CN107929338A - The new application of Pien Tze Huang and its preparation in the medicine for preparing treatment post-herpetic neuralgia - Google Patents
The new application of Pien Tze Huang and its preparation in the medicine for preparing treatment post-herpetic neuralgia Download PDFInfo
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- CN107929338A CN107929338A CN201711458148.XA CN201711458148A CN107929338A CN 107929338 A CN107929338 A CN 107929338A CN 201711458148 A CN201711458148 A CN 201711458148A CN 107929338 A CN107929338 A CN 107929338A
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- medicine
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- pien tze
- tze huang
- herpetic neuralgia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/37—Digestive system
- A61K35/413—Gall bladder; Bile
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/55—Glands not provided for in groups A61K35/22 - A61K35/545, e.g. thyroids, parathyroids or pineal glands
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/58—Reptiles
- A61K35/583—Snakes; Lizards, e.g. chameleons
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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 medicine for preparing treatment post-herpetic neuralgia.Clinical study results show that Pien Tze Huang is notable to the therapeutic effect of post-herpetic neuralgia, and the improvement degree for Patient Global's symptom is suitable with Pregabalin, and the alleviation degree for patients' neural's pain is significantly better than Pregabalin；In addition, its is safe, suitable for clinical application.
Description
Technical field
The invention belongs to the field of Chinese medicines, and in particular to Pien Tze Huang and its preparation are preparing treatment post-herpetic neuralgia
Medicine in new application.
Background technology
Post-herpetic neuralgia is that sensory nerve dominates area and leaves after the skin lesion of acute herpes zoster patient's part is healed
Or the secret anguish regenerated occurs together the disease of paroxysmal intense pain, it is the most common complication of herpes zoster, is more common in old age
People and the various patients of immunologic hypofunction, its incidence increase as the age increases.Post-herpetic neuralgia is facing
It is very common and obstinate on bed, it is a big difficult point of clinical treatment, patient has burning pain, shouting pain, tactile paralgesia or battle array
Symptom, the feeling of pains such as hair property tear sample severe pain are violent, the even several years sustainable several months, the routine work and life of severe jamming patient
It is living.
Treatment to post-herpetic neuralgia, doctor trained in Western medicine is with the original such as anti-infective, antiviral, trophic nerve, anti-inflammatory analgetic
Based on then, when doctor trained in Western medicine clinical application, answers validity, security and the tolerance of comprehensive consideration medicine and the clinical setting of patient
(such as body condition, complication, contraindication), refractory herpes zoster post herpetic neuralgia also need the scheme using drug combination.At present,
The clinical fiest-tire medication of post-herpetic neuralgia includes agents of calcium ion channel modulators (such as Pregabalin and Jia Ba sprays in doctor trained in Western medicine
Fourth), tricyclic antidepressant, due to being influenced by factors such as patient individual difference, tolerances, said medicine might not energy
Effective effect is played, and said medicine, there are obvious adverse drug reaction, poor the elderly then needs for tolerance
Consider other safer, effective treatment means.
Although the traditional Chinese medical science is with the clinical research of Longdan Xiegan Tang, Traditional Chinese medicine decoction for treating-ache and expelling atagnate treatment post-herpetic neuralgia
Report, but due to being and Western medicine or other therapy use in conjunction, clinical research sample size be small, research approach fails to be based on
Character of traditional Chinese medicine carries out scientific design etc., causes it to still suffer from larger difficulty in clinical practice.
Pien Tze Huang is country-level Chinese medicine protection kind, using natural musk, natural ox gallstone, snake gall, pseudo-ginseng etc. it is rare in
Medicine, which refines, to be formed, 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 post-herpetic neuralgia.
The content of the invention
For this reason, the present invention proposes that Pien Tze Huang and its preparation are new in the medicine for preparing treatment post-herpetic neuralgia
Purposes.
In order to solve the above technical problems, the present invention is achieved through the following technical solutions：
The present invention provides Pien Tze Huang and its preparation and is preparing the purposes in treating neuralgic medicine.
Preferably, such use, the purposes are the purposes in the medicine for preparing treatment post-herpetic neuralgia.
It is further preferred that such use, Pien Tze Huang adds 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.；Flavouring 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 lozenge, 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 '.
The above technical solution of the present invention has the following advantages over the prior art：
Clinical study results show that Pien Tze Huang is notable to the therapeutic effect of post-herpetic neuralgia, comprehensive for patient
It is suitable with Pregabalin to close the improvement degree of symptom, and the alleviation degree for patients' neural's pain is significantly better than Pregabalin；This
Outside, its is safe, suitable for clinical application.
