CN114470108A - Compound isatis root buccal tablet and processing method thereof - Google Patents
Compound isatis root buccal tablet and processing method thereof Download PDFInfo
- Publication number
- CN114470108A CN114470108A CN202210163986.9A CN202210163986A CN114470108A CN 114470108 A CN114470108 A CN 114470108A CN 202210163986 A CN202210163986 A CN 202210163986A CN 114470108 A CN114470108 A CN 114470108A
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- CN
- China
- Prior art keywords
- parts
- buccal tablet
- radix isatidis
- powder
- compound
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Abstract
The invention discloses a compound isatis root buccal tablet and a processing method thereof, which relate to the technical field of buccal tablet processing and are prepared from the following raw materials in parts by weight: 10-30 parts of isatis root, 5-20 parts of bunge corydalis herb, 1-10 parts of cogongrass rhizome, 20-50 parts of filler, 5-20 parts of disintegrating agent, 5-20 parts of adhesive, 1-10 parts of flavoring agent and 1-10 parts of lubricant; the compound isatis root buccal tablet prepared by the invention enhances the drug effect of the isatis root buccal tablet, can effectively prevent and treat viral cold, and particularly has good curative effect on pharyngitis, tonsillitis and parotitis caused by the viral cold.
Description
The technical field is as follows:
the invention relates to the technical field of buccal tablet processing, in particular to a compound isatis root buccal tablet and a processing method thereof.
Background art:
buccal tablet is a pressed tablet slowly dissolved in oral cavity, can produce lasting drug effect on oral cavity and pharynx, and can be used for local inflammation diminishing and disinfection. The buccal tablet is popular among patients due to the excellent taste and convenient taking method. The buccal tablet has the following advantages: 1) directly acts on pharynx. Has antibacterial, antiinflammatory, repercussive, viscous secretion thinning, astringent, and mucosa secretion stimulating effects. 2) Due to slow buccal administration, the medicine can stay in pharynx for a long time to exert the drug effect continuously. 3) Has quick response for relieving discomfort such as dry throat, pharyngalgia and the like. 4) Has antibacterial, antiinflammatory, repercussive, viscous secretion thinning, astringent, and mucosa secretion stimulating effects.
Radix Isatidis, the name of Chinese medicine, is the dry root of Isatis Indigotica of Cruciferae, has effects of clearing heat and detoxicating, cooling blood, relieving sore throat, and is mainly used for treating exogenous fever, early stage of epidemic febrile disease, sore throat, warm toxic macula, mumps, erysipelas, carbuncle and sore toxin. Patent CN 200910066319.3 discloses a radix isatidis buccal tablet and a preparation method thereof, the radix isatidis buccal tablet contains the following raw material medicines: the isatis root buccal tablet is prepared from isatis root, wild buckwheat rhizome, a flavoring agent and a lubricant by a water extraction and alcohol precipitation method, the cure rate of the prepared isatis root buccal tablet on diseases such as acute pharyngitis, chronic pharyngitis and acute tonsillitis reaches 64.6%, and the total effective rate reaches 97.6%.
The invention content is as follows:
the invention aims to solve the technical problem of providing a compound radix isatidis buccal tablet and a processing method thereof, which are characterized in that the radix isatidis, bunge corydalis herb and lalang grass rhizome are utilized to introduce active ingredients into the buccal tablet, and the buccal tablet is formed by adding a filling agent, a disintegrating agent, an adhesive, a flavoring agent and a lubricating agent, so that the normal exertion of the drug effect of the buccal tablet is ensured, and the buccal tablet plays a good role in preventing and treating diseases caused by influenza viruses.
The technical problem to be solved by the invention is realized by adopting the following technical scheme:
a compound radix isatidis buccal tablet is prepared from the following raw materials in parts by weight:
10-30 parts of isatis root, 5-20 parts of bunge corydalis herb, 1-10 parts of lalang grass rhizome, 20-50 parts of filler, 5-20 parts of disintegrating agent, 5-20 parts of adhesive, 1-10 parts of flavoring agent and 1-10 parts of lubricant.
Radix Isatidis, is the dry root of Isatis tinctoria fort. of Cruciferae, has bitter taste, cold nature, heart and stomach channels, has effects of clearing heat and detoxicating, cooling blood, and relieving sore throat, and is used for treating fever due to exogenous pathogens, early stage of epidemic febrile disease, sore throat, warm toxicity macula, mumps, erysipelas, carbuncle, and sore toxin.
