CN1879676A - Compound spray for treating rhinitis and preparation method thereof - Google Patents
Compound spray for treating rhinitis and preparation method thereof Download PDFInfo
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- CN1879676A CN1879676A CN 200610035453 CN200610035453A CN1879676A CN 1879676 A CN1879676 A CN 1879676A CN 200610035453 CN200610035453 CN 200610035453 CN 200610035453 A CN200610035453 A CN 200610035453A CN 1879676 A CN1879676 A CN 1879676A
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Abstract
Disclosed is a compound mist for treating rhinitis and its preparation method, wherein each 1000ml of the water solution contains 300g of ethanol extract of green chiretta, 100g aqueous extract of centipede, 5g d-pesudoephedrine hydrochloride, 1.5g of diphenhydramine hydrochloride, 10ml of peppermint oil, 10ml of eucalyptus oil, 30g of polyvidon K3O, 40g of polysorbate-80, 5.7g of sodium chloride and 2g of potassium sorbate.
Description
Technical field
The present invention relates to Chinese medicine preparation,, the invention still further relates to the preparation method of this compound spray for treating rhinitis in particular for a kind of compound spray for treating rhinitis of treatment rhinitis.
Background technology
Nasal cavity is positioned at respiratory tract foremost, to suck air have moistening, heat, filtering effect, be the first line of defence of respiratory system, also be one of the easiest infected organ, inflammation enters human body especially, to the only way that lower respiratory tract and adjacent organs spread.In recent years, degradation reason under, the Abwehrkraft des Koepers former owing to atmospheric pollution, global warming, temperature cataclysm, the infection of bacterial virus, contact allergy, the sickness rate of various nasal cavity inflammations is in rising trend.According to statistics, the prevalence of various rhinitis is about 10% to 40% in the west, estimates that according to the expert China is also near 10%.
Rhinitis refers to the inflammation of nasal membrane and submucous tissue, and its performance is varied.From the pathological change of nasal membrane, chronic simple rhinitis, chronic hypertrophic rhinitis, atrophic rhinitis etc. are arranged; From the slow length that reaches the course of disease of the urgency of morbidity, can be divided into acute rhinitis and chronic rhinitis.In addition, some rhinitis are arranged, though morbidity is slowly, the course of disease continues longer, and specific pathogenesis is arranged, just thereby specific title arranged, as allergic rhinitis (that is allergic rhinitis) etc.Because nasal cavity adjoins and continuity mutually, rhinitis patient Chang Jifa sinusitis mutually with the nasal sinuses mucosa.With nasal obstruction, watery nasal discharge, headache, hyposmia is the various rhinitis of main performance, the respiratory function that sinusitis not only influences people, and make the people produce easily tired, weak, dizzy, insomnia, hypomnesis and the various senses of discomfort of nose, if malpractice, the state of an illness can the time heavy when light, obstinate.Because inflammation enters human body, spread easy and other respiratory tract diseases merging of nasal cavity inflammation simultaneously to lower respiratory tract and adjacent organs, cause diseases such as pneumonia, asthma when serious, delay is difficult to repeatedly to healing, so harm is bigger, having a strong impact on patient's work, studying and living quality.Thereby researching and developing effective rhinitis class medicine has the huge market space.
Because the cause of disease of rhinitis, sinusitis and allergic rhinitis is comparatively complicated, the development and production of medical manufacturing enterprise medicine various in style.The rhinitis of Xiao Shouing, sinusitis and allergic rhinitis medicine have oral and local H1-antihistaminic, oral/intramuscular injection and nose glucocorticoid, oral and local Decongestant, local anti-leukotriene medicine etc. in the market, mostly be Western medicine preparation, though it is rapid-action, but life-time service easily has side effects, cause the human body imbalance of YIN and YANG, dyshormonia taking place, cause immunity of organisms to descend, makes the state of an illness difficult repeatedly.Advantages such as the medicine for the treatment of rhinitis, sinusitis and allergic rhinitis in the Chinese medicine is then based on the prescription of heat-clearing and toxic substances removing, and treating both the principal and secondary aspects of a disease improves the human body resistance against diseases, has good effect, and side effect is little, but onset is slower.So in, the shared treatment rhinitis of Western medicine, sinusitis and allergic rhinitis medicine have a lot of advantages and market potential.
