CN108042589A - The new application of Pien Tze Huang and its preparation in the drug for preparing treatment herpes zoster - Google Patents
The new application of Pien Tze Huang and its preparation in the drug for preparing treatment herpes zoster Download PDFInfo
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Abstract
The invention belongs to the field of Chinese medicines, and in particular to the new application of Pien Tze Huang and its preparation in the drug for preparing treatment herpes zoster.Experiment in vitro shows that Pien Tze Huang being capable of the dose-dependent duplication for inhibiting varicellazoster virus (VZV).Clinical research is found, the effect of Pien Tze Huang combination antiviral drug Valaciclovir and acyclovir are to stagnated heat of liver channel type acute stage herpes zoster is definite, it can not only promote the improvement of patient clinical symptom, the incrustation of bleb can be rapidly promoted, the generation of new bleb is prevented, relieves pain, and treatment time can be shortened, in addition the post herpetic neuralgia incidence and adverse reaction rate occurred after treatment can also be reduced, clinical practice has apparent advantage.
Description
Technical field
The invention belongs to the field of Chinese medicines, and in particular to Pien Tze Huang and its preparation are in the drug for preparing treatment herpes zoster
New application.
Background technology
Herpes zoster is the acute infection dermatoses as caused by varicella virus, with along unilateral peripheral nerve
The gathering bleb and neuralgia of distribution are characterized.Herpes zoster patients during acute stage neuralgia acutely unbearably, seriously affects patient
Routine work and life.
At present, doctor trained in Western medicine to the treatment of herpes zoster using antiviral, alleviation neuralgia as principle, since Western medicine is merely capable of
The symptom of reduction of patient to a certain extent, and due to Western medicine there are adverse reaction it is more apparent, easily there is the defects of drug resistance, from
And its clinical practice is caused to have some limitations.The traditional Chinese medical science thinks：Herpes zoster is fallen ill and stagnated heat of liver channel, qi depression to blood stasis, wet
Pass is accumulated in heat, channels and collaterals is caused to check, positive unsaturated vapor, the evil contamination skin of poison, treatment should be based on clearing heat and promoting diuresis, removing toxic substances qi-regulating.
At present, although the existing relevant report using swap buffers, Longdan Xiegan Tang cooperation western medicine herpes zoster, still lack at present
Curative for effect, the rapid drug of action.
Pien Tze Huang is country-level Chinese medicine protection kind, using natural musk, natural ox gallstone, snake gall, Radix Notoginseng etc. it is rare in
Medicine refines, and has effects that clearing heat and detoxicating, cooling blood and removing stasis, swelling and pain relieving, and clinic is usually used in treating the viral liver of acute and chronic
Inflammation, malignant tumour, ulcer boils nameless sores or boils, traumatic injury and various inflammation etc..
At present, there is not yet Pien Tze Huang and its preparation are used to prepare the relevant report for the treatment of herpes zoster.
The content of the invention
For this purpose, the present invention proposes the new application of Pien Tze Huang and its preparation in the drug for preparing treatment herpes zoster.
In order to solve the above technical problems, the present invention is achieved through the following technical solutions：
In a first aspect, the present invention provides the purposes of Pien Tze Huang and its preparation in the drug for preparing treatment herpes zoster.
Preferably, such use, the purposes are the purposes in the drug for preparing treatment stagnated heat of liver channel type herpes zoster.
Preferably, such use, the purposes are the purposes in the drug for preparing treatment acute stage herpes zoster.
It is further preferred that such use, the treatment herpes zoster refers to：Shorten and stop the blister time.
It is further preferred that such use, the treatment herpes zoster refers to：Shorten scab forming time.
It is further preferred that such use, the treatment herpes zoster refers to：Reduce post herpetic neuralgia incidence.
It is further preferred that such use, Pien Tze Huang adds in customary adjuvant, and according to common process, being made can clinically connect
The preparation received.
