CN105853917B - A kind of pharmaceutical composition and its preparation method and application for treating chronic pharyngitis - Google Patents
A kind of pharmaceutical composition and its preparation method and application for treating chronic pharyngitis Download PDFInfo
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
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Abstract
The invention discloses a kind of pharmaceutical compositions and its preparation method and application for treating chronic pharyngitis, the active constituent of the composition is mainly prepared from the following raw materials in parts by weight: 10-20 parts of Radix Astragali, fruit of glossy privet 10-20 parts processed, 6-18 parts of Rhizoma Atractylodis Macrocephalae, 6-18 parts of Poria cocos, 6-18 parts of Radix Curcumae, 4-8 parts of wartwort, 2-4 parts of Oroxylum indicum.The present invention has the function of yin-nourishing QI invigorating, fluid dryness, for treating chronic pharyngitis.The pharmaceutical composition is convenient to take, and effect is steady, curative for effect, stable dosage forms, quality controllable and have no toxic side effect, and can satisfy the demand of patient.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicines, and in particular to a kind for the treatment of chronic pharyngitis manufactured using Chinese medicine as raw material
Pharmaceutical composition and its preparation method and application.
Background technique
Chronic pharyngitis is under pharyngeal mucous membrane, mucous membrane and the diffusivity inflammation of lymphoid tissue, is often upper respiratory tract chronic inflammation
A part, be common clinical, frequently-occurring disease.The disease course of disease is long, touching refractory, is always otorhinolaryngologic problem, while
It brings great pain to patients.With the continuous development of industry, air, severe water pollution, in addition undesirable living habit
And the reasons such as abuse of antibiotics, cause respiratory disease growing day by day, it is especially higher with chronic pharyngitis disease incidence, according to statistics
Its disease incidence urban population accounts for the 10%~20% of disease of pharynx, and people in the countryside account for 5.5%, and present and rise year by year trend.
Doctor trained in Western medicine mostly uses the treatment of chronic pharyngitis and dispels the cause of disease, gives up tobacco and wine, avoids dust and pernicious gas etc., takes orally
Mainly use idodine.The uncertain therapeutic efficacy of Western medicine is cut, glutinous because destroying although being made moderate progress using inustion to foreign body in pharynx sense
The reasons such as the glandular secretion of film and scar contracture often bring dry throat, and pharyngalgia aggravates, and Chinese traditional treatment chronic pharyngitis compares doctor trained in Western medicine
There is its unique curative effect.
Summary of the invention
The pharmaceutical composition for manufactured treatment chronic pharyngitis that the object of the present invention is to provide a kind of using Chinese medicine as raw material.
It is a further object of the present invention to provide a kind of extracts of aforementioned pharmaceutical compositions, preparation method and applications.
The purpose of the present invention can be achieved by the following measures:
A kind of pharmaceutical composition for treating chronic pharyngitis, its active constituent is mainly by the bulk pharmaceutical chemicals system of following parts by weight
At: 10-20 parts of Radix Astragali, fruit of glossy privet 10-20 parts processed, 6-18 parts of Rhizoma Atractylodis Macrocephalae, 6-18 parts of Poria cocos, 6-18 parts of Radix Curcumae, 4-8 parts of wartwort, wood
2-4 parts of butterfly.
The active constituent of pharmaceutical composition of the present invention can only be made of above-mentioned each bulk pharmaceutical chemicals, can also in the combination into
Other Chinese medicine material medicines or Western medicine is added to improve the effect of the pharmaceutical composition or further obtain other effects in one step.
In a preferred embodiment, the active constituent of the pharmaceutical composition is primarily or entirely by the bulk pharmaceutical chemicals of following parts by weight
It is made: 12-18 parts of Radix Astragali, fruit of glossy privet 12-18 parts processed, 8-16 parts of Rhizoma Atractylodis Macrocephalae, 8-16 parts of Poria cocos, 8-16 parts of Radix Curcumae, 5-7 parts of wartwort,
2-4 parts of Oroxylum indicum.
