CN103396453A - Pharmaceutical use of Pradefovir - Google Patents
Pharmaceutical use of Pradefovir Download PDFInfo
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- CN103396453A CN103396453A CN2013103495228A CN201310349522A CN103396453A CN 103396453 A CN103396453 A CN 103396453A CN 2013103495228 A CN2013103495228 A CN 2013103495228A CN 201310349522 A CN201310349522 A CN 201310349522A CN 103396453 A CN103396453 A CN 103396453A
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Abstract
The invention belongs to the field of medicines, and mainly provides a use of Pradefovir for preparing medicines for treating male patients with hepatitis B but not suitable for women or excluded from use by women. Untoward effects generated by Pradefovir delivery can be reduced or even avoided. In addition, the invention further provides combination of Pradefovir and a second pharmaceutical active component, so that untoward effects can be further reduced.
Description
Technical field
The invention belongs to field of medicaments, particularly, the present invention relates to the purposes of Pradefovir in the medicine of the various reduction side effects of preparation.
Background technology
Pradefovir or its pharmaceutical salts (as, mesylate) be a kind of in No. 200510098771.X disclosed front drug compound of Chinese patent, the front drug compound of Adefovir (PMEA) specifically, it can be metabolized to PMEA in vivo, can be directly used in treatment or prevention of liver disease or metabolic disease, comprise hepatitis B etc.In addition, our Chinese patent discloses the Pradefovir mesylate (namely No. 2012103443337, (+)-suitable-9-{2-[4-[(S)-(3-chloro-phenyl-)-2-oxygen-1,3,2 – dioxy phospha six ring-2-methylene radical]-the 1-ethyl VITAMIN B4 mesylate) the Crystallographic Study achievement.
Progress along with arduous clinic study, we have found unexpectedly many results that there is no theoretical foundation or prior art foundation, can't expected result according to these, by targetedly in the improvement aspect pharmaceutical applications and/or preparation, we have improved the medication effect, especially can reduce or the collaborative untoward reaction that reduces medication, this is very useful under the environment that medicine prison department and the public pay close attention to drug safety day by day.
Summary of the invention
The technical problem to be solved in the present invention is purposes, method and/or the pharmaceutical preparation of the Pradefovir that provides new, is mainly used in reducing untoward reaction.
Particularly,, in first aspect, the invention provides purposes or the method for Pradefovir, wherein relate to and be used for the treatment of male sex's hepatitis B patient, but be not suitable for or get rid of the women and use.because inventor's research chances on, in the time of administration Pradefovir, headache can appear in the women of half, untoward reaction such as dizzy grade, and the male sex there will be hardly, therefore the medicine of preparing can pass through such as shape, material, color or the preparation itself that wherein the comprises adaptability to masculinity and femininity, select to prepare the medicine that is used for the treatment of male sex's hepatitis B patient but is not suitable for or gets rid of women's use, thereby effectively reduce or avoid selecting of women, even can not increase selecting of the male sex and do not affect, can objectively obtain to reduce or avoid headache, the dizzy unexpected effect that waits untoward reaction.
In this article, term " man " and " female " refer to people's sex, and correspondingly, medicine also refers to the medicine that the people uses, and the pharmaceutical preparation that comprises in medicine (as without opposite indication, referred to as preparation) is also the pharmaceutical preparation that the people uses.Preferably in the present invention, the people is the adult, and as the male sex (people) adult man preferably, and/or women (people) is the adult female preferably.Term " is grown up " and " adult " possesses legal definition in China, in this article all according to the legal definition of China.
In this article, term " is used for the treatment of male sex's hepatitis B patient but is not suitable for or gets rid of the women and use " and refers to, pass through technique means, the technique means that comprises the branch of sciences such as pharmaceutics, drug packaging, psychology and study of behaviour, make the technical characterictic of the medicine of preparing can reduce or avoid selecting or using of women, and do not affect selecting or using of (preferably can the increase) male sex, thereby increase the ratio (that is, reducing or eliminate the ratio of women's hepatitis B patient in the treatment crowd of institute) of male sex's hepatitis B patient in the treatment crowd of institute.
