CN1830471A - Application of medicinal composition containing epimedium and morinda root in preparation of medicine for treating and preventing rhinallergosis - Google Patents
Application of medicinal composition containing epimedium and morinda root in preparation of medicine for treating and preventing rhinallergosis Download PDFInfo
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- CN1830471A CN1830471A CN 200510033464 CN200510033464A CN1830471A CN 1830471 A CN1830471 A CN 1830471A CN 200510033464 CN200510033464 CN 200510033464 CN 200510033464 A CN200510033464 A CN 200510033464A CN 1830471 A CN1830471 A CN 1830471A
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Abstract
An application of the medicinal composition containing epimedium and Radix morindae officinalis in preparing the medicine for preventing and treating the strain rhinitis and/or upper respiratory tract infection by applying it via nasal mucosa is disclosed.
Description
Technical field
The present invention relates to a kind of novel medical use that contains the Pharmaceutical composition of Herba Epimedii and Radix Morindae Officinalis, specifically, the present invention relates to a kind of application of Pharmaceutical composition in preparation treatment and prevention of allergic rhinitis medicine that contains Herba Epimedii and Radix Morindae Officinalis.
Background technology
Asthma and rhinitis all are the inflammatory diseasess of air flue, but both pathogenesis, Clinical symptoms and Therapeutic Method all have to a certain degree different.Though nasal cavity all has the infiltration of (comprising eosinophilic granulocyte, mastocyte and T lymphocyte) of identical inflammatory cell with the bronchial mucosa inflammation, because the difference of both anatomical structures, thereby the mechanism that generation is blocked is also different.The obstruction of nasal cavity mainly causes owing to the congestion of blood vessel in the rhinitis, and the reversibility of air flue obstruction is that main contraction by airway smooth muscle causes in the asthma.Air flue mucosa inflammatory can cause thickening and the airway smooth muscle hypertrophy of netted basement membrane under the coming off of airway epithelia cell, the epithelium in the asthma.And in perennial rhinitis, do not have epithelial coming off usually.
The treatment rhinitis can be improved the symptom of asthma.Adopt anti-inflammatory agent glucocorticoid, cromoglicic acid class medicine, leukotrienes regulator and anticholinergic agent all effective to treatment rhinitis and asthma.But still have some difference on these two kinds of treatment of diseases: for example, the α receptor stimulating agent is only effective to the treatment rhinitis, and the beta receptor agonist is then only effective to treating asthma, and H
1Receptor antagonist is more effective than asthma to the treatment rhinitis.
(allergic rhinitis is the nasal mucosa allergy that allergen causes AR) to allergic rhinitis, is mediated by IgE.Its cardinal symptom has sneeze, watery nasal discharge, nasal congestion, rhinocnesmus, and follows allergic conjunctivitis, and symptom can be seasonal or long-term property.Now, the main medicine of two classes of treatment allergic rhinitis is oral H
1Antihistaminic and nasal cavity topical application glucocorticoid.These medicines can be separately or drug combination, and this depends on patient's cardinal symptom and to the reaction of treatment.Histamine is a kind of inflammatory mediator found the earliest that increases allergic rhinitis, rhinorrhea and pruritus.So antihistaminic is used for the treatment of allergic rhinitis very early.But the effect of treatment allergic rhinitis can not be lasting.
Leukotriene is allergic important medium, not only participates in airway inflammation reaction up and down, and may be to promote the excretory main medium of mucous gland.Anti-leukotriene medicine is the various biological agents of blocking-up leukotriene, and the performance antiinflammatory action.Anti-leukotriene medicine mainly contains two classes: the one, and CysLT
1The R blocking agent comprises zafirlukast (Zafirlusast) and Menglusitena (Montelukast).The one, 5-lipoxygenase depressant has agent to stay logical (Zileuton).Compare from effectiveness and safety: CysLT
1The R blocking agent is better, is anti-leukotriene medicine commonly used at present.Studies show that anti-leukotriene medicine---CysLT
1The R blocking agent can not prevention of allergic rhinitis patient antigen be attacked rhinitis symptoms such as the sneeze that causes, watery nasal discharge, nasal congestion, rhinocnesmus, does not also have antihistaminic good aspect the nasal congestion improving in addition.CysLT
1The curative effect of R blocking agent aspect the treatment allergic rhinitis is good at the therapeutic effect aspect the allergic asthma not as good as it.