In a preferred embodiment, the active constituent of the pharmaceutical composition is primarily or entirely by the bulk pharmaceutical chemicals of following parts by weight
It is made: 15 parts of Radix Astragali, 15 parts of the fruit of glossy privet processed, 12 parts of Rhizoma Atractylodis Macrocephalae, 12 parts of Poria cocos, 12 parts of Radix Curcumae, 6 parts of wartwort, 3 parts of Oroxylum indicum.
In pharmaceutical composition of the invention, the parts by weight of each bulk pharmaceutical chemicals can in provided range arbitrarily adjustment or
Selection, to adapt to the requirement of different situations.Such as under the parts by weight adjustment of other bulk pharmaceutical chemicals or unregulated situation, Radix Astragali can
With 10,11,12,13,14,15,16,17,18,19,20 parts or more aliquot (10.5,11.5,12.5,13.5,17.5,
18.5, it is arbitrarily selected in proportion 19.5 etc.)；It is similar, the fruit of glossy privet processed can also 10,11,12,13,14,15,16,17,
18, it is arbitrarily selected in the proportion of 19,20 parts or more aliquot (10.5,11.5,12.5,13.5,17.5,18.5,19.5 etc.)；It is white
Art can also 6,7,8,9,10,11,12,13,14,15,16,17,18 parts or more aliquot (10.5,11.5,12.5,13.5,
17.5 etc.) it is arbitrarily selected in proportion；Poria cocos can also at 6,7,8,9,10,11,12,13,14,15,16,17,18 parts or
It is arbitrarily selected in the proportion of more aliquot (10.5,11.5,12.5,13.5,17.5 etc.)；Radix Curcumae can also 6,7,8,9,10,11,
12, it is arbitrarily selected in 13,14,15,16,17,18 parts or the proportion of more aliquot (10.5,11.5,12.5,13.5,17.5 etc.)；
Wartwort can also arbitrarily select in 4,5,6,7,8 parts or the proportion of more aliquot (4.5,5.5,6.5,7.5 etc.)；Oroxylum indicum
It can arbitrarily be selected in 2,2.5,3,3.5,4 parts or the proportion of more aliquot (2.1,2.8,3.1,3.6 etc.).
Rhizoma Atractylodis Macrocephalae in the present invention uses Rhizoma Atractylodis Macrocephalae (stir-fry), i.e. the rhizoma atractylodis macrocephalae by tentatively processing.
After bulk pharmaceutical chemicals in the pharmaceutical composition for the treatment of chronic pharyngitis of the invention are extracted or directly with can pharmaceutically connect
Oral preparation, injection or external preparation is made in the auxiliary material received, further, it can be made oral solution, capsule, tablet,
The pharmaceutically acceptable dosage form such as granule, pill, micropill preparation, soft capsule, dripping pill, dispersible tablet, effervescent tablet, chewable tablets.In phase
In the preparation answered, pharmaceutically acceptable auxiliary material can include but is not limited to dextrin, lactose, starch, sucrose, glucose, crystallite
Cellulose, magnesium stearate, mannose, methylcellulose, hydroxypropyl cellulose, carboxymethyl cellulose, glycerol and Steviosin one
Kind is several.
It is above-mentioned pharmaceutical composition by extracting the present invention provides a kind of drug extract for treating chronic pharyngitis
Extracting solution or medicinal extract obtained from solvent extraction；The Extraction solvent is selected from water or alcohol, such as ethyl alcohol.
The present invention provides a kind of preparation methods of the pharmaceutical composition of above-mentioned treatment chronic pharyngitis, and each bulk pharmaceutical chemicals are distinguished
Or extracted together after mixing and obtain extract, acceptable preparation formulation in pharmacy is made after then mixing with auxiliary material.
A kind of preparation method of pharmaceutical composition that treating chronic pharyngitis comprising following steps: (1) Radix Astragali, female processed are taken
Loyal son, Rhizoma Atractylodis Macrocephalae, Poria cocos, Radix Curcumae, wartwort and Oroxylum indicum, add water to cook, and merge decoction liquor, filtration, and filtrate is concentrated, alcohol precipitation, standing,
Cream is received, extract powder is dried, crushed into；(2) take above-mentioned extract powder addition auxiliary material that acceptable preparation formulation in pharmacy is made.
