CN112168931B - A pharmaceutical composition for treating oral ulcer, and its preparation method - Google Patents
A pharmaceutical composition for treating oral ulcer, and its preparation method Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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Abstract
The invention relates to the technical field of medicines, in particular to a pharmaceutical composition for treating oral ulcer and a preparation method thereof, wherein the pharmaceutical composition comprises the following components in parts by weight: 10-20 parts of coptis chinensis, 5-12 parts of golden cypress, 5-10 parts of houttuynia cordata, 4-7 parts of corydalis bungeana, 5-10 parts of radix rehmanniae recen, 5-10 parts of lophatherum gracile, 3-6 parts of borneol, 10-15 parts of dragon's blood, 2-5 parts of asarum, 5-10 parts of lemon, 3-8 parts of aloe, 3-8 parts of mint extract and 1-5 parts of folic acid.
Description
Technical Field
The invention relates to the technical field of medicines, in particular to a pharmaceutical composition for treating oral ulcer and a preparation method thereof.
Background
The oral ulcer is commonly called as aphtha, is a local ulcer injury of oral mucosa which is characterized by periodic repeated attack and can be self-healed, but the ulcer has the characteristics of periodicity, recurrence, self-limitation and the like, is generally difficult to heal in short time, is a common ulcerative injury disease occurring in the oral mucosa, is mostly seen in the inner side of lips, tongue abdomen, buccal mucosa, vestibular sulcus, soft palate and other parts, and the mucosa of the parts is lack of a cutinized layer or has poor keratosis. Tongue ulcer refers to oral ulcer occurring on tongue and tongue abdomen. The pain is severe when the oral ulcer is attacked, the local burning pain is obvious, and serious patients can influence diet and speaking, thereby causing great inconvenience to daily life; can be used for treating halitosis, chronic pharyngitis, constipation, headache, dizziness, nausea, asthenia, dysphoria, fever, and lymphadenectasis.
The recurrent oral ulcer has high morbidity, is considered to be related to local trauma, mental stress, food, medicaments, hormone level change, virus and bacterial infection and vitamin or trace element deficiency by modern medical research, has uncertain etiology, and is considered to be related to an immune mechanism by learners. Systemic diseases, genetics, immunity and microorganisms may play an important role in their occurrence and development. The treatment is mainly local treatment, and the serious one needs systemic treatment. Modern medicine believes that recurrent oral ulceration is first of all very closely related to immunity. Some patients show immunodeficiency, and some patients show autoimmune reaction, namely, because of various factors, the normal immune system of the human body generates immune reaction to self tissue antigen, and the tissue is damaged and the disease is developed.
Burning sensation brought by the ulcer is substantial and annoying, and people can not enjoy the food or even feel pain even drinking the mouth water. At present, the methods for treating oral ulcer are various, and mainly comprise methods of western medicine oral administration, traditional Chinese medicine treatment, food nourishing treatment, ulcer sticking and the like, and the methods have certain curative effects but general effects. Although a lot of medicines for treating oral ulcer are available on the market at present, the medicines have long healing period and poor curative effect, and cannot eliminate pain of patients and improve discomfort of the patients in a short time.
Chinese patent application CN108635478A discloses a Chinese medicinal composition for treating oral ulcer, pharyngitis and tonsillitis and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials: 5-15 parts of coptis chinensis, 5-15 parts of borneol, 80-100 parts of sun-dried ginseng, 15-25 parts of golden cypress, 2-4 parts of bezoar, 5-15 parts of indigo naturalis, 50-70 parts of common andrographis herb, 5-15 parts of dragon's blood, 20-40 parts of catechu, 90-110 parts of pearl, 50-70 parts of gypsum rubrum, 20-40 parts of rheum officinale, 20-40 parts of blackberry lily, 20-40 parts of mint, 15-25 parts of liquorice and 50-70 parts of charcoal soapberry. The traditional Chinese medicine composition can kill germs causing oral cavity and throat inflammation, has the effects of clearing heat, relieving pain, promoting granulation, healing sore, relieving swelling, resolving hard mass and improving immunity of organisms, and can reduce the pain of patients to the greatest extent.
