32 example) | Treat two groups (30 examples) | Treat three groups (30 examples) | Matched group (30 example) | |
| The normalization rate of serum glutamic pyruvic transminase (SALT) | 43.75% (14 example) | 50% (15 example) | 53.3% (16 example) | 33.3% (10 example) |
| The negative conversion rate of HBsAg | ????0 | 3.33% (1 example) | 6.7% (2 example) | ??????0 |
| The negative conversion rate of HBeAg | 25% (8 example) | 43.3% (13 example) | 46.7% (14 example) | 10% (3 example) |
| The negative conversion rate of HBV-DNA | 25% (8 example) | 40% (12 example) | 43.3% (13 example) | 6.7% (2 example) |
As can be seen from Table 1, use mycobacterium vaccine of the present invention-Hepatitis B virus vaccine to treat chronic hepatitis B 6 months, treat one, two, three group of curative effect and all be better than matched group (P＜0.05) HBeAg and HBV-DNA, and be 22.5 μ g at fixing mycobacterium vaccine dosage, Hepatitis B virus vaccine dosage is in the scope of 10-60 μ g the time, and therapeutic effect has the trend that increases with Hepatitis B virus vaccine dosage.This illustrates that mycobacterium vaccine-Hepatitis B virus vaccine of the present invention has the effect of killing preferably or suppressing to chronic viral hepatitis B patient's hepatitis B virus.
Claims (2)
1. medicine that is used for the treatment of chronic hepatitis B, it is characterized in that, wherein contain mycobacterium vaccine and Hepatitis B virus vaccine as effective ingredient, diluent is any in distilled water, water for injection and the normal saline, mycobacterium vaccine: the mass ratio of Hepatitis B virus vaccine is 1: (0.4-4.5), and the total concentration of effective ingredient in this medicine is in the scope of 3 μ g/ml to 3mg/ml.
2. medicine as claimed in claim 1 is characterized in that, this medicine is an injection.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03102080 CN1429625A (en) | 2003-01-29 | 2003-01-29 | Medicine for treating chronic hepatitis B |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03102080 CN1429625A (en) | 2003-01-29 | 2003-01-29 | Medicine for treating chronic hepatitis B |
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| Publication Number | Publication Date |
|---|---|
| CN1429625A true CN1429625A (en) | 2003-07-16 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 03102080 Pending CN1429625A (en) | 2003-01-29 | 2003-01-29 | Medicine for treating chronic hepatitis B |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106237326A (en) * | 2016-08-30 | 2016-12-21 | 广东科玮生物技术股份有限公司 | A kind of pharmaceutical composition treating inactivity hepatitis B containing rhIL 12 |
-
2003
- 2003-01-29 CN CN 03102080 patent/CN1429625A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106237326A (en) * | 2016-08-30 | 2016-12-21 | 广东科玮生物技术股份有限公司 | A kind of pharmaceutical composition treating inactivity hepatitis B containing rhIL 12 |
| CN106237326B (en) * | 2016-08-30 | 2019-11-22 | 广东科玮生物技术股份有限公司 | A kind of pharmaceutical composition containing rhIL-12 treatment inactivity hepatitis B |
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