The present invention provides a kind of methods of the pharmaceutical composition of specific treatment chronic pharyngitis comprising following steps:
1) Radix Astragali, the fruit of glossy privet processed, Rhizoma Atractylodis Macrocephalae (stir-fry), Poria cocos, Radix Curcumae, wartwort, Oroxylum indicum medicine materical crude slice are taken, adding envelope-bulk to weight ratio is 6-
10 times of amount water (ml/g, similarly hereinafter) decoct 1-3 times, each 1-2h, merge decoction liquor；
2) decoction liquor filters, and filtrate is concentrated into relative density 1.10-1.20；
3) alcohol content 50-70%, alcohol precipitation is stood, time of repose 12-48h
4) 50 DEG C -70 DEG C of precipitation solution when to be concentrated into relative density be 1.20-1.25, it is dry, obtain dry extract；
5) above-mentioned dry extract is crushed, is sieved, obtains into extract powder；
6) oral solution, capsule, tablet, granule, pill, micropill preparation, flexible glue is made in above-mentioned extract powder addition auxiliary material
Capsule, dripping pill, dispersible tablet, effervescent tablet, chewable tablets.
The pharmaceutical composition for the treatment of chronic pharyngitis of the invention can be applied in preparation treatment chronic pharyngitis drug.
The beneficial effect comprise that
1. the present invention is formed by 7 taste Chinese medicine compound prescriptions, including the Radix Astragali with qi invigorating functions, strengthen the body resistance to consolidate the constitution the effect of anti-inflammatory
The Poria cocos of the benefits of Rhizoma Atractylodis Macrocephalae (stir-fry) of the benefits of fruit of glossy privet, strengthening the spleen and replenishing qi, eliminate dampness and have diuretic effect, the Radix Curcumae of promoting qi circulation and relieving pain effect, clearing damp benefit water,
The Oroxylum indicum of removing heat from the lung and relieving sorethroat effect and the wartwort of inducing diuresis for removing edema, resolving sputum detoxicating functions.
2. current Chinese medicine is mostly decoction, recipe quantity is big, flavour of a drug are more, inconvenient for use, and the present invention only uses seven flavor medicine, drug effect
It learns experiments have shown that having the function of obvious yin-nourishing QI invigorating, fluid dryness.
3. preparation process is simple, flavour of a drug are few, save the cost, and drug of the present invention can be made into the agent such as granule, capsule, tablet
Type, patient are convenient to take.
4. the present invention is through the Pharmacological experiment result shows that having the function of yin-nourishing QI invigorating, fluid dryness, exploitation is chronic at treating
The new drug of pharyngitis, market capacity is big, and economic benefit and social benefit are obvious, has preferable application in terms for the treatment of chronic pharyngitis
Value.
Specific embodiment
Form by the following examples is described in further detail above content of the invention again, but should not be by this
The range for being interpreted as the above-mentioned theme of the present invention is only limitted to example below, and all technologies realized based on above content of the present invention are equal
Belong to the scope of the present invention.
Weight proportion listed by the following equal according to the form below of example weighs raw material needed for the present invention, unit: part
Chinese medicine of the present invention is Chinese Pharmacopoeia standard in addition to wartwort.
Example of formulations
Embodiment 1:
10 parts of Radix Astragali, 20 parts of the fruit of glossy privet processed, 6 parts of Rhizoma Atractylodis Macrocephalae (stir-fry), 18 parts of Poria cocos, 6 parts of Radix Curcumae, 8 parts of wartwort, 2 parts of Oroxylum indicum.
Add envelope-bulk to weight ratio to be 6-10 times and measure water, decocts 3 times, each 1-2h, merge decoction liquor；Decoction liquor filtration, filtrate are concentrated into phase
To density 1.10-1.20；Alcohol content 50-70%, alcohol precipitation is stood, time of repose 12-48h；At 50 DEG C -70 DEG C of precipitation solution
Being concentrated into relative density is 1.20-1.25, dry, obtains dry extract；Above-mentioned dry extract is crushed, is sieved, obtains into extract powder；It will be upper
Extract powder addition dextrin or lactose or starch or magnesium stearate and Steviosin are stated, is mixed, tablet is made in granulation, tabletting.
