CN1679861A - Medicine for treating toothache - Google Patents

Medicine for treating toothache Download PDF

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Publication number
CN1679861A
CN1679861A CN200510050981.1A CN200510050981A CN1679861A CN 1679861 A CN1679861 A CN 1679861A CN 200510050981 A CN200510050981 A CN 200510050981A CN 1679861 A CN1679861 A CN 1679861A
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medicine
fine powder
toothache
folium caryophylli
group
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CN200510050981.1A
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CN1290528C (en
Inventor
陈阳
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Guangdong Taikang Pharmaceutical Co ltd
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Shenzhen Taikang Pharmacy Co ltd
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Abstract

The invention relates to a medicament for treating toothache and a preparation method thereof. The medicine has effects of clearing heat and detoxicating, dispelling pathogenic wind and relieving pain, and is suitable for wind-fire toothache etc. The medicine is prepared by taking clove leaves and asarum as raw material medicines according to a certain weight ratio, and has the characteristics of small toxic and side effects, remarkable effect and the like.

Description

A kind of medicine for the treatment of toothache
Technical field
The present invention relates to a kind of medicine for the treatment of toothache, be used for heat-clearing and toxic substances removing, dispelling wind and relieving, toothache such as treatment acute toothache are sick.
Background technology
The toothache disease is very seen clinical more, show according to for the second time national oral health epidemiological investigation, China's adult's permanent tooth is suffered from caries incidence 49.88%, child's deciduous teeth caries prevalence rate 76.55%, chewing of tooth is first procedure of digestive system, odontopathy has very important influence for health, the long-term odontopathy of suffering from can cause digestive system inflammation and ulcer, especially acute toothache, make the difficult peace in patient bedroom, the medicine that is specifically designed to the treatment toothache is not also arranged so far, generally all use analgesics, but the analgesic effect can not fundamentally be treated the disease of toothache itself, the normal employing of doctor trained in Western medicine is got into the cave and is killed nerve, repeatedly handle from after, cause very big misery to the patient, it is not thorough more to kill nerve, recurrence once more behind the stifled upper tooth makes the patient suffering can't bear; And the traditional Chinese medical science lacks the special-purpose medicaments that is specifically designed to treatment toothache disease, and market is existing of less types, and curative effect is all not remarkable, can not effectively effect a radical cure toothache.
Summary of the invention
Purpose of the present invention is exactly at the deficiencies in the prior art, and a kind of medicine for the treatment of toothache and preparation method thereof is provided.This medicine has heat-clearing and toxic substances removing, and the effect of dispelling wind and relieving is used for acute toothache, mainly is applicable to toothache battle array work, meets wind and promptly sends out, and is heated and increases the weight of, and very then toothache connects and women's head-ornaments portion, or with red swelling of gingiva, diseases such as mouthful thirst and desire for cold drink.
The present invention is realized by following technical scheme:
(1) crude drug prescription and weight portion thereof:
Folium Caryophylli 80-110 Herba Asari 6-12
Wherein preferred weight part of crude drug is:
Folium Caryophylli 100 Herba Asaris 10
(2) process recipes:
A) Folium Caryophylli, the Herba Asari of weight such as take by weighing, pulverize separately becomes fine powder, and is standby;
B) get the Folium Caryophylli of described weight ratio difference in addition, be ground into coarse powder, decoct with water twice, each 1.5 hours, collecting decoction filtered, and it is 1.05 ~ 1.15 clear paste that filtrate decompression is concentrated into relative density; Add above-mentioned a) step gained Folium Caryophylli fine powder, mixing, low temperature (below 60 ℃) drying is ground into fine powder, and the Herba Asari fine powder stirring and evenly mixing with above-mentioned a) step gained sieves and makes powder; Perhaps incapsulate and make capsule; Perhaps add the water soluble excipient mixing, make soft material, make granule by granulation machine with suitable ethanol; Perhaps add starch, pulverize, sieve, granulate, dry, tabletting, promptly get tablet.
Experimental section:
One, stability test
To this lot number sample, adopt preliminarily stabilised test room temperature to observe and waited two kinds of methods in 2 years, the character identification of this medicine, moisture checks, the observation of aspects such as content disintegration, and observed result proves that this medicine preserves at normal temperatures, physicochemical property is stable altogether, and storage life can be more than 2 years.
Two, toxicology part