Herba Violae, whole plant of Corydalis edulis Bungeana Turcz of Papaveraceae, has bitter taste and cold property, enters heart and liver channels, has effects of clearing heat and detoxicating, and is mainly used for treating carbuncle, furuncle, wind-heat type common cold, bronchitis, hepatitis, enteritis, etc.
Lalang grass rhizome, dry rhizome of Imperata cylindrica Linmedicinal Beauv.var.major (Nees) C.E.Hubb. of Gramineae, has sweet taste and cold nature, enters lung, stomach and bladder channels, has effects of cooling blood, stopping bleeding, clearing heat, and promoting urination, and is used for treating hematemesis, epistaxis, hematuria, fever polydipsia, lung heat cough, stomach heat emesis, damp-heat jaundice, edema oliguria, and heat stranguria pain.
The filler is at least one of maltodextrin, cyclodextrin, microcrystalline cellulose, mannitol, sorbitol and xylitol.
The disintegrant is at least one of crospovidone, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose and starch.
The adhesive is at least one of sodium carboxymethylcellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, gelatin and sucrose.
The correctant is at least one of stevioside, citric acid, saccharin sodium, sodium cyclamate, strawberry essence, orange essence, and pineapple essence.
The lubricant is at least one of magnesium stearate, calcium stearate, superfine silica gel powder and talcum powder.
The invention also provides a processing method of the compound isatis root buccal tablet, which comprises the following steps:
(1) soaking radix Isatidis, herba Violae and lalang grass rhizome in water, decocting for three times, each time adding water 5-10 times of the total weight of the medicinal materials, mixing decoctions, filtering, concentrating the filtrate under reduced pressure to obtain extract, and oven drying the residue;
(2) the filter residue is subjected to deep cooling and crushing at the temperature of minus 30 to minus 20 ℃ to prepare micro powder, and the medicine residue powder is obtained;
(3) adding the residue powder into the extract, mixing, adding filler, disintegrant, binder, correctant and lubricant, mixing, granulating by dry method, and tabletting to obtain compound radix Isatidis buccal tablet.
The invention adopts a water decoction method to extract water-soluble active ingredients contained in the isatis root, the bunge corydalis herb and the cogongrass rhizome, and the decoction dregs are pulverized and added into the formula, thereby not only realizing the high-efficiency utilization of the isatis root, the bunge corydalis herb and the cogongrass rhizome, but also improving the bioavailability of the active ingredients contained in the isatis root, the bunge corydalis herb and the cogongrass rhizome.
The invention also provides another processing method of the compound radix isatidis buccal tablet, which comprises the following steps:
(1) soaking radix Isatidis, herba Violae and lalang grass rhizome in water, adding biguanide hydrochloride with an amount of 1-10% of the total weight of the medicinal materials, decocting for three times with water amount of 5-10 times of the total weight of the medicinal materials, mixing decoctions, filtering, concentrating the filtrate under reduced pressure to obtain extract, and oven drying the residue;
(2) the filter residue is subjected to deep cooling and crushing at the temperature of minus 30 to minus 20 ℃ to prepare micro powder, and the medicine residue powder is obtained;
(3) adding the residue powder into the extract, mixing, adding filler, disintegrant, binder, correctant and lubricant, mixing, granulating by dry method, and tabletting to obtain compound radix Isatidis buccal tablet.
In the technical scheme, the biguanide hydrochloride is used as an extraction auxiliary agent, the solubilization function of the biguanide hydrochloride is utilized to promote the leaching of the effective components, the content of the effective components in the extract is improved, and the curative effect of the prepared compound isatis root buccal tablet is optimized.
The invention also provides a preparation method of the disintegrating agent, aiming at enhancing the disintegration capability of the prepared compound isatis root buccal tablet and ensuring the quick release of the active ingredients in the oral cavity, thereby improving the utilization rate of the active ingredients.
The disintegrant is orotic acid modified etherified starch, and is prepared from amylose and 5-bromo-orotic acid, so that the etherification rate of hydroxymethyl in the amylose structure is 60-80%.
The preparation method of the orotic acid modified etherified starch comprises the following steps: dissolving amylose in dimethyl sulfoxide, adding 5-bromo-orotic acid and sodium carbonate, heating to 60-80 ℃ for reaction after complete dissolution, stopping reaction after complete reaction of the 5-bromo-orotic acid, adding water, stirring, filtering precipitates, washing with water, and drying to obtain the orotic acid modified etherified starch.
