CN116370513A - Notoginseng orally disintegrating tablet, and preparation method and application thereof - Google Patents
Notoginseng orally disintegrating tablet, and preparation method and application thereof Download PDFInfo
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- CN116370513A CN116370513A CN202310371861.XA CN202310371861A CN116370513A CN 116370513 A CN116370513 A CN 116370513A CN 202310371861 A CN202310371861 A CN 202310371861A CN 116370513 A CN116370513 A CN 116370513A
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- notoginseng
- essence
- disintegrating tablet
- orally disintegrating
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Abstract
The invention discloses a pseudo-ginseng orally disintegrating tablet, and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine preparations. The notoginseng orally disintegrating tablet comprises 30-70 parts of notoginseng root powder, 20-60 parts of filler, 0-5 parts of adhesive, 5-20 parts of disintegrating agent, 0.5-3 parts of sweetener, 0.5-3 parts of aromatic, 0.5-2 parts of lubricant, 0.1-0.5 part of glidant and 15-30 parts of wetting agent. The invention prepares the notoginseng orally disintegrating tablet which contains notoginseng root powder and various auxiliary materials through experimental investigation, has the advantages of rapid disintegration time, good taste and the like, solves the defects of complicated taking process and the like of the traditional notoginseng powder, and is beneficial to dysphagia people to take; meanwhile, the filler is selected as a sugar substitute auxiliary material, so that the bitter taste of the pseudo-ginseng powder is covered, and meanwhile, the occurrence of blood sugar and decayed teeth of a user is not influenced, and the audience range of the pseudo-ginseng powder is greatly widened.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a pseudo-ginseng oral disintegrating tablet and a preparation method and application thereof.
Background
Notoginseng radix (Panax notoginseng (Burk.) F.H.Chen) is a plant of Panax of Araliaceae, also called Notoginseng radix, radix Stephaniae Sinicae, etc., and is mainly produced in Yunnan, guangxi, etc., and is a traditional rare Chinese medicinal material in China, and has been loaded in the past. Notoginseng radix is used as a medicine at root, has warm nature, sweet and slightly bitter taste, and has effects of removing blood stasis, stopping bleeding, detumescence and relieving pain. Can be used for treating hemoptysis, hematemesis, epistaxis, hematochezia, metrorrhagia, traumatic hemorrhage, thoracico-abdominal pain, and traumatic injury. Modern medical research shows that notoginseng also has the functions of improving myocardial blood supply, enhancing vascular elasticity and dilating arterial blood vessel. The notoginseng is taken frequently, so that cardiovascular and cerebrovascular diseases such as coronary heart disease, angina and the like can be prevented, and the notoginseng has great benefit for people with cardiovascular and cerebrovascular diseases.
Currently, the commercial pseudo-ginseng products mainly comprise pseudo-ginseng rhizome raw blocks and pseudo-ginseng rhizome powder, and are commonly used for food therapy or oral administration. The Notoginseng radix powder contains Notoginseng radix total saponin as effective component, and has bitter taste. The deposited total saponins of Notoginseng radix increase with growth age, and the bitter taste gradually deepens. In order to improve the acceptance of the users, sweet substances such as sucrose or honey and the like are added during eating, so that the eating mode is troublesome, and the utilization and acceptance of the pseudo-ginseng and the products thereof are restricted. Compared with Notoginseng radix rhizome blocks, liquid preparation, granule and capsule, notoginseng radix tablet has the advantages of simple storage, convenient carrying and use, and can improve the acceptance of Notoginseng radix product. In order to improve the utilization degree of pseudo-ginseng products, chinese patent CN 105641008A prepares pseudo-ginseng tablets by a supercritical extraction technology, and crospovidone, croscarmellose sodium and sodium carboxymethyl starch are added in the preparation process, so that the prepared tablets have longer disintegration time (more than 10 min). Chinese patent CN 1323667C developed a notoginseng dispersible tablet prepared by using notoginseng total saponins, but the dispersible tablet needs to be subjected to preliminary processing to extract notoginseng total saponins, and is not prepared by directly using notoginseng raw powder, so that some acceptation barriers exist for some audiences who are interested in taking the raw powder, and the preparation process is troublesome.
