CN103142874A - Granule preparation for treating cold - Google Patents
Granule preparation for treating cold Download PDFInfo
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- CN103142874A CN103142874A CN2013100929545A CN201310092954A CN103142874A CN 103142874 A CN103142874 A CN 103142874A CN 2013100929545 A CN2013100929545 A CN 2013100929545A CN 201310092954 A CN201310092954 A CN 201310092954A CN 103142874 A CN103142874 A CN 103142874A
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Abstract
The invention provides a granule preparation for treating cold. The granule preparation is prepared from raw pharmaceutical materials selected from schizonepeta spike, burdock fruit, ledebouriella root, bupleurum root, purple perilla leaf, kudzu root, balloonflower root, bitter apricot seed, dahurian angelica root, herba corydalis bungeanae and reed rhizome. According to the granule preparation, due to micronized crushing granulation, the efficacy of the raw pharmaceutical materials is more effectively preserved.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, particularly a kind of granular preparation for the treatment of flu and preparation method thereof.
Background technology
Flu claims again cold, and whenever anyone all can occur.Clinical manifestation is take nasal obstruction, watery nasal discharge, cough, headache, aversion to cold, heating, general malaise etc. as its feature.Flu all can be fallen ill at all seasons, take spring, summer, autumn as common.How anxious the symptom of flu just onset is, with nose mucositis symptom and sneeze, watery nasal discharge, nasal obstruction; Very the person has aversion to wind and cold, heating, headache, giddy, cough etc.The acute viral pharyngitis is itched and pharyngeal burning sensation with pharyngeal, pharyngalgia can with fever and headache, cough weak etc. be cardinal symptom.The viral laryngitis of main acute pain during with hoarseness, difficulty speaking, cough is often cardinal symptom with heating, cough etc.As seen the nasal membrane congestion and edema, have secretions.Pharyngeal mild hyperaemia.The visible pharyngeal obvious hyperemia of viral pharyngitis and edema, the enlargement of neck submental lymph nodes, and tenderness is arranged.But and viral laryngitis congested, edema of throat when checking, regional nodes's silght enlargement and tenderness also can be heard whoop.
Primary disease has certain infectiousness, and is very high at susceptible sickness rate in season, people ' s health and work production often brought larger impact, therefore actively control.And at present, one-sidedness is arranged, and side effect is large in the treatment of doctor trained in Western medicine.There is anaphylactoid patient may cause suffering a shock lethal.
2000 version " pharmacopeia " prescription and the preparation technology of GANMAO QINGRE KELI are disclosed, prescription: Herba Schizonepetae 200g, Herba Menthae 60g, Radix Saposhnikoviae 100g, Radix Bupleuri 100g, Folium Perillae 60g, Radix Puerariae 100g, Radix Platycodonis 60g, Semen Armeniacae Amarum 80g, Radix Angelicae Dahuricae 60g, Herba Corydalis Bungeanae 200g and Rhizoma Phragmitis 160g.
Method for making: above ten simply, gets Herba Schizonepetae, Herba Menthae, Folium Perillae extraction volatile oil, and the another device of the aqueous solution after distillation is collected; Eight flavors such as medicinal residues and all the other Radix Saposhnikoviaes decoct with water secondary, and each 1.5 hours, collecting decoction filtered, and filtrate and above-mentioned aqueous solution merge.Amalgamation liquid is condensed into the clear paste that relative density is 1.35～1.38 (55 ℃), qinghuo reagent, and with sucrose, dextrin and appropriate amount of ethanol, granulation, drying adds above-mentioned volatile oil, and mixing is made 1600g; Or amalgamation liquid is condensed into the clear paste that relative density is 1.32～1.35 (55 ℃), and adding right amount of auxiliary materials, mixing is made the sugar-free granule, and drying adds above-mentioned volatile oil, and mixing is made 800g; Or amalgamation liquid is evaporated to the medicinal liquid that relative density is 1.08～1.10 (55 ℃), and spray drying is made dry extract, gets dry extract, adds lactose appropriate, mixes, and adds above-mentioned volatile oil, and mixing driedly is rolled into granule 400g, and get final product.