Chinese patent application CN108524812A discloses a medicine for treating oral ulcer and a preparation method thereof, wherein the medicine comprises the following raw materials in parts by weight: 3-12 parts of phellodendron, 6-15 parts of bletilla, 3-9 parts of pseudo-ginseng, 1-15 parts of borneol, 3-25 parts of coptis, 6-15 parts of forsythia, 1-15 parts of catechu, 6-15 parts of bamboo leaf roll core, 10-30 parts of figwort, 3-20 parts of radix ophiopogonis, 5-30 parts of salvia miltiorrhiza and 1-20 parts of dragon's blood. The preparation method comprises the following steps: processing golden cypress; processing coptis chinensis; pulverizing Catechu, sanguis Draxonis, and Notoginseng radix; pulverizing Borneolum Syntheticum; extracting medicinal materials; and finally, uniformly mixing the prepared medicinal powder to obtain the Chinese medicinal composition. The medicine can treat aphtha caused by various reasons, is used for 60 clinical patients, and has a total effective rate of 91.6%.
Chinese patent application CN106109944A discloses a traditional Chinese medicine composition for treating oral ulcer, which is prepared from the following traditional Chinese medicine raw materials: coptis chinensis, scutellaria baicalensis, phellodendron amurense, radix sophorae flavescentis, selfheal, aloe, lotus leaf, radix zanthoxyli, radix berberidis, rhizoma alismatis, snake slough, polygonum cuspidatum, bighead atractylodes rhizome, honeysuckle, fingered citron, dragon's blood, talc, radix ophiopogonis, fructus evodiae, cistanche, glossy privet fruit, eclipta, bezoar, watermelon frost, ginkgo leaf, radix puerariae, pinellia ternate, cassia twig, bletilla striata, blackberry lily, achyranthes bidentata and humifuse euphorbia herb. The traditional Chinese medicine composition adopts natural traditional Chinese medicines as raw materials, and carries out compatibility and prescription based on syndrome differentiation aiming at the oral ulcer according to the principle of clearing away fire and cooling blood, detoxifying and reducing swelling, soothing liver and regulating qi, and astringing and promoting granulation, so as to achieve the purpose of treating both symptoms and root causes.
However, the medicine for treating the dental ulcer has long treatment time, poor curative effect, easy relapse after the treatment of the dental ulcer, certain irritation in the treatment process and poor patient compliance.
Therefore, it is very necessary to develop a pharmaceutical composition for treating oral ulcer and a method for preparing the same, which can solve the above technical problems.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provide a pharmaceutical composition for treating oral ulcer, which has good effect, quick response, no recurrence of oral ulcer, no irritation and no toxic or side effect, and a preparation method thereof. The invention has carried on a large number of screening, recombinating, trying to the pharmaceutical composition, and has also passed a large number of animal experimental studies, the raw materials medicinal materials and its weight constituent amount of the said medicament of the invention are that the inventor is carried on a large number of groping to conclude to get final product, each constituent amount has better effects within this range, the invention has provided a curative effect, it is fast to take effect, pharmaceutical composition for the treatment of canker sore with low costs, it is used for the treatment of canker sore, it has high efficiency, the ulcer heals the time short and advantage without side effect.
The invention is realized by the following technical scheme:
the pharmaceutical composition comprises the following components in parts by weight: 10-20 parts of coptis chinensis, 5-12 parts of golden cypress, 5-10 parts of houttuynia cordata, 4-7 parts of corydalis bungeana, 5-10 parts of radix rehmanniae recen, 5-10 parts of lophatherum gracile, 3-6 parts of borneol, 10-15 parts of dragon's blood, 2-5 parts of asarum, 5-10 parts of lemon, 3-8 parts of aloe, 3-8 parts of mint extract and 1-5 parts of folic acid.
The present invention is not particularly limited in terms of the source of the above raw materials, and commercially available products known to those skilled in the art may be used.
Preferably, the pharmaceutical composition comprises the following components in parts by weight: 12-17 parts of coptis chinensis, 8-10 parts of golden cypress, 6-8 parts of houttuynia cordata, 5-7 parts of corydalis bungeana, 6-8 parts of radix rehmanniae recen, 7-10 parts of lophatherum gracile, 4-6 parts of borneol, 10-13 parts of dragon's blood, 2-4 parts of asarum, 6-8 parts of lemon, 5-7 parts of aloe, 5-7 parts of mint extract and 2-4 parts of folic acid.
Preferably, the pharmaceutical composition comprises the following components in parts by weight: 15 parts of coptis chinensis, 9 parts of golden cypress, 7 parts of houttuynia cordata, 6 parts of bunge corydalis herb, 7 parts of radix rehmanniae recen, 8 parts of lophatherum gracile, 5 parts of borneol, 12 parts of dragon's blood, 3 parts of asarum, 7 parts of lemon, 6 parts of aloe, 6 parts of mint extract and 3 parts of folic acid.