Some consumers may have problems with dysphagia and the like, while they receive less than adequate tablets for chewing. In order to improve the acceptance of users and the utilization rate of active ingredients in the pseudo-ginseng powder, the invention prepares the pseudo-ginseng orally disintegrating tablet which can be rapidly disintegrated in the oral cavity within 1min, has pleasant taste and expands the popularization and application of pseudo-ginseng products.
Disclosure of Invention
The invention aims to provide a pseudo-ginseng orally disintegrating tablet, a preparation method and application thereof, which are used for solving the problems in the prior art.
In order to achieve the above object, the present invention provides the following solutions:
the invention provides a pseudo-ginseng orally disintegrating tablet which comprises the following components in parts by weight:
30-70 parts of pseudo-ginseng root powder, 20-60 parts of filler, 0-5 parts of adhesive, 5-20 parts of disintegrating agent, 0.5-3 parts of sweetener, 0.5-3 parts of aromatic, 0.5-2 parts of lubricant, 0.1-0.5 part of glidant and 15-30 parts of wetting agent.
Further, the filler includes one or more of xylitol, mannitol, sorbitol, erythritol, cyclodextrin, starch, lactose, pregelatinized starch, microcrystalline cellulose, calcium carbonate, and calcium phosphate.
Further, the binder comprises one or more of starch, pregelatinized starch, sucrose, glucose, methylcellulose, hydroxypropyl cellulose, hypromellose, sodium carboxymethyl cellulose, ethylcellulose, povidone, gelatin, polyethylene glycol, and sodium alginate.
Further, the disintegrating agent comprises one or more of dry starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, croscarmellose sodium, crospovidone, microcrystalline cellulose, alginic acid and sodium alginate.
Further, the sweetener comprises one or more of glucose, sucrose, stevioside, saccharin sodium, aspartame and sucralose;
the aromatic comprises one or more of strawberry essence, grape essence, peach essence, lemon essence, watermelon essence, cherry essence, hawthorn essence, sweet orange essence, peppermint essence, green tea essence, vanilla essence and sweet essence;
the lubricant comprises one or more of stearate, stearic acid, hydrogenated vegetable oil, polyethylene glycol and lauryl sulfate;
the glidant comprises one or more of micropowder silica gel and talcum powder;
the wetting agent comprises water or ethanol with the volume fraction of 10-60%.
Further, the paint comprises the following components in parts by weight:
50 parts of notoginseng root powder, 29.4 parts of xylitol, 3 parts of povidone, 15 parts of crospovidone, 1 part of sucralose, 1 part of watermelon essence, 0.5 part of magnesium stearate, 0.1 part of micro silica gel and 20 parts of ethanol with the volume fraction of 50 percent.
Further, the povidone includes povidone K30 or povidone K90.
The invention also provides a preparation method of the pseudo-ginseng oral disintegrating tablet, which comprises the following steps:
weighing according to parts by weight, mixing uniformly radix notoginseng powder, filler, adhesive and 1/2-2/3 of disintegrating agent, adding wetting agent to prepare wet granules, sieving, drying, granulating, adding sweetener, glidant, lubricant and 1/3-1/2 of disintegrating agent, mixing uniformly, tabletting to obtain the radix notoginseng orally disintegrating tablet.
Further, the wet granules are produced by a high-speed shearing granulator through a wet granulation method.
The invention also provides an application of the pseudo-ginseng oral disintegrating tablet in preparing health-care food for preventing cardiovascular and cerebrovascular diseases.
The invention discloses the following technical effects:
1. the filler used in the invention is mainly sugar-substituted auxiliary materials, has the function of covering up the bitter taste of the pseudo-ginseng powder, is not absorbed by human body, does not change the blood sugar change and the occurrence of decayed teeth in the body of a user, and is beneficial to improving the acceptance of the user.
2. Compared with dry granulation, wet granulation is the most widely used granulation mode at present, the process and equipment are more mature, and meanwhile, the granules obtained by the wet granulation have the advantages of attractive appearance, good fluidity, good wear resistance, good compression formability and the like; according to the invention, the disintegrating agent is added by internal and external addition in the preparation process, so that the disintegrating time effect can be obviously shortened, and the disintegrating effect is better.