The compound recipe rhinitis ointment is the Chinese medicine and western medicine compound preparation, records in the 13 of ministry standard, and standard No. is WA3-B-2581-97.Its effect heat-clearing and detoxication antiphlogistic is used for the treatment of allergic rhinitis, acute or chronic rhinitis and sinusitis.Herba Andrographis, Herba Centipedae heat-clearing and detoxication antiphlogistic in the prescription; Ephedrine hydrochloride is an adrenoceptor agonists, has pressor effect; Diphhydramine hydrochloride is H
1Receptor antagonist, antiinflammatory, antiallergic; Oleum menthae, Oleum Eucalypti are proposed effect, and compatibility uses, and have better curative effect by the proof of clinical practice for many years.But owing to be ointment, on dosage form, have a lot of weak points, slow such as onset, be difficult to quantitatively, carry easy pollution clothes and be difficult for preserving etc., its use is restricted.So market reaction is flat, only there is Guangzhou Hejigong Pharmaceutical Factory to produce at present.In addition, this kind is also having a lot of shortcomings aspect technology and the quality control: at first, Herba Andrographis concentrated solution in the prescription is the water extracting liquid of Herba Andrographis medical material, and according to the literature, the effective ingredient andrographolide and the dehydrorographolide of Herba Andrographis anti-inflammation all are insoluble in water, obviously, the extraction process by water loss of effective components is big, and inadvisable; Secondly, contain adrenoceptor agonists ephedrine hydrochloride and antihistaminic diphhydramine hydrochloride in this kind prescription, should strict its consumption of control, but the quality standard of this kind do not control the content of the two, causes Product Safety relatively poor.
Summary of the invention
The object of the present invention is to provide a kind of easy to use, absorb fast, bioavailability is high, a kind of compound spray for treating rhinitis of shelf stability.
Another object of the present invention provide a kind of technology rationally, the preparation method of the above-mentioned compound spray for treating rhinitis of medical material utilization rate height, constant product quality.
Last purpose of the present invention is achieved in that a kind of compound spray for treating rhinitis, contains the ethanol extraction of 300g Herba Andrographis, water extract, 5g ephedrine hydrochloride, 1.5g diphhydramine hydrochloride, 10ml Oleum menthae, 10ml Oleum Eucalypti, 30g 30 POVIDONE K 30 BP/USP 30,40g Tween-80,5.7g sodium chloride and the 2g potassium sorbate of 100g Herba Centipedae in every 1000ml water preparation.
Back of the present invention one purpose is achieved in that a kind of preparation method of compound spray for treating rhinitis, comprises the steps: that (1) Herba Andrographis adds 85% alcohol reflux twice, merges medicinal liquid, filter, filtrate recycling ethanol is evaporated to 2 times of crude drug amounts, the active carbon that adds crude drug amount 4% refluxed 30 minutes, filter, filtering residue filters with 50～65% washing with alcohol, merge above filtrate, reclaim ethanol, it is 1.15～1.25/60 ℃ thick paste that concentrating under reduced pressure becomes relative density, standby; (2) Herba Centipedae decocts with water twice, and collecting decoction filters, and it is 1.10/60 ℃ clear paste that filtrate is concentrated into relative density, and adding ethanol is 60% to containing the alcohol amount, stirs evenly, and standing over night is got supernatant and reclaimed ethanol to there not being the alcohol flavor, and is standby; (3) above Herba Andrographis thick paste and 30 POVIDONE K 30 BP/USP 30 add 85% dissolve with ethanol respectively, and mix homogeneously adds the Tween-80 mixing, flings to ethanol, put coldly, add Oleum menthae and Oleum Eucalypti, and mixing adds Herba Centipedae concentrated solution and water, stirs evenly; Other gets ephedrine hydrochloride and diphhydramine hydrochloride is dissolved in water, and adds in the above-mentioned medicinal liquid, stirs evenly, and adds sodium chloride accent etc. and oozes, and adds potassium sorbate, and regulating pH value is 6.0, adds water to 1000ml, stirs evenly, and leaves standstill, and filters, promptly.