The nasal cavity inhaled glucocorticoid is the first-line treatment medicine of severe allergic rhinitis.Glucocorticoid has very strong antiinflammatory anti-allergic effects, and therefore, it can improve nasal congestion (the topmost symptom of chronic allergic rhinitis) alleviation watery nasal discharge, sneeze, rhinocnesmus.But the glucocorticoids medicine can suppress upgrowth and development of children, and therefore, the child should reduce the dose of this class medicine as far as possible, and measures height routinely.The adult, the systemic adverse reactions of nasal cavity inhaled glucocorticoid is lighter.But can cause epistaxis, rhinalgia during the use of this type of medicine, can cause perforate membrane under the rare occasion.
Immunotherapy is mainly used in the allergy due to the treatment suction allergen, is applicable to the serious allergic rhinitis that Drug therapy is invalid.But immunotherapy has certain hidden danger aspect safety.Office's treatment redness that diameter surpasses 5cm can take place in allergen injection once in a while.General reaction comprises erythema, pruritus, blood pressure reduction etc., takes place in allergen injection back 30min.Death toll in Britain committee on Safety of Medicines in 1986 report, pro-30 years due to the immunization therapy is 26 people, and main causes of death are that in time urgent the rescue takes place not do when irritated.
Nasal cavity topical application sodium cromoglicate has confirmed to alleviate some allergic rhinitis patients' symptom.It suppresses the mastocyte release medium, thereby stops allergic generation.Therefore, before it was applied to the symptom appearance as prophylactic, sodium cromoglicate had drop and spray, can select to use.
Local use decongestant drug is the collapsible blood vessel of a class, alleviates the preparation of congestive state, and it causes that by activation concha nasalis vascular smooth muscle, adrenoreceptor concha nasalis shrinks, and improves the nasal obstruction symptom, but can only play the effect of relief of symptoms.
SCH 1000 (Ipratropine) 0.06% or 0.03% nasal spray (spraying nose every day 2 times to 3 times) have better effect to relief allergic rhinitis patient rhinorrhea, but invalid to nasal obstruction, sneeze symptom, its untoward reaction mainly contains the puckery and epistaxis of dryness in the nasal cavity.
Anti symptom treatment is adopted in the treatment of western medicine more, can control clinical symptoms preferably, but shortcoming is easy recurrence, and long-term prescription has certain side effect.
Allergic rhinitis belong to categories such as " allergic rhinitis " in motherland's medical science, " allergic rhinitis with sneezing ", " water of having a stuffy nose "." interior warp " has: the record of " kidney is for owing, for sneezing ", and " element asks YIN YANG classification of natural phenomena a big opinion piece of writing " cloud: " extreme exhaustion of QI, dysfunction of the nine orifices, deficiency in the lower and excess in the upper, running nose and shedding tears simultaneously." it belongs to substantially and empty belongs to coldly, from the determining the pathogenesis of ZANG-FU disease based on the differentiation of symptoms and signs person, belongs to kidney, weakness that mostly is kidney yang, kidney qi is not enough, belongs to spleen, mostly is the spleen sun, temper lose empty deficiency; Belong to lung, the deficiency of vital energy, deficiency and coldness are then arranged, stop drink, latent heat, the deficiency of YIN etc., but discuss maximum still lung qi deficiency and coldness.Existing Chinese prescription such as YUPINGFENG SAN are made up of the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae.Radix Astragali lung benefiting gas, solid flesh table in the side, Rhizoma Atractylodis Macrocephalae spleen invigorating is set upright, and helps Radix Astragali strengthening superficial resistance to stop perspiration, and Radix Saposhnikoviae is dispeled ailment said due to cold or exposure, and three medicines have share benefiting QI for strengthening the superficies, and the merit of strengthening vital QI to eliminate pathogenic factors makes the spleen kidney healthy and vigorous.The flesh table enriches, and exopathogen is difficult for invasion.The medicine of external has the compound recipe of employing Fructus Xanthii nasal drop, contains Fructus Xanthii, Flos Magnoliae, Radix Scutellariae, Indigo Naturalis etc. (1985 the 5th 12 phases of volume of combination of Chinese and Western medicine magazine) and Cortex Moutan drop nose (Hunan medical magazine the 4th phase of nineteen eighty-three).