1, acute toxicity test: medicine of the present invention fails to survey LD for the mouse stomach administration 50, maximum tolerance determination gives none death and toxic reaction in the maximum volume (5g/kg) seven days of Cmax 30% of animals received.Extrapolating adult (50kg) therapeutic dose thus is 3.6g, is equivalent to 625 times of clinical application amounts.
2, long term toxicity test: select 60 of healthy rat, male and female half and half, random packet, test, the result shows, heavy dose of group, average 4.8g/kg, calculate with oral administration and to be equivalent to 66.7 times of clinical adult's consumptions, so a large amount of medications are after 30 days, through becoming celestial substantially and the liver of histopathologic examination animal, the heart, lung, spleen, kidney, stomach, brain etc. there is no abnormal change.Can think medicine non-toxic reaction of the present invention.
Three, pharmacodynamics part
1, analgesic experiment: medicine of the present invention, drug level lumbar injection 0.6%HACO, 0.3ml/ only contrast with the normal saline matched group, observe its abdominal part after 15 minutes and paste ground, be the stretching, extension of contracting, buttocks is askew etc., the result shows, toothache rather can suppress the writhing response that HAD causes significantly, hot pulling manipulation, medicine of the present invention can suppress HAD significantly and cause writhing response, the oral a certain amount of medicine of the present invention of pain administration group then before hot its administration of pulling manipulation measuring, the administration of positive controls (morphine hydrochloride) subcutaneous injection, matched group is oral with the volume normal saline, measure each Mus pain threshold, the result shows: no matter self relatively still compares between group the oral administration group, all can obviously improve its pain threshold.
2, antiinflammatory action: select dimethylbenzene to cause the influence of Mus otitis disease, administration group and cortisone group, blank group, put to death mice after 80 minutes and cut two ears and get same position with card punch and weigh, the difference of showing two ear weight is as the swelling degree, survey its suppression ratio, the result shows, the medicine of the present invention of doses can obviously be held inhibition dimethylbenzene and cause Mus otitis disease swelling effect, simultaneously, experiment shows that also heavy dose of medicine of the present invention has remarkable reduction mouse peritoneal vascular permeability effects to the mouse peritoneal vascular permeability.
3, to anesthesia rabbit normal arterial pressure and breathing influence: animal is used urethane (1g/kg) anesthesia, presses 0.5ml/kg (1: 5) intravenous injection medicine of the present invention and Sanguis Leporis seu oryctolagi is pressed and breathe the nothing influence.
4, gastrointestinal motility is influenced, the administration group, medicine group of the present invention and blank group are even to prepared Chinese ink 0.2ml, calculate the percentage rate that every group of mice prepared Chinese ink mobile distance in small intestinal accounts for the small intestinal total length, the result shows that medicine of the present invention has potentiation to the mouse GI tract wriggling.
5, bacteriostatic test, select group B streptococcus for use, staphylococcus aureus, the epidemic cerebrospinal meningitis coccus, bacillus typhi murium, lactobacillus, the Nai Shi diplococcus carries out the bacteriostatic test result of medicine of the present invention, medicine medicinal liquid of the present invention (1: 10) is to group B streptococcus, and lactobacillus, Nai Shi diplococcus have the height bacteriostasis.Staphylococcus aureus there is not bacteriostasis.
Four, clinical trial structure
Ended on October 20th, 15 days 1 from JIUYUE in 1987, carry out clinical observation 739 examples breathing out the attached First Academy of medical university.
1, medicine of the present invention through clinical verification, to the clinical obvious effective rate 97.9% of acute pulpitis (144 example), is compared with simple tooth body specific treatment (matched group 45 examples) clinical efficacy, and there were significant differences.
2, there were significant differences to acute suppurative pulpitis and matched group (simple tooth body specific treatment) 38 examples.
3, there were significant differences to give simple tooth body treatment to chronic pulpitis (no locking type) 26 examples and contrast.
4, chronic pulpitis acute attack 42 examples and simple tooth body being treated 30 examples compares notable difference is also arranged.
5, ascending pulpitis 30 examples and simple tooth body being treated 24 examples compares notable difference is also arranged.
6, medicine group of the present invention and bacterium medicine contrast medicine group, medicine group effective percentage of the present invention is 97.9%, and the indometacin group is 72%, and the spiramycin group is 64%.
The aggregate analysis statistical procedures, administration group and simple tooth body specific treatment recovery from illness X 2=11.91 P=<0.001, total effective rate X 2=37.30 P<0.0001, notable difference, second group of observation group and matched group recovery from illness number X 2=6.04 P<0.01, total significant figure X 2There is notable difference=9.07 P<0.05.
