CN106729672A - A kind of composition for treating upper respiratory tract mucositis and its application - Google Patents

Abstract

The present invention relates to the composition with treatment upper respiratory tract mucositis and its application.The composition is made up of mussel soft tissue extract and bromelain, can optionally include other carriers.The present composition can form uniform diaphragm on respiratory mucosa, and sensibiligen is come with mucous membrane isolation, play reduction outside stimulus, reduce moisture evaporation, keep the protective effect of mucous membrane moistening；Simultaneously as the molecular weight of the protein ingredient contained in mussel soft tissue extract is big, will not transdermal or percutaneous absorbtion, can lasting stability played a role in disease sites, the protection of long period is realized to respiratory mucosa, play a part of long-acting treatment.The composition for the treatment of upper respiratory tract mucositis prepared by the present invention works rapidly, and short treating period, cure rate are high, and without any side effects, do not produce dependence.

Description

A kind of composition for treating upper respiratory tract mucositis and its application

Technical field

The present invention relates to biomedicine field, more particularly, to a kind of composition for treating upper respiratory tract mucositis and Its application.

Background technology

Respiratory inflammation, is mainly shown as because of lesions such as mucous membrane hyperemia, oedema, the ulcer that allergy causes, therefore also referred to as For respiratory mucosa is scorching.The concrete position being inflamed by mucous membrane is referred to as again：Rhinitis, pharyngitis, nasosinusitis, tracheae, branch gas Guan Yan etc..The upper respiratory tract of people typically refers to nose, pharynx, throat position, and its surface is covered with mucosal epithelium layer, and this layer of false cladding is fine Hair columnar epithelial cell ceaselessly swings, the barrier action with machinery.This layer of mucous layer is very tender and lovely, may be because of extremely Small paathogenic factor and be inflamed, and be difficult to cure.The cardinal symptom of inflammation of upper respiratory tract have drying, runny nose, blocking, Pain, sneeze, cough, asthma etc., death can be caused when serious because of expiratory dyspnea.It is generally acknowledged that upper respiratory tract mucous membrane Inflammation has two Fundamentals：One is that susceptible person's respiratory mucosa capacity of self-regulation is weak；Two is that external environment condition is present Anaphylactogen, after susceptible person is subject to the stimulation of anaphylactogen, respiratory tract physiology environment is unbalance, will cause that mucous membrane occurs abnormal anti- Answer, i.e. anaphylaxis mucosal inflammation.

Mussel (Mytilusedulis Linnaeus) is a kind of sea mollusk, belongs to bivalve shellfish, is commonly called as " blue or green Mouthful " and " mussel ", each coastwise contries of throughout world.Mussel species are various, and only coastal area of china just has kind more than 30, and economic worth is higher Have kind more than 10, wherein Mytilus galloprovincialis, Perna viridis and Trachyostracous mussel is main breed variety.Enriched Mussel containing protein, fat, The nutrients such as carbohydrate, calcium, phosphorus, iron, riboflavin, niacin, and with medical value very high.