The technical scheme of first aspect present invention can be embodied as Pradefovir for the preparation for the treatment of male sex's hepatitis B patient but the purposes in being not suitable for or getting rid of medicine that the women uses.
The technical scheme of first aspect present invention also can be embodied as preparation and contain the method for the medicine of Pradefovir, and wherein said medicine is used for the treatment of male sex's hepatitis B patient but is not suitable for or gets rid of the women and use.
Because the inventor finds, treat male sex's hepatitis B patient but be not suitable for or get rid of the women and use, can reduce or eliminate the ratio of women's hepatitis B patient in the treatment crowd of institute, thereby objectively reduce the caused untoward reaction of Pradefovir (certainly, the while can keep the effective treatment to hepatitis B).So the technical scheme of first aspect present invention can also be embodied as Pradefovir for the preparation of the treatment hepatitis B and the purposes in reducing the untoward reaction medicine of (as, headache and/or dizzy), wherein hepatitis B is male patient's hepatitis B.Perhaps, the technical scheme of first aspect present invention also can be embodied as preparation and contain the method for the medicine of Pradefovir, wherein said medicine is used for the treatment of hepatitis B and reduces untoward reaction (as, headache and/or dizzy), and wherein hepatitis B is male patient's hepatitis B.
In this article, term " medicine " has the popular implication of being familiar with, even the direct cognitive of the existing medicine of selling from pharmacy, usually medicine comprises outer packaging and at the pharmaceutical preparation of this outer packaging inside, and optional its also is included in the inner and direct internal packing of packaged pharmaceuticals preparation of this outer packaging.
Medicine generally also comprises specification sheets.Wherein, specification sheets also can occur with the label form of outer packaging or internal packing.Can directly indicate the Gender of use medicine due to specification sheets, thereby realize being used for the treatment of male sex's hepatitis B patient but be not suitable for or get rid of the women and use, so preferably in the present invention, specification sheets is to record the specification sheets that is used for the treatment of male sex's hepatitis B patient but is not suitable for or gets rid of women's use.
Based on packing, psychology and study of behaviour technique means, obtain to realize to distinguish the outer package product of different use crowds' technique effect in the fast-moving consumer goods field, the personnel of learning a skill know for packing.In recent years, this technology is also used for reference by the drug packaging field gradually, as to improving for technical characterictics such as the shape (or moulding) of drug purchase person vision visible packing, color (or color), materials (or material), the preference that can be fit to different crowd, thereby improve or reduce the ratio that corresponding crowd uses or select (as referring to, the impact of pharmaceutical packing design on consumer psychology. medical Leader, 29(1): 130; Drug packaging and consumer psychology. Shanxi economic management cadre academy journal, 19(3): 16; The demand of drugs Packaging Design to patient's subconsciousness consumer psychology. decorate 202:106; Drugs Packaging Design based on consumer psychology. Packaging Engineering, 28(2): 158; The utilization of color in drug packaging. Packaging Engineering, 33(12): 104, etc.).So the packing in the preferred medicine of the present invention is be used for the treatment of male sex's hepatitis B patient but be not suitable for or get rid of the packing that the women uses.Owing to being more directly that visible vision when buying affects selecting or using of different sexes crowd, therefore, the present invention more preferably outer packaging in medicine is be used for the treatment of male sex's hepatitis B patient but be not suitable for or get rid of the outer packaging that the women uses, that is the step that, prepares described in first aspect present invention comprises packs Pradefovir to be fit to male sex's hepatitis B patient but to be not suitable for or to get rid of in the outer packaging of women's use into.Such outer packaging can entrust the Packaging Engineering company of specialty to obtain by market channel, and for example the form of questionnaire obtains to determine the data of packaging feature by inquiry; And for example, by the men and women, the outer packaging preference difference is made outer packaging, comprise selection material, make shaping and/or coating color.