7, all observe case, have in the medication observation process and all do not find any untoward reaction.
8, through clinical verification, the function of medicine of the present invention cures mainly, and has clearing away heat-fire, the detumescence dispel the pain effect, be the active drug of clinical treatment pulpitis, periodontitis, gingivitis and various acute toothache, because of its steady quality, preservation and easy to carry is particularly suitable for clinical expansion and uses.
Five, acute toxicity test
Test specimen preparation: get medicine Chinese medicine powder of the present invention, add water and make certain density medicine medicated powder suspension of the present invention and be for experiment.Through repeatedly prerun, 30% (g/v) is its Cmax.Dosage is by its capsule Chinese medicine powder re-computation.
1, median lethal dose(LD 50) (LD 50) measure:
(1) pilot study: it gives result of the test and fails to find out 100% animal dead dosage.
(2) formal test: an oral administration gavage administration, agent was apart from 1: 0: 8.The maximum dose level group gives the dosage of the maximum volume under the Cmax that animal can accept.Table 1 as a result.
Table 1
Group Number of animals (only) Dosage (g/kg) Gavage capacity ( Ml/ only) and concentration Death toll in seven days (only)
????1 ????10 ????15.0 ????1.00(3∶10) ?????0
????2 ????10 ????12.0 ????0.80(3∶10) ?????0
????3 ????10 ?????9.6 ????0.64(3∶10) ?????0
????4 ????10 ?????7.7 ????0.51(3∶10) ?????0
????5 ????10 ?????6.1 ????0.41(3∶10) ?????0
As seen from Table 1, give mouse gavaging medicine medicated powder of the present invention suspension by 6.1 ~ 15g/kg dosage, none dead mouse in seven days is not also observed the toxic reaction of mice after the administration.Because of administration concentration 30% and administration volume (1.0ml/ only) to maximum, thereby oral administration gavage medicine medicated powder of the present invention suspension mice LD is failed to measure in this test one time 50
2, maximum tolerance determination: be administered three times to mouse stomach in 24 hours, give the dosage (15g/kg) of the maximum volume (1ml/20g) under the Cmax (30%) of animals received at every turn, interval 7 hours, none dead mouse and toxic reaction situation in seven days.
Calculating in one day total dosage is 45g/kg, and (50kg) day therapeutic dose of being grown up is 3.6g, by through extrapolating the clinical application amount that is equivalent to=45g%kg ÷ 3.6g/50kg=625 doubly.
3, untoward reaction: in 24 hours, connect administration for the third time, behind the mouse stomach 2 hours, finding had 1/3 animal loose stool to occur, and promptly total dosage is that 45g/kg is the dosage that causes loose stool, fails to occur this symptom with next mice.
Six, long term toxicity test pathologic finding report
1, tried thing: medicine of the present invention provides lot number by the emerging Chinese medicine institute in Harbin City: 930928
2, animal grouping: the Wistar kind is 60 of healthy white rats, and male and female half and half are supplied with by workers and peasants' animal cultivation field, Harbin, and animal produces the quality certification number: 007.Be divided into three groups at random, every group 20, each 10 of male and female.
3, dosage, approach:
Low dose group: 2.4g/kg dosage (being equivalent to be grown up clinical day therapeutic dose X33.3 doubly).
High dose group: 4.8g/kg dosage (being equivalent to be grown up clinical day therapeutic dose X66.6 doubly).
Irritate stomach 12 and 24% medicine medicated powder suspension 2ml/100g body weight of the present invention respectively once to rat, continuous 4 weeks by above-mentioned dosage every day.
4, check result: after last administration 24 hours, half animal is killed in every group of work, and processing method is got animal viscera routinely, fix with 10% formalin solution, paraffin wax Bao Li, section, HE dyeing, do the histopathologic examination of blank group and high dose group with optical microscope, the result shows that high dose group and blank group compare, and organs such as its heart, liver, spleen, lung, kidney, stomach, brain, adrenal gland, testis, ovary, small intestinal are not seen the toxicity pathological change.
The preservation though low dose group has been drawn materials is because of the no abnormal pathological changes of high dose, so do not carry out histological examination again.
The rat long term toxicity test result of histopathologic examination:
Each organizational structure of organizing the organ such as the heart, liver, spleen, lung, kidney, stomach, brain, adrenal gland, testis, ovary, small intestinal of laboratory animal all belongs to normally, does not see morphological changes of various tissue components such as degeneration, necrosis.The lung of minority animal, spleen, the nephremia may in time not cut off head when putting to death animal so that thrombosis is relevant.A small amount of cell infiltration is arranged in the lung tissue of small part administration group and blank treated animal, may be that administration, feedwater mistiming pour into lung and the inflammatory reaction that causes.The visible kitchen range pneumorrhagia of minority administration group and blank group is not seen hemosiderosis in the hemorrhagic focus, thus may with the time extruding lungs of locating animal, cause rupture of pulmonary vessel hemorrhage due to.