Step in the preparation method of above-mentioned compound spray for treating rhinitis (1) Central Plains medicine Herba Andrographis is cut into the segment less than 5cm, adds 9 times of amount ethanol during extraction for the first time, adds 8 times of amount ethanol for the second time, each reflux, extract, 1.5 hours.
Purification condition described in the step in the preparation method of above-mentioned compound spray for treating rhinitis (1) is: extracting solution is evaporated to 2 times of crude drug amounts, and the active carbon that adds crude drug amount 4% refluxed 30 minutes.
Add 10 times of water in the step in the preparation method of above-mentioned compound spray for treating rhinitis (2) at every turn, decocted 1.5 hours.
The present invention is directed to its effective ingredient andrographolide of Herba Andrographis and be soluble in methanol, ethanol, be insoluble in the characteristics of water, in order to bring into play the medicinal efficacy of Herba Andrographis better, Herba Andrographis carried by water change alcohol extraction into, determine optimised process with concentration of alcohol, ethanol consumption, extraction time and medical material granularity, and adopt active carbon backflow purification extracting solution.
The present invention is directed in the Herba Centipedae water extract and have macromolecular components such as a large amount of resins, lymphatic temperament, influence the clarity and the stability of liquid preparation, adopt to add pure sedimentation method purification, serves as to investigate index with the amount of total flavones, determines best alcohol precipitation process.
The present invention compared with prior art has following advantage:
(1) to have a droplet of ejection thinner for spray of the present invention, be evenly distributed at nasal cavity, be difficult for running off, absorb fast, bioavailability is high, be easy to be accepted by the patient.
(2) spray of the present invention proves through the pharmacodynamics related experiment, and tangible antiinflammatory, raise immunity are arranged, and fixed antipruritic, analgesia and antibacterial action are arranged.
(3) spray of the present invention is deposited experiment through the constant temperature and humidity of six months accelerated test and a year and is shown that its character, discriminating, inspection, content etc. have no significant change, and prove that its shelf stability is good.
Description of drawings
Below in conjunction with drawings and Examples the present invention is described in further detail, but does not constitute any limitation of the invention.
Fig. 1 is a process flow diagram of the present invention.
The specific embodiment
Compound spray for treating rhinitis of the present invention, its prescription is: 300g Herba Andrographis, 100g Herba Centipedae, 5g ephedrine hydrochloride, 1.5g diphhydramine hydrochloride, 10ml Oleum menthae, 10ml Oleum Eucalypti, 30g 30 POVIDONE K 30 BP/USP 30,40g Tween-80,5.7g sodium chloride, 2g potassium sorbate.