, by the selection of the dosage form in medicine, also can realize being fit to male sex's hepatitis B patient but be not suitable for or get rid of the women and use.For example, preparation of the present invention is not the vagina administration preparation, if not being suppository.Like this, more be not suitable for women's use, and do not affect the male sex's use.
In this article, term " unit formulation " is the abbreviation of unit pharmaceutical preparation, has implication well-known to those skilled in the art, and each unit of described preparation (as individual, sheet, grain or pin etc.) comprises the amount of the required active constituents of medicine of single administration.Medicine comprises the unit formulation of one or more units, generally includes the unit formulation of a plurality of units.
Determine the amount of active drug composition in unit formulation, a step in the process for preparing medicine or pharmaceutical preparation.In order to be fit to male sex's hepatitis B patient but be not suitable for or get rid of the women and use, can determine with the male individual body weight, but, for the pharmacy corporation commercial application, usually with male sex's mean body weight, determine.In the present invention, preferred medicine comprises the unit formulation of one or more units, the effective dose of the weight of the Pradefovir that each unit formulation contains=adult's per weight * adult man mean body weight.In this article, the effective dose of adult's per weight is not distinguished the men and women, and the male sex's mean body weight of growing up is greater than grownup's mean body weight (that is, grownup's mean body weight of not distinguishing the men and women of these adult man affiliated areas; Adult man mean body weight certain (also more) is greater than adult female's mean body weight (that is, adult female's mean body weight of these adult man affiliated areas).So the weight range of the Pradefovir that each unit formulation of the present invention contains is the preferable range in the fuzzy scope of prior art enlightenment, and preferably the weight of the Pradefovir that contains of each unit formulation is not 5mg, 10mg, 20mg or 30mg.The such numerical value of the latter is the empirical value that need not to obtain through calculating, and the male sex's mean body weight of growing up is not integer usually, so the weight of the Pradefovir that each unit formulation of the present invention that product obtains contains is not integer usually yet.For example, according to Data of Civil Constitution Monitoring communique in 2000, the Chinese adult male sex's mean body weight was 67.7kg.
Further, the needs that prepare medicine for personalization or zonule, pharmacy corporation can be in the drug use zones (as, a province), statistics or random sampling obtain the mean body weight of adult man, as can according to the medicine prison or medical institutions add up or random sampling.So preferably in a first aspect of the present invention, the step of described preparation comprises,
(1) in the drug use zone, statistics or random sampling obtain the mean body weight of adult man;
The effective dose of the weight of the Pradefovir that (2) contains with each unit formulation=adult's per weight * adult man mean body weight, calculate the weight that obtains the Pradefovir that each unit formulation contains; With
(3) Pradefovir that gets the weight of the Pradefovir that each unit formulation contains makes unit formulation, wherein optionally comprises the process that Pradefovir mixes with pharmaceutically acceptable auxiliary material.
In the prior art, to prepare medicine seldom universal due to personalization or zonule, so have no the aforesaid method flow process is arranged in the process for preparing medicine of Pradefovir report.
Further, the step of described preparation can also comprise afterwards in step (3),
(4) unit formulation of one or more units is packaged into medicine process (as, the unit formulation of one or more units is packed into and is fit to male sex's hepatitis B patient but is not suitable for or gets rid of forming medicine in outer packaging that the women uses); With
(5) optional to add in medicine specification sheets (as, record and be used for the treatment of male sex's hepatitis B patient but be not suitable for or get rid of the specification sheets that the women uses).
In this article, the effective dose of adult's per weight is not distinguished the men and women,, so be the value of determining, is the effective dose that adult's per weight of men and women is not distinguished in the drug use zone.This dosage can be obtained by integral body (irrespective of sex) sampling test of pharmacy corporation for the zone of required input medicine.As in the present invention, according to the difference of ethnic group, the effective dose of adult's per weight is 0.25～0.65mg/kg, and preferably 0.4～0.6mg/kg, be more preferably 0.45～0.55mg/kg, in the specific embodiment of the present invention, can be for example 0.5mg/kg.