Embodiment 2:
15 parts of Radix Astragali, 15 parts of the fruit of glossy privet processed, 12 parts of Rhizoma Atractylodis Macrocephalae (stir-fry), 12 parts of Poria cocos, 12 parts of Radix Curcumae, 6 parts of wartwort, Oroxylum indicum 3
Part.Add envelope-bulk to weight ratio to be 6-10 times and measure water, decocts 3 times, each 1-2h, merge decoction liquor；Decoction liquor filtration, filtrate are concentrated into
Relative density 1.10-1.20；Alcohol content 50-70%, alcohol precipitation is stood, time of repose 12-48h；50 DEG C -70 DEG C of precipitation solution
When to be concentrated into relative density be 1.20-1.25, it is dry, obtain dry extract；Above-mentioned dry extract is crushed, is sieved, obtains into extract powder；It will
Above-mentioned extract powder addition dextrin or lactose or starch or microcrystalline cellulose and Steviosin, mix, granule is made in granulation.
Embodiment 3:
20 parts of Radix Astragali, 10 parts of the fruit of glossy privet processed, 18 parts of Rhizoma Atractylodis Macrocephalae (stir-fry), 6 parts of Poria cocos, 18 parts of Radix Curcumae, 4 parts of wartwort, Oroxylum indicum 6
Part.Add envelope-bulk to weight ratio to be 6-10 times and measure water, decocts 1-3 times, each 1-2h, merge decoction liquor；Decoction liquor filtration, filtrate concentration
To relative density 1.10-1.20；Alcohol content 50-70%, alcohol precipitation is stood, time of repose 12-48h；50 DEG C -70 of precipitation solution
DEG C when to be concentrated into relative density be 1.20-1.25, it is dry, obtain dry extract；Above-mentioned dry extract is crushed, is sieved, obtains into extract powder；
Above-mentioned extract powder is added into dextrin or lactose or starch and Steviosin, is mixed, granulation is distributed into capsule, that is, capsule is made.
Pharmacodynamics test
The drug of each dosage group specifically uses the preparation gained of embodiment 2 in embodiment 4-7.
Embodiment 4: the influence to mouse dimethylbenzene proinflammatory effect
(1) method: selecting weight 20g or so male ICR mouse, is randomly divided into 5 groups, Normal group, and positive group, low dose
Amount group (5.625/kg), middle dose group (11.25g/kg)；High dose group (22.5g/kg).The dimethylbenzene of 0.03ml is applied to often
The front and back two sides of the auris dextra exterior feature of mouse, left ear as control, cause it is scorching after 1h, animal is put to death under etherization, with 9mm diameter
Punch remove the auricle of left-right ear same area, weighing calculates swelling and inhibiting rate, swelling=auris dextra slice weight
Amount-left auricle weight；Inhibiting rate (%)=(blank control group ear swelling-administration group ear swelling)/blank control group ear is swollen
Expansibility × 100%.
(2) result
The influence that pharynx is rather formed mouse ear swelling slowly of watch 1
Note: compared with model group: P < 0.01 * P < 0.05, * *
(3) conclusion: this drug in 5.625g/kg (p < 0.05 *) can conspicuousness inhibit mouse ear swelling formation.It presses down
The inhibitory effect (p < 0.05 *) of the dexamethasone acetate of effect processed and 0.45mg/kg is suitable.
Embodiment: 5: the influence (hot plate method) to mouse analgesic activity
(1) method: selecting weight 20g or so male ICR mouse, is randomly divided into 5 groups, Normal group, and positive group, low dose
Amount group (5.625/kg), middle dose group (11.25g/kg)；High dose group (22.5g/kg).Successive administration 7 days, intraperitoneal injection Ah
It takes charge of a woods (0.15ml/10g), drug gastric infusion (1.5ml/100g) of the present invention.The 7th day administration after 15,30,45,
60min respectively surveys the pain sensation and reacts 1 time.In testing, analgesia reaction such as in 60 seconds, should take out, and immediately in terms of 60 seconds.Record pain
Thresholding, the performance of observation two mouse administration front and back, and carefully record observation result.