Bromelain (Bromelain, also known as full name bromelain, bromelin or Bromelain) is from pineapple (Ananascomosus) stem end, leaf, skin are extracted, through obtained from refined, purification, concentration, enzyme immobilization, freeze-drying A kind of natural plant enzyme.Its outward appearance is light gray powder, and molecular weight is 33000, and isoelectric point is 9.55.Performance optimal Bromelain be to be processed using the middle stem of pineapple, filtering and concentrating is carried out using hyperfiltration process, obtained by frozen drying. Product has been widely used in the industries such as food, medicine.Following aspect is mainly used in pharmaceuticals industry：1st, tumour cell is suppressed Growth：Show that bromelain can suppress the growth of tumour cell through relevant clinical research observation；2nd, to angiocardiopathy Preventing and treating：Preventing and treating of the bromelain as proteolytic enzyme to angiocardiopathy is beneficial, and it can suppress platelet aggregation and draw The heart attack for rising and apoplexy, allevating angina pectoris symptom relax arterial contraction, the decomposition of accelerating fibers proteinogen；3rd, it is used for Decrustation after burn：Bromelain can be allowanced for bark optionally, new skin grafting dermepenthesis is carried out as early as possible, and correlative study is proved, pineapple egg White enzyme has no adverse effects to neighbouring normal skin.Part does not influence the effect of bromelain using antibiotic；4th, anti-inflammatory is made With：Bromelain can effectively treat inflammation and oedema (including thrombophlebitis, Skeletal muscle injury, blood in various tissues Swollen, stomatitis, diabetes patient's ulcer and injury gained in sports), bromelain has the potentiality of activation inflammatory reaction, bromelain Diarrhoea can also be treated；5th, drug absorption is promoted：By bromelain and various antibiotic (such as tetracycline, Amoxicillin etc.) connection With its curative effect can be improved.Correlative study shows that it can promote antibiotic in the transmission of infection site, so as to reduce antibiotic Dosage.It was deduced that for cancer therapy drug, also playing the role of similar.Additionally, bromelain can promote the suction of nutriment Receive.

At present, because modern medicine mainly has following several to the Prevention Technique means of upper respiratory tract mucositis, while depositing In many deficiencies：First, anti-inflammatory treatment：Antihistamine, hormone (ephedrine) etc., the method can only a period of time relief of symptoms, and have Certain side effect；2nd, physics and surgical operation therapy：Being only limitted to allergic rhinitis, pharyngitis to the upper respiratory tract etc. is carried out, and is had Laser, flatiron, plasma etc. method, these surgical methods have wound to human body, and prognosis is not good；3rd, smoke and smell and spray Agent is treated.Aerosol is smoked to be smelt or aqua, pulvis is administered by nasal cavity or throat, and drug absorption is fast, but the continuous action time compared with It is short；4th, desensitization treatment：3 kinds of prophylactic treatment means relatively above, desensitization therapy enters from the angle for improving immunity of human body itself Hand, from medical science cognition from the perspective of be most energetically, but due to this method only to the original effect of single sensitization, and treatment cost With height, the cycle is long, and actual therapeutic effect is simultaneously imprecise, and the patient's enforcement difficulty to various sensibiligen allergy is very big.In addition with Isolation anaphylactogen, supplement beneficial bacterium, replenishing vitamins and physical therapy etc. method, because its means is excessively indirect, effect is equal It is difficult such as people's will.

The content of the invention

For solve the treatment existing for existing upper respiratory tract mucositis treatment product not thoroughly, easily repeatedly, side effect it is strong, easily The defects such as the resistance to the action of a drug or DeGrain are formed, the present invention proposes a kind of composition for treating upper respiratory tract mucositis.

To achieve the above object, one aspect of the present invention is related to a kind of composition, including mussel soft tissue extract and Bromelain.

One or more implementation methods of the invention, the composition can be by weight：Mussel soft tissue is carried Take thing 0.1-20 parts, and bromelain 0.2-10 parts.

One or more implementation methods of the invention, based on the weight of composition, mussel soft tissue extract can be with Such as 0.1 part, 0.15 part, 0.2 part, 0.25 part, 0.3 part, 0.35 part, 0.4 part, 0.45 part, 0.5 part, 0.55 part, 0.6 part, 0.65 part, 0.7 part, 0.75 part, 0.8 part, 0.85 part, 0.9 part, 0.95 part, 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 Part, 4.5 parts, 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts etc., and bromelain Can be such as 0.2 part, 0.25 part, 0.3 part, 0.35 part, 0.4 part, 0.45 part, 0.5 part, 0.55 part, 0.6 part, 0.65 part, 0.7 part, 0.75 part, 0.8 part, 0.85 part, 0.9 part, 0.95 part, 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 Part, 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts etc..

One or more implementation methods of the invention, in the composition：Mussel soft tissue extract and bromelain Presence can be individually insulated or can be mixed.Here, " isolation is present " refers to two kinds of compositions to keep the mutual of respective property The independent packaging do not disturbed is present." being mixed " refers to that two kinds of compositions are mixed in a packaging.