3. Different auxiliary materials can be added in the preparation process of the pseudo-ginseng tablet prepared by the invention to improve the flavor of the tablet, so that the flavor of the tablet is more diversified, and the tablet is suitable for the demands of different people.
4. The notoginseng powder orally disintegrating tablet prepared by the invention can be rapidly disintegrated in the oral cavity within 1min through saliva, is very friendly to dysphagia people, and can improve the utilization rate of active ingredients in the notoginseng powder through rapid disintegration in the oral cavity.
The invention prepares the notoginseng orally disintegrating tablet through a large number of experiments, which contains notoginseng root powder with a certain proportion and auxiliary materials with a certain proportion. The orally disintegrating tablet has the advantages of rapid disintegration time, good taste, and the like, overcomes the defects of complicated administration process and the like of the traditional pseudo-ginseng powder, and is beneficial to dysphagia people. Meanwhile, the filler is selected as a sugar substitute auxiliary material, so that the bitter taste of the pseudo-ginseng powder is covered, and meanwhile, the occurrence of blood sugar and decayed teeth of a user is not influenced, and the audience range of the pseudo-ginseng powder is greatly widened.
Detailed Description
Various exemplary embodiments of the invention will now be described in detail, which should not be considered as limiting the invention, but rather as more detailed descriptions of certain aspects, features and embodiments of the invention.
It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. In addition, for numerical ranges in this disclosure, it is understood that each intermediate value between the upper and lower limits of the ranges is also specifically disclosed. Every smaller range between any stated value or stated range, and any other stated value or intermediate value within the stated range, is also encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. All documents mentioned in this specification are incorporated by reference for the purpose of disclosing and describing the methods and/or materials associated with the documents. In case of conflict with any incorporated document, the present specification will control.
It will be apparent to those skilled in the art that various modifications and variations can be made in the specific embodiments of the invention described herein without departing from the scope or spirit of the invention. Other embodiments will be apparent to those skilled in the art from consideration of the specification of the present invention. The specification and examples of the present invention are exemplary only.
As used herein, the terms "comprising," "including," "having," "containing," and the like are intended to be inclusive and mean an inclusion, but not limited to.
The notoginseng root powder and the auxiliary materials used in the invention have finer particle size, and the selected raw materials and auxiliary materials are required to be granulated in order to improve the fluidity and the disintegration effect. Wet granulation is one of the most traditional granulation techniques, and the granules prepared by the wet granulation have good fluidity and density, meanwhile, the use of liquid is involved in the granulation process, the dust generation is less in the production process, and the pollution to air is also less. Therefore, wet granulation is selected as the granulation mode in the production process.
As a simple and effective taste masking mode, the sucrose auxiliary material is used as a filling agent, so that the taste masking effect can be well achieved. The invention discovers that the crowd who purchases the pseudo-ginseng powder for taking in the market at present is generally middle-aged and elderly people, and hopefully can improve the health problem of the crowd by taking the pseudo-ginseng powder for a long time. However, at the same time, the part of people may have the problem of 'three highs'. The use of sucrose-based excipients can greatly limit the use of such people. Through continuous fumbling, the invention selects the sugar substitute auxiliary material as the filling agent, and can not cause the problems of blood sugar, decayed tooth and the like of a user while masking the taste with high efficiency.
Example 1
The raw materials of the notoginseng oral disintegrating tablet are shown in table 1:
TABLE 1
The preparation method of the pseudo-ginseng oral disintegrating tablet comprises the following steps: weighing Notoginseng radix powder, filler, disintegrating agent and binder in proportion, mixing, adding wetting agent to obtain wet granule, wet granulating with high speed shearing granulator to obtain wet granule, sieving wet granule, drying, granulating, adding sweetener and glidant, mixing, adding lubricant, and tabletting.
In the preparation process of the notoginseng powder orally disintegrating tablet, the viscosity of the notoginseng total saponins as an active ingredient in the notoginseng powder is extremely high, so that the granulation process is smoothly realized, and the influence of different wetting agents and contents on the granulation process is examined based on the formula of the table 1. See in particular table 2.