Embodiment 1 compound spray for treating rhinitis
Concrete process flow diagram is consulted shown in 1, and preparation method is:
(1) takes by weighing the former medicine of 3000g Herba Andrographis and be cut into segment less than 5cm, add 85% alcohol reflux twice, add for the first time 9 times of ethanol, add for the second time 8 times of ethanol, the each backflow 1.5 hours merges medicinal liquid, filters, filtrate recycling ethanol, be evaporated to 2 times of crude drug amounts, the active carbon that adds crude drug amount 4% refluxed 30 minutes, filtered, filtering residue is with an amount of 50～65% washing with alcohol, filter, merge above filtrate, reclaim ethanol, concentrating under reduced pressure becomes relative density to be the thick paste of 1.15～1.25 (60 ℃), and is standby;
(2) take by weighing the 1000g Herba Centipedae and decoct with water twice, add 10 times of water at every turn, decocted collecting decoction 1.5 hours, filter, filtrate is concentrated into the clear paste that relative density is 1.10 (60 ℃), and adding ethanol is 60% to containing the alcohol amount, stirs evenly, standing over night is got supernatant and reclaimed ethanol to there not being the alcohol flavor, and is standby;
(3) above Herba Andrographis thick paste and 300g 30 POVIDONE K 30 BP/USP 30 are added an amount of 85% dissolve with ethanol respectively, mix homogeneously adds 400g Tween-80 mixing, fling to ethanol, put coldly, add 100ml Oleum menthae and 100ml Oleum Eucalypti, mixing adds Herba Centipedae concentrated solution and suitable quantity of water, stirs evenly; Other gets 50g ephedrine hydrochloride and 15g diphhydramine hydrochloride and adds the suitable quantity of water dissolving, adds in the above-mentioned medicinal liquid, stirs evenly, and adds 57g sodium chloride accent etc. and oozes, and adds the 20g potassium sorbate, and regulating pH value is 6.0, adds water to 10000ml, stirs evenly, and leaves standstill, filter, and fill, promptly.
The extraction demonstration test of experimental example 1 Herba Andrographis
Experimental technique: Herba Andrographis medical material 100g, cutting adds 85% alcohol reflux secondary, adds 9 times for the first time, for the second time add 8 times, refluxed 1.5 hours at every turn, merge medicinal liquid, filter, weigh, measure andrographolide and dehydrorographolide content, calculate total rate of transform, the results are shown in Table 1.
Table 1 Herba Andrographis extracts active ingredients demonstration test result
| The experiment number | The total lactone amount of medical material (g/100g medical material) | The total lactone amount of extracting solution (g/100g medical material) | The rate of transform (%) |
| 123 is average | 1.212 1.212 1.212. 1.212 | 1.095 1.073 1.112 1.093 | 90.35 88.53 91.75 90.21 |
Demonstration test is basically identical as a result, and three test RSD=1.75% illustrate the extracting method good stability.
The purifying process confirmatory experiment of the extracting solution of experimental example 2 Herba Andrographis
Experimental technique: carry out three batches of checkings by process conditions, get Herba Andrographis medical material 1kg for every batch, be cut into＜the 5cm segment, add 85% alcohol reflux 2 times, add 9 times for the first time, add 8 times for the second time, each reflux, extract, 1.5 hours, collecting decoction filters filtrate recycling ethanol to 2 times crude drug amount, the active carbon that adds crude drug amount 4% refluxed 30 minutes, filter while hot,, filter with an amount of Diluted Alcohol washing filtering residue, merging filtrate, reclaim ethanol, measure andrographolide and dehydrorographolide total amount in the medicinal liquid, calculate the rate of transform.The results are shown in Table 2:
The extracting solution purification confirmatory experiment result of table 2 Herba Andrographis
| The experiment number | The total lactone amount of medical material (g/1kg medical material) | The total lactone amount of extracting solution (g/1kg medical material) | The rate of transform (%) |
| 123 is average | 12.12 12.12 12.12 12.12 | 8.498 8.388 8.625 8.504 | 70.12 69.21 71.16 70.16 |
The result shows: extraction and purification process of the present invention is stable, the total rate of transform basically identical of andrographolide and dehydrorographolide, RSD=2.92%.
The purifying process confirmatory experiment of experimental example 3 Herba Centipedae extracting solution
Experimental technique: carry out three batches of checkings by process conditions, get Herba Centipedae 1kg for every batch, extract, filter according to former technology, filtrate is concentrated into about 1.10 (60 ℃) of relative density, transfers to make with 95% ethanol to contain the alcohol amount and reach 60%, stirs evenly, and placement is spent the night, get supernatant, measure general flavone content, the results are shown in Table 3:
Table 3 Herba Centipedae extracting solution purification confirmatory experiment is table as a result
| The experiment number | 1 | 2 | 3 |
| General flavone content g/100g medical material | 5.15 | 5.22 | 4.98 |
Confirmatory experiment is basically identical as a result, and RSD=2.38% illustrates that extraction and purification process is stable.