In second aspect, the invention provides the pharmaceutical preparation for the treatment of hepatitis B patient, it comprises Pradefovir and the second active constituents of medicine, and pharmaceutically acceptable auxiliary material, and wherein the second active constituents of medicine is not KETOKONAZOL, Rifampin or erythromycin.The inventor studies discovery, and KETOKONAZOL, Rifampin or erythromycin can suppress the Pradefovir metabolism and go out activeconstituents, affect drug effect, perhaps increase suddenly the metabolic activity of Pradefovir, cause drug safety hidden danger, therefore gets rid of and uses.
The technical scheme of second aspect present invention also can be presented as Pradefovir and the second active constituents of medicine unite for the preparation of the treatment hepatitis B patient pharmaceutical preparation in purposes, wherein the second active constituents of medicine is not KETOKONAZOL, Rifampin or erythromycin.
The second active constituents of medicine can be the active constituents of medicine that can not treat hepatitis B.Under not being bound by any theory restrictions, the inventor found surprisingly, and antacid can reduce the untoward reaction of Pradefovir, especially the untoward reaction of female patient.So preferably in a second aspect of the present invention, the second active constituents of medicine is antacid, alkaline calcium salt preferably, as calcium carbonate.In this article, the pharmaceutical preparation that term " antacid " refers to can neutralizing acid (as, hydrochloric acid in gastric juice).Multiple antacid list marketing has been arranged at present, as
Deng.
Therefore in unit formulation, the weight of Pradefovir can be fit to all Adult Groups, preferably with the effective dose of adult's per weight * grownup's mean body weight, determines, preferably can determine according to first aspect present invention.And in unit formulation, the weight of antacid can be fit to all Adult Groups, therefore also preferably with the effective dose of adult's per weight (as 0.25～0.4mL/kg, preferably 0.3～0.35mL/kg, for example 0.33mL/kg) * grownup's mean body weight, determine.
In addition, also the preferred agents preparation is oral preparations, for example tablet or capsule.
In the third aspect, the invention provides the adult man mean body weight, obtain the method (as in the drug use zone, statistics or random sampling obtain the mean body weight of adult man) of the mean body weight of adult man and/or suitable male sex's hepatitis B patient but be not suitable for or get rid of the purposes of the outer packaging that the women uses.
The method that the technical scheme of third aspect present invention can be embodied as the adult man mean body weight or obtain the mean body weight of adult man contains purposes in the medicine of Pradefovir in preparation.
The technical scheme of third aspect present invention also can be embodied as preparation and contain the method for the medicine of Pradefovir, and it comprises the method for using the adult man mean body weight or comprising the mean body weight that obtains adult man.
The technical scheme of third aspect present invention can also be embodied as and be fit to male sex's hepatitis B patient but be not suitable for or get rid of outer packaging that the women uses contain purposes in the medicine of Pradefovir in preparation.
Perhaps, the technical scheme of third aspect present invention also can be embodied as preparation and contain the method for the medicine of Pradefovir, and it comprises the outer packaging of using suitable male sex's hepatitis B patient but being not suitable for or getting rid of women's use.
Feature in these purposes or method is the aforesaid preferred feature of this paper preferably, for example can comprise, described medicine is used for the treatment of male sex's hepatitis B patient but is not suitable for or gets rid of the women and use, perhaps, described medicine be used for the treatment of hepatitis B and reduce untoward reaction (as, headache and/or dizzy), wherein hepatitis B is male patient's hepatitis B, etc.
The present invention has following beneficial effect: keep drug effect, but can reduce or the collaborative untoward reaction that reduces medication, got rid of potential reduction drug effect or caused the medicine of safety issue; Obtain the required cost of above-mentioned effect low, prepare the medicine process convenient.