(2) result: invention formulation effect is evaluated using hot plate method, either invention formulation or positive drug
The pain domain of mouse, 30 minutes high dose groups after administration are not all significantly improved within 15 minutes after aspirin administration compared to the blank group
The pain domain of mouse can be improved with conspicuousness, analgesic effect is suitable with positive drug aspirin.The onset time of middle dose group is wanted
By 45 minutes, and high dose group analgesic activity at this time was then weakened, and aspirin still keeps significant analgesic effect.When
When administration time was by 60 minutes, only high dose group has significant analgesic activity.
(3) conclusion: invention formulation 11.25g/kg dosage administration after 45 minutes with conspicuousness analgesic activity (P* <
0.5) 30 minutes (P*** < 0.001) after, 22.5g/kg analgesic activity works and is administered, compared with the analgesic activity of aspirin,
The analgesic activity duration is long, still has conspicuousness analgesic activity (P* < 0.5) within 60 minutes after administration.
Embodiment 6: the influence to rat saliva secretion
(1) method: weight 180g-220g rat 48 is selected, is randomly divided into 6 groups, every group 8, be male.Stomach-filling is given
Medicine (1ml/100g), once a day, successive administration 6d, 12h fasting, can't help water, in 30min after the last administration, stomach-filling before testing
Atropine (0.16mg/kg) is given, after giving atropine 20min, is injected intraperitoneally chloraldurate (10%, 0.35mL/100g), and
Start the salivary secretion amount of measurement rat.Method: rat is fixed, with haemostatic clamp by dry cotton ball (50 ± 5) mg of similar weight
It puts that National People's Congress mouse is sublingual, measures the salivary secretion amount of rat, the every 30min of every cotton balls is replaced 1 time, and METHOD FOR CONTINUOUS DETERMINATION 120min passes through
The weight difference for weighing front and back dry cotton ball calculates maximum salivary secretion amount.
(2) result: drug 15g/kg can conspicuousness promote rat dry model salivary secretion (P < 0.05 *), work as agent
It is that it promotes salivary secretion effect to increase (P < 0.01 * *) that amount, which reaches 30g/kg,.
The influence (x ± sd, n=8) that table 2 secretes rat saliva
(3) conclusion: invention formulation promotes the model salivary secretion of rat dry in the equal conspicuousness of 15g/kg, 30g/kg,
Facilitation is slightly below the facilitation of positive drug atropine.
Embodiment 7: the influence to the phenol red excretion of mouse salivary
(1) method: selecting weight 20g or so male ICR mouse, be randomly divided into 5 groups, respectively blank control group, positive
(Mucosolvin) group, low dose group (3.75g/kg), middle dose group (7.5g/kg)；High dose group (15g/kg), every group 10.It fills
Stomach administration, once a day, administered volume 20mL/kg, successive administration 8d, 30min, intraperitoneal injection 2.5% are phenol red after the last administration
Normal saline solution 0.1ml/10g.Put to death animal after injection 30min, fixed mouse body separates tracheae, trachea cannula and with injection
Device is connected, and with 5%NaHCO3 1mL, is slowly injected into intratracheally, is then gently sucked out, 3 times repeatedly, merges 3 irrigating solutions
Placing certain time makes contamination precipitation, obtained transparent red supernatant, with spectrophotometer wavelength 545nm colorimetric, according to phenol
Red standard curve calculates phenol red amount.
(2) result:
Table 3 to the phenol red excretion of mouse influence (N=10)
Note: compared with the control group,*P<0.05；***P<0.01。
(3) conclusion: invention formulation can the phenol red excretion (* of conspicuousness promotion mouse since 11.25g/kg dosage
P < 0.05), the promotion excretion of high dose is more significant (P < 0.01 * * *), lets out with the decorporation of positive drug Mucosolvin 18.2mg/kg
Efficiency is suitable.
Claims (9)
1. a kind of pharmaceutical composition for treating chronic pharyngitis, it is characterised in that its active constituent by following parts by weight bulk pharmaceutical chemicals
It is made: 12-18 parts of Radix Astragali, fruit of glossy privet 12-18 parts processed, 8-16 parts of Rhizoma Atractylodis Macrocephalae, 8-16 parts of Poria cocos, 8-16 parts of Radix Curcumae, 5-7 parts of wartwort,
2-4 parts of Oroxylum indicum.