Yet, the main component of the Herba Menthae Haplocalycis volatile oil in this prescription is Mentholum, be used for mucosa and can produce refrigerant sense, have the sore-throat relieving that wets one's whistle, alleviate the effect of discomfort and pain, therefore have clinically all to have added Herba Menthae in a lot of Chinese medicine preparation, in especially existing various throat lozenges, Chang Yiqi is used for pharyngolaryngitis and tonsillitic auxiliary treatment as main active.But, the shortcoming that there is fusing point low (its fusing point is the 42-44 degree) in Mentholum itself, easily distils, therefore performance is extremely unstable in preparation, especially volatile in the processing of granular preparation and storage, so that in existing cold granules preparation the content of Mentholum on the low side, detect defective and the problem such as result of use is not remarkable, affected on the contrary its effect.
The inventor is by the discovery that studies for a long period of time, and the effect of Fructus Arctii is dispelling wind and heat pathogens, lung qi dispersing rash, resolving toxin and disinhibiting the throat.Be used for anemopyretic cold, cough with copious phlegm, measles, rubella, laryngopharynx swelling and pain, mumps, erysipelas, carbuncle sore tumefacting virus.In the symptom of anemopyretic cold, laryngopharynx swelling and pain is the most distinctive symptom, and this symptom allows the patient feel to feel bad the most in the flu process, and Fructus Arctii mainly plays pharynx-clearing throat-benefiting in prescription, alleviate the symptom of laryngopharynx swelling and pain.
Therefore, in order to overcome above-mentioned shortcoming, the inventor further improves the prescription of cold granules, has proposed a kind of new cold granules pharmaceutical formulation and preparation method thereof.
Summary of the invention
Therefore, the purpose of this invention is to provide the pharmaceutical composition that a kind of new treatment is caught a cold.
A kind of pharmaceutical composition for the treatment of flu is made by following crude drug: Herba Schizonepetae 120-300g, Fructus Arctii 40-100g, Radix Saposhnikoviae 60-200g, Radix Bupleuri 60-200g, Folium Perillae 40-100g, Radix Puerariae 60-200g, Radix Platycodonis 40-100g, Semen Armeniacae Amarum 40-180g, Radix Angelicae Dahuricae 40-100g, Herba Corydalis Bungeanae 100-300g and Rhizoma Phragmitis 100-250g.
As one of preferred embodiment of the invention, pharmaceutical composition, the especially granular preparation for the treatment of flu of the present invention are to be made by following crude drug: Herba Schizonepetae 300g, Fructus Arctii 60g, Radix Saposhnikoviae 150g, Radix Bupleuri 100g, Folium Perillae 50g, Radix Puerariae 150g, Radix Platycodonis 50g, Semen Armeniacae Amarum 150g, Radix Angelicae Dahuricae 50g, Herba Corydalis Bungeanae 100g and Rhizoma Phragmitis 250g.
The purpose of this invention is to provide a kind of method for preparing the granular preparation for the treatment of flu, comprise the following steps: get the above-mentioned raw materials medicine of recipe quantity, micronization is pulverized, and crosses 100 mesh sieves.Add sucrose in above-mentioned powder, mixing take 70% ethanol water as binding agent, is granulated, drying, and granulate, sterilization is packed in 100 bags and get final product.
For above-mentioned dosage form can be realized, need to add the acceptable adjuvant of pharmacy when these dosage forms of preparation, such as: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic, substrate etc.Filler comprises: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.; Disintegrating agent comprises: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.; Lubricant comprises: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.; Suspending agent comprises: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl emthylcellulose etc.; Binding agent comprises, starch slurry, polyvinylpyrrolidone, hydroxypropyl emthylcellulose etc.; Sweeting agent comprises: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.; Correctives comprises: sweeting agent and various essence; Antiseptic comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, acetic acid chloroethene are decided, the Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods; Substrate comprises: PEG6000, PEG4000, insect wax etc.
The specific embodiment
Following examples are to further illustrate of the present invention, but never limit the scope of the present invention.Further elaborate the present invention below with reference to embodiment, but it will be appreciated by those skilled in the art that the present invention is not limited to the preparation method of these embodiment and use.And those skilled in the art can be equal to replacement, combination, improvement or modify the present invention according to description of the invention, but these all will comprise within the scope of the invention.
Embodiment 1 cold granules
Choose Herba Schizonepetae 300g, Fructus Arctii 60g, Radix Saposhnikoviae 150g, Radix Bupleuri 100g, Folium Perillae 50g, Radix Puerariae 150g, Radix Platycodonis 50g, Semen Armeniacae Amarum 150g, Radix Angelicae Dahuricae 50g, Herba Corydalis Bungeanae 100g and Rhizoma Phragmitis 250g;
With the crude drug of above-mentioned recipe quantity, micronization is pulverized, and crosses 100 mesh sieves, adds sucrose 50g in above-mentioned powder, and mixing take 70% ethanol water as binding agent, is granulated, drying, and granulate, sterilization is packed in 100 bags and get final product.