Preferably, the preparation method of the mint extract comprises the following steps: cleaning herba Menthae, oven drying, grinding, sieving with 20 mesh sieve, collecting powder, adding 8-12 times of water, heating to boiling state for 3-5 hr for extraction, centrifuging the extractive solution, collecting the upper layer extractive solution, and distilling under reduced pressure to obtain herba Menthae extract.
The invention also relates to a preparation method of the pharmaceutical composition, which comprises the following steps:
s1, taking extracts of raw material medicines including coptis chinensis, golden cypress, houttuynia cordata, bunge corydalis herb, radix rehmanniae recen, lophatherum gracile, dragon's blood, asarum, lemon, aloe and mint according to a ratio, mixing uniformly, leaching the raw material medicines with a solvent A, filtering to obtain a medicine residue A and an extracting solution A, concentrating and filtering the extracting solution A, passing through a macroporous adsorption resin column, collecting eluent, concentrating and drying to obtain an extract A;
s2, taking the medicine residue A obtained in the step S1, performing reflux extraction by using a solvent B, filtering to obtain medicine residue B and an extracting solution B, concentrating and filtering the extracting solution B, passing through a macroporous adsorption resin column, collecting an eluent, concentrating and drying to obtain an extract B;
s3, uniformly mixing the extract A and the extract B, and the folic acid and the borneol to obtain the medicinal composition.
Preferably, in step S1, the solvent a is 20-22% ethanol by weight.
Preferably, in step S1, the leaching process includes: extracting at 35-37 deg.C for 12-15 times (each time for 1.5-2.5 hr) with solvent A11-12 times of the total weight of the raw materials (i.e. the ratio of solvent A to raw materials in step S1 is 11-12 mL/g).
Preferably, the macroporous adsorbent resin column in the step S1 is an LKS04 macroporous adsorbent resin column.
Preferably, the elution process in step S1 is specifically: eluting with water, eluting with 24-25 wt% ethanol solution, and collecting the eluate containing 24-25 wt% ethanol solution.
More preferably, step S1 includes the steps of:
taking extracts of raw material medicines of coptis chinensis, phellodendron amurense, houttuynia cordata, bunge corydalis herb, radix rehmanniae recen, lophatherum gracile, dragon's blood, asarum, lemon, aloe and mint according to a proportion, uniformly mixing, leaching the raw material medicines by using ethanol with the weight percentage concentration of 20-22% as a solvent, performing warm-leaching extraction at 35-37 ℃, wherein the extraction frequency is 12-15 times, the extraction time is 1.5-2.5 hours each time, the dosage of the solvent is 11-12 times of the total weight of the raw material medicines, filtering to obtain medicine residue A and an extracting solution A, recovering ethanol from the extracting solution A, concentrating to the relative density of 1.03-1.07 at 90-95 ℃, filtering the obtained liquid medicine, passing through an LKS04 macroporous adsorption resin column, eluting by using water firstly, then eluting by using an ethanol solution with the weight percentage concentration of 24-25%, collecting the ethanol solution with the weight percentage concentration of 24-25%, recovering the ethanol, concentrating and drying, thus obtaining the extract A.
Preferably, in step S2, the solvent B is ethanol with a concentration of 65-67% by weight.
Preferably, in step S2, the specific process of reflux extraction is: heating and reflux-extracting for 7-9 times, wherein each extraction time is 0.15-0.25 hr, and the amount of solvent B is 17-18 times of the weight of residue A (i.e. the liquid-to-material ratio of solvent B to residue A is 17-18 mL/g).
Preferably, the macroporous adsorbent resin column in the step S2 is a DM130C macroporous adsorbent resin column.
Preferably, the elution process in step S2 is specifically: eluting with water, eluting with 78-79% ethanol solution, and collecting 78-79% ethanol solution eluate.
More preferably, step S2 includes the steps of:
taking the medicine residue A in the step S1, using ethanol with the weight percentage concentration of 65-67% as a solvent, heating and refluxing for extraction for 7-9 times, wherein the extraction time is 0.15-0.25 hour each time, the dosage of the solvent is 17-18 times of the weight of the medicine residue A each time, filtering to obtain medicine residue B and an extracting solution B, recovering ethanol from the extracting solution B, concentrating to the relative density of 1.1-1.4 at the temperature of 60-80 ℃, filtering to obtain a medicine liquid, passing through a DM130C macroporous adsorption resin column, eluting with water, eluting with an ethanol solution with the weight percentage concentration of 78-79%, collecting the ethanol solution eluent with the weight percentage concentration of 78-79%, recovering ethanol, concentrating and drying to obtain an extract B.