, for the ease of understanding, below will be described in detail the present invention by specific embodiment.It needs to be noted, these descriptions are only exemplary descriptions, do not form limitation of the scope of the invention.According to the discussion of this specification sheets, many variations of the present invention, change are all apparent concerning one of ordinary skill in the art.
In addition, the present invention has quoted open source literature, and these documents are in order more clearly to describe the present invention, and their full text content is all included this paper in and carried out reference, just looks like that repeated description is excessively the same in this article for their full text.
Embodiment
Further illustrate by the following examples content of the present invention.As do not specialize, the clinical trial means that in embodiment, technique means used is well known to those skilled in the art, can referring to drug regulatory department (as, SFDA) to open guide of drug approval etc.
Embodiment 1 clinical safety test:
Under the license of drug regulatory department, to 24 random adult experimenters (12 male sex and 12 women), in the Pradefovir mesylate of the 1st day oral 0.5mg/kg dosage (in Pradefovir itself) under the empty stomach situation.From the-1 day, all experimenters can not leave clinical study mechanism, until safety evaluation finishes.Carry out during this time every medicine for test, and observe clinical response; 12 asian population adult experimenters of random assignment (6 male sex and 6 women) take placebo the same period in addition, as negative control group.
Result according to body weight after to the data stdn shows, the Cmax of Pradefovir mesylate and AUC in the serum of female subjects
0-96hGeometric mean is low by 6% and 12% respectively than male subject respectively, Cmax and the AUC of (metabolism of Pradefovir mesylate produces) PMEA in female subjects
0-96hGeometric mean is respectively than male subject low 9% and 6%, yet, the renal clearance (CLR) of Pradefovir mesylate in female subjects and PMEA is but low by 21% and 11% than male subject respectively, and the clinical adverse of observing is headache or dizzy (7/24,29%; In negative control group, the men and women does not observe headache and dizzy), wherein female subjects occur to have a headache or dizzy frequency (6/12,50%) far away higher than male subject (1/12,8%).
In test, do not report death and serious adverse reaction, and with negative control group, compare, other vital signs and physical examination etc. all do not have to find significant result and Sexual-related trend clinically.
The clinical test of pesticide effectiveness of embodiment 2:
Under the license of drug regulatory department, random adult experimenter (is disregarded (majority is the women) of because of untoward reaction, withdrawing from, final 50 hepatitis B patients altogether effectively participate in test), every day oral 0.5mg/kg dosage under the empty stomach situation the Pradefovir mesylate, continue altogether to take for 48 weeks, then cut out, during once make a house call in every 4-8 weeks; In addition random adult experimenter (disregard because of untoward reaction and withdraw from, finally amount to 9 hepatitis B patients and effectively participate in test) is taken adefovir ester the same period, as positive controls.
Result shows, in the making a house call of the 24th week and the 48th week, can't detect blood plasma HBV DNA(level less than 10 in the experimenter who adopts the Pradefovir mesylate to treat
-6The instrument limit of detection of/mL) experimenter's ratio is respectively 72% and 80%, and can't detect blood plasma HBV DNA ratio in the experimenter who adopts adefovir ester to treat, is respectively 33% and 44%.
The Combined Preparation test of embodiment 3Pradefovir and antacid:
Under the license of drug regulatory department, to random 16 adult experimenters (8 male sex and 8 women), in the 1st day the Pradefovir mesylate of oral 0.5mg/kg dosage and 0.33mL/kg dosage simultaneously under the empty stomach situation
Calcium carbonate oral liquid (can available from Johnson Co.).From the-1 day, all experimenters can not leave clinical study mechanism, until off-test.Carry out during this time every medicine generation and efficacy testing, and observe clinical response.
