CN106692496B - Compound traditional Chinese medicine buccal tablet and preparation method and application thereof - Google Patents
Compound traditional Chinese medicine buccal tablet and preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a compound traditional Chinese medicine buccal tablet with the effects of clearing away heat and toxic materials and relieving swelling and pain, a preparation method and application thereof, and belongs to the field of traditional Chinese medicine preparations. The compound traditional Chinese medicine buccal tablet consists of 4 to 10 weight percent of Chinese violet extract, 1 to 5 weight percent of dandelion extract and 85 to 95 weight percent of pharmaceutic adjuvant. The invention also discloses a method for preparing the compound traditional Chinese medicine buccal tablet, which mainly comprises the steps of preparing the Chinese violet extract, preparing the dandelion extract and preparing the compound traditional Chinese medicine buccal tablet. In addition, the invention also discloses application of the compound traditional Chinese medicine buccal tablet in preparing a medicine for treating pharyngitis. Compared with the preparation for treating pharyngitis sold in the market at present, the compound traditional Chinese medicine contains tablet monosodium glutamate, has little potency, treats both principal and secondary aspect of disease, can enable the medicine to stay at the focus part of pharynx for a long time, quickly and continuously exerts the medicine effect, and has strong pertinence; meanwhile, the oral buccal tablet avoids the first pass effect of the liver and has high bioavailability.
Description
Technical Field
The invention relates to a compound traditional Chinese medicine buccal tablet with the effects of clearing away heat and toxic material and relieving swelling and pain, a preparation method and application thereof, and belongs to the field of traditional Chinese medicines.
Background
Pharyngitis belongs to the category of pharyngitis in traditional Chinese medicine. Pharyngitis refers to a throat disease characterized by sore throat or discomfort due to foreign body sensation, red and swollen throat, or granular protrusion of the throat floor. Because the pathogenesis of the disease is divided into wind-heat and yin deficiency, the sore throat caused by wind-heat evil and toxin is called wind-heat sore throat, and the sore throat caused by viscera deficiency and flaring-up of deficient fire is called deficient fire sore throat.
Wind-heat pharyngitis is usually caused by the invasion of wind-heat evil toxin due to deficiency, direct attack on the throat from the mouth and nose, internal injury to the lung, and inability to mutually beat due to rapid climate change, careless daily life and failure of lung defense, resulting in sore throat. The pathogenic factors are in the lung defense, the condition is mild, and if the treatment is lost or mistreated or the heat of the lung and stomach is transmitted to the interior in a quintessence manner, the condition is severe. Deficiency fire pharyngitis is caused by the deficiency of viscera and flaring-up of deficiency fire, and is usually caused by chronic lingering disease, yin impairment due to pathogenic heat, or residual pathogenic factors after warm disease. The deficiency of the zang-fu organs is usually due to lung yin deficiency and kidney yin deficiency. Lung and kidney deficiency leading to fluid deficiency leading to up-flaming of deficient fire and fumigating throat. But are often associated with occupational factors such as long-term irritation by chemical gases, dust, etc., and addiction to smoking, drinking, pungent taste, etc.
Pharyngitis is a common disease, which is not serious but has disadvantages of long course of disease, stubborn symptoms and difficult cure. With the change of environmental quality, and the factors of smoke and wine stimulation, spicy diet, dust, harmful gas and the like, the incidence rate of pharyngitis tends to rise year by year in recent years. For a long time, pharyngitis is not sufficiently valued by people and cannot be effectively treated in time, but is delayed to other adjacent organs. This affects not only the health condition of people, but also the normal work and life of people.
For thousands of years, the traditional Chinese medicine accumulates abundant clinical practice experiences for treating pharyngitis. Patent CN102988903B discloses a Chinese medicinal composition comprising honeysuckle, Chinese olive, trichosanthes root, asiatic moonseed rhizome, pinellia tuber, stemona root, notoginseng, etc., which can effectively treat chronic pharyngitis and is not easy to recur. Chinese patent CN1273153C discloses a preparation prepared by extracting, refining and purifying inula cappa, liquorice, scutellaria baicalensis and borneol, which can be used for treating pharyngolaryngitis. Chinese patent CN201510429144.3 discloses a Chinese medicinal composition for treating pharyngitis, which is composed of radix Isatidis, radix scrophulariae, periostracum Cicadae, Glycyrrhrizae radix, and peppermint oil. Chinese patent CN201510181997.X discloses a Chinese medicinal composition consisting of Chinese olive, fructus momordicae, honeysuckle, dark plum and liquorice, which can obviously improve the symptoms of patients with chronic pharyngitis clinically. The preliminary pharmacodynamics of a dibutyl mixture consisting of Chinese medicines such as Chinese violet, dandelion and the like is researched by the taibaihua and the like, and the preliminary pharmacodynamics research of the dibutyl mixture [ J ] Chongqing Chinese herbal medicine research 1999, 39: 37-38 shows that the dibutyl mixture has obvious anti-inflammatory effect and bacteriostatic effect, but the mixture is inconvenient to carry, store and take.
At present, from the clinical medication, the western medicine treatment generally adopts antibiosis and antiphlogosis, the medicines mostly adopt antibiotics, but the overall effect is poor, the medicine resistance is easy to generate, the toxic and side effects are large, the abuse of the antibiotics is easy to cause the dysbacteriosis in vivo, and the treatment of pharyngitis by adopting the traditional Chinese medicine is increasingly concerned by people. According to the traditional Chinese medicine theory, the abundant experiences accumulated by predecessors are fully developed, and the latest progress of modern medical research results and traditional Chinese medicine prevention and treatment is combined, so that a traditional Chinese medicine preparation which is more accurate in compatibility, more definite in curative effect, free of toxic and side effects and convenient to carry needs to be developed urgently.