The invention also relates to a pharmaceutical preparation, which comprises the pharmaceutical composition or the pharmaceutical composition prepared by the preparation method.
Preferably, the pharmaceutical preparation further comprises pharmaceutically acceptable auxiliary materials or auxiliary components.
Preferably, the pharmaceutical preparation is a tablet, powder, capsule or drop pill.
The invention also relates to application of the pharmaceutical composition or the pharmaceutical composition prepared by the preparation method or the pharmaceutical preparation in preparing a medicament for treating oral ulcer.
The invention has the beneficial effects that:
(1) the pharmaceutical composition for treating the dental ulcer, provided by the invention, combines the medicines, has a synergistic effect, and has the effects of tonifying qi, expelling toxin, clearing heat, relieving pain, eliminating swelling and promoting granulation.
(2) The pharmaceutical composition provided by the invention is used for treating oral ulcer or skin mucosa injury, and has the advantages of good treatment effect, quick response and no toxic or side effect.
(3) The pharmaceutical composition provided by the invention has the functions of clearing heat, drying dampness, purging fire, detoxifying, cooling blood, stopping bleeding, astringing, stopping bleeding, reducing swelling and promoting granulation, can shorten the course of disease, and can control the recurrence of oral ulcer.
(4) The pharmaceutical composition provided by the invention has good clinical effect on treating oral ulcer, particularly has quick effect on improving local pain and congestion edema, and has no irritation.
(5) The preparation process is simple and low in cost.
Detailed Description
The invention will be further described with reference to specific embodiments, and the advantages and features of the invention will become apparent as the description proceeds. These examples are illustrative only and do not limit the scope of the present invention in any way. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention, and that such changes and modifications may be made without departing from the spirit and scope of the invention.
The preparation process of the mint extracts in the examples and comparative examples of the invention is as follows: cleaning herba Menthae, oven drying, grinding, sieving with 20 mesh sieve, collecting powder, adding 10 times of distilled water, heating to boiling state for 4 hr for extraction, centrifuging at 4000 rpm for 20 min, separating the upper layer extractive solution, and vacuum distilling on rotary evaporator to obtain herba Menthae extract.
Example 1
The pharmaceutical composition comprises the following components in parts by weight: 10 parts of coptis chinensis, 5 parts of golden cypress, 5 parts of houttuynia cordata, 4 parts of bunge corydalis herb, 5 parts of radix rehmanniae recen, 5 parts of lophatherum gracile, 3 parts of borneol, 10 parts of dragon's blood, 2 parts of asarum, 5 parts of lemon, 3 parts of aloe, 3 parts of mint extract and 1 part of folic acid.
The preparation method of the pharmaceutical composition comprises the following steps:
s1, taking extracts of raw material medicines including coptis chinensis, golden cypress, houttuynia cordata, bunge corydalis herb, radix rehmanniae recen, lophatherum gracile, dragon's blood, asarum, lemon, aloe and mint according to a ratio, uniformly mixing, leaching the raw material medicines by using 20% by weight of ethanol as a solvent, performing warm-leaching extraction at 35 ℃ for 12 times, wherein the extraction time is 1.5 hours each time, the dosage of the solvent is 11 times of the total weight of the raw material medicines, filtering to obtain a medicine residue A and an extracting solution A, recovering the ethanol from the extracting solution A, concentrating to a relative density of 1.03 at 95 ℃, filtering the obtained medicine liquid, passing through an LKS04 macroporous adsorption resin column, eluting by using water, then eluting by using 24% by weight of ethanol solution, collecting 24% by weight of ethanol solution eluent, recovering the ethanol, concentrating and drying to obtain an extract A;
s2, taking the medicine residue A obtained in the step S1, using 65% ethanol in percentage by weight as a solvent, heating and carrying out reflux extraction for 7 times, wherein the extraction time is 0.15 hour each time, the dosage of the solvent is 17 times of the weight of the medicine residue A each time, filtering to obtain medicine residue B and an extracting solution B, recovering ethanol from the extracting solution B, concentrating to the relative density of 1.1 at 80 ℃, filtering to obtain medicine liquid, passing through a DM130C macroporous adsorption resin column, eluting with water firstly, eluting with 78% ethanol in percentage by weight, collecting 78% ethanol solution eluent in percentage by weight, recovering ethanol, concentrating and drying to obtain an extract B;
s3, uniformly mixing the extract A and the extract B, and the folic acid and the borneol to obtain the medicinal composition.