4 acute toxicity tests of test example
1. experimental technique: with the Kunming mouse is the research system, observes toxic reaction and the death condition that gives mice behind the compound spray for treating rhinitis of the present invention with gastric infusion (i.g.) approach.The dosage of 5 groups of compound spray for treating rhinitis is respectively 17.06,13.65,10.92,8.73,6.99g/kg.An i.g. administration was observed 7 days continuously, record animal toxicity response situation and dead animal number.
2. experimental result: to jump all appear in mice 30min after the 1st administration, dry moving, extremity and lip are baby pink; Above-mentioned phenomenon is more obvious behind the 1h; Behind the 2h, 17.06g/kg group and 13.65g/kg group respectively have 1 dead mouse; 17.06g/kg group and 13.65g/kg group respectively increase by 2 dead mouses behind the 3h; 17.06g/kg group mice is all dead behind the 24h, and the 13.65g/kg group increases by 4 death again, and 10.92g/kg organizes dead 5, and 8.73g/kg organizes dead 2; 6.99g/kg is dead 1 behind the 36h.Above-mentioned dead mice is dissected perusal and there is no unusual performances such as vitals such as the heart, liver, lung, kidney, spleen are hemorrhage, necrosis.Spirit, activity, defecation, the appetite of 72h survival mice is all no abnormal to the medicine.We have measured LD with the Bliss method
50, its value is 10.88g/kg, the 95% credible 9.47～12.45g/kg that is limited to.
Experimental example 5 long-term toxicity test for animals
1. experimental technique: getting the Wistar rat is subjects, be respectively 0.616g (1.44ml)/kg, 0.308g (0.72ml)/kg, 0.154g (0.36ml)/kg by high dose group, middle dosage group, low dose group dosage, be equivalent to 80,40,20 times of clinical day plan of people consumption 0.0077g (0.018ml)/kg respectively.Via intranasal application splashed into administration 3 months continuously, continued after the drug withdrawal to observe 21 days.
2. observation item: general situation such as the outward appearance sign of (1) animal, behavioral activity, appetite, defecation; (2) hematological indices such as erythrocyte, leukocyte, platelet and bone marrow nucleated cell; (3) blood parameters such as glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, alkali phosphatase, lactic acid dehydrogenase, creatinine, blood urea nitrogen, total serum protein, albumin, blood glucose, T-CHOL, globulin, triglyceride and bilirubin; (4) dirty hierarchy numbers such as the heart, liver,kidney,spleen, lung, brain, thymus, bladder, adrenal gland, uterus, ovary, testis, epididymis, prostate, seminal vesicle etc.; (5) organ-tissue pathology such as the heart, liver,kidney,spleen, lung, brain, thymus, spleen, adrenal gland, stomach, large intestine, small intestinal, bladder, uterus, ovary, testis, epididymis, pancreas, prostate, seminal vesicle, bone marrow, hypophysis cerebri, aorta, trachea, thyroid, parathyroid gland, optic nerve, sciatic nerve, lymph node, spinal cord, nasal mucosa.
3. the result shows: each organize rat generally in order, body weight, food ration, dirty hierarchy number are no abnormal, hematology, blood biochemical are learned index and are shown no obvious abnormalities, histopathology finds no abnormal change.Point out compound spray for treating rhinitis of the present invention not have obvious toxic and side effects, show simultaneously under this experimental condition, the toxic effects dosage＞0.616g/kg of compound spray for treating rhinitis.Thereby think that by using the clinical dosage of drafting, route of administration and the course of treatment compound spray for treating rhinitis should be safe.