Herba Epimedii is dry stem and the leaf of Berberidaceae plant Epimedium breviocrnum Maxim, and its main component is flavone (icariin), epimedium brevicornum polysaccharide etc., has functions such as temperature male wind-supplying kidney, supporing yang beneficial essence and expelling wind and removing dampness.The dry root of the plant MorindaOffcinalis How of Radix Morindae Officinalis genus rubia section, main component is polysaccharides from morinda officinalis how, resin, and contains abundant trace element and vitamin C etc., has the function of temperature male wind-supplying kidney and wind-damp dispelling equally.
The main preparation of being made by Herba Epimedii and Radix Morindae Officinalis compositions has " breathe heavily and can control " injection on the market, authentication code: the accurate word Z20010172 of traditional Chinese medicines, sell by Jianxin Medicine Co., Ltd., Zhuhai Economic Special Zone, the DaRi Biology Chemicals Medicine Co., Ltd., Guangdong Province produces, be treatment acute bronchial asthma, paracmastic effective good medicine, also can be used for treating chronic bronchial, chronic obstructive pulmonary disease, recurrent respiratory tract infection.Injection " breathe heavily and can control " is by people's whole body (mainly being systemic immunity) is regulated, imperial condition of disease power of enhancing body, and the outbreak that can significantly reduce asthma is until the purpose that reaches long-term remission (healing).
Chinese patent application 03121891.1 (publication number CN 1457830A) discloses a kind of compositions of being made up of Herba Epimedii and Radix Morindae Officinalis, and said composition can be used for preparing treatment and prevention bronchitis, the medicine of asthma and the medicine that is used to prepare adjuvant therapy of tumors, acquired immune deficiency syndrome (AIDS) immunologic hypofunction." the CHUANKEZHI ZHUSHEYE atomizing sucks regulating the unbalance experimentation of bronchial asthma rat immunity " literary composition that 2003 the 26th the 12nd phases of volume of shanghai Medicine deliver is pointed out, CHUANKEZHI ZHUSHEYE can influence the content of the various kinds of cell factor in the alveolar, regulate immunologic balance, thus treatment asthma.But above bibliographical information and patent application all are the combination treatment asthma of utilizing Herba Epimedii and Radix Morindae Officinalis; Whether can prepare the Chinese medicine compound local mucosal drug delivery of per nasal, oral cavity and throat, that form by Herba Epimedii and Radix Morindae Officinalis to be used to regulating mucosa-immune, treatment and prevention of allergic rhinitis, still unknown.
In order to develop a kind of medicine that can treat allergic rhinitis effectively, be necessary it is studied.
Summary of the invention
One of purpose of the present invention is to adopt the preparation of compositions contain Herba Epimedii and Radix Morindae Officinalis to treat and/or prevent the medicine of allergic rhinitis and/or upper respiratory tract infection, and the purposes aspect the compositions of Herba Epimedii and Radix Morindae Officinalis treats and/or prevents allergic rhinitis and/or upper respiratory tract infection in preparation the medicine promptly is provided.
In order to realize this purposes, the compositions of Herba Epimedii and Radix Morindae Officinalis can not be with injection or other form administration, because once there was the people will " breathe heavily and can control " that injection is used for the treatment of allergic rhinitis by drug administration by injection, but poor effect.Its reason may be that mucosa-immune is different from systemic immunity, be that the activated lymphocyte in mucosa position is optionally gone back to the nest to the mucosa lymphoid tissue, mucosa-immune and systemic immunity are in half isolation, as if the mucosa system separated with systemic immunity, therefore, attempt is just not obvious by the adjusting of systemic immunity being treated the unbalance caused disease effects of mucosa-immune.
But the present inventor finds that if with Herba Epimedii and Radix Morindae Officinalis compositions per nasal mucosal drug delivery, then Herba Epimedii and Radix Morindae Officinalis compositions display go out the powerful effect that treats and/or prevents allergic rhinitis and/or upper respiratory tract infection.
The present invention can directly adopt Herba Epimedii and Radix Morindae Officinalis or adopt the effective component extracts of Herba Epimedii, Radix Morindae Officinalis.For ease of the per nasal mucosal drug delivery, Herba Epimedii is preferably its extract, and Radix Morindae Officinalis also is preferably its extract.