One or more implementation methods of the invention, in the composition：Mussel soft tissue extract and bromelain Can be dry powder.

One or more implementation methods of the invention, in the composition：Mussel soft tissue extract and bromelain Can be liquid.

One or more implementation methods of the invention, the composition is formulated as the final ph after liquid for 2.5- 9.0, for example, it is preferable to pH value is 4.5-8.0, or, such as preferable ph is 5.5-7.0.

One or more implementation methods of the invention, the mussel soft tissue extract be with mussel in addition to shell All components be raw material, by acidic aqueous solution extract and obtain supernatant, wherein protein content be 0.2-15mg/ Ml, pH value 1.0-6.0.Especially, can be with byssus as raw material.

One or more aspects of the invention, the mussel includes in Mytilus galloprovincialis, Perna viridis, Trachyostracous mussel Kind, two or three.

One or more implementation methods of the invention, the acidic aqueous solution can include：Acetic acid-acetate buffer Liquid, acetic acid, citric acid, perchloric acid etc., but not limited to this.

One or more implementation methods of the invention, the protein content of the mussel soft tissue extract can be Such as 0.2mg/ml, 0.3mg/ml, 0.4mg/ml, 0.5mg/ml, 0.6mg/ml, 0.7mg/ml, 0.8mg/ml, 0.9mg/ml, 1.0mg/ml、1.5mg/ml、2.0mg/ml、2.5mg/ml、3.0mg/ml、3.5mg/ml、4.0mg/ml、4.5mg/ml、 5.0mg/ml、5.5mg/ml、6.0mg/ml、6.5mg/ml、7.0mg/ml、7.5mg/ml、8.0mg/ml、8.5mg/ml、 9.0mg/ml、9.5mg/ml、10.0mg/ml、10.5mg/ml、11.0mg/ml、11.5mg/ml、12.0mg/ml、12.5mg/ Ml, 13.0mg/ml, 13.5mg/ml, 14.0mg/ml, 14.5mg/ml and 15.0mg/ml etc., but not limited to this.

One or more implementation methods of the invention, the bromelain can be conventional purchase from the market.Replace Dai Di, the bromelain can be prepared by methods such as column chromatographies.

Another aspect of the present invention is related to a kind of pharmaceutical composition for treating upper respiratory tract mucositis, it is characterised in that institute Stating pharmaceutical composition includes mussel soft tissue extract of the invention and bromelain.

One or more implementation method of the invention, described pharmaceutical composition can also include pharmaceutically acceptable Carrier.

One or more implementation method of the invention, described pharmaceutical composition can be drops.

One or more implementation methods of the invention, described pharmaceutical composition can be spray.

One or more implementation methods of the invention, described pharmaceutical composition can be tablet.

One or more implementation methods of the invention, the carrier can include any and all of solvent, salt, Decentralized medium, coating material, surfactant, antioxidant, preservative (such as antiseptic, antifungal agent), isotonic agent, absorption Delayed-action activator, drug stabilizing agent, adhesive, excipient, disintegrant, lubricant, sweetener, flavouring, dyestuff etc. and they in one Kind, various or whole combinations, this is well-known to those skilled in the art (for example, see Remington's Pharmaceutical Sciences,18th Ed.Mack Printing Company,1990,pp.1289-1329).Except Outside the carrier incompatible with active component, it is contemplated that any conventional carrier used in treatment use or pharmaceutical composition.

A further object of the present invention is related to the composition of the invention described above or pharmaceutical composition to be sticked in the treatment upper respiratory tract Application in film inflammation.

One or more implementation methods of the invention, the upper respiratory tract mucositis can include pharyngitis, laryngitis and Allergic rhinitis.A further object of the present invention be related to it is a kind of treat the method for upper respiratory tract mucositis, including give the present invention Composition or pharmaceutical composition.

One or more implementation methods of the invention, combination of the invention is given to subject in need Thing, the composition includes mussel soft tissue extract and bromelain or is made from it.