Disclosure of Invention
The invention aims to provide the traditional Chinese medicine buccal tablet which has the effects of clearing away heat and toxic materials, relieving swelling and pain and can safely and effectively treat pharyngitis. The buccal tablet is suitable for treating pharyngitis caused by affection of exogenous wind-heat, with symptoms of swelling and pain of throat, dry mouth and throat, and hoarseness; acute and chronic pharyngolaryngitis with the above syndromes.
The invention relates to a compound traditional Chinese medicine buccal tablet with the effects of clearing away heat and toxic material and relieving swelling and pain, which comprises the following components in percentage by weight:
A. 4 to 10 percent of Chinese violet extract;
B. 1 to 5 percent of dandelion extract;
C. 85% -95% of pharmaceutic adjuvant;
preferably, the Chinese violet extract accounts for 5-8%, the dandelion extract accounts for 2-4%, and the pharmaceutic adjuvant accounts for 88-93% by weight.
Preferably, the Chinese violet extract accounts for 5%, the dandelion extract accounts for 4%, and the pharmaceutical excipients account for 91% by weight.
Wherein the pharmaceutic adjuvant comprises a filler, a flavoring agent, a lubricant and an adhesive.
Preferably, the filler is one or more of starch, dextrin, sucrose, lactose, mannitol or sorbitol; the correctant is one or more of sucralose, aspartame, citric acid, menthol and peppermint essence; the lubricant is one or more of magnesium stearate, calcium stearate or talcum powder; the adhesive is one of water, 40-60% ethanol and starch slurry.
The invention also aims to provide a preparation method of the compound traditional Chinese medicine buccal tablet.
The invention relates to a preparation method of a compound traditional Chinese medicine buccal tablet, which comprises the following steps:
1) preparing the Chinese violet extract: taking a Chinese violet medicinal material, respectively adding 14 times and 10 times of 80% ethanol, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining filtrates, recovering ethanol under reduced pressure, concentrating to the medicinal material amount, centrifuging, adding a centrifugate onto a treated macroporous adsorption resin column at the flow rate of 0.5BV/h, eluting with 3BV water at the flow rate of 3BV/h, sequentially eluting with 2BV 30% -60% and 2BV 60% -80% ethanol at the flow rate of 2BV/h, collecting corresponding ethanol eluent, recovering ethanol, concentrating into thick paste, vacuum drying, and crushing to obtain the Chinese violet extract.
2) Preparation of dandelion extract: decocting dandelion herb respectively by adding 12 times, 10 times and 10 times of water for 3 times, each time for 1 hour, filtering, combining filtrates, concentrating under reduced pressure to obtain clear paste with the relative density of 1.10(50 ℃), adding alcohol until the alcohol content is 60-80%, standing for more than 24 hours, filtering, concentrating the filtrate to the medicinal material amount, adjusting the pH to 2-5 by using dilute hydrochloric acid, adding the diluted hydrochloric acid to a treated macroporous adsorption resin column at the flow rate of 1BV/h, eluting by using 3BV purified water at the flow rate of 3BV/h, eluting by using 2BV 30-60% and 3BV 60-80% at the flow rate of 2BV/h in sequence, collecting corresponding alcohol eluent, concentrating to obtain thick paste, drying in vacuum, and crushing.
3) The preparation process comprises the following steps: pulverizing herba Violae extract and herba Taraxaci extract respectively, sieving, adding filler, correctant and binder, mixing, granulating, drying, grading, adding lubricant, mixing, and making into tablet.
Preferably, the model of the macroporous absorption resin in the step 1) is one of HPD-826, HPD-750, HPD-100 and D-101, and the optimum is HPD-826.
Preferably, the concentration of ethanol for elution in step 1) is 40% and 70%, respectively.
Preferably, the model of the macroporous absorption resin in the step 2) is one of HPD-826, HPD-750, HPD-100, D-101, XDA-8 and AB-8, and the best XDA-8.
Preferably, the concentration of ethanol for elution in step 2) is 40% and 70%, respectively.
Preferably, the clear paste in the step 2) is added with alcohol until the alcohol content is 70%, and is kept stand for more than 24 hours, and then is filtered, the filtrate is concentrated to the medicinal material amount, and the pH value is adjusted to 4 by using dilute hydrochloric acid.
The invention also discloses application of the compound traditional Chinese medicine buccal tablet in preparing a medicine for treating pharyngitis.
The compound traditional Chinese medicine buccal tablet has the effects of clearing away heat and toxic material and relieving swelling and pain, and is suitable for treating pharyngitis caused by wind-heat, with the symptoms of sore throat, dry mouth and throat, hoarseness and acute and chronic pharyngolaryngitis with the symptoms.
Animal experiment results show that the compound traditional Chinese medicine buccal tablet has a strong inhibition effect on acute pharyngitis of rats caused by ammonia water, and has a strong inhibition effect on chronic pharyngitis of rabbits caused by a compound factor of ammonia water and turpentine.
From the perspective of Chinese medical prescriptions, the Chinese violet in the invention is pungent, bitter and cold in nature, enters heart and liver channels, and has the functions of clearing away heat and toxic materials, cooling blood and relieving swelling; the compendium of materia Medica records: viola Yedoensis Makino is mainly used for treating all carbuncle, cellulitis, swollen scrofula, innominate toxic swelling and malignant sore. The dandelion is bitter and sweet in taste and cold in nature, enters liver and stomach channels, can clear away heat and toxic materials, relieve swelling and dissipate stagnation, and induce diuresis for treating stranguria, and is recorded in the Chinese herbal medicine compilation: clearing away heat and toxic material, curing abscess and dissipating nodulation. It can be used for treating upper respiratory infection, acute tonsillitis, pharyngolaryngitis, conjunctivitis, and epidemic parotitis. The two medicines are combined to mutually complement each other, complement each other and multiply the effect, and the effects of clearing heat and removing toxicity, cooling blood and relieving sore throat are achieved together.