Result shows, associating
Administration, do not have significant difference with the efficiency assay result of the individually dosed Pradefovir mesylate of embodiment 2, show drug effect not can because of with
Combined Preparation and improving; Compare with the test-results of the individually dosed Pradefovir mesylate of embodiment 1,
Combined Preparation affects for producing significantly the medicine of Pradefovir mesylate itself, but makes the AUC of the PMEA of its metabolism generation
0-infThe 90%CI(67.0 of geometric mean ratio, 86.4) drop on 80-125% fully without under the effect border, and the 90%CI(77.5 of Cmax ratio, 108.8) overlapping with 80% lower limit, show
Combined Preparation is on exposing clinical significant impact is arranged PMEA; And after Combined Preparation, headache occurs female subjects or dizzy frequency (2/8,25%) also descends greatly with respect to the individually dosed of embodiment 1, and the male sex is not report headache, makes more suitable patient (especially women) medication safely.
The Combined Preparation test (comparative example) of embodiment 4Pradefovir and KETOKONAZOL or Rifampin, erythromycin
Process is basic identical in the method for embodiment 3, and difference is KETOKONAZOL, the Rifampin of 10mg/kg dosage or the erythromycin of 8.3mg/kg dosage that antacid is replaced by respectively 6.7mg/kg dosage.
Result shows, Pradefovir mesylate and KETOKONAZOL Combined Preparation, make respectively AUC and the Cmax of Pradefovir mesylate increase by 348% and 250%, yet but make respectively the AUC of PMEA and Cmax reduce by 84.8% and 92.4%, produce the PMEA of significant quantity owing to being difficult to metabolism, so test and end; Pradefovir mesylate and Rifampin Combined Preparation, make respectively AUC and the Cmax of Pradefovir mesylate reduce by 84.7% and 75.9%, yet but make respectively the AUC of PMEA and Cmax increase by 52% and 224%, owing to may causing safety issue, therefore test is ended; Pradefovir mesylate and erythromycin Combined Preparation, make respectively the Pradefovir mesylate AUC and Cmax increased about 285% and 253%, yet but make respectively the AUC of PMEA and Cmax reduce by 22.7% and 25.3%, the significant quantity of estimating former Pradefovir has been difficult to support drug effect, and therefore test is ended.
The sex preference of embodiment 5Pradefovir medicine outer packaging is selected test:
Owing to also there is no so far the Pradefovir marketing drugs, so also there is no the outer packaging of existing Pradefovir medicine.We entrust Xi'an Package Design company to carry out potential consumer (HBV carrier, whether no matter clinical symptom arranged) the outer packaging preference is tested, preference with reduce women (patient), and do not affect the preference that even meets the male sex (patient), reduce purchase, the usage quantity of female patient with this, increase male patient's purchase, usage quantity, thereby reduce the generating capacity of the patient's that uses the untoward reactions such as headache.
the preference test is undertaken by figure and survey form in kind, in the situation that inform and be to treat the medicine of disease aspect its liver or potential disease and be to have to select to substitute medicine, shape to outer packaging, color and material are investigated, select positive, neutrality and negative preferences, add up scoring, reclaim altogether 325 parts of effective questionnaires (137 parts of men, 188 parts of female), result is as shown in table 1 below, shown that the men and women is still larger to the preference difference of different outer packagings, therefore can be according to table 1, choose between men and women's property preference difference large and be conducive to the packaging feature that the male sex selects, account for 70%～100% of the total area as the cool colour area, and the warm colour area accounts for 30%～0% of the total area.
The preference survey table (in bracket be scoring be positive, neutral, negative number, predilection grade with front surpass negative number shared overall ratio calculate) of the potential men and women patient of table 1 to different outer packagings
Claims (10)
1.Pradefovir for the preparation of the treatment male sex's (especially adult man) hepatitis B patient but the purposes in being not suitable for or getting rid of medicine that women (especially adult female) uses;
Perhaps, Pradefovir is for the preparation of the treatment hepatitis B and the purposes in reducing the untoward reaction medicine of (as, headache and/or dizzy), and wherein hepatitis B is male sex's (especially adult man) patient's hepatitis B;
Perhaps, preparation contains the method for the medicine of Pradefovir, and wherein said medicine is used for the treatment of the male sex's (especially adult man) hepatitis B patient but is not suitable for or gets rid of women (especially adult female) and use;
Perhaps, preparation contains the method for medicine of Pradefovir, and wherein said medicine is used for the treatment of hepatitis B and reduces untoward reaction (as, headache and/or dizzy), and wherein hepatitis B is male sex's (especially adult man) patient's hepatitis B.