Example 2
The pharmaceutical composition comprises the following components in parts by weight: 20 parts of coptis chinensis, 12 parts of golden cypress, 10 parts of houttuynia cordata, 7 parts of bunge corydalis herb, 10 parts of radix rehmanniae recen, 10 parts of lophatherum gracile, 6 parts of borneol, 15 parts of dragon's blood, 5 parts of asarum, 10 parts of lemon, 8 parts of aloe, 8 parts of mint extract and 5 parts of folic acid.
The preparation method of the pharmaceutical composition comprises the following steps:
s1, taking extracts of raw material medicines including coptis chinensis, golden cypress, houttuynia cordata, bunge corydalis herb, radix rehmanniae recen, lophatherum gracile, dragon's blood, asarum, lemon, aloe and mint according to a ratio, uniformly mixing, leaching the raw material medicines by using 22% by weight of ethanol as a solvent, performing warm-leaching extraction at 37 ℃ for 15 times, wherein the extraction time is 2.5 hours each time, the dosage of the solvent is 12 times of the total weight of the raw material medicines, filtering to obtain a medicine residue A and an extracting solution A, recovering the ethanol from the extracting solution A, concentrating to a relative density of 1.07 at 90 ℃, filtering the obtained medicine liquid, passing through an LKS04 macroporous adsorption resin column, eluting by using water, eluting by using 25% by weight of an ethanol solution, collecting 25% by weight of an ethanol solution eluent, recovering the ethanol, concentrating and drying to obtain an extract A;
s2, taking the medicine residue A obtained in the step S1, using ethanol with the weight percentage concentration of 67% as a solvent, heating and carrying out reflux extraction for 9 times, wherein the extraction time is 0.25 hour each time, the dosage of the solvent is 18 times of the weight of the medicine residue A each time, filtering to obtain medicine residue B and an extracting solution B, recovering ethanol from the extracting solution B, concentrating to the relative density of 1.4 at 60 ℃, filtering to obtain medicine liquid, passing the medicine liquid through a DM130C macroporous adsorption resin column, eluting with water firstly, eluting with an ethanol solution with the weight percentage concentration of 79%, collecting an ethanol solution eluent with the weight percentage concentration of 79%, recovering ethanol, concentrating and drying to obtain an extract B;
s3, uniformly mixing the extract A and the extract B, and the folic acid and the borneol to obtain the medicinal composition.
Example 3
The pharmaceutical composition comprises the following components in parts by weight: 15 parts of coptis chinensis, 9 parts of golden cypress, 7 parts of houttuynia cordata, 6 parts of bunge corydalis herb, 7 parts of radix rehmanniae recen, 8 parts of lophatherum gracile, 5 parts of borneol, 12 parts of dragon's blood, 3 parts of asarum, 7 parts of lemon, 6 parts of aloe, 6 parts of mint extract and 3 parts of folic acid.
The preparation method of the pharmaceutical composition comprises the following steps:
s1, taking extracts of raw material medicines including coptis chinensis, golden cypress, houttuynia cordata, bunge corydalis herb, radix rehmanniae recen, lophatherum gracile, dragon's blood, asarum, lemon, aloe and mint according to a ratio, mixing uniformly, leaching the raw material medicines by using 21% by weight of ethanol as a solvent, performing warm leaching extraction at 36 ℃, wherein the extraction frequency is 14 times, the extraction time is 2 hours each time, the dosage of the solvent is 12 times of the total weight of the raw material medicines, filtering to obtain a medicine residue A and an extracting solution A, recovering the ethanol from the extracting solution A, concentrating to a relative density of 1.05 at 93 ℃, filtering the obtained medicine liquid, passing through an LKS04 macroporous adsorption resin column, eluting by using water, eluting by using 24% by weight of ethanol solution, collecting 24% by weight of ethanol solution eluent, recovering the ethanol, concentrating and drying to obtain an extract A;
s2, taking the medicine residue A obtained in the step S1, using 66% ethanol in percentage by weight as a solvent, heating and carrying out reflux extraction for 8 times, wherein the extraction time is 0.2 hour each time, the dosage of the solvent is 17 times of the weight of the medicine residue A each time, filtering to obtain medicine residue B and an extracting solution B, recovering ethanol from the extracting solution B, concentrating to the relative density of 1.2 at 70 ℃, filtering to obtain medicine liquid, passing through a DM130C macroporous adsorption resin column, eluting with water, eluting with 78% ethanol solution in percentage by weight, collecting 78% ethanol solution eluent in percentage by weight, recovering ethanol, concentrating and drying to obtain an extract B;
s3, uniformly mixing the extract A and the extract B, and the folic acid and the borneol to obtain the medicinal composition.