The pharmaceutically acceptable auxiliary material is：Filler, disintegrant, lubricant, suspending agent, adhesive, sweetener, rectify
Taste agent, preservative, matrix etc..Filler includes：Starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose,
Sucrose etc.；Disintegrant includes：Starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, crosslinked polyvinylpyrrolidone,
Low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose are received；Lubricant includes：Magnesium stearate, lauryl sodium sulfate, talcum
Powder, silica etc.；Suspending agent includes：Polyvinylpyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methyl cellulose
Deng；Adhesive includes, starch slurry, polyvinylpyrrolidone, hydroxypropyl methyl cellulose etc.；Sweetener includes：Saccharin sodium, A Si
Pa Tan, sucrose, honey element, enoxolone etc.；Corrigent includes：Sweetener and various essence；Preservative includes：Parabens,
Benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, the fixed, eucalyptus oil of acetic acid chloroethene etc.；Matrix includes：PEG6000、
PEG4000, insect wax etc..
It is further preferred that such use, the preparation be selected from pastille, tablet, capsule, granule, powder, pill,
Tincture, vina, soft extract or mixture.
It is further preferred that such use, 0.3-0.9g containing Pien Tze Huang in each drug-delivery preparation of 'Pianzaihuang '.
It is further preferred that such use, the purposes is controlled for Pien Tze Huang and its agents antiviral drugs in preparation
Treat the purposes in the drug of herpes zoster.
It is further preferred that such use, the antiviral drugs in Valaciclovir and acyclovir at least one
Kind.
The above technical solution of the present invention has the following advantages over the prior art：
Experiment in vitro shows that Pien Tze Huang is capable of the duplication of dose-dependent inhibition varicella virus (VZV), EC50
About 0.3336mM.Clinical research finds that Pien Tze Huang combination antiviral drug Valaciclovir and acyclovir are to stagnated heat of liver channel type
The effect of acute stage herpes zoster, is definite, can not only promote the improvement of patient clinical symptom, can rapidly promote bleb incrustation,
It prevents the generation of new bleb, relieve pain, and treatment time can be shortened, the rear something lost god occurred after treatment can also be reduced in addition
Dysmenorrhoea incidence and adverse reaction rate, clinical practice have apparent advantage.
Description of the drawings
In order to make the content of the present invention more clearly understood, below according to specific embodiments of the present invention and combine
Attached drawing, the present invention is described in further detail, wherein：
Fig. 1 is specific inhibitory action of the Pien Tze Huang sample to VZV and the toxicity data to ARPE-19 cells in experimental example 1.
Specific embodiment
In following embodiment of the present invention and experimental example, Pien Tze Huang is produced by Zhongzhou Pianziguang Pharmaceutical Industry Co., Ltd..
Embodiment 1
Pien Tze Huang adds in customary adjuvant and clinically acceptable pastille is made according to common process.
Embodiment 2
Pien Tze Huang adds in customary adjuvant and clinically acceptable tablet is made according to common process.
Embodiment 3
Pien Tze Huang adds in customary adjuvant and clinically acceptable capsule is made according to common process.
Embodiment 4
Pien Tze Huang adds in customary adjuvant and clinically acceptable granule is made according to common process.
Experimental example 1Evaluation of the Pien Tze Huang to the inhibitory action of varicella virus (VZV) activity
1st, experiment material
Strain：Varicella virus VZV-Luc-GFP reporter virus carries GFP and luciferase report bases
Cause.It is preserved by this laboratory amplification.
Cell model：Human RPE Cells in Vitro system ARPE-19 (Human Retinal Pigment
Epithelial cell line), it is preserved by this laboratory amplification.Condition of culture：DMEM+10% hyclones, 37 DEG C, 5%
CO2。
Pien Tze Huang：Zhongzhou Pianziguang Pharmaceutical Industry Co., Ltd. produces, and is ground into fine powder.