Compared with the prior art, the compound traditional Chinese medicine buccal tablet has the following remarkable progress:
1. compared with the existing medicines for treating pharyngitis, the traditional Chinese medicine composition only consists of the Chinese violet and the dandelion, has the advantages of precise and less medicinal flavor, special effect, treatment of both principal and secondary aspects of diseases, exact curative effect, capability of avoiding the defects of drug resistance, toxic and side effects, flora imbalance and the like caused by the continuous use of antibiotics in the western medicine antibacterial and anti-inflammatory therapy, and high safety.
2. The preparation is designed into oral buccal tablets, so that the medicine can stay at the pharyngeal focus for a long time, the medicine effect can be quickly and continuously exerted, and the pertinence is strong; the buccal tablet is mainly absorbed by sublingual and oral mucosa, thereby avoiding first pass of liver and having high bioavailability.
3. The oral buccal tablet is developed and prepared selectively, is convenient to carry and take, and overcomes the inconvenience of carrying, storing and taking of mixture, granules, oral liquid and the like; the flavoring agent which is preferably determined is used for flavoring, the taste is obviously improved, and the patient compliance is good.
Detailed Description
The invention is further illustrated by the following specific implementation modes of the Chinese violet herb extract and the dandelion herb extract for the test of resisting the acute pharyngitis and the chronic pharyngitis of animals and the preparation of the compound traditional Chinese medicine buccal tablet, but the invention is not limited by the specific implementation modes, and various modifications or improvements can be made by the technical personnel according to the basic idea of the invention, but the technical personnel in the field can be within the scope of the invention as long as the technical personnel in the field do not depart from the basic idea of the invention.
Example 1 Effect test on rat acute pharyngitis model
1. Test materials
Sample preparation: the viola yedoensis makino extract and dandelion extract prepared by the process described in best example 11 were used as test samples, and a uniform suspension was prepared with 0.5% sodium carboxymethylcellulose solution. Positive control drug: gold throat lozenge.
Animals and groups: wistar rats were divided into a normal control group, a model control group, a positive control group and the group of example 1. The spray is applied to the pharynx, the dose of the group in example 1 is 76mg/kg/d of the Chinese violet extract and 38mg/kg/d of the dandelion extract, and the dose of the positive control group is 926 mg/kg/d.
The instrument comprises the following steps: electronic scale, superclean bench, magnetic stirrers.
2. Test method
After fixing the rat by a tongue depressor, spraying 15% ammonia water solution on the pharyngeal portion of the rat; spraying 0.5ml each time, 1 times each day at 9:00, 13:00, and 16:00 for 4 days. Spraying for administration at 9:00, 13:00, and 16:00 times per day for 3 days. Before the experiment, the appearance and the pharyngeal condition of the rats in each group are visually observed and scored.
The criteria are as follows:
(integral 3): scratching the mouth frequently, drinking water, and causing congestion and swelling of the pharynx, the mucous membrane is bright red;
(integral 2): swollen pharynx, partial congestion;
(integral 1): swelling of pharynx without congestion;
(integral 0): this is not the case.
3. Test results
The influence of the evaluation on the pharyngeal observation of the rat acute pharyngitis model is shown in the table 1.
TABLE 1 influence on pharyngeal observation scores (X + -SD) of rat acute pharyngitis model
| Group of | n | Observation scoring |
| Model control group | 10 | 2.60±0.52△ |
| EXAMPLE 1 group | 10 | 1.70±0.82* |
| Positive control group | 10 | 1.90±0.74* |
| Normal control group | 10 | 0 |
Note: p <0.05 compared to model control;△p <0.05 compared with normal control group.
After ammonia water spray molding is adopted, the pharyngeal observation score of the rat is obviously increased, and the significant difference (P <0.05) is compared with that of a normal control group; after 3 days of treatment by the purple English buccal tablets after the molding is finished, the pharyngeal observation score of the group in the example 1 is greatly reduced, and the pharyngeal observation score is remarkably different from that of a model control group (P is less than 0.05).
4. Conclusion of the experiment
The traditional Chinese medicine preparation disclosed by the invention has a strong inhibition effect on the acute pharyngitis of rats caused by ammonia water.
Example 2 Effect test on Rabbit model of chronic pharyngitis
1. Test materials
Sample preparation: the viola yedoensis makino extract and dandelion extract prepared by the process described in best example 11 were used as test samples, and a uniform suspension was prepared with 0.5% sodium carboxymethylcellulose solution. Positive control drug: dibutyl particles.
Animals and groups: japanese white big ear rabbits were divided into a normal control group, a model control group, a positive control group and example 1. The spray is applied to the pharynx, the dose of the group in example 1 is 43.4mg/kg/d of the Chinese violet extract and 21.7mg/kg/d of the dandelion extract, and the dose of the positive control group is 2657.3 mg/kg/d.
The instrument comprises the following steps: electronic scale, superclean bench, magnetic stirrers.
2. Test method
Molding according to a Peng molding method, namely fixing the tongue of the rabbit by using a tongue depressor, and spraying 2.5% ammonia water solution on the pharynx of the rabbit; spraying 0.5ml each time, 1 time each of 9:00 am and 14:00 pm for 16 days. On days 4 and 8, 0.1ml of oleum Terebinthinae is injected under pharyngeal mucosa. Grouping and spraying for administration after molding, wherein the administration is carried out 1 time each at 9:00 and 14:00 every day for 14 days. The observation and scoring of throat pathological section are shown in Table 2
TABLE 2 Rabbit pharyngeal pathological section observation and scoring table
3. Test results
The influence on the pharyngeal pathology observation score of the rabbit chronic pharyngitis model is shown in table 3.
TABLE 3 influence on evaluation of pharyngeal pathology in rabbit chronic pharyngitis model (X + -SD)
Note: p <0.05, compared to model control;△△p is less than 0.01, compared with normal control group.