Another object of the present invention provides a kind of pharmaceutical preparation that treats and/or prevents allergic rhinitis and/or upper respiratory tract infection, and this pharmaceutical preparation is adopted the dosage form of per nasal mucosal drug delivery and contained the extract of Herba Epimedii and the extract of Radix Morindae Officinalis.
Owing in treatment and prevention of allergic rhinitis process, adopt the effect of per nasal mucosal drug delivery mode administration better pharmaceutical preparation of the present invention, therefore, preferably, be made into the nasal mucosa absorption preparation.For example, can be nasal drop or nasal spray.With the Herba Epimedii of " breathe heavily and can the control " injection buied on the market or water containing ethanol extraction and Radix Morindae Officinalis extract with pharmaceutically acceptable dissolution with solvents after, add adjuvants such as mucosa absorption enhancer, mucosa adhesion agent and antiseptic, can be prepared into pernasal preparation.
Wherein, the extract of Herba Epimedii and the extract of Radix Morindae Officinalis can directly be buied from the market, as the Herba Epimedii extract of Shaanxi plant development corporation, Ltd. of intelligent section production, the Radix Morindae Officinalis extract that Maoming City remittance profit chemical industry company limited is produced, the CHUANKEZHI ZHUSHEYE that the DaRi Biology Chemicals Medicine Co., Ltd., Guangdong Province produces, also can oneself extract, extracting method can adopt known method, as the method described in the CN 03121891.1.
In the above-mentioned pharmaceutical preparation, Herba Epimedii extract accounts for the 1-130 weight portion, and Radix Morindae Officinalis extract accounts for the 1-130 weight portion.Choosing ground, Herba Epimedii extract accounts for the 20-13 weight portion, and Radix Morindae Officinalis extract accounts for the 5-50 weight portion; Perhaps Herba Epimedii extract accounts for the 1-29 weight portion, and Radix Morindae Officinalis extract accounts for the 51-100 weight portion; Perhaps Herba Epimedii extract accounts for the 111-1130 weight portion, and Radix Morindae Officinalis extract accounts for the 1-4 weight portion.
Can also contain acceptable adjuvant pharmaceutically and/or one or more in the pharmaceutical preparation of the present invention and be selected from composition: the composition of Decongestant, glucocorticoid, sodium cromoglicate and reduction SERUM IgE as next group.The Decongestant that is adopted can be an ephedrine etc., and glucocorticoid can be a beclometasone etc., and the medicine that reduces SERUM IgE can be an anti-IgE antibodies.Pharmaceutically the acceptable adjuvant can be buffer agent, isotonic agent, antiseptic, absorption enhancer etc.
The present inventor has carried out clinical experiment to the nasal administration preparation of Pharmaceutical composition of the present invention in the effect aspect the treatment allergic rhinitis.Utilize allergic rhinitis patients nasal discharge oxyphil cell than the principle that the normal person on average will exceed several times, select the measurement index of oxyphil cell's minimizing number as experiment.
Case is selected and diagnostic criteria is carried out with reference to the standard of " the allergic rhinitis combination of Chinese and Western medicine diagnosis criterion of therapeutical effect (draft) " of Chinese Medical Association's Haikou in 1997 annual meeting formulation.The rhinitis history of repeated attack is arranged, be seasonal or long-term property and send out the author; Typical outbreak symptom is arranged, rhinocnesmus, continuous sneeze, nasal obstruction, snivel etc.; Nasal cavity is checked: visible nasal membrane is pale, edema or plumpness, and minority has nasal polyp; Nasal secretion plate coating checking: see that count for eosinophil is greater than 5%.
The criterion of therapeutical effect of treatment: the standard of " the allergic rhinitis combination of Chinese and Western medicine diagnosis criterion of therapeutical effect (draft) " formulated with reference to Chinese Medical Association Haikou in 1997 annual meeting is carried out.Produce effects: transference cure, sign obviously alleviates, and the nasal smear count for eosinophil is followed up a case by regular visits to and is not recurred half a year less than 5%; Take a turn for the better: transference cure, sign obviously alleviates, and the nasal smear count for eosinophil is greater than 5%, but the course of disease finishes in later six months recurrence is arranged; Invalid, doing well,improving is not obvious, and sign changes little, and the nasal smear count for eosinophil is greater than 5%, and curative effect finishes that repeatedly recurrence was arranged in later six months.Formulate the detailed subjective symptom and the standard of keeping the score of objective sign, the nasal secretion eosinophil count.