Embodiment
In following embodiments 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 customary adjuvant and clinically acceptable lozenge is made according to common process.
Embodiment 2
Pien Tze Huang adds customary adjuvant and clinically acceptable tablet is made according to common process.
Embodiment 3
Pien Tze Huang adds customary adjuvant and clinically acceptable capsule is made according to common process.
Embodiment 4
Pien Tze Huang adds customary adjuvant and clinically acceptable granule is made according to common process.
Experimental example 1Research of the Pien Tze Huang to the therapeutic effect of post-herpetic neuralgia
1st, experiment purpose
Study therapeutic effect of the Pien Tze Huang to post-herpetic neuralgia.
2nd, experimental method
2.1 general information
The post-herpetic neuralgia patient accepted for medical treatment in January, 2016 to December 108, wherein male 52, women 56
Example, it is age 35-67 Sui, 49.2 years old average.All patients meet post-herpetic neuralgia Western medicine diagnostic criteria (reference
《Clinic diagnosis guide (pain credit volume)》, 2007, People's Health Publisher).All patients are randomly divided into 2 groups, are respectively
Treatment group and control group, every group 54.Two groups of patients are in age, gender, the course of disease, VAS pain scores isobases data without aobvious
Write difference (P ＞ 0.05).
2.2 inclusive criteria
(1) age：18-75 Sui；
(2) Western medicine diagnostic criteria is met；
(3) painful area is trunk (including four limbs)；
(4) enter not take in 1 week before group or outer used associated treatment medicine；
(5) cognitive function is complete, signs informed consent form.
2.3 exclusion standard
(1) painful area is excluded as Head And Face, four limbs, buttocks, perianal area；
(2) enter and used in group the last week to the medicative medicine of herpes zoster, or using glucocorticoid and exempt from
Epidemic disease inhibitor person；
(3) allergic constitution person, with other serious diseases patient such as cancer, AIDS；
(4) gestational period, women breast-feeding their children；
(5) other drugs clinical test person was participated in 3 months before entering group.
2.4 treatment method
Control group：Oral Pregabalin capsule (diazepam, pfizer inc's production, specification 75mg/), once
1,2 times/day, as therapeutic effect is undesirable, dose is increased to once two grains.
Treatment group：Pien Tze Huang capsule prepared by oral embodiment 3 (Zhongzhou Pianziguang Pharmaceutical Industry Co., Ltd. produces,
0.3g/), once two grains, 3 times/day.
Two groups of courses for the treatment of of the above are 7 days, and observation after the course for the treatment of is as a result, evaluation curative effect.
2.5 observation index
(1) totall effective rate in clinical treatment；
(2) pretherapy and post-treatment VAS pain scores：0 point is painless；Less than 3 points are to have slight pain, can endure；4-6 points are
Patient pain influences sleep, can still endure；7-10 points are to have progressive pain, in great pain, influence appetite, influence to sleep；
(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..
2.6 curative effect determinate standard
Recovery from illness：Patients' neural's pain symptom disappears, and diet, sleep and daily life state recover normal completely；
Effectively：Patients' neural's pain symptom mitigates, suffer from cold, it is tired after still suffer from paroxysmal throe, diet, sleep and daily
Animation improves；
It is invalid：Patients' neural's pain symptom has no to change, and diet, sleep and daily life state are poor.
Totall effective rate in clinical treatment=(recovery from illness+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's curative effects compare
The experimental result of two groups of patient's curative effects is as shown in table 1.
1 two groups of curative effects of table compare
| Group | n | Recovery from illness | Effectively | It is invalid | Total effective rate (%) |
| Treatment group | 54 | 27 | 22 | 5 | 90.7 |
| Control group | 54 | 25 | 20 | 9 | 83.3 |
As shown in Table 1, the suitable (no statistical difference of total effective rate after the clinical treatment of two groups of patients for the treatment of group and control group
Meaning).
3.2 two groups of patient's VAS pain scores compare
The experimental result of two groups of patient's VAS pain scores is as shown in table 2.
Pain degree compares before and after 2 two groups of table
| Group | n | Before treatment | After treatment |
| Treatment group | 30 | 7.2±1.7 | 1.6±0.8* |
| Control group | 30 | 7.3±1.5 | 2.1±1.2 |
Note：Compared with control group, * P ＜ 0.05
As shown in Table 2, before treatment, two groups of VAS pain scores no significant differences (P ＞ 0.05)；After treatment, treatment
Group VAS pain scores are substantially less than control group VAS pain scores (P ＜ 0.05).