One or more implementation methods of the invention, the mussel soft tissue extract and bromelain can be mixing It is present in composition.

One or more implementation methods of the invention, the mussel soft tissue extract and bromelain can be difference Isolation is present in composition.Here, when by mussel soft tissue extract and bromelain combination medicine-feeding, administration can be order It is administered or is administered simultaneously, preferably can is order of administration.For order of administration, can by mussel soft tissue extract and Bromelain is administered in any order.For example, can first give mussel soft tissue extract gives bromelain again, with this sequence alternate It is administered and continues whole treatment, or can first give bromelain and give mussel soft tissue extract again, is administered with this sequence alternate Continue whole treatment, or can be administered with different order in every day for the treatment of.

Composition proposed by the present invention is physical action and the mussel for having adhesion characteristics using mussel soft tissue extract The bioactivity of soft tissue extract and bromelain is combined, for the preventing and treating of upper respiratory tract mucositis.Present composition energy It is enough that uniform diaphragm is formed on respiratory mucosa, sensibiligen is come with mucous membrane isolation, reduction outside stimulus are played, reduce Moisture evaporation, keeps the protective effect of mucous membrane moistening；Simultaneously as the protein ingredient contained in mussel soft tissue extract point Son amount is big, will not transdermal or percutaneous absorbtion, can lasting stability played a role in disease sites, when realizing more long to respiratory mucosa Between protection, play a part of long-acting treatment.Active component contained by the present composition is formed in upper respiratory tract mucous membrane surface It is evenly distributed in film, realizes the continued administration to the respiratory mucosa long period；Active component has antihistamine, antiallergy, suppression Microorganism processed, healing scar, anti-oxidant etc. multiple efficacies, can from multiple angles promote mucous membrane produce the various sensitization of resistance because The ability of son；Active component can also improve mucus quality, increase mucus discharge, and excited mucociliary has in promotion respiratory tract Evil material discharge, is conducive to the reparation of respiratory mucosa.

The composition of the treatment upper respiratory tract mucositis for preparing of the invention works rapidly, and short treating period, cure rate are high, and nothing is appointed What toxic and side effect, does not produce dependence.

Specific embodiment

Following examples are illustrated as a example by treating the composition of upper respiratory tract mucositis, but not limited to this, above-mentioned Invent the various upper respiratory tract mucositis treatment products comprising mussel soft tissue extract and bromelain for proposing and be applied to this Invention.

Embodiment 1：The preparation method of mussel soft tissue extract.

Take mussel to shell, collect soft tissue 300g, be divided into three parts, in every part of table 1 below of addition 100ml contents 0.3% Acid solution, centrifugation obtains supernatant as mussel soft tissue extract after homogenate 10min.

Protein content and pH value in supernatant are determined, protein content is determined using Coomassie Brilliant Blue.

Table 1

Example	Acid solution	Protein content	PH value
				1	Citric acid	2.6mg/ml	4.5
2	Acetic acid	3.5mg/ml	3.2
				3	Perchloric acid	3.0mg/ml	1.0

Embodiment 2：The spray of the treatment sphagitis of bromelain and mussel soft tissue extract combination.

Collect 13 sphagitis volunteers and participate in test, subject has pharyngeal drying using preceding, and scorching hot, pain is swallowed Pain is obvious, congestion of throat swelling etc. symptom.

From Shanghai is good bromelain is bought with biotechnology company.Bromelain dry powder 100mg is taken, with soft group of the mussel of example 1 Extract dry powder 200mg mixing is knitted, 100ml deionized water dissolvings are used, spray is made.Spray three times daily, after 7 days, pay a return visit And record effect.

Efficacy assessment standard

Recovery from illness：The symptoms such as abscess of throat disappear, and throat inspection recovers normal.

It is effective：The symptoms such as abscess of throat substantially mitigate, and throat inspection is returned to normal.

Effectively：The symptom mitigations such as abscess of throat, throat inspection has taken a turn for the better.

It is invalid：Symptom is without being clearly better.