The pharyngeal mucosa epithelium of the normal control group animals under the mirror is complete, and the mucosa has no pathological changes such as congestion, edema, ulcer and the like; the glands of the normal animals secrete normal, and are not changed in expansion, hypertrophy and the like. Most samples of the model group can show obvious mucosal epithelial injury, inflammatory reactions such as mucosal congestion, edema, inflammatory cell infiltration and the like, gland secretion is obvious, and fiber hyperplasia partially appears. The model group has statistical significance compared with the normal control group in the individual scores of vasodilation congestion and inflammatory cell infiltration and the total score; the positive control group and the group in the example 1 are treated, the individual scores and the total scores of pharyngeal lesion parts of the test animals are obviously lower than those of the model group, and the statistical significance is achieved.
4. Conclusion of the experiment
The traditional Chinese medicine preparation has a strong inhibiting effect on rabbit chronic pharyngitis caused by the compound factors of ammonia water and turpentine.
EXAMPLE 3 preparation of Compound Chinese medicinal buccal tablet
1) Preparing the Chinese violet extract: taking a Chinese violet medicinal material, respectively adding 14 times and 10 times of 80% ethanol, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining filtrates, recovering ethanol under reduced pressure, concentrating to the medicinal material amount, centrifuging, adding a centrifugate onto a treated HPD-826 macroporous adsorption resin column at the flow rate of 0.5BV/h, eluting with 3BV water at the flow rate of 3BV/h, sequentially eluting with 2BV 30% and 2BV 60% ethanol at the flow rate of 2BV/h, collecting corresponding ethanol eluates, recovering ethanol, concentrating to form a thick paste with the relative density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8Mpa, and crushing to obtain the Chinese violet extract.
2) Preparation of dandelion extract: decocting dandelion medicinal materials respectively by adding 12 times, 10 times and 10 times of water for 3 times, each time for 1 hour, filtering, combining filtrates, concentrating under reduced pressure to obtain clear paste with the relative density of 1.10(50 ℃), adding alcohol until the alcohol content is 60%, standing for more than 24 hours, filtering, concentrating the filtrate to the medicinal material content, adjusting the pH to 2 by using dilute hydrochloric acid, adding the mixture onto a processed HPD-826 macroporous adsorption resin column at the flow rate of 1BV/h, eluting by using 3BV purified water at the flow rate of 3BV/h, eluting by using 2BV 30% ethanol and 3BV 60% ethanol at the flow rate of 2BV/h in sequence, collecting corresponding alcohol eluent, recovering ethanol, concentrating to obtain thick paste with the density of 1.25-1.30, vacuum drying at 80 ℃ and the vacuum degree of more than 0.8MPa, and crushing to obtain the dandelion health care product.
3) The preparation process comprises the following steps:
| formulation of | Amount of use, g |
| Herba Violae extract | 24 |
| Dandelion extract | 6 |
| Starch | 546 |
| Sucralose | 9 |
| Magnesium stearate | 5 |
| 40% ethanol | Proper amount of |
Pulverizing the above two extracts, sieving, adding starch, sucralose and appropriate amount of 40% ethanol, mixing, granulating, drying, grading, adding magnesium stearate, mixing, and making into 1000 tablets.
EXAMPLE 4 preparation of Compound Chinese medicinal buccal tablet
1) Preparing the Chinese violet extract: taking a Chinese violet medicinal material, respectively adding 14 times and 10 times of 80% ethanol, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining filtrates, recovering ethanol under reduced pressure, concentrating to the medicinal material amount, centrifuging, adding a centrifugate onto a treated HPD-750 macroporous adsorption resin column at the flow rate of 0.5BV/h, eluting with 3BV water at the flow rate of 3BV/h, sequentially eluting with 2BV 50% and 2BV 80% ethanol at the flow rate of 2BV/h, collecting corresponding ethanol eluates, recovering ethanol, concentrating to form a thick paste with the relative density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8Mpa, and crushing to obtain the Chinese violet extract.
2) Preparation of dandelion extract: decocting dandelion medicinal materials respectively by adding 12 times, 10 times and 10 times of water for 3 times, each time for 1 hour, filtering, combining filtrates, concentrating under reduced pressure to obtain clear paste with the relative density of 1.10(50 ℃), adding alcohol until the alcohol content is 80%, standing for more than 24 hours, filtering, concentrating the filtrate until the medicinal material content is about, adjusting the pH value to 5 by using dilute hydrochloric acid, adding the clear paste onto a processed HPD-100 macroporous adsorption resin column at the flow rate of 1BV/h, eluting by using 3BV purified water at the flow rate of 3BV/h, eluting by using 2BV 60% ethanol and 3BV 80% ethanol at the flow rate of 2BV/h in sequence, collecting corresponding alcohol eluent, recovering ethanol, concentrating to obtain thick paste with the density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8MPa, and crushing to obtain the dandelion health care product.
3) The preparation process comprises the following steps:
| formulation of | Amount of use, g |
| Herba Violae extract | 60 |
| Dandelion extract | 30 |
| Dextrin | 484.8 |
| Aspartame | 15.6 |
| Talcum powder | 9.6 |
| Water (W) | Proper amount of |
Pulverizing the above two extracts, sieving, adding dextrin, aspartame and appropriate amount of water, mixing, granulating, drying, grading, adding pulvis Talci, mixing, and making into 1000 tablets.
EXAMPLE 5 preparation of Compound Chinese medicinal buccal tablet
1) Preparing the Chinese violet extract: taking a Chinese violet medicinal material, respectively adding 14 times and 10 times of 80% ethanol, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining filtrates, recovering ethanol under reduced pressure, concentrating to the medicinal material amount, centrifuging, adding a centrifugate on a treated D-101 macroporous adsorption resin column at the flow rate of 0.5BV/h, eluting with 3BV water at the flow rate of 3BV/h, sequentially eluting with 2BV 50% and 2BV 60% ethanol at the flow rate of 2BV/h, collecting corresponding ethanol eluates, recovering ethanol, concentrating to form a thick paste with the relative density of 1.25-1.30, vacuum-drying at the temperature of 80 ℃ and the vacuum degree of more than 0.8Mpa, and crushing to obtain the Chinese violet extract.