Experimental result shows, use Pharmaceutical composition treatment of the present invention back patient's symptom obviously to improve, the eosinophilic granulocyte of nasal discharge reduces, thereby has proved that the treatment of Pharmaceutical composition per nasal mucosal drug delivery and the prevention of allergic rhinitis that contain Herba Epimedii and Radix Morindae Officinalis are safely and effectively.And results suggest: the per nasal mucosal drug delivery preparation can be by regulating other air flue sensitive diseases that the mucosa-immune treatment causes because of allergic constitution, the cough and the asthma that cause as allergy, and by regulating mucosa-immune prevention upper respiratory tract infection, as influenza and SARS.
Below in conjunction with embodiment, further specify the present invention, but the present invention is not limited to these embodiment, any on essence spirit of the present invention improvement or substitute, still belong to desired protection domain in claims of the present invention.
The specific embodiment
Main material of the present invention and source thereof:
(authentication code: the batch number accurate word Z20010172 of traditional Chinese medicines): 03030510402281 Jianxin Medicine Co., Ltd., Zhuhai Economic Special Zone DaRi Biology Chemicals Medicine Co., Ltd., Guangdong Province produces CHUANKEZHI ZHUSHEYE.
Herba Epimedii extract (〉=30% icariin) Shaanxi plant development corporation, Ltd. of intelligent section
Radix Morindae Officinalis extract (4: 1 polysaccharide) Maoming City converges and moistens the chemical industry company limited
Hismanal Xian-Janssen Pharmaceutical Ltd.
The HP-Shaanxi limited industrial corporation of Liquan chemical industry
Chitosan (molecular weight 3000-6000) Yufeng Biological Engineering Co. Ltd., Hubei
Embodiment 1
CHUANKEZHI ZHUSHEYE 2ml active component
Sodium hydrogen phosphate 10mg buffer agent
Crystallization sodium dihydrogen phosphate 1.65mg buffer agent
Dense glycine 13mg isotonic agent
Right-propylparaben 0.35mg antiseptic
Right-oxybenzene butyl formate 0.1mg antiseptic
Pure water is to total amount 3ml
Said components is mixed, regulate pH to 5.5, obtain nasal spray with the 1N sodium hydroxide.
Embodiment 2
CHUANKEZHI ZHUSHEYE 2ml active component
Chitosan (molecular weight 3000-6000) 2mg absorption enhancer and binder
Sodium hydrogen phosphate 10mg buffer agent
Crystallization sodium dihydrogen phosphate 1.65mg buffer agent
Dense glycine 13mg isotonic agent
Right-propylparaben 0.35mg antiseptic
Right-oxybenzene butyl formate 0.1mg antiseptic
Pure water is to total amount 3ml
Said components is mixed, regulate pH to 5.5, obtain nasal drop with the 1N sodium hydroxide.
Embodiment 3
CHUANKEZHI ZHUSHEYE 2ml active component
HP-20mg absorption enhancer
Right-propylparaben 0.35mg antiseptic
Right-oxybenzene butyl formate 0.1mg antiseptic
Pure water is to total amount 3ml
Said components is mixed, regulate pH to 5.5, obtain nasal spray with 1N hydrochloric acid and 1N sodium hydroxide.
Embodiment 4
Herba Epimedii extract 130mg active component
Radix Morindae Officinalis extract 1mg active component
Chitosan (molecular weight 3000-6000) 20mg absorption enhancer and binder
Sodium hydrogen phosphate 100mg buffer agent
Crystallization sodium dihydrogen phosphate 16.5mg buffer agent
Dense glycine 13mg isotonic agent
Right-propylparaben 3.5mg antiseptic
Right-oxybenzene butyl formate 1mg antiseptic
Pure water is to total amount 60ml
Said components is mixed, regulate pH to 5.5, divide to be filled to each 3ml, obtain nasal drop with 1N hydrochloric acid and 1N sodium hydroxide.
Embodiment 5
Herba Epimedii extract 1mg active component
Radix Morindae Officinalis extract 130mg active component
Chitosan (molecular weight 3000-6000) 20mg absorption enhancer and binder
Sodium hydrogen phosphate 100mg buffer agent
Crystallization sodium dihydrogen phosphate 16.5mg buffer agent
Dense glycine 13mg isotonic agent
Right-propylparaben 3.5mg antiseptic
Right-oxybenzene butyl formate 1mg antiseptic
Pure water is to total amount 60ml
Said components is mixed, regulate pH to 5.5, divide to be filled to each 3ml, obtain nasal spray with 1N hydrochloric acid and 1N sodium hydroxide.