TABLE 2 types and contents of wetting agents
It has been found that in order to achieve good granulation, ethanol or water with a low volume concentration (10-60%) is preferably used as wetting agent in the wet granulation process, and the amount of wetting agent is more than 10 parts, preferably 20 parts, for the following investigation.
Example 2
The invention discovers that the cellulose content in the pseudo-ginseng rootstock powder is higher, and the adhesive has a larger influence on the particle size distribution of particles in the granulating process. The proper adhesive type and the proper addition content can greatly improve the granulating effect, increase the fluidity of the granules and facilitate the subsequent further processing. In order to better realize the granulating effect, the particle size distribution of the granules is more uniform, and the adhesive is added in the preparation process. Based on the raw material formulation of example 1, the invention explores the influence of several binders and amounts on the pelletization process, and is shown in Table 3.
TABLE 3 kinds and amounts of binders
Adhesive agent | Dosage (weight portions) | Granulating effect | |
Scheme one | Povidone K30 | 2.5 | Granulation of |
Scheme II | Povidone K30 | 5 | Granulation of |
Scheme III | Povidone K30 | 6 | Paste form |
Scheme IV | Povidone K90 | 2.5 | Granulation of |
Scheme five | Povidone K90 | 5 | Paste form |
Scheme six | Povidone K90 | 6 | Paste form |
Scheme seven | Polyethylene glycol 6000 | 2.5 | Granulation of |
Scheme eight | Polyethylene glycol 6000 | 5.0 | Granulation of |
Scheme nine | Polyethylene glycol 6000 | 6.0 | Paste form |
Scheme ten | Polyethylene glycol 8000 | 2.5 | Granulation of |
Scheme eleven | Polyethylene glycol 8000 | 5.0 | Granulation of |
Scheme twelve | Polyethylene glycol 8000 | 6.0 | Paste form |
It has been found by investigation that in order to achieve a better granulation effect, in the wet granulation process, a polymer with a lower molecular weight is preferably used as the binder, and the amount of the polymer is not more than 5 parts, otherwise, the polymer is very easy to form a soft paste in the granulation process, and the granulation cannot be successfully performed.
Example 3
The prepared tablet is pseudo-ginseng powder orally disintegrating tablet, and in order to achieve the aim of rapid disintegration, a disintegrating agent is added in the preparation process, and the type and the adding mode of the disintegrating agent have great influence on the disintegration of the tablet. Based on the raw material formulation of example 1, the present invention examined the influence of several kinds of disintegrants and the addition modes of the disintegrants on the disintegration of tablets, and specifically, see table 4.
TABLE 4 types of disintegrants and modes of addition
Disintegrating agent | Addition mode | Disintegrating effect(s) | |
Scheme one | Microcrystalline cellulose | Internal addition | 80 |
Scheme II | Microcrystalline cellulose | External addition | 80 |
Scheme III | Microcrystalline cellulose | Internal and external addition | 70 |
Scheme IV | Sodium carboxymethyl starch | Internal addition | 55 |
Scheme five | Sodium carboxymethyl starch | External addition | 50 |
Scheme six | Sodium carboxymethyl starch | Internal and external addition | 45 |
Scheme seven | Crosslinked povidone | Internal addition | 40 |
Scheme eight | Crosslinked povidone | External addition | 60 |
Scheme nine | Crosslinked povidone | Internal and external addition | 30 |
The internal addition preparation process is the same as in example 1; the external addition is to dry all disintegrating agents, granulate and add; the internal and external addition is to add 1/2 of the disintegrating agent in the same preparation process as in the example 1, and add the rest disintegrating agent after drying and granulating.
According to the research, in order to achieve a better disintegrating effect, in the wet granulation process, crospovidone or sodium carboxymethyl starch or both can be selected as a disintegrating agent, and the adding mode is combined with the internal addition and the external addition, so that the good disintegrating effect can be achieved.
In order to better realize the disintegration effect, the invention carries out partial formula screening based on the above preferred formula, and the specific formula is shown in table 5.