The preparation principle of the orotic acid modified etherified starch is as follows: the hydroxymethyl in the amylose structure and 5-bromo-orotic acid undergo a condensation reaction to generate ether bonds, and the obtained orotic acid modified etherified starch is used for solving the problems existing in the direct use of starch as a disintegrant (the starch has poor compressibility, the hardness of a tablet is influenced when the amount of the starch is large, and the tablet forming is influenced when the fluidity is poor).
The invention takes the orotic acid modified etherified starch as the disintegrant, not only has good fluidity and compressibility, but also can effectively improve the moldability of the compound isatis root buccal tablet; and the compound radix isatidis buccal tablet has good water absorption and expansibility, can ensure the disintegration performance of the compound radix isatidis buccal tablet, can be disintegrated into fine particles after rapidly absorbing water in an oral cavity, and enables the active ingredients to be rapidly dissolved and absorbed so as to exert the drug effect.
The invention has the beneficial effects that:
(1) the invention adopts radix isatidis, bunge corydalis herb and lalang grass rhizome to form a traditional Chinese medicine prescription, and adopts filler, disintegrant, adhesive, flavoring agent and lubricant as preparation auxiliary materials to prepare the compound radix isatidis buccal tablet; enhances the drug effect of the radix isatidis buccal tablets, can effectively prevent and treat viral influenza, and particularly has good curative effect on pharyngitis, tonsillitis and parotitis caused by the viral influenza.
(2) Through screening of the disintegrating agent, the buccal tablet has the advantages of optimizing the tabletting and forming performance of the buccal tablet, improving the disintegrating performance of the buccal tablet, promoting the dissolution and absorption of the active ingredients, improving the bioavailability of the active ingredients and enhancing the prevention and treatment effects of the buccal tablet.
The specific implementation mode is as follows:
in order to make the technical means, the creation characteristics, the achievement purposes and the effects of the invention easy to understand, the invention is further described with the specific embodiments.
Example 1
(1) Soaking 250g of radix isatidis, 100g of herba violae and 60g of rhizoma imperatae in water for 3 hours, then decocting for three times, wherein the water addition amount for the first time is 8 times of the total weight of the medicinal materials, the water addition amount for the second time is 5 times of the total weight of the medicinal materials, the water addition amount for the third time is 5 times of the total weight of the medicinal materials, 4 hours each time, combining decoction liquids, filtering, concentrating the filtrate under reduced pressure to prepare an extract with the relative density of 1.15, and drying filter residues for later use;
(2) deep cooling the filter residue at-25 deg.C, pulverizing into micropowder to obtain 100 mesh medicinal residue powder;
(3) and adding the medicine residue powder into the extract, uniformly mixing, adding 200g of maltodextrin, 200g of microcrystalline cellulose, 100g of crospovidone, 50g of sodium carboxymethylcellulose, 50g of ethyl cellulose, 30g of stevioside, 20g of strawberry essence, 20g of magnesium stearate and 20g of superfine silica gel powder, uniformly mixing, granulating by adopting a dry method, and pressing into tablets to obtain the compound radix isatidis buccal tablets.
Example 2
(1) Soaking 220g of radix isatidis, 120g of herba violae and 80g of rhizoma imperatae in water for 3 hours, then decocting for three times, wherein the water addition amount for the first time is 8 times of the total weight of the medicinal materials, the water addition amount for the second time is 5 times of the total weight of the medicinal materials, the water addition amount for the third time is 5 times of the total weight of the medicinal materials, 4 hours each time, combining decoction liquids, filtering, concentrating the filtrate under reduced pressure to prepare an extract with the relative density of 1.25, and drying filter residues for later use;
(2) deep cooling the filter residue at-25 deg.C, pulverizing into micropowder to obtain 100 mesh medicinal residue powder;
(3) adding the medicine residue powder into the extract, uniformly mixing, adding 200g of maltodextrin, 150g of mannitol, 100g of crospovidone, 50g of sodium carboxymethylcellulose, 40g of gelatin, 30g of saccharin sodium, 20g of pineapple essence, 20g of calcium stearate and 10g of talcum powder, uniformly mixing, performing dry granulation, and pressing into tablets to obtain the compound radix isatidis buccal tablets.
Example 3
Example 3 was obtained by replacing crospovidone in example 1 with sodium carboxymethyl starch, and the remaining conditions and procedures were exactly the same as in example 1.