Embodiment 6
Herba Epimedii extract 111mg active component
Radix Morindae Officinalis extract 4mg active component
Herba Ephedrae extract 30mg active component
HP-20mg absorption enhancer
Sodium hydrogen phosphate 100mg buffer agent
Crystallization sodium dihydrogen phosphate 16.5mg buffer agent
Dense glycine 13mg isotonic agent
Right-propylparaben 3.5mg antiseptic
Right-oxybenzene butyl formate 1mg antiseptic
Pure water is to total amount 60ml
Said components is mixed, regulate pH to 5.5 with 1N hydrochloric acid and 1N sodium hydroxide, branch is filled to each 3ml and obtains nasal spray.
Embodiment 7
Herba Epimedii extract 111mg active component
Radix Morindae Officinalis extract 4mg active component
Sodium hydrogen phosphate 100mg buffer agent
Crystallization sodium dihydrogen phosphate 16.5mg buffer agent
Dense glycine 13mg isotonic agent
Right-propylparaben 3.5mg antiseptic
Right-oxybenzene butyl formate 1mg antiseptic
Pure water is to total amount 60ml
Said components is mixed, regulate pH to 5.5 with 1N hydrochloric acid and 1N sodium hydroxide, branch is filled to each 3ml and obtains nasal spray.
Embodiment 8
Herba Epimedii extract 29mg active component
Radix Morindae Officinalis extract 51mg active component
Chitosan (molecular weight 3000-6000) 20mg absorption enhancer and binder
Sodium hydrogen phosphate 100mg buffer agent
Crystallization sodium dihydrogen phosphate 16.5mg buffer agent
Dense glycine 13mg isotonic agent
Right-propylparaben 3.5mg antiseptic
Right-oxybenzene butyl formate 1mg antiseptic
Pure water is to total amount 60ml
Said components is mixed, regulate pH to 5.5 with 1N hydrochloric acid and 1N sodium hydroxide, branch is filled to each 3ml and obtains nasal spray.
Embodiment 9
Herba Epimedii extract 29mg active component
Radix Morindae Officinalis extract 51mg active component
Chitosan (molecular weight 3000-6000) 20mg absorption enhancer and binder
Ephedrine 3mg Decongestant
Sodium hydrogen phosphate 100mg buffer agent
Crystallization sodium dihydrogen phosphate 16.5mg buffer agent
Dense glycine 13mg isotonic agent
Right-propylparaben 3.5mg antiseptic
Right-oxybenzene butyl formate 1mg antiseptic
Pure water is to total amount 60ml
Said components is mixed, regulate pH to 5.5 with 1N hydrochloric acid and 1N sodium hydroxide, branch is filled to each 3ml and obtains nasal spray.
Embodiment 10
Herba Epimedii extract 29mg active component
Radix Morindae Officinalis extract 51mg active component
Chitosan (molecular weight 3000-6000) 20mg absorption enhancer and binder
Sodium cromoglicate 10mg labrocyte medium release inhibitor
Sodium hydrogen phosphate 100mg buffer agent
Crystallization sodium dihydrogen phosphate 16.5mg buffer agent
Dense glycine 13mg isotonic agent
Right-propylparaben 3.5mg antiseptic
Right-oxybenzene butyl formate 1mg antiseptic
Pure water is to total amount 60ml
Said components is mixed, regulate pH to 5.5 with 1N hydrochloric acid and 1N sodium hydroxide, branch is filled to each 3ml and obtains nasal spray.
Embodiment 11
Herba Epimedii extract 29mg active component
Radix Morindae Officinalis extract 51mg active component
Chitosan (molecular weight 3000-6000) 20mg absorption enhancer and binder
Beclometasone 20mg glucocorticoid
Sodium hydrogen phosphate 100mg buffer agent
Crystallization sodium dihydrogen phosphate 16.5mg buffer agent
Dense glycine 13mg isotonic agent
Right-propylparaben 3.5mg antiseptic
Right-oxybenzene butyl formate 1mg antiseptic
Pure water is to total amount 60ml
Said components is mixed, regulate pH to 5.5 with 1N hydrochloric acid and 1N sodium hydroxide, branch is filled to each 3ml and obtains nasal spray.