Experimental example 6 pharmacodynamics tests
1. test method: cause the antiinflammatory action that Mice Auricle inflammation, carrageenin cause rat paw edema and the swollen scale-model investigation compound spray for treating rhinitis of the present invention of rat granuloma with Oleum Tiglii; Observe its antihistamine itching-relieving action with histamine induced mice skin pruritus; Observe its analgesic activity with the mice hot plate method; With sheep red blood cell (SRBC) cause that the mice hemolytic antibody generates and the clearance in mice experimental observation its to Immune Effects; Method with the in-vitro antibacterial experiment is observed its antibacterial action.
2. experimental result shows, compound spray for treating rhinitis of the present invention has tangible antiinflammatory action, can significantly alleviate auricle edema due to the proinflammatory agent Oleum Tiglii and the rat paw edema due to the carrageenin; Suppress the bullate formation of rat granuloma; Promote anti-SRBC production of antibodies and improve the carbon clearance index, showing has the raise immunity effect; And certain antipruritic, analgesic activity arranged.External Candida albicans also there is certain bacteriostasis.Above results suggest, compound spray for treating rhinitis of the present invention has tangible antiinflammatory, raise immunity, and certain antipruritic, analgesia and antibacterial action are arranged.
The test of experimental example 7 animal safeties
By compound spray for treating rhinitis having been carried out rabbit nasal membrane irritant test and guinea pig skin hypersensitive test, the result shows that compound spray for treating rhinitis do not see tangible irritative response to the rabbit nasal membrane, does not also see skin allergy.
Claims (5)
1. a compound spray for treating rhinitis is characterized in that containing in every 1000ml water preparation the ethanol extraction of 300g Herba Andrographis, water extract, 5g ephedrine hydrochloride, 1.5g diphhydramine hydrochloride, 10ml Oleum menthae, 10ml Oleum Eucalypti, 30g 30 POVIDONE K 30 BP/USP 30,40g Tween-80,5.7g sodium chloride and the 2g potassium sorbate of 100g Herba Centipedae.
2. the preparation method of the described compound spray for treating rhinitis of claim 1 is characterized in that comprising the steps: that (1) Herba Andrographis adds 85% alcohol reflux twice, merges medicinal liquid, filter, filtrate recycling ethanol adds active carbon backflow purification behind the concentrating under reduced pressure, filter, filtering residue is with 50～65% washing with alcohol, filter, merge above filtrate, reclaim ethanol, it is 1.15～1.25/60 ℃ thick paste that concentrating under reduced pressure becomes relative density, standby; (2) Herba Centipedae decocts with water twice, and collecting decoction filters, and it is 1.10/60 ℃ clear paste that filtrate is concentrated into relative density, and adding ethanol is 60% to containing the alcohol amount, stirs evenly, and standing over night is got supernatant and reclaimed ethanol to there not being the alcohol flavor, and is standby; (3) Herba Andrographis thick paste and 30 POVIDONE K 30 BP/USP 30 are added 85% dissolve with ethanol respectively, mix homogeneously adds the Tween-80 mixing, flings to ethanol, puts coldly, adds Oleum menthae and Oleum Eucalypti, and mixing adds Herba Centipedae concentrated solution and water, stirs evenly; Other gets ephedrine hydrochloride and diphhydramine hydrochloride is dissolved in water, and adds in the above-mentioned medicinal liquid, stirs evenly, and adds sodium chloride accent etc. and oozes, and adds potassium sorbate, and regulating pH value is 6.0, adds water to 1000ml, stirs evenly, and leaves standstill, and filters, promptly.
3. preparation method according to claim 2 is characterized in that step (1) Central Plains medicine Herba Andrographis is cut into the segment less than 5cm, adds 9 times of amount ethanol during extraction for the first time, adds 8 times of amount ethanol for the second time, each reflux, extract, 1.5 hours.
4. preparation method according to claim 2, it is characterized in that the purification condition described in the step (1) is: extracting solution is evaporated to 2 times of crude drug amounts, and the active carbon that adds crude drug amount 4% refluxed 30 minutes.
5. preparation method according to claim 2 is characterized in that adding in the step (2) 10 times of water at every turn, decocts 1.5 hours.
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