2) Preparation of dandelion extract: decocting dandelion medicinal materials respectively by adding 12 times, 10 times and 10 times of water for 3 times, each time for 1 hour, filtering, combining filtrates, concentrating under reduced pressure to obtain clear paste with the relative density of 1.10(50 ℃), adding alcohol until the alcohol content is 70%, standing for more than 24 hours, filtering, concentrating the filtrate until the medicinal material content is about, adjusting the pH value to 5 by using dilute hydrochloric acid, adding the clear paste onto a processed D-101 macroporous adsorption resin column at the flow rate of 1BV/h, eluting by using 3BV purified water at the flow rate of 3BV/h, eluting by using 2BV 50% ethanol and 3BV 70% ethanol at the flow rate of 2BV/h in sequence, collecting corresponding alcohol eluent, recovering ethanol, concentrating to obtain thick paste with the density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8MPa, and crushing to obtain the dandelion oral liquid.
3) The preparation process comprises the following steps:
| formulation of | Amount of use, g |
| Herba Violae extract | 30 |
| Dandelion extract | 12 |
| Sucrose | 532.2 |
| Citric acid | 8.4 |
| Sucralose | 7.8 |
| Talcum powder | 9.6 |
| Starch slurry | Proper amount of |
Pulverizing the above two extracts, sieving, adding sucrose, citric acid, sucralose and appropriate amount of starch slurry, mixing, granulating, drying, grading, adding pulvis Talci, mixing, and making into 1000 tablets.
Example 6 preparation of Compound Chinese medicinal buccal tablet
1) Preparing the Chinese violet extract: taking a Chinese violet medicinal material, respectively adding 14 times and 10 times of 80% ethanol, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining filtrates, recovering ethanol under reduced pressure, concentrating to the medicinal material amount, centrifuging, adding a centrifugate onto a treated HPD-100 macroporous adsorption resin column at the flow rate of 0.5BV/h, eluting with 3BV water at the flow rate of 3BV/h, sequentially eluting with 2BV 40% and 2BV 70% ethanol at the flow rate of 2BV/h, collecting corresponding ethanol eluates, recovering ethanol, concentrating to form a thick paste with the relative density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8Mpa, and crushing to obtain the Chinese violet extract.
2) Preparation of dandelion extract: decocting dandelion medicinal materials respectively by adding 12 times, 10 times and 10 times of water for 3 times, each time for 1 hour, filtering, combining filtrates, concentrating under reduced pressure to obtain clear paste with the relative density of 1.10(50 ℃), adding alcohol until the alcohol content is 80%, standing for more than 24 hours, filtering, concentrating the filtrate until the medicinal material content is about, adjusting the pH to 4 by using dilute hydrochloric acid, adding the clear paste onto a processed HPD-750 macroporous adsorption resin column at the flow rate of 1BV/h, eluting by using 3BV purified water at the flow rate of 3BV/h, eluting by using 2BV 40% ethanol and 3BV 50% ethanol at the flow rate of 2BV/h in sequence, collecting corresponding alcohol eluent, recovering ethanol, concentrating to obtain thick paste with the density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8MPa, and crushing to obtain the dandelion health care product.
3) The preparation process comprises the following steps:
| formulation of | Amount of use, g |
| Herba Violae extract | 48 |
| Dandelion extract | 24 |
| Lactose | 496.8 |
| Menthol crystal | 6 |
| Aspartame | 9.6 |
| Talcum powder | 7.2 |
| Magnesium stearate | 6.4 |
| 50% ethanol | Proper amount of |
Pulverizing the above two extracts, sieving, adding lactose, Mentholum, aspartame and appropriate amount of 50% ethanol, mixing, granulating, drying, grading, adding magnesium stearate, mixing, and making into 1000 tablets.
Example 7 preparation of Compound Chinese medicinal buccal tablet
1) Preparing the Chinese violet extract: taking a Chinese violet medicinal material, respectively adding 14 times and 10 times of 80% ethanol, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining filtrates, recovering ethanol under reduced pressure, concentrating to the medicinal material amount, centrifuging, adding a centrifugate onto a treated HPD-100 macroporous adsorption resin column at the flow rate of 0.5BV/h, eluting with 3BV water at the flow rate of 3BV/h, sequentially eluting with 2BV 50% and 2BV 80% ethanol at the flow rate of 2BV/h, collecting corresponding ethanol eluates, recovering ethanol, concentrating to form a thick paste with the relative density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8Mpa, and crushing to obtain the Chinese violet extract.
2) Preparation of dandelion extract: decocting dandelion herb respectively by adding 12 times, 10 times and 10 times of water for 3 times, each time for 1 hour, filtering, combining filtrates, concentrating under reduced pressure to obtain clear paste with the relative density of 1.10(50 ℃), adding alcohol until the alcohol content is 70%, standing for more than 24 hours, filtering, concentrating the filtrate to the medicine content, adjusting the pH to 3.5 by using dilute hydrochloric acid, adding the mixture onto a treated XDA-8 macroporous adsorption resin column at the flow rate of 1BV/h, eluting by using 3BV purified water at the flow rate of 3BV/h, eluting by using 2BV 50% ethanol and 3BV 80% ethanol at the flow rate of 2BV/h in sequence, collecting corresponding alcohol eluent, recovering ethanol, concentrating into thick paste with the density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8MPa, and crushing to obtain the dandelion herb preparation.
3) The preparation process comprises the following steps:
| formulation of | Amount of use, g |
| Herba Violae extract | 42 |
| Dandelion extract | 21 |
| Sucrose | 204 |
| Lactose | 187.8 |
| Dextrin | 120 |
| Aspartame | 9.6 |
| Citric acid | 6 |
| Talcum powder | 6 |
| Magnesium stearate | 3.6 |
| 50% ethanol | Proper amount of |
Pulverizing the above two extracts, sieving, adding sucrose, lactose, dextrin, aspartame, citric acid and appropriate amount of 50% ethanol, mixing, granulating, drying, grading, adding magnesium stearate, mixing, and making into 1000 tablets.