Embodiment 2 cold granules
Choose Herba Schizonepetae 300g, Fructus Arctii 60g, Radix Saposhnikoviae 150g, Radix Bupleuri 100g, Folium Perillae 50g, Radix Puerariae 150g, Radix Platycodonis 50g, Semen Armeniacae Amarum 150g, Radix Angelicae Dahuricae 50g, Herba Corydalis Bungeanae 100g and Rhizoma Phragmitis 250g;
With the crude drug of above-mentioned recipe quantity, micronization is pulverized, and crosses 100 mesh sieves, and mixing take 70% ethanol water as binding agent, is granulated, drying, and granulate, sterilization is packed in 100 bags and get final product.
Comparative Examples 1 cold granules
Choose Herba Schizonepetae 300g, Herba Menthae 60g, Radix Saposhnikoviae 150g, Radix Bupleuri 100g, Folium Perillae 50g, Radix Puerariae 150g, Radix Platycodonis 50g, Semen Armeniacae Amarum 150g, Radix Angelicae Dahuricae 50g, Herba Corydalis Bungeanae 100g and Rhizoma Phragmitis 250g; The official granule that is prepared into of above composition.
Embodiment 3 case researches
Accept flu patient 20 examples for medical treatment, wherein, male 10 examples, female's 10 examples, age 15-31 year, 23 years old mean age, the course of disease 1 day-7 days, average course of disease 2 days.Cold symptoms: 1. Western medicine diagnose: upper respiratory tract infection, heating is more than 37.5 ℃, with headache, feel sick.2. tcm diagnosis: pestilence is from the beginning of, abnormal climates in four seasons is invaded heresy, cold, suddenly cold and suddenly hot, headache is felt sick, bitter taste is tasteless, anorexia, four strands are aching and limp, yellowish or reddish urine, constipation and disease belong to the various cold and hot deficiency and excess of flu disease.The hemogram numeration of leukocyte is normal or on the low side, and percentage of lymphocyte raises.
Choosing the granule of preparation in embodiment 1 treats.Described granule is taken 3 times every day, each one bag.3 days is a course for the treatment of.
Referring to " new Chinese medicine guideline of clinical investigations " (Zheng Xiao cornel chief editor, Chinese Medicine science and technology publishing house, in May, 2002 front page, the 60th page) formulate the flu curative effect determinate standard:
Recovery from illness: clinical symptoms, sign disappear or basic the disappearance; The sign integration reduces 〉=95%;
Produce effects: clinical symptoms, sign are obviously improved; The sign integration reduces 〉=70%;
Effectively: clinical symptoms, sign all take a favorable turn; The sign integration reduces 〉=30%;
Invalid: clinical symptoms, sign are all without obviously improving, even increase the weight of; The sign integration reduces less than 30%.
After treating 1 course for the treatment of, all patients all fully recover, and cure rate reaches 100%.And do not observe the untoward reaction such as nauseating, dizzy, irritated.
Embodiment 4 analgesic test
Experimental agents:
Of the present invention group: embodiment 1
Matched group: Comparative Examples 1
Hot way: select in 55 ± 0.1 ℃ of super tepidariums and lick rear foot reaction.45 of the female healthy mice white mice of the 18-22g that is no more than 30 seconds incubation period are divided into 3 groups at random, 15 every group: of the present invention group, matched group, dolantin group all adopt the aqueous solution gavage.Measure mice after 1h and lick metapedes incubation period.Experimental result sees Table 1.
Table 1
Namely be equivalent to commercially available granule with obviously being better than Comparative Examples 1().
Embodiment 5 antiinflammatory experiments
Of the present invention group: embodiment 1
Matched group: Comparative Examples 1
45 of 180-220g male rats are divided into 15 of normal saline matched groups at random, of the present invention group, matched group.Normal saline matched group and of the present invention group were successive administration two days, all adopted the aqueous solution gavage, after fasting 10h, first survey before the last administration and do not cause scorching each Rat Right foot sole of the foot volume, then administration, and only give 1% carrageenin 0.2ml/, left sufficient sole of the foot fascia hemostasis.Then respectively at cause scorching after 1,2,4,6h surveys respectively each Rat Right foot sole of the foot volume, the variant time is respectively organized the rat paw change in volume, swelling=(cause scorching front volume-cause scorching after volume)/cause scorching front volume * 100%.The foot swelling that 1 pair of rat carrageenan of the results show: embodiment causes has obvious inhibitory action than Comparative Examples 1.