Table 5 prescription composition and amount (parts by weight)
Table 6 five different investigation indices and results
The results of the above examination show (Table 6) that the indices of the second formulation are all optimal, indicating that the disintegration effect is best when crospovidone is used alone.
Example 4
The raw materials of the notoginseng oral disintegrating tablet are shown in table 7:
TABLE 7
The preparation process comprises the following steps:
pulverizing adjuvants, sieving with 80 mesh sieve, weighing Notoginseng radix powder, xylitol, povidone and 2/3 of cross-linked povidone according to the above formula, mixing, adding 20% ethanol, making into soft mass, sieving to obtain wet granule, drying, grading, adding 1/3 of cross-linked povidone, sweetener, essence, micropowder silica gel and magnesium stearate, mixing, and tabletting (pressure 5 KN).
Example 5
The raw materials of the notoginseng oral disintegrating tablet are shown in table 8:
TABLE 8
The preparation process comprises the following steps:
pulverizing adjuvants, sieving with 80 mesh sieve, weighing Notoginseng radix powder, xylitol, mannitol, polyethylene glycol (Mw=6000) and 1/2 crosslinked povidone according to the above formula, mixing, adding appropriate amount of 10% ethanol, making into soft mass, sieving, granulating, drying, grading, adding 1/2 crosslinked povidone, sweetener, essence, micropowder silica gel and magnesium stearate, mixing, and tabletting (pressure is 10 KN).
Example 6
The raw materials of the notoginseng oral disintegrating tablet are shown in table 9:
TABLE 9
The preparation process comprises the following steps: the procedure was as in example 5.
Example 7
The raw materials of the notoginseng oral disintegrating tablet are shown in table 10:
table 10
The preparation process comprises the following steps:
pulverizing adjuvants, sieving with 80 mesh sieve, weighing Notoginseng radix powder, mannitol, polyethylene glycol (Mw=6000) and 2/3 carboxyl sodium starch according to the above formula, mixing, adding appropriate amount of 20% ethanol, making into soft material, sieving to obtain wet granule, drying, grading, adding 1/3 carboxymethyl sodium starch, sweetener, essence, micropowder silica gel and magnesium stearate, mixing, and tabletting (pressure of 8 KN).
Example 8
The raw materials of the notoginseng oral disintegrating tablet are shown in table 11:
TABLE 11
The preparation process comprises the following steps: the procedure is as in example 7.
Example 9
The raw materials of the notoginseng oral disintegrating tablet are shown in table 12:
table 12
The preparation process comprises the following steps:
pulverizing adjuvants, sieving with 80 mesh sieve, weighing Notoginseng radix powder, xylitol, polyethylene glycol (Mw=8000) and 1/2 crosslinked povidone according to the above formula, mixing, adding appropriate amount of 10% ethanol, making into soft material, sieving to obtain wet granule, drying, grading, adding 1/2 crosslinked povidone, sweetener, essence, micropowder silica gel and magnesium stearate, mixing, and tabletting (pressure 10 KN).
Each index of the notoginseng oral disintegrating tablets prepared in examples 4 to 9 was examined, and the results were as follows:
table 13 investigation index and results of the samples prepared in examples 4 to 9
Investigation index | Example 4 | Example 5 | Example 6 | Example 7 | Example 8 | Example 9 |
Appearance of | Smooth and beautiful | Smooth and beautiful | Smooth and beautiful | Smooth and beautiful | Smooth and beautiful | Smooth and beautiful |
Compressibility of | Good (good) | Good (good) | Good (good) | Good (good) | Good (good) | Good (good) |
Weight difference | Meets the regulations | Meets the regulations | Meets the regulations | Meets the regulations | Meets the regulations | Meets the regulations |
Time limit of disintegration | 40s | 45s | 50s | 55s | 40s | 55s |
The results show that the orally disintegrating tablets prepared in examples 4-9 all meet the regulations on appearance, compressibility and weight difference, and the disintegration time is within 1 min.
The above embodiments are only illustrative of the preferred embodiments of the present invention and are not intended to limit the scope of the present invention, and various modifications and improvements made by those skilled in the art to the technical solutions of the present invention should fall within the protection scope defined by the claims of the present invention without departing from the design spirit of the present invention.