EXAMPLE 8 preparation of Compound Chinese medicinal buccal tablet
1) Preparing the Chinese violet extract: taking a Chinese violet medicinal material, respectively adding 14 times and 10 times of 80% ethanol, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining filtrates, recovering ethanol under reduced pressure, concentrating to the medicinal material amount, centrifuging, adding a centrifugate onto a treated HPD-100 macroporous adsorption resin column at the flow rate of 0.5BV/h, eluting with 3BV water at the flow rate of 3BV/h, sequentially eluting with 2BV 40% and 2BV 70% ethanol at the flow rate of 2BV/h, collecting corresponding ethanol eluates, recovering ethanol, concentrating to form a thick paste with the relative density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8Mpa, and crushing to obtain the Chinese violet extract.
2) Preparation of dandelion extract: decocting dandelion herb respectively by adding 12 times, 10 times and 10 times of water for 3 times, each time for 1 hour, filtering, combining filtrates, concentrating under reduced pressure to obtain clear paste with the relative density of 1.10(50 ℃), adding alcohol until the alcohol content is 70%, standing for more than 24 hours, filtering, concentrating the filtrate to the medicine content, adjusting the pH to 3 by using dilute hydrochloric acid, adding the mixture onto a treated AB-8 macroporous adsorption resin column at the flow rate of 1BV/h, eluting by using 3BV purified water at the flow rate of 3BV/h, eluting by using 2BV 50% ethanol and 3BV 80% ethanol at the flow rate of 2BV/h in sequence, collecting corresponding alcohol eluent, recovering ethanol, concentrating to obtain thick paste with the density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8MPa, and crushing to obtain the dandelion herb preparation.
3) The preparation process comprises the following steps:
| formulation of | Amount of use, g |
| Herba Violae extract | 30 |
| Dandelion extract | 30 |
| Starch | 300 |
| Mannitol | 214.8 |
| Mint essence | 5.4 |
| Aspartame | 9 |
| Calcium stearate | 10.8 |
| 60% ethanol | Proper amount of |
Pulverizing the above two extracts, sieving, adding starch, mannitol, herba Menthae essence, aspartame and appropriate amount of 60% ethanol, mixing, granulating, drying, grading, adding calcium stearate, mixing, and making into 1000 tablets.
Example 9 preparation of Compound Chinese medicinal buccal tablet
1) Preparing the Chinese violet extract: taking a Chinese violet medicinal material, respectively adding 14 times and 10 times of 80% ethanol, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining filtrates, recovering ethanol under reduced pressure, concentrating to the medicinal material amount, centrifuging, adding a centrifugate on a treated D-101 macroporous adsorption resin column at the flow rate of 0.5BV/h, eluting with 3BV water at the flow rate of 3BV/h, sequentially eluting with 2BV 50% and 2BV 80% ethanol at the flow rate of 2BV/h, collecting corresponding ethanol eluates, recovering ethanol, concentrating to form a thick paste with the relative density of 1.25-1.30, vacuum-drying at the temperature of 80 ℃ and the vacuum degree of more than 0.8Mpa, and crushing to obtain the Chinese violet extract.
2) Preparation of dandelion extract: decocting dandelion herb respectively by adding 12 times, 10 times and 10 times of water for 3 times, each time for 1 hour, filtering, combining filtrates, concentrating under reduced pressure to obtain clear paste with the relative density of 1.10(50 ℃), adding alcohol until the alcohol content is 80%, standing for more than 24 hours, filtering, concentrating the filtrate to the medicinal material content, adjusting the pH to 2.5 by using dilute hydrochloric acid, adding the clear paste onto a processed XDA-8 macroporous adsorption resin column at the flow rate of 1BV/h, eluting by using 3BV purified water at the flow rate of 3BV/h, eluting by using 2BV 50% ethanol and 3BV 60% ethanol at the flow rate of 2BV/h in sequence, collecting corresponding alcohol eluent, recovering ethanol, concentrating into thick paste with the density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8MPa, and crushing to obtain the dandelion herb preparation.
3) The preparation process comprises the following steps:
| formulation of | Amount of use, g |
| Herba Violae extract | 36 |
| Dandelion extract | 28 |
| Sorbitol | 246 |
| Starch | 275.4 |
| Sucralose | 9 |
| Citric acid | 4.8 |
| Magnesium stearate | 7.2 |
| Calcium stearate | 3.6 |
| 60% ethanol | Proper amount of |
Pulverizing the above two extracts, sieving, adding starch, sorbitol, sucralose, citric acid and appropriate amount of 60% ethanol, mixing, granulating, drying, grading, adding calcium stearate and magnesium stearate, mixing, and tabletting to obtain 1000 tablets.
Example 10 preparation of Compound Chinese medicinal buccal tablet
1) Preparing the Chinese violet extract: taking a Chinese violet medicinal material, respectively adding 14 times and 10 times of 80% ethanol, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining filtrates, recovering ethanol under reduced pressure, concentrating to the medicinal material amount, centrifuging, adding a centrifugate onto a treated HPD-826 macroporous adsorption resin column at the flow rate of 0.5BV/h, eluting with 3BV water at the flow rate of 3BV/h, sequentially eluting with 2BV 60% and 2BV 60% ethanol at the flow rate of 2BV/h, collecting corresponding ethanol eluates, recovering ethanol, concentrating to form a thick paste with the relative density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8Mpa, and crushing to obtain the Chinese violet extract.
2) Preparation of dandelion extract: decocting dandelion herb respectively by adding 12 times, 10 times and 10 times of water for 3 times, each time for 1 hour, filtering, combining filtrates, concentrating under reduced pressure to obtain clear paste with the relative density of 1.10(50 ℃), adding alcohol until the alcohol content is 70%, standing for more than 24 hours, filtering, concentrating the filtrate to the medicinal material content, adjusting the pH to 3.5 by using dilute hydrochloric acid, adding the clear paste onto a processed XDA-8 macroporous adsorption resin column at the flow rate of 1BV/h, eluting by using 3BV purified water at the flow rate of 3BV/h, eluting by using 2BV 60% ethanol and 3BV 60% ethanol at the flow rate of 2BV/h in sequence, collecting corresponding alcohol eluent, recovering ethanol, concentrating into thick paste with the density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8MPa, and crushing to obtain the dandelion herb preparation.