Embodiment 6 bacteriostatic tests
Of the present invention group: embodiment 1
Matched group: Comparative Examples 1
Embodiment 1 granule and Comparative Examples 1 granule, the steel pipe method is done bacteriostatic test consequently: to the cure the disease inhibitory action of bacterium of various respiratory road, see Table 2
Table 2
Result shows, the fungistatic effect of granule of the present invention all is better than Comparative Examples 1(and namely is equivalent to commercially available granule).
Claims (3)
1. a medicine granule for treating for the treatment of flu, is characterized in that being made by following crude drug: Herba Schizonepetae 120-300g, Fructus Arctii 40-100g, Radix Saposhnikoviae 60-200g, Radix Bupleuri 60-200g, Folium Perillae 40-100g, Radix Puerariae 60-200g, Radix Platycodonis 40-100g, Semen Armeniacae Amarum 40-180g, Radix Angelicae Dahuricae 40-100g, Herba Corydalis Bungeanae 100-300g and Rhizoma Phragmitis 100-250g.
2. according to claim 1 medicine granule for treating, is characterized in that described material medicine is selected from Herba Schizonepetae 300g, Fructus Arctii 60g, Radix Saposhnikoviae 150g, Radix Bupleuri 100g, Folium Perillae 50g, Radix Puerariae 150g, Radix Platycodonis 50g, Semen Armeniacae Amarum 150g, Radix Angelicae Dahuricae 50g, Herba Corydalis Bungeanae 100g and Rhizoma Phragmitis 250g.
3. method for preparing medicine granule for treating as claimed in claim 1, it is characterized in that comprising the following steps: get the above-mentioned raw materials medicine of recipe quantity, micronization is pulverized, and crosses 100 mesh sieves, can add sucrose in above-mentioned powder, mixing take 70% ethanol water as binding agent, is granulated, dry, granulate, sterilization is packed in 100 bags and get final product.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2013100929545A CN103142874A (en) | 2013-03-21 | 2013-03-21 | Granule preparation for treating cold |
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| CN2013100929545A CN103142874A (en) | 2013-03-21 | 2013-03-21 | Granule preparation for treating cold |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114306524A (en) * | 2017-01-13 | 2022-04-12 | 石药控股集团河北唐威药业有限公司 | Preparation method of cold heat-clearing tablet |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101822697A (en) * | 2009-07-13 | 2010-09-08 | 湖南省中医药研究院 | Preparation method of traditional Chinese medicine ultrafine formula particles |
| CN101954003A (en) * | 2009-07-21 | 2011-01-26 | 修正药业集团股份有限公司 | Method for preparing Chinese medicinal granules for treating cold |
| CN102145129A (en) * | 2010-02-09 | 2011-08-10 | 北京亚东生物制药有限公司 | Method for preparing medicinal composition for treating anemofrigid cold |
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- 2013-03-21 CN CN2013100929545A patent/CN103142874A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101822697A (en) * | 2009-07-13 | 2010-09-08 | 湖南省中医药研究院 | Preparation method of traditional Chinese medicine ultrafine formula particles |
| CN101954003A (en) * | 2009-07-21 | 2011-01-26 | 修正药业集团股份有限公司 | Method for preparing Chinese medicinal granules for treating cold |
| CN102145129A (en) * | 2010-02-09 | 2011-08-10 | 北京亚东生物制药有限公司 | Method for preparing medicinal composition for treating anemofrigid cold |
Non-Patent Citations (1)
| Title |
|---|
| 张雪峰: "高效液相色谱法测定感冒灵颗粒中对乙酰氨基酚含量", 《中国药业》, vol. 19, no. 6, 31 December 2010 (2010-12-31), pages 30 - 31 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114306524A (en) * | 2017-01-13 | 2022-04-12 | 石药控股集团河北唐威药业有限公司 | Preparation method of cold heat-clearing tablet |
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Address after: 266103 Qingdao economic and Technological Development Zone, unity Road, No. 3601, Shandong Applicant after: Qingdao Zhengda Haier Pharmaceutical Co., Ltd. Address before: 266103 Haier Road, Shandong, Qingdao, No. 1 Applicant before: Qingdao Zhengda Haier Pharmaceutical Co., Ltd. |
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Application publication date: 20130612 |