Embodiment 12
Herba Epimedii extract 29mg active component
Radix Morindae Officinalis extract 51mg active component
Chitosan (molecular weight 3000-6000) 20mg absorption enhancer and binder
Anti-IgE antibodies 20mg reduces the IgE agent
Sodium hydrogen phosphate 100mg buffer agent
Crystallization sodium dihydrogen phosphate 16.5mg buffer agent
Dense glycine 13mg isotonic agent
Right-propylparaben 3.5mg antiseptic
Right-oxybenzene butyl formate 1mg antiseptic
Pure water is to total amount 60ml
Said components is mixed, regulate pH to 5.5 with 1N hydrochloric acid and 1N sodium hydroxide, branch is filled to each 3ml and obtains nasal spray.
The experiment of embodiment 13 effects
The treatment group adopts embodiment 3 prescriptions, is active component with CHUANKEZHI ZHUSHEYE 2ml promptly, and HP-20mg is the nasal spray of absorption enhancer, each 1-2 spray, every day 4 times, 10 days courses of treatment.Matched group gives oral hismanal, every day 1 time, 10 days courses of treatment.In patient nearly March and experimental period and with not using immunomodulator and glucocorticoid treatment such as antiallergic during examining, seriously nasal obstruction person allows to take the circumstances into consideration to use Decongestant (0.5% ephedrine) collunarium, every day 2 times in early stage 3 days of the course of treatment.
1, the mensuration that eosinophilic granulocyte is counted in the nasal discharge before and after the treatment:
(1) sampling: embrocate repeatedly 3 times with rotation mode by concha nasalis inferior rear end forward end 0.5 centimeters under direct-view with sizeable cotton swab during mensuration, then it is coated in the secretions on the cotton swab on the microscope slide with roll mode and dries up, drip 95% alcohol fixation, adopt Rui Shi-Giemsa staining method, make cell divide according to morphological criteria under the light microscopic, calculate the shared percentage ratio of eosinophilic granulocyte, treatment group, matched group are respectively at measuring 1 time before and after the treatment.
(2) nasal secretion smear cytolgical examination: treatment group, matched group were all got the cytolgical examination of nasal secretion smear before the course of treatment, adopted Wright Stain, according to cytology's typoiogical classification, calculated the shared percentage ratio of eosinophilic granulocyte under the light microscopic.It is the same to get nasal secretion smear cytolgical examination direction after finishing the course of treatment.
2, result and statistical analysis nasal discharge eosinophilic granulocyte counting experimental data represents that with X ± S statistical analysis adopts paired t-test.Clinical symptoms and sign classification efficacy evaluation are through x
2Check.
Table 1 nasal discharge eosinophilic granulocyte counting relatively
| Table 1 nasal discharge eosinophilic granulocyte is counted the shared percentage ratio (% of X ± S) | |||
| Group | The example number | Before the treatment | After the treatment |
| Treatment group matched group | 14 12 | 36.8±16.5 38.2±17.1 | 6.7±4.1 8.4±4.8 |
Eosinophilic granulocyte counting there was no significant difference (P＞0.05) before two groups of treatments; Two groups of treatment back eosinophilic granulocyte counting there was no significant differences (P＞0.05); Relatively, the eosinophilic granulocyte counting obviously reduces, and significant difference (P＜0.01) is arranged before and after the treatment group.
3, mark curative effect relatively before and after two groups of treatments
(1) evaluation criteria: according to the allergic rhinitis efficacy assessment standard, two groups of cases are passed judgment on clinical efficacy again after treating back 10 days judge clinical efficacies, following up a case by regular visits to February.According to treating the sum total that the front and back sings and symptoms is kept the score, the percentage rate that improves is evaluated perennial allergic rhinitis's curative effect by following formula: total points * 100% 〉=51% is a produce effects before total points before the treatment-treatment back total points/treatment, 50%～21% is that effectively≤2% is invalid.
(2) result and statistical analysis: treatment back produce effects and effective treatment group are 92%; Matched group is to compare curative effect there was no significant difference (P＞0.05) between 89%, two group, and relatively, curative effect has significant difference (P＜0.01) before and after the treatment group.
