CN105641383A - Traditional Chinese medicine lozenge with fat-reducing effect and preparation method thereof - Google Patents
Traditional Chinese medicine lozenge with fat-reducing effect and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine lozenge with fat-reducing effect. The traditional Chinese medicine lozenge is prepared from hawthorn, perilla seed, lonicera japonica, Chinese wolfberry, Chinese yam, angelica dahurica, chrysanthemum, cinnamon, lily, clove and other Chinese medicinal raw materials and pharmaceutical excipients in appropriate proportion. The traditional Chinese medicine lozenge provided by the invention dissolves slowly in the buccal cavity to play a therapeutic role, can be absorbed quickly to reach a therapeutic concentration rapidly. After taking of the lozenge, the lozenge directly enters systemic circulation through mouth mucosa with no need of reaching the liver first, can overcome the first pass effect and decrease metabolic inactivation of drugs, and improves the curative effect. The preparation method provided by the invention is easy to operate, and is suitable for industrial production.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicines, it is specifically related to a kind of Chinese medicine lozenge and its preparation method with antiobesity action.
Background technology
Along with socioeconomic development, the standard of living of people improves constantly. Take under increasing the comprehensive action with the multiple factor such as amount of exercise minimizing in supernutrition, high fat diet, fat occurs in human body, and excessively accumulation or the abnormal probability that distributes are more and more higher, if not paid attention to, cause the most at last based on the unbalance trophicity metabolic disturbance diseases-obesity of metabolism of fat. Obesity is very easily brought out or is increased the weight of the diseases such as hypertension, hyperlipidemia, diabetes, coronary heart disease, fatty liver and endocrine disturbance, and the mankind are very harmful, has become global public health problem. At present, obese patient gets more and more, and has generation in children, teenager, youth, middle age and all kinds of crowd such as old, and sickness rate is ascendant trend year by year, and morbidity crowd starts to expand to rural area from city, and age of onset starts to present the trend of becoming younger. The statistical information display of the World Health Organization: global overweight number, more than people more than 1,000,000,000, has people's severe obesity more than 300,000,000, and the fat ratio of developing country significantly increases; Having 200,000,000 people overweight in China, particularly children are overweight increases rapidly. Estimating that fat morbidity also will have growth by a relatively large margin from now on, fat meeting cause serious threat to national health, bring heavy economical load also can to individual and society. Owing to obesity affects the health of people and attractive in appearance, many worries are brought to work, studying and living, and cause great stress, seriously have impact on life quality, therefore prevention and therapy obesity has become an important topic of medical circle, pharmacy circle and nutrition educational circles, causes the common concern of society.
In order to healthy or beautiful, people have carried out a large amount of methodological studies about Bariatric, achieve great successes in treatment principle and methods for the treatment of. People are under the guidance reducing the Bariatric principles such as Energy intaking amount and increase energy consumption, propose bantingism (not easily to adhere to for a long time, easily recurrence after prohibiting, psychological problems very easily occurs), kinesitherapy (need to persevere, common people are difficult to accomplish, more can get fat after stopping), operative therapy (easily rebounding, post-operative complication easily occur) and pharmacotherapy (be only applicable to some morbid oberity colony,, there is side effect in various degree in unsuitable life-time service) etc. Bariatric method. For most of obese patient, it is far from being enough for reducing Heat energy absorption and increasing sports, is usually body weight rapid rise after stopping fat-reducing, has even exceeded the body weight before fat-reducing. And select surgical operation, then patient may be brought bigger risk. The treatment of early stage drug application then both can the appearance of complication prevention, the self-confidence of patient can be strengthened again.