2. it is according to claim 1 treatment chronic pharyngitis pharmaceutical composition, it is characterised in that its active constituent by with
The bulk pharmaceutical chemicals of lower parts by weight are made: 15 parts of Radix Astragali, 15 parts of the fruit of glossy privet processed, and 12 parts of Rhizoma Atractylodis Macrocephalae, 12 parts of Poria cocos, 12 parts of Radix Curcumae, wartwort 6
Part, 3 parts of Oroxylum indicum.
3. the pharmaceutical composition for the treatment of chronic pharyngitis according to claim 1, it is characterised in that the raw material in the composition
Medicine is extracted rear or oral preparation, injection or external preparation directly is made with pharmaceutically acceptable auxiliary material.
4. the pharmaceutical composition for the treatment of chronic pharyngitis according to claim 3, it is characterised in that the raw material in the composition
Medicine is extracted rear or oral solution, capsule, tablet, granule or pill directly is made with pharmaceutically acceptable auxiliary material.
5. the pharmaceutical composition for the treatment of chronic pharyngitis according to claim 3, it is characterised in that described pharmaceutically acceptable
Auxiliary material include dextrin, lactose, starch, sucrose, glucose, microcrystalline cellulose, magnesium stearate, mannose, methylcellulose,
The one or more of hydroxypropyl cellulose, carboxymethyl cellulose, glycerol and Steviosin.
6. a kind of drug extract for treating chronic pharyngitis, it is characterised in that it is pharmaceutical composition described in claim 1 warp
Cross extracting solution or medicinal extract obtained from Extraction solvent extracts；The Extraction solvent is selected from water or alcohol.
7. treating the preparation method of the pharmaceutical composition of chronic pharyngitis described in a kind of claim 1, it is characterised in that by each raw material
Extraction obtains extract to medicine together respectively or after mixing, and acceptable preparation agent in pharmacy is made after then mixing with auxiliary material
Type.
8. the preparation method of the pharmaceutical composition for the treatment of chronic pharyngitis according to claim 7, it is characterised in that it includes
Following steps:
(1) Radix Astragali, the fruit of glossy privet processed, Rhizoma Atractylodis Macrocephalae, Poria cocos, Radix Curcumae, wartwort and Oroxylum indicum are taken, is added water to cook, decoction liquor is merged, is filtered,
Filtrate concentration, alcohol precipitation, receive cream at standing, are dried, crushed into extract powder；
(2) take above-mentioned extract powder addition auxiliary material that acceptable preparation formulation in pharmacy is made.
9. application of the pharmaceutical composition for the treatment of chronic pharyngitis described in claim 1 in preparation treatment chronic pharyngitis drug.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1513508A (en) * | 2003-06-03 | 2004-07-21 | 金陵药业股份有限公司技术中心 | Medicine composition for treating uppe respiration channel infetion and its preparing process |
| CN103933398A (en) * | 2014-04-22 | 2014-07-23 | 湖州康企药业有限公司 | Traditional Chinese medicine compositionfor treating chronic pharyngitis |
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2016
- 2016-04-29 CN CN201610286872.8A patent/CN105853917B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1513508A (en) * | 2003-06-03 | 2004-07-21 | 金陵药业股份有限公司技术中心 | Medicine composition for treating uppe respiration channel infetion and its preparing process |
| CN103933398A (en) * | 2014-04-22 | 2014-07-23 | 湖州康企药业有限公司 | Traditional Chinese medicine compositionfor treating chronic pharyngitis |
Non-Patent Citations (2)
| Title |
|---|
| 慢性咽炎证治的现代文献研究;范秀东;《中国优秀硕士论文全文数据库医药卫生科技辑》;20120115;第2012年卷(第1期);第7-8、13-16页 |
| 论慢喉痹;陈国丰;《中华中医药学会耳鼻咽喉科分会第十二次学术研讨会暨嗓音言语听力医学专题学术研讨会论文集 》;20050801;226-236 |
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