Claims (10)
1. The notoginseng orally disintegrating tablet is characterized by comprising the following components in parts by weight:
30-70 parts of pseudo-ginseng root powder, 20-60 parts of filler, 0-5 parts of adhesive, 5-20 parts of disintegrating agent, 0.5-3 parts of sweetener, 0.5-3 parts of aromatic, 0.5-2 parts of lubricant, 0.1-0.5 part of glidant and 15-30 parts of wetting agent.
2. The notoginseng orally disintegrating tablet of claim 1, wherein the filler comprises one or more of xylitol, mannitol, sorbitol, erythritol, cyclodextrin, starch, lactose, pregelatinized starch, microcrystalline cellulose, calcium carbonate, and calcium phosphate.
3. The notoginseng orally disintegrating tablet of claim 1, wherein the binder comprises one or more of starch, pregelatinized starch, sucrose, glucose, methylcellulose, hydroxypropyl cellulose, hypromellose, sodium carboxymethyl cellulose, ethylcellulose, povidone, gelatin, polyethylene glycol, and sodium alginate.
4. The notoginseng orally disintegrating tablet of claim 1, wherein the disintegrant comprises one or more of dry starch, sodium carboxymethyl starch, low substituted hydroxypropyl cellulose, croscarmellose sodium, crospovidone, microcrystalline cellulose, alginic acid, and sodium alginate.
5. The notoginseng orally disintegrating tablet of claim 1, wherein the sweetener comprises one or more of glucose, sucrose, stevioside, sodium saccharin, aspartame, sucralose;
the aromatic comprises one or more of strawberry essence, grape essence, peach essence, lemon essence, watermelon essence, cherry essence, hawthorn essence, sweet orange essence, peppermint essence, green tea essence, vanilla essence and sweet essence;
the lubricant comprises one or more of stearate, stearic acid, hydrogenated vegetable oil, polyethylene glycol and lauryl sulfate;
the glidant comprises one or more of micropowder silica gel and talcum powder;
the wetting agent comprises water or ethanol with the volume fraction of 10-60%.
6. The notoginseng orally disintegrating tablet according to claim 1, comprising the following components in parts by weight:
50 parts of notoginseng root powder, 29.4 parts of xylitol, 3 parts of povidone, 15 parts of crospovidone, 1 part of sucralose, 1 part of watermelon essence, 0.5 part of magnesium stearate, 0.1 part of micro silica gel and 20 parts of ethanol with the volume fraction of 50 percent.
7. The notoginseng orally disintegrating tablet of claim 6, wherein the povidone comprises povidone K30 or povidone K90.
8. A method for preparing the notoginseng oral disintegrating tablet according to claim 1, comprising the following steps:
weighing according to parts by weight, mixing uniformly radix notoginseng powder, filler, adhesive and 1/2-2/3 of disintegrating agent, adding wetting agent to prepare wet granules, sieving, drying, granulating, adding sweetener, glidant, lubricant and 1/3-1/2 of disintegrating agent, mixing uniformly, tabletting to obtain the radix notoginseng orally disintegrating tablet.
9. The method of claim 8, wherein the wet granulation is performed by a high-speed shear granulator.
10. Use of an orally disintegrating tablet of pseudo-ginseng according to any one of claims 1-6 in the preparation of a health food for preventing cardiovascular and cerebrovascular diseases.
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Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN1739533A (en) * | 2004-08-27 | 2006-03-01 | 郑州三创释药技术有限公司 | Oral disintegrating notoginseng total saponin tablet and its prepn process |
CN1742743A (en) * | 2005-09-21 | 2006-03-08 | 重庆康刻尔制药有限公司 | Pseudo-ginseng saponin oral disintegration tablet and preparing method |
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Publication number | Priority date | Publication date | Assignee | Title |
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CN1739533A (en) * | 2004-08-27 | 2006-03-01 | 郑州三创释药技术有限公司 | Oral disintegrating notoginseng total saponin tablet and its prepn process |
CN1742743A (en) * | 2005-09-21 | 2006-03-08 | 重庆康刻尔制药有限公司 | Pseudo-ginseng saponin oral disintegration tablet and preparing method |
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