At present, diet products on market are a feast for the eyes, use for oral administration from outward, it is of a great variety, but the product really with prevention or result for the treatment of is few, most product all is difficult to make consumer satisfaction in curative effect, toxicity, side effect and price etc., so it may be said that people not yet find the Perfected process of combating obesity so far.Formulate unified fat-reducing principle now in the world, i.e. not depress appetite, do not caused diarrhoea, alleviate body weight and do not alleviate muscle power. Therefore, developing diet products new, that effect is significant and security is high, tool is of great significance and good market outlook. Combining along with the medical model of the mankind turns into current " preventing and treating, support " from simple disease therapy, especially support as main pattern, herbal medicine is improving body resistivity comprehensively, and the effect and the advantage that strengthen human physique aspect are more and more obvious. Namely China have the tradition of tonic dietotherapy from ancient times, gives full play to the advantage of Chinese materia medica in body-care, the diet products that development more can be selected for people, imperative.
Conventional tablet needs through the process such as disintegration, dispersion, dissolving, absorption release active constituents of medicine wherein, although therefore some medicinal tablet meets States Pharmacopoeia specifications disintegration, but its bioavailability may be very poor. And lozenge slowly dissolves in cheek chamber and plays therapeutic action, therefore absorb fast, treatment concentration can be reached rapidly.
Oral pharmaceutical are after gastrointestinal absorption, first liver is arrived through portal vein, some medicine is by mucous membrane and very easily metabolic inactivation during liver, destroyed by major part during liver in first time, the effective medicine amount entering blood circulation reduces, drug effect reduces, and this i.e. first pass effect (FirstPassEffect), also known as the first pass effect. Conventional tablet, oral liquid, granule and capsule etc. nearly all absorb due to the reason of formulation itself in gi tract, there is first pass effect. But, after lozenge is taken, directly absorb via oral mucosa and enter body circulation, it is not necessary to first arrive liver, it is possible to overcome first pass effect and reduce medicine by metabolic inactivation, it is to increase curative effect. Lozenge is for especially applicable when old, young and patient's oral medication that is that swallow difficult. We select lozenge as research and development formulation, and one is facilitate patient to take, then are improve drug bioavailability, to meet the needs of patient medication better.
Summary of the invention
It is an object of the invention to provide a kind of Chinese medicine lozenge with antiobesity action, this lozenge belongs to compound Chinese medicinal preparation, and antiobesity action is good.
Another object of the present invention is to provide the preparation method of the above-mentioned Chinese medicine lozenge with antiobesity action.
The present invention is based on motherland's medical science to the understanding of fat disease and principle of reatment, with reference to clinical application experience and modern pharmacology achievement in research, filter out there is stomach strengthening and digestion promoting, reduce phlegm the Chinese medicine of effect of fat, tonifying spleen benefit lung and regulating functional activities of qi of dispelling, by theory of traditional Chinese medical science prescription, adopt modern pharmacy technological achievement the other side's Chinese traditional medicine to carry out extraction purification, make modern Chinese herbal medicine preparation.
Chinese medicine lozenge of the present invention, is by the stock and adjunct of suitable proportion, makes according to certain technical process. Described raw material refers to the extract of the Chinese medicine composition containing antiobesity action, this Chinese medicine composition is made up of hawthorn, perilla seed, Japanese Honeysuckle, wolfberry fruit, Chinese yam, the root of Dahurain angelica, chrysanthemum, Chinese cassia tree, lily and cloves, each composition flavour of a drug belong to the Chinese medicine of integration of drinking and medicinal herbs, adopt modern extraction and purification process to make extract before use. Described auxiliary material is medicinal rank, and meets national standard.
For achieving the above object, the present invention takes following measure:
A kind of Chinese medicine lozenge with antiobesity action, it is characterised in that: extract and the pharmaceutical excipient of Chinese medicine composition are made;Described Chinese medicine composition is hawthorn 10��30 parts, perilla seed 8��24 parts, Japanese Honeysuckle 6��18 parts, wolfberry fruit 6��18 parts, Chinese yam 5��15 parts, the root of Dahurain angelica 4��12 parts, chrysanthemum 4��12 parts, Chinese cassia tree 3��9 parts, lily 2��6 parts, cloves 2��6 parts.