3) The preparation process comprises the following steps:
| formulation of | Amount of use, g |
| Herba Violae extract | 24 |
| Dandelion extract | 24 |
| Starch | 274.2 |
| Dextrin | 252 |
| Aspartame | 12 |
| Mint essence | 3.6 |
| Talcum powder | 5.4 |
| Magnesium stearate | 4.8 |
| 50% ethanol | Proper amount of |
Pulverizing the above two extracts, sieving, adding dextrin, starch, aspartame, peppermint essence and appropriate amount of 50% ethanol, mixing, granulating, drying, grading, adding pulvis Talci and magnesium stearate, mixing, and making into 1000 tablets.
EXAMPLE 11 preparation of Compound Chinese medicinal buccal tablet
1) Preparing the Chinese violet extract: taking a Chinese violet medicinal material, respectively adding 14 times and 10 times of 80% ethanol, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining filtrates, recovering ethanol under reduced pressure, concentrating to the medicinal material amount, centrifuging, adding a centrifugate onto a treated HPD-826 macroporous adsorption resin column at the flow rate of 0.5BV/h, eluting with 3BV water at the flow rate of 3BV/h, sequentially eluting with 2BV 40% and 2BV 70% ethanol at the flow rate of 2BV/h, collecting corresponding ethanol eluates, recovering ethanol, concentrating to form a thick paste with the relative density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8Mpa, and crushing to obtain the Chinese violet extract.
2) Preparation of dandelion extract: decocting dandelion herb respectively by adding 12 times, 10 times and 10 times of water for 3 times, each time for 1 hour, filtering, combining filtrates, concentrating under reduced pressure to obtain clear paste with the relative density of 1.10(50 ℃), adding alcohol until the alcohol content is 70%, standing for more than 24 hours, filtering, concentrating the filtrate to the medicine content, adjusting the pH to 4 by using dilute hydrochloric acid, adding the mixture onto a treated XDA-8 macroporous adsorption resin column at the flow rate of 1BV/h, eluting by using 3BV purified water at the flow rate of 3BV/h, eluting by using 2BV 40% ethanol and 3BV 70% ethanol at the flow rate of 2BV/h in sequence, collecting corresponding alcohol eluent, recovering ethanol, concentrating to obtain thick paste with the density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8MPa, and crushing to obtain the dandelion herb preparation.
3) The preparation process comprises the following steps:
| formulation of | Amount of use, g |
| Herba Violae extract | 30 |
| Dandelion extract | 24 |
| Sucrose | 120 |
| Lactose | 310.2 |
| Dextrin | 90 |
| Aspartame | 9.6 |
| Citric acid | 6.6 |
| Talcum powder | 3.6 |
| Magnesium stearate | 6 |
| 50% ethanol | Proper amount of |
Pulverizing the above two extracts, sieving, adding dextrin, lactose, sucrose, aspartame, citric acid and appropriate amount of 50% ethanol, mixing, granulating, drying, grading, adding pulvis Talci and magnesium stearate, mixing, and making into 1000 tablets.
EXAMPLE 12 preparation of Compound Chinese medicinal buccal tablet
1) Preparing the Chinese violet extract: taking a Chinese violet medicinal material, respectively adding 14 times and 10 times of 80% ethanol, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining filtrates, recovering ethanol under reduced pressure, concentrating to the medicinal material amount, centrifuging, adding a centrifugate onto a treated HPD-750 macroporous adsorption resin column at the flow rate of 0.5BV/h, eluting with 3BV water at the flow rate of 3BV/h, sequentially eluting with 2BV 30% and 2BV 70% ethanol at the flow rate of 2BV/h, collecting corresponding ethanol eluates, recovering ethanol, concentrating to form a thick paste with the relative density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8Mpa, and crushing to obtain the Chinese violet extract.
2) Preparation of dandelion extract: decocting dandelion medicinal materials respectively by adding 12 times, 10 times and 10 times of water for 3 times, each time for 1 hour, filtering, combining filtrates, concentrating under reduced pressure to obtain clear paste with the relative density of 1.10(50 ℃), adding alcohol until the alcohol content is 60%, standing for more than 24 hours, filtering, concentrating the filtrate to the medicinal material content, adjusting the pH to 2 by using dilute hydrochloric acid, adding the mixture onto a processed HPD-100 macroporous adsorption resin column at the flow rate of 1BV/h, eluting by using 3BV purified water at the flow rate of 3BV/h, eluting by using 2BV 30% ethanol and 3BV 80% ethanol at the flow rate of 2BV/h in sequence, collecting corresponding alcohol eluent, recovering ethanol, concentrating to obtain thick paste with the density of 1.25-1.30, vacuum drying at 80 ℃ and the vacuum degree of more than 0.8MPa, and crushing to obtain the dandelion health care product.
3) The preparation process comprises the following steps:
| formulation of | Amount of use, g |
| Herba Violae extract | 30 |
| Dandelion extract | 6 |
| Sucrose | 330 |
| Lactose | 150 |
| Sorbitol | 84 |
| Aspartame | 6.6 |
| Menthol crystal | 9 |
| Talcum powder | 3.6 |
| Calcium stearate | 7.2 |
| Starch slurry | Proper amount of |
Pulverizing the above two extracts, sieving, adding sucrose, lactose, sorbitol, aspartame, Mentholum and appropriate amount of starch slurry, mixing, granulating, drying, grading, adding pulvis Talci and calcium stearate, mixing, and making into 1000 tablets.