2nd, experimental principle and method
2.1 samples are to the toxicity detection of ARPE-19 cells
Experiment is using CellTiter-GloTM (Promega) kit detection sample to the toxic action of cell.
Experimental principle：CellTiter-Glo kits detect living cells in culture by being quantitative determined to ATP
Number.There are the respiration of metabolic active cells and other vital movement processes that can generate ATP, luciferin is used in kit
The steady glow type signal of enzyme generation, luciferase needs the participation of ATP in luminescence process.It is added in into cell culture medium
CellTiter-Glo reagent measuring luminous values, ATP amounts are directly proportional in optical signal and system, and ATP amounts and viable count are in positive
It closes, therefore optical signal value can reflect the number of living cells.
Experimental procedure：It is spare after cell attachment by ARPE-19 cell inoculations in 96 porocyte culture plates.Drug is used
DMEM culture mediums continuous 10 gradients of multiple proportions gradient dilution from highest test concentrations.It adds drug in cell, in 37 DEG C
CO2 incubators in cultivate.After dosing culture 3d, cell adds in CellTiter-Glo detection cell survival rates.Drug is to cell
Toxicity size and the activity of cell reflect in inverse ratio, and with cytoactive.
Calculation formula：Cytoactive (%)=medicine group numerical value/cell controls group numerical value average * 100
The anti-VZV Activity determinations of 2.2 samples
Experimental principle：VZV-Luc-GFP reporter virus carries GFP reporter genes, and the expression of the gene can reflect that virus is multiple
The level of system, therefore, the level that GFP is expressed in the cell of observation and analysis virus infection can reflect drug to virus replication
Suppression level.
Method and step：ARPE-19 cell inoculations are spare after 37 DEG C of overnight incubations in 96 porocyte culture plates.Drug is used
DMEM culture mediums continuous 10 gradients of multiple proportions gradient dilution from suitable concentration.Drug and virus storage liquid are added to cell.
It is placed in 37 DEG C of cell incubator cultures.After 3d, pass through high intension cytoanalyze (Operetta High-Content
Screening System, HCS, Perkin Elmer) observation GFP expressions and to the fluorecyte number of GFP in the visual field into
Digitized analyzes (Harmony 3.5software, Perkin Elmer).
Inhibiting rate (%)=100- sample wells numerical value/virus control group numerical value average * 100
The anti-VZV Activity determinations result of 2.3 samples
Pien Tze Huang sample is as shown in Figure 1 to the specific inhibitory action of VZV and to the toxicity data of ARPE-19 cells.
As shown in Figure 1, examined sample Pien Tze Huang is at high concentrations to ARPE-19 cells without overt toxicity, to VZV viruses
There is the very strong concentration EC for being in dose-dependent inhibitory action, causing 50% depression effect50About 0.3336mM.
2.4 experimental results and analysis
By detecting influence of the Pien Tze Huang to VZV viruses levels of replication in ARPE-19 cell lines, the results showed that Pien Tze Huang
It being capable of the dose-dependent duplication for inhibiting VZV.
Experimental example 2Research of the Pien Tze Huang to the therapeutic effect of stagnated heat of liver channel type herpes zoster
1st, experiment purpose
Study therapeutic effect of the Pien Tze Huang to stagnated heat of liver channel type herpes zoster.
2nd, experimental method
2.1 general information
The herpes zoster patients during acute stage accepted for medical treatment in January, 2016 to December 144, wherein male 69, women 75, year
It is age 34-69 Sui, 50.2 years old average.All patients meet herpes zoster Western medicine diagnostic criteria and stagnated heat of liver channel card tcm diagnosis mark
It is accurate.All patients are randomly divided into two groups, respectively treatment group and control group, wherein, treatment group 72, male 33, women 39
Example；Control group 72, man 35, women 37.Two groups of patients are in age, gender, the course of disease, VAS pain scores isobase data
Without significant difference (P ＞ 0.05).