Total effective rate fully recovering+it is effective in terms of.

Curative effect is shown in Table 2.

Table 2:Experiment curative effect

Recovery from illness	It is effective	Take a turn for the better	It is invalid	It is total	Efficient (%)
						5	6	2	0	13	84.62

Using after the spray that mussel soft tissue extract and pineapple enzymatic compositions are made, sphagitis situation has clear improvement, Prove that mussel soft tissue extract and pineapple enzymatic compositions have the function for the treatment of sphagitis.

Embodiment 3：Bromelain treats the drops of allergic rhinitis with mussel soft tissue extractive composition.

From Shanghai is good bromelain is bought with biotechnology company.Bromelain dry powder 1000mg is taken, with soft group of the mussel of example 1 Extractive composition dry powder 500mg is knitted, appropriate vegetable oil is made drops.

Collect 28 allergic rhinitis volunteers and participate in test, subject nasal obstruction occurs using preceding, and runny nose is dizzy, smells Feel the symptoms such as decline.Volunteer is divided into 2 groups, and control group uses commercially available Clarityne drops, and experimental group is prepared using the present embodiment Drops, drop 2-3 drops, daily drop 3 times, after 7 days, pay a return visit and record effect every time.

Efficacy assessment standard

Cure：Allergic rhinitis symptoms disappear, and body surface recovers normal；

It is effective：Allergic rhinitis symptoms substantially mitigate, and body surface is returned to normal；

Effectively：Allergic rhinitis symptoms gradually mitigate；

It is invalid：Allergic rhinitis symptoms are without improvement.Total effective rate fully recovering+it is effective in terms of.

Curative effect is shown in Table 3.

Table 3:Experiment curative effect

	Recovery from illness	It is effective	Take a turn for the better	It is invalid	It is total	Efficient (%)
							Experimental group	5	7	2	0	14	85.71
Control group	3	7	3	1	14	71.43

After control can be seen that the drops being made using mussel soft tissue extract and pineapple enzymatic compositions, allergy Property rhinitis situation have clear improvement, it was demonstrated that mussel soft tissue extract and pineapple enzymatic compositions have the work(for the treatment of allergic rhinitis Energy.

Embodiment 4：The tablet of the treatment sphagitis of bromelain and mussel soft tissue extract combination.

Collect 17 sphagitis volunteers and participate in test, subject has pharyngeal drying using preceding, and scorching hot, pain is swallowed Pain is obvious, congestion of throat swelling etc. symptom.

From Shanghai is good bromelain is bought with biotechnology company.Bromelain dry powder 100mg is taken, with soft group of the mussel of example 1 Extract dry powder 200mg mixing is knitted, sodium acid carbonate 5g, lactic acid 5g is added, tablet is pressed into after granulation.Respectively take one sooner or later daily Piece, after 7 days, pays a return visit and record effect.

Efficacy assessment standard

Recovery from illness：The symptoms such as abscess of throat disappear, and throat inspection recovers normal.

It is effective：The symptoms such as abscess of throat substantially mitigate, and throat inspection is returned to normal.

Effectively：The symptom mitigations such as abscess of throat, throat inspection has taken a turn for the better.

It is invalid：Symptom is without being clearly better.

Total effective rate fully recovering+it is effective in terms of.

Curative effect is shown in Table 4.

Table 4:Experiment curative effect

Recovery from illness	It is effective	Take a turn for the better	It is invalid	It is total	Efficient (%)
						7	8	2	0	17	88.24

Using after the tablet that mussel soft tissue extract and pineapple enzymatic compositions are made, sphagitis situation has clear improvement, Prove that mussel soft tissue extract and pineapple enzymatic compositions have the function for the treatment of sphagitis.

Certainly, the present invention can also have other various embodiments, ripe in the case of without departing substantially from spirit of the invention and its essence Knowing those skilled in the art can make various corresponding changes and deformation, but these corresponding changes and deformation according to the present invention The protection domain of the claims in the present invention should all be belonged to.