The combination of the preferred inclusion agents of above-mentioned pharmaceutical excipient 0.632��4.211 part, weighting agent 2.105��14.737 parts, disintegrating agent 0.316��2.105 part, lubricant 0.021��0.316 part, correctives 0.042��0.589 part.
The one or more combination that above-mentioned inclusion agents is selected from alpha-cylodextrin, beta-cyclodextrin, ��-cyclodextrin, Hydroxyproply-��-cyclodextrin, hydroxypropyl-beta-cyclodextrin, hydropropyl-y-cyclodextrin, first group-beta-cyclodextrin, carboxymethyl-beta-cyclodextrin or one chlorotriazine-beta-cyclodextrin.
One or more combinations that above-mentioned disintegrating agent is selected from Xylo-Mucine cross-linked polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, Sodium Hydroxymethyl Stalcs, croscarmellose sodium, hydroxypropylated starch or micropowder silica gel.
One or more combinations that above-mentioned weighting agent is selected from lactose, sorbyl alcohol, N.F,USP MANNITOL, Xylitol, pregelatinized Starch, Microcrystalline Cellulose or dextrin.
One or more combinations that above-mentioned lubricant is selected from Magnesium Stearate, micropowder silica gel or talcum powder.
Above-mentioned correctives is selected from that sucrose, A Siba are sweet, one or more combinations in stevioside, acesulfame potassium or Sodium Cyclamate.
Preferably, Chinese medicine lozenge of the present invention is made up of bulk drug and the pharmaceutical excipient of following weight part:
The sheet of Chinese medicine lozenge of the present invention is heavily 100��1000mg.
The preparation method of Chinese medicine lozenge of the present invention, comprises the following steps:
(1) perilla seed, Japanese Honeysuckle, the root of Dahurain angelica, Chinese cassia tree and cloves meal, add water soaking 4��12h, and heating is extracted, and collects volatile oil, filter residue I and the aqueous solution;
(2) filter residue I by step (1) gained adds 6��10 times amount water, decocts and boils 1��2 hour, filters, and collects filtrate and obtains filtrate I, gets filtrate I and merge with the aqueous solution of step (1) gained, obtain amalgamation liquid;
(3) by hawthorn, wolfberry fruit, lily three taste medicine, add 6��10 times amount 70%��75% alcohol reflux 2 times, each 1��1.5 hour, filter, get filter residue and merge to obtain filter residue II, get filtrate and merge to obtain filtrate II, by filtrate II decompression recycling ethanol to the greatest extent;
(4) Chinese yam and chrysanthemum meal is got, mix even with the filter residue II of step (3) gained, add 10��12 times amount water, decoct and boil 2 times, each 1��2 hour, filter, get filtrate and merge to obtain filtrate II I, the amalgamation liquid of filtrate II I and step (2) gained is mixed even, being evaporated to relative density is 1.02��1.04(50 DEG C��60 DEG C) liquid time, every 100mL liquid adds 1% II type ZTC1+1 natural clarifying agent component A 4.5��5.5mL, add 1% II type ZTC1+1 natural clarifying agent B component 2.5��3.5mL again, stir even, 60 DEG C��70 DEG C water bath heat preservations 1��1.5 hour, 2��4 DEG C leave standstill 20��24 hours, filter, collect filtrate and obtain filtrate IV, add the filtrate II of step (3) gained, concentrated, dry, pulverize, cross 40 order sieves, obtain drug extract powder,
(5) get the volatile oil of step (1) gained and the drug extract powder of step (4) gained, dissolve by ethanol low-grade fever; Under 80 DEG C of conditions, inclusion agents water is made saturated solution; Under agitation condition, medicine material ethanolic soln is slowly added in inclusion agents saturated solution, constant temperature stops heating after stirring 1��2h, continue to be stirred to room temperature, obtaining white suspension, refrigeration 72��120h, takes out filter, throw out washing with alcohol 2��4 times, 40��60 DEG C of drying under reduced pressure, pulverize, obtain medicine material inclusion compound;By weighting agent, disintegrating agent and correctives, pulverize, mixed even, add medicine material inclusion compound, mixed even, cross 60��200 order sieves, with water or 20��80% ethanol softwoods, 20��30 order sieves are granulated, 60��70 DEG C of drying under reduced pressure 60��120min, pellet moisture controls below 5%, and 20��30 orders sieve whole grain, add lubricant, compressing tablet, quality inspection, packaging, obtains Chinese medicine lozenge.