(1) Soaking 250g of radix isatidis, 100g of herba violae and 60g of rhizoma imperatae in water for 3 hours, then decocting for three times, wherein the water addition amount for the first time is 8 times of the total weight of the medicinal materials, the water addition amount for the second time is 5 times of the total weight of the medicinal materials, the water addition amount for the third time is 5 times of the total weight of the medicinal materials, 4 hours each time, combining decoction liquids, filtering, concentrating the filtrate under reduced pressure to prepare an extract with the relative density of 1.15, and drying filter residues for later use;
(2) deep cooling the filter residue at-25 deg.C, pulverizing into micropowder to obtain 100 mesh medicinal residue powder;
(3) adding the medicine residue powder into the extract, uniformly mixing, adding 200g of maltodextrin, 200g of microcrystalline cellulose, 100g of sodium carboxymethyl starch, 50g of sodium carboxymethyl cellulose, 50g of ethyl cellulose, 30g of stevioside, 20g of strawberry essence, 20g of magnesium stearate and 20g of superfine silica powder, uniformly mixing, granulating by adopting a dry method, and pressing into tablets to obtain the compound radix isatidis buccal tablets.
Example 4
Example 4 was obtained by replacing crospovidone in example 1 with low-substituted hydroxypropylcellulose, and the rest of the conditions and steps were completely the same as in example 1.
(1) Soaking 250g of radix isatidis, 100g of herba violae and 60g of rhizoma imperatae in water for 3 hours, then decocting for three times, wherein the water addition amount for the first time is 8 times of the total weight of the medicinal materials, the water addition amount for the second time is 5 times of the total weight of the medicinal materials, the water addition amount for the third time is 5 times of the total weight of the medicinal materials, 4 hours each time, combining decoction liquids, filtering, concentrating the filtrate under reduced pressure to prepare an extract with the relative density of 1.15, and drying filter residues for later use;
(2) deep cooling the filter residue at-25 deg.C, pulverizing into micropowder to obtain 100 mesh medicinal residue powder;
(3) adding the medicine residue powder into the extract, uniformly mixing, adding 200g of maltodextrin, 200g of microcrystalline cellulose, 100g of low-substituted hydroxypropyl cellulose, 50g of sodium carboxymethylcellulose, 50g of ethyl cellulose, 30g of stevioside, 20g of strawberry essence, 20g of magnesium stearate and 20g of superfine silica powder, uniformly mixing, granulating by adopting a dry method, and pressing into tablets to obtain the compound isatis root buccal tablets.
Example 5
Example 5 was obtained by replacing crospovidone in example 1 with amylose, and the remaining conditions and procedures were exactly the same as in example 1.
(1) Soaking 250g of radix isatidis, 100g of herba violae and 60g of rhizoma imperatae in water for 3 hours, then decocting for three times, wherein the water addition amount for the first time is 8 times of the total weight of the medicinal materials, the water addition amount for the second time is 5 times of the total weight of the medicinal materials, the water addition amount for the third time is 5 times of the total weight of the medicinal materials, 4 hours each time, combining decoction liquids, filtering, concentrating the filtrate under reduced pressure to prepare an extract with the relative density of 1.15, and drying filter residues for later use;
(2) deep cooling the filter residue at-25 deg.C, pulverizing into micropowder to obtain 100 mesh medicinal residue powder;
(3) and adding the medicine residue powder into the extract, uniformly mixing, adding 200g of maltodextrin, 200g of microcrystalline cellulose, 100g of amylose, 50g of sodium carboxymethylcellulose, 50g of ethyl cellulose, 30g of stevioside, 20g of strawberry essence, 20g of magnesium stearate and 20g of superfine silica gel powder, uniformly mixing, granulating by adopting a dry method, and pressing into tablets to obtain the compound radix isatidis buccal tablets.
Example 6
Addition of the biguanide hydrochloride in step (1) of example 1 provides example 6 with the remaining conditions and steps being identical to those of example 1.
(1) Soaking 250g of radix isatidis, 100g of herba violae and 60g of rhizoma imperatae in water for 3 hours, then adding 15g of biguanide hydrochloride, decocting for three times, wherein the water addition amount for the first time is 8 times of the total weight of the medicinal materials, the water addition amount for the second time is 5 times of the total weight of the medicinal materials, the water addition amount for the third time is 5 times of the total weight of the medicinal materials, 4 hours each time, combining the decoctions, filtering, concentrating the filtrate under reduced pressure to prepare an extract with the relative density of 1.15, and drying the filter residue for later use;
(2) deep cooling the filter residue at-25 deg.C, pulverizing into micropowder to obtain 100 mesh medicinal residue powder;
(3) and adding the medicine residue powder into the extract, uniformly mixing, adding 200g of maltodextrin, 200g of microcrystalline cellulose, 100g of crospovidone, 50g of sodium carboxymethylcellulose, 50g of ethyl cellulose, 30g of stevioside, 20g of strawberry essence, 20g of magnesium stearate and 20g of superfine silica gel powder, uniformly mixing, granulating by adopting a dry method, and pressing into tablets to obtain the compound radix isatidis buccal tablets.