Claims (9)

1. a kind of composition for treating upper respiratory tract mucositis, it is characterised in that the composition includes that mussel soft tissue is extracted Thing and bromelain.

2. it is according to claim 1 treatment upper respiratory tract mucositis composition, it is characterised in that the composition is by weight Including：0.1-20 parts of mussel soft tissue extract, bromelain 0.2-10 parts, such as based on the weight of composition, mussel soft tissue Extract is, for example, 0.1 part, 0.15 part, 0.2 part, 0.25 part, 0.3 part, 0.35 part, 0.4 part, 0.45 part, 0.5 part, 0.55 part, 0.6 part, 0.65 part, 0.7 part, 0.75 part, 0.8 part, 0.85 part, 0.9 part, 0.95 part, 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts, and spinach Trailing plants enzyme is, for example, 0.2 part, 0.25 part, 0.3 part, 0.35 part, 0.4 part, 0.45 part, 0.5 part, 0.55 part, 0.6 part, 0.65 part, 0.7 part, 0.75 part, 0.8 part, 0.85 part, 0.9 part, 0.95 part, 1 part, 1.5 parts, 2 parts, 2.5 parts, 3 parts, 3.5 parts, 4 parts, 4.5 Part, 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts.

3. according to the composition for treating upper respiratory tract mucositis of foregoing any claim, wherein in the composition：Mussel Soft tissue extract is individually insulated presence or is mixed with bromelain；And/or in wherein described composition：Mussel soft tissue is carried It is dry powder or liquid that thing is taken with bromelain.

4. according to the composition for treating upper respiratory tract mucositis of foregoing any claim, wherein the composition is formulated as liquid Final ph after body is 2.5-9.0, for example, it is preferable to pH value is 4.5-8.0, for example, it is preferable to pH value is 5.5-7.0；And/or its Described in mussel soft tissue extract be the supernatant for being extracted by acidic aqueous solution and being obtained, wherein egg with mussel as raw material White matter content is 0.2-15mg/ml, pH value 1.0-6.0.

5. according to the composition for treating upper respiratory tract mucositis of foregoing any claim, wherein the mussel is made a gift of including purple One kind in shellfish, Perna viridis, Trachyostracous mussel, two or three, and/or wherein described acidic aqueous solution includes：Acetic acid-acetic acid Sodium buffer solution, acetic acid, citric acid, perchloric acid, or the protein content of wherein described mussel soft tissue extract is, for example, 0.2mg/ml、0.3mg/ml、0.4mg/ml、0.5mg/ml、0.6mg/ml、0.7mg/ml、0.8mg/ml、0.9mg/ml、 1.0mg/ml、1.5mg/ml、2.0mg/ml、2.5mg/ml、3.0mg/ml、3.5mg/ml、4.0mg/ml、4.5mg/ml、 5.0mg/ml、5.5mg/ml、6.0mg/ml、6.5mg/ml、7.0mg/ml、7.5mg/ml、8.0mg/ml、8.5mg/ml、 9.0mg/ml、9.5mg/ml、10.0mg/ml、10.5mg/ml、11.0mg/ml、11.5mg/ml、12.0mg/ml、12.5mg/ Ml, 13.0mg/ml, 13.5mg/ml, 14.0mg/ml, 14.5mg/ml and 15.0mg/ml.

6. according to the composition for treating upper respiratory tract mucositis of foregoing any claim, wherein the upper respiratory tract mucositis Including pharyngitis, laryngitis and allergic rhinitis.

7. a kind of pharmaceutical composition, it is characterised in that described pharmaceutical composition is the composition according to foregoing any claim, Or including the composition according to foregoing any claim, described pharmaceutical composition is the medicine for treating upper respiratory tract mucositis Composition, described pharmaceutical composition includes mussel soft tissue extract and bromelain or is made from it.

8. pharmaceutical composition according to claim 7, wherein described pharmaceutical composition also include pharmaceutically acceptable carrier.

9., according to the pharmaceutical composition of claim 7 or 8, wherein described pharmaceutical composition is spray, drops or tablet.