Comparative example 1
The difference from the embodiment 3 is only that the dosage and the proportion of each component are different, and the other conditions are the same, and the specific conditions are as follows:
the pharmaceutical composition comprises the following components in parts by weight: 25 parts of coptis chinensis, 15 parts of golden cypress, 15 parts of houttuynia cordata, 6 parts of bunge corydalis herb, 15 parts of radix rehmanniae recen, 15 parts of lophatherum gracile, 5 parts of borneol, 20 parts of dragon's blood, 3 parts of asarum, 7 parts of lemon, 6 parts of aloe, 6 parts of mint extract and 3 parts of folic acid.
Comparative example 2
The difference from the embodiment 3 is only that the dosage and the proportion of each component are different, and the other conditions are the same, and the specific conditions are as follows:
the pharmaceutical composition comprises the following components in parts by weight: 5 parts of coptis chinensis, 3 parts of golden cypress, 3 parts of houttuynia cordata, 6 parts of bunge corydalis herb, 4 parts of radix rehmanniae recen, 2 parts of lophatherum gracile, 5 parts of borneol, 5 parts of dragon's blood, 3 parts of asarum, 7 parts of lemon, 6 parts of aloe, 6 parts of mint extract and 3 parts of folic acid.
Comparative example 3
The difference from example 3 is only that folic acid is replaced by vitamin B12 of equal mass, and the rest conditions are the same.
Comparative example 4
The difference from the embodiment 3 is that 9 parts of golden cypress is replaced by 4.5 parts of golden thread and 4.5 parts of corydalis bungeana, and the rest conditions are the same, and the specific conditions are as follows:
the pharmaceutical composition comprises the following components in parts by weight: 19.5 parts of coptis chinensis, 7 parts of houttuynia cordata, 10.5 parts of corydalis bungeana, 7 parts of radix rehmanniae recen, 8 parts of lophatherum gracile, 5 parts of borneol, 12 parts of dragon's blood, 3 parts of asarum, 7 parts of lemon, 6 parts of aloe, 6 parts of mint extract and 3 parts of folic acid.
Comparative example 5
The difference from the embodiment 3 is only that 15 parts of coptis and 6 parts of corydalis are replaced by 21 parts of phellodendron, and the rest conditions are the same as follows:
the pharmaceutical composition comprises the following components in parts by weight: 30 parts of golden cypress, 7 parts of houttuynia cordata, 7 parts of radix rehmanniae recen, 8 parts of lophatherum gracile, 5 parts of borneol, 12 parts of dragon's blood, 3 parts of asarum, 7 parts of lemon, 6 parts of aloe, 6 parts of mint extract and 3 parts of folic acid.
Comparative example 6
The only difference from example 3 is that the extraction process was carried out with 30% ethanol for the 21% ethanol concentration by weight of step S1 and 75% ethanol for the 66% ethanol concentration by weight of step S2, and the other conditions were the same.
Comparative example 7
The only difference from example 3 is that the preparation process was carried out in which the 21% by weight ethanol concentration of step S1 was replaced by 15% ethanol, the 66% by weight ethanol concentration of step S2 was replaced by 55% ethanol, and the other conditions were the same.
Test example 1
The pharmaceutical compositions of examples 1-3 and comparative examples 1-7 were tested for their efficacy in treating canker sores.
The following criteria were met for the selection of the persons to participate in the test: the history of oral ulcer is more than 1 year; recurrent attacks, at least once a month; in the attack phase and the attack time is within 48 hours. The test participants were 160 persons in total, wherein 80 men and 80 women were randomly divided into 10 groups of 16 persons each, and tested using the pharmaceutical compositions of examples 1 to 3 and comparative examples 1 to 7, respectively.