The present invention both had fat-reducing, fall fat and the pharmacological action such as anti-oxidant, moreover it is possible to reach the requirements such as use safety, quality controllable, bioavailability height, taking dose are little and easy to carry.
Chinese medicine lozenge of the present invention is compared with conventional tablet has following advantage:
(1) absorption is faster: this Chinese medicine lozenge slowly dissolves in cheek chamber and plays therapeutic action, therefore absorbs fast, can reach rapidly treatment concentration.
(2) drug effect is stronger: after this Chinese medicine lozenge is taken, and directly absorbs via oral mucosa and enters body circulation, it is not necessary to first arrives liver, it is possible to overcome first pass effect and reduce medicine by metabolic inactivation, it is to increase curative effect.
(3) scope of application is wider: this Chinese medicine lozenge is particularly useful for patient and the pediatric pharmaceuticals of dysphagia; Also can be made into be conducive to diabetic to take without carbohydrate type.
Embodiment
Below by embodiment, the present invention is further described, it should be understood that following embodiment is only for illustration of the present invention, and unrestricted the present invention. The present invention is raw materials used is commercially available prod.
Embodiment 1
[formula]
The bulk drug of above-mentioned weight and pharmaceutical excipient are made 1000 tablets of Chinese medicine lozenges altogether, the heavy 500mg of every sheet.
Method for making]
(1) perilla seed, Japanese Honeysuckle, the root of Dahurain angelica, Chinese cassia tree and cloves meal, add water soaking 6h, and heating is extracted, and collects volatile oil, filter residue I and the aqueous solution;
(2) the times amount water that adds 7 by the filter residue I of step (1) gained, decocts and boils 1 hour, filters, and collects filtrate and obtains filtrate I, gets filtrate I and merge with the aqueous solution of step (1) gained, obtain amalgamation liquid;
(3) by hawthorn, wolfberry fruit, lily three taste medicine, times amount 70% alcohol reflux that adds 72 times, each 1 hour, filters, gets filter residue and merge to obtain filter residue II, get filtrate and merge to obtain filtrate II, and decompression recycling ethanol is to the greatest extent;
(4) Chinese yam and chrysanthemum meal is got, mix even with the filter residue II of step (3) gained, the times amount water that adds 10, decoct and boil 2 times, each 1 hour, filter, get filtrate and merge to obtain filtrate II I, mix even with the amalgamation liquid of step (2) gained, be evaporated to relative density and be 1.02(50 DEG C) liquid time, every 100mL liquid adds 1% II type ZTC1+1 natural clarifying agent component A 4.5mL, add 1% II type ZTC1+1 natural clarifying agent B component 3mL again, stir even, 60 DEG C of water bath heat preservations 1 hour, 2 DEG C leave standstill 21 hours, filter, collect filtrate and obtain filtrate IV, add the filtrate II of step (3) gained, concentrated, dry, pulverize, cross 40 order sieves, obtain drug extract powder,
(5) get the volatile oil of step (1) gained and the drug extract powder of step (4) gained, dissolve by ethanol low-grade fever; Beta-cyclodextrin saturated aqueous solution is prepared under 80 DEG C of conditions; Slowly adding in beta-cyclodextrin saturated aqueous solution by medicine material ethanolic soln under agitation condition, constant temperature stops heating after stirring 1h, continues to be stirred to room temperature, obtains white suspension, refrigeration 72h, takes out filter, throw out washing with alcohol 2 times, 60 DEG C of drying under reduced pressure, pulverize, obtain medicinal inclusion compound; By sweet to sorbyl alcohol, Xylitol, Xylo-Mucine, Microcrystalline Cellulose and A Siba, pulverize, mixed even, add medicinal inclusion compound, cross 100 order sieves, with 30% ethanol softwood, 30 order sieves are granulated, 70 DEG C of drying under reduced pressure 100min, and pellet moisture controls at 5%(W/W) below, 30 orders sieve whole grain, add Magnesium Stearate, compressing tablet, quality inspection, packaging, to obtain final product.