Example 7
The crospovidone in example 1 was replaced with orotate modified etherified starch and the remaining conditions and steps were exactly the same as in example 1.
Preparing orotic acid modified etherified starch: firstly, 20g of amylose is dissolved in dimethyl sulfoxide, then 23.5g of 5-bromo-orotic acid and 5.3g of sodium carbonate are added, the mixture is heated to 65 ℃ after complete dissolution and reacts for 5 hours, the reaction is stopped after the 5-bromo-orotic acid completely reacts, water is added and stirred for 30min until no precipitate is generated again, the precipitate is filtered, washed and dried, and the orotic acid modified etherified starch is obtained.
(1) Soaking 250g of radix isatidis, 100g of herba violae and 60g of rhizoma imperatae in water for 3 hours, then adding 15g of biguanide hydrochloride, decocting for three times, wherein the water addition amount for the first time is 8 times of the total weight of the medicinal materials, the water addition amount for the second time is 5 times of the total weight of the medicinal materials, the water addition amount for the third time is 5 times of the total weight of the medicinal materials, 4 hours each time, combining the decoctions, filtering, concentrating the filtrate under reduced pressure to prepare an extract with the relative density of 1.15, and drying the filter residue for later use;
(2) deep cooling the filter residue at-25 deg.C, pulverizing into micropowder to obtain 100 mesh medicinal residue powder;
(3) adding the medicine residue powder into the extract, uniformly mixing, adding 200g of maltodextrin, 200g of microcrystalline cellulose, 100g of orotic acid modified etherified starch, 50g of sodium carboxymethylcellulose, 50g of ethyl cellulose, 30g of stevioside, 20g of strawberry essence, 20g of magnesium stearate and 20g of superfine silica powder, uniformly mixing, granulating by adopting a dry method, and pressing into tablets to obtain the compound isatis root buccal tablet.
Amylose used in the examples was purchased from Shandong Fengtai Biotech limited.
The granules obtained by the dry granulation in the step (3) in examples 1, 2, 3, 4, 5 and 7 were subjected to angle of repose measurement (fixed cone bottom method).
The water absorption of the disintegrants used in examples 1, 2, 3, 4, 5 and 7 (volume of 1g of the particles after absorbing water) was measured.
The buccal tablets finally prepared in the steps (3) of example 1, example 2, example 3, example 4, example 5 and example 7 were subjected to disintegration property measurement (pharmacopoeia 2010 version).
The average value was taken three times, and the measurement results are shown in Table 1.
TABLE 1
| Angle of repose/° | Water absorption/mL | Disintegration time | |
| Example 1 | 30.8 | 7.0 | 11min15s |
| Example 2 | 31.3 | 7.0 | 12min06s |
| Example 3 | 33.9 | 18.7 | 9min24s |
| Example 4 | 57.2 | 9.1 | 14min30s |
| Example 5 | 45.1 | 0.3 | Greater than 15min |
| Example 7 | 29.4 | 36.2 | 7min42s |
The smaller the angle of repose, the better the flowability. The larger the volume after water absorption, the better the swellability. The shorter the disintegration time, the faster the onset of action.
The compound radix isatidis buccal tablets prepared in example 1, example 6 and example 7 are subjected to the drug effect test of acute tonsillitis:
300 cases of acute tonsillitis patients are randomly selected, the age is 10-68 years old, 158 cases of males and 142 cases of females are randomly and averagely divided into 3 groups, 100 cases of each group are randomly and averagely divided, the compound radix isatidis buccal tablets prepared in the above examples and comparative examples are respectively taken, 1 tablet is taken each time, 3 times are taken each day, 7 days are a treatment course, and the symptoms of the patients are recorded. The test results are shown in Table 2.
TABLE 2
| Rate of recovery/%) | Effective rate% | |
| Example 1 | 50 | 98 |
| Example 6 | 56 | 100 |
| Example 7 | 52 | 100 |
The foregoing shows and describes the general principles and broad features of the present invention and advantages thereof. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are described in the specification and illustrated only to illustrate the principle of the present invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the present invention, which fall within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.