DP grading is used for the evaluation of the local therapeutic effect
Evaluation indexes are as follows:
mean ulcer period (days) (duration, D): dividing the sum of the durations of the ulcers in the evaluation period by the total number of ulcers;
pain index (score) (pain, P): recording the daily pain score during the ulceration period using a Visual Analogue Scale (VAS); VAS means that a straight line of 10cm is adopted, the 0 end of the straight line represents 'no pain', the 10cm end represents 'most severe pain', and patients record on the corresponding scale of the straight line for 1 time per day according to different pain feeling degrees;
grading evaluation indexes:
d1-mean reduction in ulcer stage (t-test, P < 0.05);
d0-mean no change in ulcer stage (t test, P > 0.05);
p1-decrease in pain index (t-test, P < 0.05);
p0-no change in pain index (t-test, P > 0.05);
evaluation criteria:
the effect is shown: D1P 1;
the method has the following advantages: D0P1 or D1P 0;
and (4) invalidation: D0P 0;
local treatment evaluation cycle: after the treatment, the curative effect evaluation is carried out after the ulcer is healed, and the result is shown in table 1.
TABLE 1 test of the Effect of the pharmaceutical compositions of examples 1-3 and comparative examples 1-7 on treating canker sores
The patients of the groups of examples 1-3 were not able to relapse after healing of the ulcer within 4 months, and there was no irritation during the treatment. While 1 month of the test participants in comparative examples 1-2, 4 and 7, 2 months of the test participants in comparative example 3, and 1 month and half of the test participants in comparative examples 5-6.
The time required for the pain index to decrease (t-test, P <0.05) for each group is shown in table 2.
TABLE 2 time required for pain index reduction (t-test, P <0.05)
| Time/h | |
| Example 1 | 1.4 |
| Example 2 | 1.3 |
| Example 3 | 1.2 |
| Comparative example 1 | 2.1 |
| Comparative example 2 | 1.9 |
| Comparative example 3 | 1.5 |
| Comparative example 4 | 2.0 |
| Comparative example 5 | 2.3 |
| Comparative example 6 | 1.6 |
| Comparative example 7 | 1.4 |
The above detailed description is specific to one possible embodiment of the present invention, and the embodiment is not intended to limit the scope of the present invention, and all equivalent implementations or modifications without departing from the scope of the present invention should be included in the technical scope of the present invention.
Claims (10)
1. The pharmaceutical composition for treating the dental ulcer is characterized by being prepared from the following components in parts by weight: 10-20 parts of coptis chinensis, 5-12 parts of golden cypress, 5-10 parts of houttuynia cordata, 4-7 parts of corydalis bungeana, 5-10 parts of radix rehmanniae recen, 5-10 parts of lophatherum gracile, 3-6 parts of borneol, 10-15 parts of dragon's blood, 2-5 parts of asarum, 5-10 parts of lemon, 3-8 parts of aloe, 3-8 parts of mint extract and 1-5 parts of folic acid;
the preparation method of the pharmaceutical composition comprises the following steps:
s1, taking extracts of raw material medicines including coptis chinensis, golden cypress, houttuynia cordata, bunge corydalis herb, radix rehmanniae recen, lophatherum gracile, dragon's blood, asarum, lemon, aloe and mint according to a ratio, mixing uniformly, leaching the raw material medicines with a solvent A, filtering to obtain a medicine residue A and an extracting solution A, concentrating and filtering the extracting solution A, passing through a macroporous adsorption resin column, collecting eluent, concentrating and drying to obtain an extract A; the solvent A is ethanol with the weight percentage concentration of 20-22%;
s2, taking the medicine residue A obtained in the step S1, performing reflux extraction by using a solvent B, filtering to obtain medicine residue B and an extracting solution B, concentrating and filtering the extracting solution B, passing through a macroporous adsorption resin column, collecting an eluent, concentrating and drying to obtain an extract B; the solvent B is ethanol with the weight percentage concentration of 65-67%;
s3, uniformly mixing the extract A and the extract B, and the folic acid and the borneol to obtain the medicinal composition.
2. The pharmaceutical composition for treating oral ulcer according to claim 1, wherein the pharmaceutical composition is prepared from the following components in parts by weight: 12-17 parts of coptis chinensis, 8-10 parts of golden cypress, 6-8 parts of houttuynia cordata, 5-7 parts of corydalis bungeana, 6-8 parts of radix rehmanniae recen, 7-10 parts of lophatherum gracile, 4-6 parts of borneol, 10-13 parts of dragon's blood, 2-4 parts of asarum, 6-8 parts of lemon, 5-7 parts of aloe, 5-7 parts of mint extract and 2-4 parts of folic acid.