4, untoward reaction:
The treatment group tangible untoward reaction do not occur except that individual patient has rhinocnesmus.And hismanal is tested non-evident effect at this, but bibliographical information side effect such as drug allergy purpura, headache, arrhythmia and anaphylactic shock once.
Experiment shows, the compositions per nasal mucosal drug delivery that mainly contains Herba Epimedii and Radix Morindae Officinalis is used for treating allergic rhinitis and preventive effect is obvious, the composition injection life-time service of Herba Epimedii and Radix Morindae Officinalis is not found side effect, and the per nasal mucosal drug delivery uses more convenient, safer than injection.
Claims (10)
1, the compositions that contains Herba Epimedii and Radix Morindae Officinalis treats and/or prevents purposes aspect allergic rhinitis and/or the upper respiratory tract infection medicine in preparation.
2, purposes as claimed in claim 1 is characterized in that, described Herba Epimedii and Radix Morindae Officinalis are respectively its extracts.
3, purposes as claimed in claim 1 is characterized in that, described medicine by the preparation of compositions that contains Herba Epimedii and Radix Morindae Officinalis is the dosage form of per nasal mucosal drug delivery.
4, purposes as claimed in claim 3 is characterized in that, described dosage form is nasal drop or nasal spray.
5, purposes as claimed in claim 1 is characterized in that, in described Herba Epimedii and Radix Morindae Officinalis compositions, Herba Epimedii or its extract account for the 1-130 weight portion, and Radix Morindae Officinalis or its extract account for the 1-130 weight portion.
6, a kind of pharmaceutical preparation that treats and/or prevents allergic rhinitis and/or upper respiratory tract infection is characterized in that, described pharmaceutical preparation is adopted the dosage form of per nasal mucosal drug delivery and contained the extract of Herba Epimedii and the extract of Radix Morindae Officinalis.
7, pharmaceutical preparation as claimed in claim 6 is characterized in that, described dosage form is nasal drop or nasal spray.
8, pharmaceutical preparation as claimed in claim 6 is characterized in that, in the described pharmaceutical preparation, Herba Epimedii extract accounts for the 1-130 weight portion, and Radix Morindae Officinalis extract accounts for the 1-130 weight portion.
9, pharmaceutical preparation as claimed in claim 8 is characterized in that, in the described pharmaceutical preparation, Herba Epimedii extract accounts for the 20-13 weight portion, and Radix Morindae Officinalis extract accounts for the 5-50 weight portion; Perhaps Herba Epimedii extract accounts for the 1-29 weight portion, and Radix Morindae Officinalis extract accounts for the 51-100 weight portion; Perhaps Herba Epimedii extract accounts for the 111-130 weight portion, and Radix Morindae Officinalis extract accounts for the 1-4 weight portion.
10, pharmaceutical preparation as claimed in claim 6, it is characterized in that, also contain acceptable adjuvant pharmaceutically and/or one or more in the described pharmaceutical preparation and be selected from composition: the composition of Decongestant, glucocorticoid, sodium cromoglicate and reduction SERUM IgE as next group.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510033464 CN1830471A (en) | 2005-03-11 | 2005-03-11 | Application of medicinal composition containing epimedium and morinda root in preparation of medicine for treating and preventing rhinallergosis |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510033464 CN1830471A (en) | 2005-03-11 | 2005-03-11 | Application of medicinal composition containing epimedium and morinda root in preparation of medicine for treating and preventing rhinallergosis |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102764339A (en) * | 2012-08-01 | 2012-11-07 | 陈彦文 | Maca composition for improving sexual dysfunction and preparation method and application thereof |
| CN104940134A (en) * | 2015-06-30 | 2015-09-30 | 深圳清华大学研究院 | Method using traditional Chinese medicine injection for preparing mucosal drug delivery dosage form |
-
2005
- 2005-03-11 CN CN 200510033464 patent/CN1830471A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102764339A (en) * | 2012-08-01 | 2012-11-07 | 陈彦文 | Maca composition for improving sexual dysfunction and preparation method and application thereof |
| CN102764339B (en) * | 2012-08-01 | 2014-04-02 | 陈彦文 | Maca composition for improving sexual dysfunction and preparation method and application thereof |
| CN104940134A (en) * | 2015-06-30 | 2015-09-30 | 深圳清华大学研究院 | Method using traditional Chinese medicine injection for preparing mucosal drug delivery dosage form |
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