Embodiment 2
[formula]
The bulk drug of above-mentioned weight and pharmaceutical excipient are made 1000 tablets of Chinese medicine lozenges altogether, the heavy 400mg of every sheet.
Method for making]
(1) perilla seed, Japanese Honeysuckle, the root of Dahurain angelica, Chinese cassia tree and cloves meal, add water soaking 10h, and heating is extracted, and collects volatile oil, filter residue I and the aqueous solution;
(2) the times amount water that adds 10 by the filter residue I of step (1) gained, decocts and boils 2 hours, filters, and collects filtrate and obtains filtrate I, gets filtrate I and merge with the aqueous solution of step (1) gained, obtain amalgamation liquid;
(3) by hawthorn, wolfberry fruit, lily three taste medicine, times amount 75% alcohol reflux that adds 82 times, each 1.5 hours, filters, gets filter residue and merge to obtain filter residue II, get filtrate and merge to obtain filtrate II, and decompression recycling ethanol is to the greatest extent;
(4) Chinese yam and chrysanthemum meal is got, mix even with the filter residue II of step (3) gained, the times amount water that adds 12, decoct and boil 2 times, each 2 hours, filter, get filtrate and merge to obtain filtrate II I, mix even with the amalgamation liquid of step (2) gained, be evaporated to relative density and be 1.04(55 DEG C) liquid time, every 100mL liquid adds 1% II type ZTC1+1 natural clarifying agent component A 5.5mL, add 1% II type ZTC1+1 natural clarifying agent B component 3.5mL again, stir even, 70 DEG C of water bath heat preservations 1.5 hours, 4 DEG C leave standstill 20 hours, filter, collect filtrate and obtain filtrate IV, add the filtrate II of step (3) gained, concentrated, dry, pulverize, cross 40 order sieves, obtain drug extract powder,
(5) get the volatile oil of step (1) gained and the drug extract powder of step (4) gained, dissolve by ethanol low-grade fever; Beta-cyclodextrin saturated aqueous solution is prepared under 80 DEG C of conditions; Slowly adding in beta-cyclodextrin saturated aqueous solution by medicine material ethanolic soln under agitation condition, constant temperature stops heating after stirring 1.5h, continues to be stirred to room temperature, obtains white suspension, refrigeration 84h, takes out filter, throw out washing with alcohol 3 times, 50 DEG C of drying under reduced pressure, pulverize, obtain medicinal inclusion compound; By sweet to sorbyl alcohol, Xylitol, Xylo-Mucine, Microcrystalline Cellulose and A Siba, pulverize, mixed even, cross 200 order sieves, add medicine material inclusion compound, mixed even, crossing 200 order sieves, with 75% ethanol softwood, 20 order sieves are granulated, 60 DEG C of drying under reduced pressure 60min, pellet moisture controls at 5%(W/W) below, 20 orders sieve whole grain, add Magnesium Stearate, compressing tablet, quality inspection, packaging, to obtain final product.