2.2 inclusion criteria
(1) age 18-75 Sui；
(2) Western medicine diagnostic criteria is met；
(3) stagnated heat of liver channel card Chinese medical discrimination patient is met；
(4) herpes zoster pain intensity >=5 point；
(5) calculated by burn surface area " palm test ", skin lesion area is no more than 2% body surface area；
(6) cutaneous lesion is trunk (including four limbs)；
(7) within herpes zoster skin lesion disease time is when 72 is small；
(8) enter not take in 1 week before group or outer used associated treatment drug；
(9) cognitive function is complete, signs informed consent form.
2.3 exclusion criteria
(1) privileged sites herpes zoster, such as Head And Face, front and rear two cloudy and crissum bleb patients are excluded；
(2) there is warts, erosion, ulcer, necrosis etc., severe infection person in skin lesion；
(3) enter and used in group the last week to the medicative drug of herpes zoster or used glucocorticoid and exempt from
Epidemic disease inhibitor person；
(4) allergic constitution person or to this medicine principal component allergy sufferers；
(5) with other serious diseases such as cancer, AIDS, Liver and kidney function is low, and (such as ALT, AST are more than on normal value
1.5 times of limit, Cr are more than Upper Limit of Normal Value) or other immunocompromised diseases patient；
(6) gestation, preparation gestation or women breast-feeding their children；
(7) subject is participating in or was being participated in before enrollment in 3 months other drugs clinical test；
(8) researcher thinks to be not suitable for participating in this clinical test person.
2.4 therapy
Primary Care：Tablets of vacyclovir (GlaxoSmithKline PLC (China) Investment Co., Ltd, each 0.3g, 2 times/day, mouth
Clothes)+Virless Cream (GlaxoSmithKline PLC (China) Investment Co., Ltd, skin affected part cleans, sterilize after, be applied to affected part,
4 times/day)+methylcobalamin tablet (Hangzhou Kang'Enbei Pharmaceutical Co., Ltd, each 0.5mg, 3 times/day).
Treatment group：(ZhangZhou Pien Tze Huang medicine company share is limited for Pien Tze Huang capsule (0.3g/) prepared by oral embodiment 3
Company produces, 2 tablets each time, 3 times/day)+Primary Care；
Control group：Oral Pien Tze Huang capsule simulant (0.3g/) is (i.e.：Placebo) (2 tablets each time, 3 times/day)+basis
Treatment；
Other treatment：Ibuprofen sustained release capsules (0.3g/), take, 1 tablet each time on demand.
More than two groups of courses for the treatment of be 7 days, result, evaluation curative effect are observed after the course for the treatment of, can be drunk according to the recovery situation of patient
Feelings extend drug usage time.
2.5 observation index
(1) patient is observed during treating and stops blister, incrustation, analgesic, cure time；Only blister：No new blister occurs, original blister
Start to dry up；Incrustation：Blister dries up incrustation；Analgesic：Pain disappears；
(2) totall effective rate in clinical treatment；
(3) safety indexes：Including vital sign, blood routine, routine urinalysis+urinary sediment microscopy, stool routine examination+OB, liver function
Energy, renal function, adverse events etc.；
(4) 1 month observation patient of follow-up, which whether there is, is left neuralgia.
2.6 curative effect judging standard
Recovery from illness：Symptom and sign completely disappear, and fash disappears substantially, pain disappears；
It is effective：Symptom and sign are obviously improved, and skin lesion disappearance ＞ 70.0%, pain is relieved；
Effectively：Symptom and sign make moderate progress, and skin lesion disappearance ＞ 50.0%, pain is mitigated；
It is invalid：Symptom and sign are not improved, and skin lesion disappearance ＜ 50.0%, pain is apparent.
Totall effective rate in clinical treatment=(recovery from illness+effective+effectively)/total number of cases × 100%.
2.7 statistical analysis
At the end of experiment, while every observation index is evaluated and analyzed, using P ＜ 0.05 as the difference examined
Statistically significant standard.