EXAMPLE 13 preparation of Compound Chinese medicinal buccal tablet
1) Preparing the Chinese violet extract: taking a Chinese violet medicinal material, respectively adding 14 times and 10 times of 80% ethanol, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining filtrates, recovering ethanol under reduced pressure, concentrating to the medicinal material amount, centrifuging, adding a centrifugate onto a treated HPD-100 macroporous adsorption resin column at the flow rate of 0.5BV/h, eluting with 3BV water at the flow rate of 3BV/h, sequentially eluting with 2BV 50% and 2BV 60% ethanol at the flow rate of 2BV/h, collecting corresponding ethanol eluates, recovering ethanol, concentrating to form a thick paste with the relative density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8Mpa, and crushing to obtain the Chinese violet extract.
2) Preparation of dandelion extract: decocting dandelion herb respectively by adding 12 times, 10 times and 10 times of water for 3 times, each time for 1 hour, filtering, combining filtrates, concentrating under reduced pressure to obtain clear paste with the relative density of 1.10(50 ℃), adding alcohol until the alcohol content is 70%, standing for more than 24 hours, filtering, concentrating the filtrate to the medicine content, adjusting the pH to 5 by using dilute hydrochloric acid, adding the mixture onto a treated AB-8 macroporous adsorption resin column at the flow rate of 1BV/h, eluting by using 3BV purified water at the flow rate of 3BV/h, eluting by using 2BV 40% ethanol and 3BV 70% ethanol at the flow rate of 2BV/h in sequence, collecting corresponding alcohol eluent, recovering ethanol, concentrating to obtain thick paste with the density of 1.25-1.30, vacuum-drying at 80 ℃ and the vacuum degree of more than 0.8MPa, and crushing to obtain the dandelion herb preparation.
3) The preparation process comprises the following steps:
| formulation of | Amount of use, g |
| Herba Violae extract | 7％42 |
| Dandelion extract | 4％24 |
| Starch | 58％348 |
| Mannitol | 11％66 |
| Sorbitol | 20％120 |
| Sucralose | 1.6％9.6 |
| Mint essence | 1.4％8.4 |
| Talcum powder | 0.5％3 |
| Calcium stearate | 1.5％9 |
| 50% ethanol | Proper amount of |
Pulverizing the above two extracts, sieving, adding starch, mannitol, sorbitol, sucralose, herba Menthae essence and appropriate amount of 50% ethanol, mixing, granulating, drying, grading, adding pulvis Talci and calcium stearate, mixing, and making into 1000 tablets.
Claims (7)
1. A compound traditional Chinese medicine buccal tablet with the effects of clearing away heat and toxic material and relieving swelling and pain is characterized by comprising the following components in percentage by weight:
A. 5 to 8 percent of Chinese violet extract
B. 2 to 4 percent of dandelion extract
C. 88 to 93 percent of pharmaceutic adjuvant
Wherein, the Chinese violet extract is prepared by an ethanol reflux extraction method, the dandelion extract is prepared by a water decoction extraction method, and the pharmaceutic adjuvants are a filler, a flavoring agent, a lubricant and an adhesive;
the process for preparing the viola yedoensis makino extract by the ethanol reflux extraction method comprises the following steps: taking a Chinese violet medicinal material, respectively adding 14 times and 10 times of 80% ethanol, heating, refluxing and extracting for 2 times, each time for 1 hour, filtering, combining filtrates, recovering ethanol under reduced pressure, concentrating to the medicinal material amount, centrifuging, adding the centrifugate onto a processed HPD-826 type macroporous adsorption resin column at the flow rate of 0.5BV/h, eluting with 3BV water at the flow rate of 3BV/h, sequentially eluting with 2BV 40% and 2BV 70% ethanol at the flow rate of 2BV/h, collecting corresponding ethanol eluates, recovering ethanol, concentrating into thick paste, vacuum drying, and crushing to obtain the Chinese violet extract;
the process for preparing the dandelion extract by the water decoction extraction method comprises the following steps: decocting herba Taraxaci respectively with 12 times, 10 times and 10 times of water for 3 times, each time for 1 hr, filtering, mixing filtrates, concentrating under reduced pressure to obtain fluid extract with relative density of 1.10 at 50 deg.C, adding alcohol to ethanol content of 70%, standing for more than 24 hr, filtering, concentrating the filtrate to medicinal material amount, adjusting pH to 4 with dilute hydrochloric acid, adding onto processed XDA-8 type macroporous adsorbent resin column at flow rate of 1BV/h, eluting with 3BV purified water at flow rate of 3BV/h, eluting with 2BV 40% and 3BV 70% ethanol at flow rate of 2BV/h, collecting corresponding alcohol eluate, recovering ethanol, concentrating into soft extract, vacuum drying, and pulverizing.
2. The traditional Chinese medicine buccal tablet according to claim 1, wherein the herba violae extract accounts for 5%, the dandelion extract accounts for 4%, and the pharmaceutic adjuvant accounts for 91% by weight.
3. The traditional Chinese medicine buccal tablet according to any one of claims 1 to 2, wherein the filler is one or more of starch, dextrin, sucrose, lactose, mannitol or sorbitol.
4. The traditional Chinese medicine buccal tablet according to any one of claims 1 to 2, wherein the flavoring agent is one or more of sucralose, aspartame, citric acid, menthol and peppermint essence.
5. The traditional Chinese medicine buccal tablet according to any one of claims 1 to 2, wherein the lubricant is one or more of magnesium stearate, calcium stearate or talc.
6. The traditional Chinese medicine buccal tablet according to any one of claims 1 to 2, characterized in that the adhesive is one of water, 40 to 60 percent ethanol and starch slurry.
7. The preparation method of the compound traditional Chinese medicine buccal tablet as claimed in any one of claims 1 to 6, which is characterized by comprising the following steps:
pulverizing herba Violae extract and herba Taraxaci extract respectively, sieving, adding filler, correctant and binder, mixing, granulating, drying, grading, adding lubricant, mixing, and making into tablet.
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