3. The pharmaceutical composition for treating oral ulcer according to claim 1, wherein the pharmaceutical composition is prepared from the following components in parts by weight: 15 parts of coptis chinensis, 9 parts of golden cypress, 7 parts of houttuynia cordata, 6 parts of bunge corydalis herb, 7 parts of radix rehmanniae recen, 8 parts of lophatherum gracile, 5 parts of borneol, 12 parts of dragon's blood, 3 parts of asarum, 7 parts of lemon, 6 parts of aloe, 6 parts of mint extract and 3 parts of folic acid.
4. A method for preparing a pharmaceutical composition for treating canker sores as claimed in any one of claims 1 to 3, including the steps of:
s1, taking extracts of raw material medicines including coptis chinensis, golden cypress, houttuynia cordata, bunge corydalis herb, radix rehmanniae recen, lophatherum gracile, dragon's blood, asarum, lemon, aloe and mint according to a ratio, mixing uniformly, leaching the raw material medicines with a solvent A, filtering to obtain a medicine residue A and an extracting solution A, concentrating and filtering the extracting solution A, passing through a macroporous adsorption resin column, collecting eluent, concentrating and drying to obtain an extract A; the solvent A is ethanol with the weight percentage concentration of 20-22%;
s2, taking the medicine residue A obtained in the step S1, performing reflux extraction by using a solvent B, filtering to obtain medicine residue B and an extracting solution B, concentrating and filtering the extracting solution B, passing through a macroporous adsorption resin column, collecting an eluent, concentrating and drying to obtain an extract B; the solvent B is ethanol with the weight percentage concentration of 65-67%;
s3, uniformly mixing the extract A and the extract B, and the folic acid and the borneol to obtain the medicinal composition.
5. The preparation method according to claim 4, wherein in step S1, the specific process of leaching is as follows: extracting at 35-37 deg.C for 12-15 times, each time for 1.5-2.5 hr, and the amount of solvent A is 11-12 times of the total weight of the raw materials.
6. The method according to claim 4, wherein the macroporous adsorbent resin column in step S1 is LKS04 macroporous adsorbent resin column; the elution process specifically comprises the following steps: eluting with water, eluting with 24-25 wt% ethanol solution, and collecting 24-25 wt% ethanol solution eluate; the preparation method of the mint extract comprises the following steps: cleaning herba Menthae, oven drying, grinding, sieving with 20 mesh sieve, collecting powder, adding 8-12 times of water, heating to boiling state for 3-5 hr for extraction, centrifuging the extractive solution, collecting the upper layer extractive solution, and distilling under reduced pressure to obtain herba Menthae extract.
7. The preparation method according to claim 4, wherein in step S2, the specific process of the reflux extraction is as follows: heating and reflux-extracting for 7-9 times, wherein the extraction time is 0.15-0.25 hr each time, and the amount of solvent B is 17-18 times of the weight of residue A each time.
8. The method according to claim 4, wherein the macroporous adsorbent resin column in step S2 is a DM130C macroporous adsorbent resin column; the elution process specifically comprises the following steps: eluting with water, eluting with 78-79% ethanol solution, and collecting 78-79% ethanol solution eluate.
9. A pharmaceutical preparation comprising the pharmaceutical composition for treating oral ulcer according to any one of claims 1 to 3 or the pharmaceutical composition for treating oral ulcer prepared by the preparation method according to any one of claims 4 to 8.
10. Use of the pharmaceutical composition for treating oral ulcer according to any one of claims 1 to 3 or the pharmaceutical composition for treating oral ulcer prepared by the preparation method according to any one of claims 4 to 8 or the pharmaceutical preparation according to claim 9 in the preparation of a medicament for treating oral ulcer.
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|---|---|---|---|---|
| CN102697937A (en) * | 2012-06-28 | 2012-10-03 | 王佳丽 | Medicine for treating dental ulcer and preparation method for same |
| CN103655852A (en) * | 2012-09-05 | 2014-03-26 | 杨波 | Medicament for treating dental ulcer and preparation method thereof |
| CN103720866A (en) * | 2013-12-27 | 2014-04-16 | 廖勇 | Traditional Chinese medicinal composition for treating dental ulcer and preparation method thereof |
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| CN102697937A (en) * | 2012-06-28 | 2012-10-03 | 王佳丽 | Medicine for treating dental ulcer and preparation method for same |
| CN103655852A (en) * | 2012-09-05 | 2014-03-26 | 杨波 | Medicament for treating dental ulcer and preparation method thereof |
| CN103720866A (en) * | 2013-12-27 | 2014-04-16 | 廖勇 | Traditional Chinese medicinal composition for treating dental ulcer and preparation method thereof |
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