3rd, experimental result
3.1 two groups of patient symptoms improve the time, post herpetic neuralgia incidence compares
Two groups of patient symptoms improvement times, experimental results of post herpetic neuralgia incidence are as shown in table 1.
1 two groups of patient symptoms of table improve the time, post herpetic neuralgia incidence compares
| Group | n | The only blister time | Scab forming time | Analgesic time | Post herpetic neuralgia incidence (%) |
| Control group | 72 | 5.6±1.1 | 8.8±1.0 | 6.5±1.3 | 27.8 |
| Treatment group | 72 | 2.9±0.7** | 5.7±1.3* | 6.0±0.9 | 2.8** |
Note：Compared with the control group,*P ＜ 0.05,**P ＜ 0.01
As shown in Table 1, compared with the control group, only blister time, the scab forming time for the treatment of group significantly shorten, post herpetic neuralgia hair
Raw rate is remarkably decreased, and difference is statistically significant (P ＜ 0.05, P ＜ 0.01)；Two groups of analgesic time is suitable, this shows piece
Young Huang also has good analgesic effect.
3.2 two groups of patient's curative effects compare
The experimental result of two groups of patient's curative effects is as shown in table 2.
2 two groups of patient outcomes of table compare
| Group | n | Recovery from illness | It is effective | Effectively | It is invalid | Total effective rate (%) |
| Treatment group | 72 | 13 | 28 | 24 | 7 | 90.3 |
| Control group | 72 | 2 | 17 | 38 | 15 | 79.2 |
As shown in Table 2, after treating 7 days, the total effective rate for the treatment of group is 90.3%, and the total effective rate of control group is
79.2%, and the recovery from illness number of cases of the recovery from illness number of cases for the treatment of group and effective number of cases obviously higher than control group and effective number of cases.
3.3 adverse reaction
General adverse reaction have headache, nausea, skin burns, have a stomach upset, anorexia, leucocyte decline, insomnia, egg
Albiduria etc..It finds that adverse reaction occur in 9 patients in control group, finds that adverse reaction occur in 2 patients in treatment group, show to control
The adverse reaction rate for the treatment of group is significantly lower than the adverse reaction rate of control group.
4th, experiment conclusion
Clinical research finds that Pien Tze Huang combination antiviral drug Valaciclovir, acyclovir and Mecobalamin are to stagnated heat of liver channel
The effect of type acute stage herpes zoster, is definite, can not only promote the improvement of patient clinical symptom, can rapidly promote the knot of bleb
Scab, the generation for preventing new bleb relieve pain, and can shorten treatment time, can also reduce in addition after occurring after treating
Neuralgia incidence and adverse reaction rate are lost, clinical practice has apparent advantage.
Obviously, the above embodiments are merely examples for clarifying the description, and is not intended to limit the embodiments.It is right
For those of ordinary skill in the art, can also make on the basis of the above description it is other it is various forms of variation or
It changes.There is no necessity and possibility to exhaust all the enbodiments.And the obvious variation thus extended out or
Among changing still in the protection domain of the invention.
Claims (10)
1. the purposes of Pien Tze Huang and its preparation in the drug for preparing treatment herpes zoster.
2. purposes according to claim 1, which is characterized in that the purposes is to prepare treatment stagnated heat of liver channel type banding blister
Purposes in the drug of rash.
3. purposes according to claim 1, which is characterized in that the purposes is to prepare treatment acute stage herpes zoster
Purposes in drug.
4. according to claim 1-3 any one of them purposes, which is characterized in that the treatment herpes zoster refers to：Shortening stops
The blister time.
5. according to claim 1-3 any one of them purposes, which is characterized in that the treatment herpes zoster refers to：Shorten knot
The scab time.
6. according to claim 1-3 any one of them purposes, which is characterized in that the treatment herpes zoster refers to：After reduction
Lose neuralgia incidence.