2. purposes claimed in claim 1 or method, wherein said medicine comprises the unit formulation of one or more units, the effective dose of the weight of the Pradefovir that each unit formulation contains=adult's per weight * adult man mean body weight, wherein the adult man mean body weight is greater than grownup's mean body weight, more greater than adult female's mean body weight.
3. the described purposes of claim 1 or 2 or method, the step of wherein said preparation comprises:
(1) in the drug use zone, statistics or random sampling obtain the mean body weight of adult man;
The effective dose of the weight of the Pradefovir that (2) contains with each unit formulation=adult's per weight * adult man mean body weight, calculate the weight that obtains the Pradefovir that each unit formulation contains; With
(3) Pradefovir that gets the weight of the Pradefovir that each unit formulation contains makes unit formulation, wherein optionally comprises the process that Pradefovir mixes with pharmaceutically acceptable auxiliary material.
4. purposes claimed in claim 2 or method, the effective dose of wherein said adult's per weight is the effective dose that adult's per weight of men and women is not distinguished in the drug use zone.
5. purposes claimed in claim 2 or method, wherein said preparation is not the vagina administration preparation, if not being suppository.
6. purposes claimed in claim 1 or method, the step of wherein said preparation comprise packs Pradefovir to be fit to the male sex's (especially adult man) hepatitis B patient but to be not suitable for or to get rid of in outer packaging that women (especially adult female) uses into.
7. treat the pharmaceutical preparation of hepatitis B patient, it comprises Pradefovir and the second active constituents of medicine, and pharmaceutically acceptable auxiliary material, and wherein the second active constituents of medicine is not KETOKONAZOL, Rifampin or erythromycin; Perhaps, Pradefovir and the second active constituents of medicine are united the purposes in the pharmaceutical preparation for the preparation of the treatment hepatitis B patient, and wherein the second active constituents of medicine is not KETOKONAZOL, Rifampin or erythromycin.
8. pharmaceutical preparation claimed in claim 7 or purposes, wherein the second active constituents of medicine is antacid, alkaline calcium salt preferably, as calcium carbonate.
9. adult man mean body weight or the method that obtains the mean body weight of adult man contain purposes in the medicine of Pradefovir in preparation;
Perhaps, preparation contains the method for the medicine of Pradefovir, and it comprises the method for using the adult man mean body weight or comprising the mean body weight that obtains adult man;
Perhaps, be fit to the male sex's (especially adult man) hepatitis B patient but be not suitable for or get rid of outer packaging that women (especially adult female) uses and contain purposes in the medicine of Pradefovir in preparation;
Perhaps, preparation contains the method for the medicine of Pradefovir, and it comprises the outer packaging of using the suitable male sex's (especially adult man) hepatitis B patient but being not suitable for or getting rid of women (especially adult female) use.
10. purposes claimed in claim 9 or method, wherein said medicine is used for the treatment of male sex's (especially adult man) hepatitis B patient (especially adult patients) but is not suitable for or gets rid of women (especially adult female) and use, perhaps, described medicine be used for the treatment of hepatitis B and reduce untoward reaction (as, headache and/or dizzy), wherein hepatitis B is male sex's (especially adult man) patient's hepatitis B.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102827206A (en) * | 2012-09-17 | 2012-12-19 | 西安新通药物研究有限公司 | Pradefovir crystal |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102827206A (en) * | 2012-09-17 | 2012-12-19 | 西安新通药物研究有限公司 | Pradefovir crystal |
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