Claims (8)
1. A compound radix isatidis buccal tablet is characterized in that: the feed is prepared from the following raw materials in parts by weight:
10-30 parts of isatis root, 5-20 parts of bunge corydalis herb, 1-10 parts of lalang grass rhizome, 20-50 parts of filler, 5-20 parts of disintegrating agent, 5-20 parts of adhesive, 1-10 parts of flavoring agent and 1-10 parts of lubricant.
2. The compound radix isatidis buccal tablet according to claim 1, wherein: the filler is at least one of maltodextrin, cyclodextrin, microcrystalline cellulose, mannitol, sorbitol and xylitol.
3. The compound radix isatidis buccal tablet according to claim 1, wherein: the disintegrant is at least one of crospovidone, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose and starch.
4. The compound radix isatidis buccal tablet according to claim 1, wherein: the adhesive is at least one of sodium carboxymethylcellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, gelatin and sucrose.
5. The compound radix isatidis buccal tablet according to claim 1, wherein: the correctant is at least one of stevioside, citric acid, saccharin sodium, sodium cyclamate, strawberry essence, orange essence, and pineapple essence.
6. The compound radix isatidis buccal tablet according to claim 1, wherein: the lubricant is at least one of magnesium stearate, calcium stearate, superfine silica gel powder and talcum powder.
7. The processing method of the compound radix isatidis buccal tablet as claimed in claim 1, is characterized in that: the method comprises the following steps:
(1) soaking radix Isatidis, herba Violae and lalang grass rhizome in water, decocting for three times, each time adding water 5-10 times of the total weight of the medicinal materials, mixing decoctions, filtering, concentrating the filtrate under reduced pressure to obtain extract, and oven drying the residue;
(2) the filter residue is subjected to deep cooling and crushing at the temperature of minus 30 to minus 20 ℃ to prepare micro powder, and the medicine residue powder is obtained;
(3) adding the residue powder into the extract, mixing, adding filler, disintegrant, binder, correctant and lubricant, mixing, granulating by dry method, and tabletting to obtain compound radix Isatidis buccal tablet.
8. The processing method of the compound radix isatidis buccal tablet as claimed in claim 1, is characterized in that: the method comprises the following steps:
(1) soaking radix Isatidis, herba Violae and lalang grass rhizome in water, adding biguanide hydrochloride with an amount of 1-10% of the total weight of the medicinal materials, decocting for three times with water amount of 5-10 times of the total weight of the medicinal materials, mixing decoctions, filtering, concentrating the filtrate under reduced pressure to obtain extract, and oven drying the residue;
(2) the filter residue is subjected to deep cooling and crushing at the temperature of minus 30 to minus 20 ℃ to prepare micro powder, and the medicine residue powder is obtained;
(3) adding the residue powder into the extract, mixing, adding filler, disintegrant, binder, correctant and lubricant, mixing, granulating by dry method, and tabletting to obtain compound radix Isatidis buccal tablet.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1698664A (en) * | 2004-05-21 | 2005-11-23 | 江西本草天工科技有限责任公司 | Isatic root effervescence tablet and preparation method thereof |
| CN1706413A (en) * | 2004-06-11 | 2005-12-14 | 上海中洲天然药物科技开发有限公司 | Dispersant isatis root tablet and its prepn process |
| CN101396382A (en) * | 2007-09-27 | 2009-04-01 | 上海市脑血管病防治研究所 | Composite isatis root orally disintegrating tablet and preparation method thereof |
| CN101695512A (en) * | 2009-10-30 | 2010-04-21 | 洛阳新春都生物制药有限公司 | Banlangen buccal tablet and preparation method thereof |
-
2022
- 2022-02-22 CN CN202210163986.9A patent/CN114470108A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1698664A (en) * | 2004-05-21 | 2005-11-23 | 江西本草天工科技有限责任公司 | Isatic root effervescence tablet and preparation method thereof |
| CN1706413A (en) * | 2004-06-11 | 2005-12-14 | 上海中洲天然药物科技开发有限公司 | Dispersant isatis root tablet and its prepn process |
| CN101396382A (en) * | 2007-09-27 | 2009-04-01 | 上海市脑血管病防治研究所 | Composite isatis root orally disintegrating tablet and preparation method thereof |
| CN101695512A (en) * | 2009-10-30 | 2010-04-21 | 洛阳新春都生物制药有限公司 | Banlangen buccal tablet and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 马建中等编著, 世界图书出版广东有限公司 * |
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Application publication date: 20220513 |