7. according to claim 1-6 any one of them purposes, which is characterized in that Pien Tze Huang adds in customary adjuvant, according to routine
Clinically acceptable preparation is made in technique.
8. purposes according to claim 7, which is characterized in that the preparation be selected from pastille, tablet, capsule, granule,
Powder, pill, tincture, vina, soft extract or mixture.
9. according to claim 1-8 any one of them purposes, which is characterized in that contain in each drug-delivery preparation of 'Pianzaihuang '
Pien Tze Huang 0.3-0.9g.
10. according to claim 1-8 any one of them purposes, which is characterized in that the purposes joins for Pien Tze Huang and its preparation
Close purposes of the antiviral drugs in the drug for preparing treatment herpes zoster；
Preferably, the antiviral drugs is selected from least one of Valaciclovir and acyclovir.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
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| CN201711458150.7A CN108042589A (en) | 2017-12-28 | 2017-12-28 | The new application of Pien Tze Huang and its preparation in the drug for preparing treatment herpes zoster |
| PCT/CN2018/115528 WO2019128510A1 (en) | 2017-12-28 | 2018-11-15 | Application for pien tze huang and preparation thereof in treatment of herpes zoster |
| TW107147789A TWI785178B (en) | 2017-12-28 | 2018-12-28 | Use of Pien Tze Huang and its preparations in the treatment of herpes zoster |
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| CN201711458150.7A CN108042589A (en) | 2017-12-28 | 2017-12-28 | The new application of Pien Tze Huang and its preparation in the drug for preparing treatment herpes zoster |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108815412A (en) * | 2018-09-12 | 2018-11-16 | 杭州嘉莲信息科技有限公司 | A kind of drug of effective treatment shingles zoster |
| WO2019128511A1 (en) * | 2017-12-28 | 2019-07-04 | 漳州片仔癀药业股份有限公司 | Use of pien tze huang or preparation thereof in preparing drug for treating postherpetic neuralgia |
| WO2019128510A1 (en) * | 2017-12-28 | 2019-07-04 | 漳州片仔癀药业股份有限公司 | Application for pien tze huang and preparation thereof in treatment of herpes zoster |
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| CN101352464B (en) * | 2007-07-27 | 2013-10-09 | 华润片仔癀药业有限公司 | Quality control method of Chinese medicinal composition |
| GB0815179D0 (en) * | 2008-08-20 | 2008-09-24 | Sharma Anant | Medication and treatment for infection |
| CN103623023B (en) * | 2013-11-29 | 2015-12-02 | 漳州片仔癀药业股份有限公司 | A kind of medicinal usage of Pien Tze Huang compositions |
| CN105193928A (en) * | 2015-09-17 | 2015-12-30 | 漳州片仔癀药业股份有限公司 | Pien Tze Huang unguentum compositum and preparation method thereof |
| CN108042589A (en) * | 2017-12-28 | 2018-05-18 | 漳州片仔癀药业股份有限公司 | The new application of Pien Tze Huang and its preparation in the drug for preparing treatment herpes zoster |
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| 柏正平主编: "《中成药家庭使用全解》", 31 January 2013 * |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019128511A1 (en) * | 2017-12-28 | 2019-07-04 | 漳州片仔癀药业股份有限公司 | Use of pien tze huang or preparation thereof in preparing drug for treating postherpetic neuralgia |
| WO2019128510A1 (en) * | 2017-12-28 | 2019-07-04 | 漳州片仔癀药业股份有限公司 | Application for pien tze huang and preparation thereof in treatment of herpes zoster |
| CN108815412A (en) * | 2018-09-12 | 2018-11-16 | 杭州嘉莲信息科技有限公司 | A kind of drug of effective treatment shingles zoster |
Also Published As
| Publication number | Publication date |
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| WO2019128510A1 (en) | 2019-07-04 |
| TW201929874A (en) | 2019-08-01 |
| TWI785178B (en) | 2022-12-01 |
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