3.3 adverse reaction
Treatment group does not find adverse reaction, control group have 16 patients occur during treatment drowsiness, dizzy, oedema,
The adverse reaction such as have a stomach upset.
4. conclusion
Clinical study results show that Pien Tze Huang is notable to the therapeutic effect of post-herpetic neuralgia, comprehensive for patient
It is suitable with Pregabalin to close the improvement degree of symptom, and the alleviation degree for patients' neural's pain is significantly better than Pregabalin；This
Outside, its is safe, suitable for clinical application.
Obviously, the above embodiments are merely examples for clarifying the description, and the restriction not to embodiment.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 change or
Change.There is no necessity and possibility to exhaust all the enbodiments.And the obvious change thus extended out or
Among changing still in the protection domain of the invention.
Claims (5)
1. Pien Tze Huang and its preparation are preparing the purposes in treating neuralgic medicine.
2. purposes according to claim 1, it is characterised in that the purposes is to lose nerve after treatment herpes zoster is prepared
Purposes in the medicine of pain.
3. purposes according to claim 1 or 2, it is characterised in that Pien Tze Huang adds customary adjuvant, according to common process,
Clinically acceptable preparation is made.
4. according to claim 1-3 any one of them purposes, it is characterised in that the preparation is selected from lozenge, tablet, capsule
Agent, granule, powder, pill, tincture, vina, soft extract or mixture.
5. according to claim 1-4 any one of them purposes, it is characterised in that contain in each drug-delivery preparation of 'Pianzaihuang '
Pien Tze Huang 0.3-0.9g.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711458148.XA CN107929338A (en) | 2017-12-28 | 2017-12-28 | The new application of Pien Tze Huang and its preparation in the medicine for preparing treatment post-herpetic neuralgia |
| PCT/CN2018/115530 WO2019128511A1 (en) | 2017-12-28 | 2018-11-15 | Use of pien tze huang or preparation thereof in preparing drug for treating postherpetic neuralgia |
| TW107147791A TWI720396B (en) | 2017-12-28 | 2018-12-28 | Use of Pien Tze Huang and its preparations in treating neuralgia after herpes zoster |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711458148.XA CN107929338A (en) | 2017-12-28 | 2017-12-28 | The new application of Pien Tze Huang and its preparation in the medicine for preparing treatment post-herpetic neuralgia |
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| Publication Number | Publication Date |
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| CN107929338A true CN107929338A (en) | 2018-04-20 |
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| CN201711458148.XA Pending CN107929338A (en) | 2017-12-28 | 2017-12-28 | The new application of Pien Tze Huang and its preparation in the medicine for preparing treatment post-herpetic neuralgia |
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| Country | Link |
|---|---|
| CN (1) | CN107929338A (en) |
| TW (1) | TWI720396B (en) |
| WO (1) | WO2019128511A1 (en) |
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| 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 |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN107929338A (en) * | 2017-12-28 | 2018-04-20 | 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 medicine for preparing treatment post-herpetic neuralgia |
| 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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2017
- 2017-12-28 CN CN201711458148.XA patent/CN107929338A/en active Pending
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2018
- 2018-11-15 WO PCT/CN2018/115530 patent/WO2019128511A1/en active Application Filing
- 2018-12-28 TW TW107147791A patent/TWI720396B/en active
Non-Patent Citations (4)
| Title |
|---|
| 刘泽虎: "新癀片治疗带状疱疹后神经痛疗效观察 ", 《中国中西医结合皮肤性病学杂志》 * |
| 康爱多网上药店: "复方片仔癀软膏能治疗带状疱疹后遗神经痛吗", 《HTTPS://WWW.360KAD.COM/MEDICATION/164323.SHTML》 * |
| 李吉等: "中药治疗带状疱疹后遗神经痛的临床研究进展 ", 《药学服务与研究》 * |
| 李梅英等: "应用新癀片治疗病毒性疱疹的护理 ", 《天津护理》 * |
Cited By (1)
| 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 |
Also Published As
| Publication number | Publication date |
|---|---|
| TWI720396B (en) | 2021-03-01 |
| WO2019128511A1 (en) | 2019-07-04 |
| TW201929875A (en) | 2019-08-01 |
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