High dose administration group compares with blank, there is no to be the dose dependent pathological change, so may be histopathologic examination's non-toxic reaction of administration group laboratory animal.See Table 5-1 and table 5-2.
Table 5-1 medicine rat of the present invention long term toxicity test pathological examination result
Organ Lesion tissue The blank group High dose group
The heart Cytopathy ??????0 ??????0
Necrocytosis ??????0 ??????0
Inflammatory cell is moistening ??????0 ??????0
The liver spleen Blood stasis ??????0 ??????0
Cytopathy ??????0 ??????0
Necrocytosis ????±(2) ????±(1)
Blood stasis ????+(2) ????+(3)
Downright bad ??????0 ??????0
Cell infiltration ??????0 ??????0
Blood stasis ????+(2) ????+(3)
Lung Edema ??????0 ??????0
Hemorrhage ????+(1) ????+(2)
Cell infiltration ????±(2) ????±(1)
Kidney The renal tubular epithelial degeneration ??????0 ??????0
The renal tubular epithelial necrosis ??????0 ??????0
Matter blood stasis between kidney ????+(3) ????+(2)
Cell infiltration ??????0 ??????0
Stomach Mucous hyperemia ??????0 ??????0
Flesh layer cell infiltration ??????0 ??????0
The mucous epithelium degeneration ??????0 ??????0
The mucositis cellular infiltration ??????0 ??????0
The mucous epithelium necrosis ??????0 ??????0
Brain Neurocyte hyperemia ???0 ???0
Purkinje cell is changed in quality ???0 ???0
The cell degeneration ???0 ???0
Table 5-2 medicine rat of the present invention long term toxicity test pathological examination result
Organ Lesion tissue The blank group High dose group
The adrenal gland Cytopathy ??????0 ??????0
Necrocytosis ??????0 ??????0
Hemorrhage ??????0 ??????0
Cell infiltration ??????0 ??????0
Testis Cytopathy ??????0 ??????0
Necrocytosis ??????0 ??????0
Cell infiltration ??????0 ??????0
Ovary The inner membrance glandular hyperplasia ??????0 ??????0
The atrophy of inner membrance body of gland ??????0 ??????0
The intimitis cellular infiltration ???+(1)++(1) ????++(2)
The degeneration of flesh confluent monolayer cells ??????0 ??????0
The necrosis of flesh confluent monolayer cells ??????0 ??????0
Flesh layer cell infiltration ??????0 ??????0
Small intestinal Mucous hyperemia ??????0 ??????0
The mucous epithelium degeneration ??????0 ??????0
The mucous epithelium necrosis ??????0 ??????0
The mucositis cellular infiltration ??????0 ??????0
The degeneration of flesh confluent monolayer cells ??????0 ??????0
The necrosis of flesh confluent monolayer cells ??????0 ??????0
Specific embodiment
Further specify the present invention below in conjunction with embodiment.
Embodiment 1:
A) take by weighing Folium Caryophylli, the Herba Asari of 100g respectively, pulverize separately becomes fine powder again, and is standby;
B) get the 900g Folium Caryophylli in addition, be ground into coarse powder, decoct with water twice, each 1.5 hours, collecting decoction filtered, and it is 1.15 clear paste that filtrate decompression is concentrated into relative density; Add above-mentioned a) step gained Folium Caryophylli fine powder, mixing, low temperature (below 60 ℃) drying is ground into fine powder, and the Herba Asari fine powder stirring and evenly mixing with above-mentioned a) step gained sieves, and incapsulates and makes 1000, promptly gets capsule.
Embodiment 2:
A) take by weighing Folium Caryophylli, the Herba Asari of 60g respectively, pulverize separately becomes fine powder again, and is standby;
B) get the 740g Folium Caryophylli in addition, be ground into coarse powder, decoct with water twice, each 1.5 hours, collecting decoction filtered, and it is 1.10 clear paste that filtrate decompression is concentrated into relative density; Add above-mentioned a) step gained Folium Caryophylli fine powder, mixing, low temperature (below 60 ℃) drying is ground into fine powder, and with the Herba Asari fine powder stirring and evenly mixing of above-mentioned a) step gained, powder sieves.
Embodiment 3:
A) take by weighing Folium Caryophylli, the Herba Asari of 120g respectively, pulverize separately becomes fine powder again, and is standby;
B) get the 980g Folium Caryophylli in addition, be ground into coarse powder, decoct with water twice, each 1.5 hours, collecting decoction filtered, and it is 1.15 clear paste that filtrate decompression is concentrated into relative density; Add above-mentioned a) step gained Folium Caryophylli fine powder, mixing, low temperature (below 60 ℃) drying; be ground into fine powder, the Herba Asari fine powder stirring and evenly mixing with above-mentioned a) step gained sieves; add an amount of dextrin mixing, make soft material, make granule by granulation machine with suitable ethanol.
Embodiment 4:
A) take by weighing Folium Caryophylli, the Herba Asari of 80g respectively, pulverize separately becomes fine powder again, and is standby;
B) get the 920g Folium Caryophylli in addition, be ground into coarse powder, decoct with water twice, each 1.5 hours, collecting decoction filtered, and it is 1.15 clear paste that filtrate decompression is concentrated into relative density; Add above-mentioned a) step gained Folium Caryophylli fine powder, mixing, low temperature (below 60 ℃) drying is ground into fine powder, and the Herba Asari fine powder stirring and evenly mixing with above-mentioned a) step gained sieves, and adds starch, pulverizes, sieves, granulates, dry, tabletting, promptly gets tablet.

Claims (3)

1, a kind of medicine that is used for the treatment of toothache is characterized in that it is to be made by following raw materials by weight proportions:
Folium Caryophylli 80-110 Herba Asari 6-12.
2, the medicine that is used for the treatment of toothache according to claim 1 is characterized in that it is to be made by following raw materials by weight proportions:
Folium Caryophylli 100 Herba Asaris 10.
3, the preparation method that is used for the treatment of the medicine of having a toothache according to claim 1 and 2 is characterized in that, comprises the following steps:
A) Folium Caryophylli, the Herba Asari of weight such as take by weighing, pulverize separately becomes fine powder, and is standby;
B) get the Folium Caryophylli of described weight ratio difference in addition, be ground into coarse powder, decoct with water twice, each 1.5 hours, collecting decoction filtered, and it is 1.05 ~ 1.15 clear paste that filtrate decompression is concentrated into relative density; Add above-mentioned a) step gained Folium Caryophylli fine powder, mixing, cold drying below 60 ℃ is ground into fine powder, and the Herba Asari fine powder stirring and evenly mixing with above-mentioned a) step gained sieves and makes powder; Perhaps incapsulate and make capsule; Perhaps add the water soluble excipient mixing, make soft material, make granule by granulation machine with suitable ethanol; Perhaps add starch, pulverize, sieve, granulate, dry, tabletting, promptly get tablet.
CN200510050981.1A 2005-02-04 2005-02-04 Medicine for treating toothache Active CN1290528C (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104208159A (en) * 2013-11-27 2014-12-17 詹其旸 Chinese herbal medicine for treating wind-fire toothache
CN105832854A (en) * 2016-05-18 2016-08-10 庄章彬 Application of four-leaved clover juice to preparation of medicine for treating toothache
CN114432362A (en) * 2022-03-24 2022-05-06 北京明阳华夏科技有限公司 Traditional Chinese medicine composition for easing pain, resisting inflammation and reducing swelling, preparation and application

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104208159A (en) * 2013-11-27 2014-12-17 詹其旸 Chinese herbal medicine for treating wind-fire toothache
CN105832854A (en) * 2016-05-18 2016-08-10 庄章彬 Application of four-leaved clover juice to preparation of medicine for treating toothache
CN114432362A (en) * 2022-03-24 2022-05-06 北京明阳华夏科技有限公司 Traditional Chinese medicine composition for easing pain, resisting inflammation and reducing swelling, preparation and application
CN114432362B (en) * 2022-03-24 2023-09-01 北京明阳华夏科技有限公司 Traditional Chinese medicine composition for easing pain, resisting inflammation and relieving swelling, preparation and application

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