Embodiment 3
[formula]
| Hawthorn | 100 | g |
| Perilla seed | 80 | g |
| Japanese Honeysuckle | 60 | g |
| Wolfberry fruit | 60 | g |
| Chinese yam | 50 | g |
| The root of Dahurain angelica | 40 | g |
| Chrysanthemum | 40 | g |
| Chinese cassia tree | 30 | g |
| Lily | 20 | g |
| Cloves | 20 | g |
| Beta-cyclodextrin | 11.25 | g |
| Sorbyl alcohol | 67.93 | g |
| Xylitol | 71.17 | g |
| Microcrystalline Cellulose | 13.36 | g |
| Xylo-Mucine | 8.51 | g |
| Magnesium Stearate | 0.78 | g |
| A Siba is sweet | 2 | g |
The bulk drug of above-mentioned weight and pharmaceutical excipient are made 1000 tablets of Chinese medicine lozenges altogether, the heavy 250mg of every sheet.
Method for making]
(1) perilla seed, Japanese Honeysuckle, the root of Dahurain angelica, Chinese cassia tree and cloves meal, add water soaking 4h, and heating is extracted, and collects volatile oil, filter residue I and the aqueous solution;
(2) the times amount water that adds 6 by the filter residue I of step (1) gained, decocts and boils 1 hour, filters, and collects filtrate and obtains filtrate I, gets filtrate I and merge with the aqueous solution of step (1) gained, obtain amalgamation liquid;
(3) by hawthorn, wolfberry fruit, lily three taste medicine, times amount 75% alcohol reflux that adds 10 2 times, each 1.5 hours, filters, gets filter residue and merge to obtain filter residue II, get filtrate and merge to obtain filtrate II, and decompression recycling ethanol is to the greatest extent;
(4) Chinese yam and chrysanthemum meal is got, mix even with the filter residue II of step (3) gained, the times amount water that adds 8, decoct and boil 2 times, each 2 hours, filter, get filtrate and merge to obtain filtrate II I, mix even with the amalgamation liquid of step (2) gained, be evaporated to relative density and be 1.04(60 DEG C) liquid time, every 100mL liquid adds 1% II type ZTC1+1 natural clarifying agent component A 5.5mL, add 1% II type ZTC1+1 natural clarifying agent B component 2.5mL again, stir even, 70 DEG C of water bath heat preservations 1.5 hours, 3 DEG C leave standstill 20 hours, filter, collect filtrate and obtain filtrate IV, add the filtrate II of step (3) gained, concentrated, dry, pulverize, cross 40 order sieves, obtain drug extract powder,
(5) get the volatile oil of step (1) gained and the drug extract powder of step (4) gained, dissolve by ethanol low-grade fever; Beta-cyclodextrin saturated aqueous solution is prepared under 80 DEG C of conditions; Slowly adding in beta-cyclodextrin saturated aqueous solution by medicine material ethanolic soln under agitation condition, constant temperature stops heating after stirring 2h, continues to be stirred to room temperature, obtains white suspension, refrigeration 96h, takes out filter, throw out washing with alcohol 4 times, 40 DEG C of drying under reduced pressure, pulverize, obtain medicinal inclusion compound; By sweet to sorbyl alcohol, Xylitol, Xylo-Mucine, Microcrystalline Cellulose and A Siba, pulverize, mixed even, add medicinal inclusion compound, cross 120 order sieves, with 45% ethanol softwood, 20 order sieves are granulated, 60 DEG C of drying under reduced pressure 80min, and pellet moisture controls at 5%(W/W) below, 20 orders sieve whole grain, add Magnesium Stearate, compressing tablet, quality inspection, packaging, to obtain final product.
Embodiment 4
[formula]
| Hawthorn | 133.33 | g |
| Perilla seed | 64 | g |
| Japanese Honeysuckle | 80 | g |
| Wolfberry fruit | 53.33 | g |
| Chinese yam | 40 | g |
| The root of Dahurain angelica | 32 | g |
| Chrysanthemum | 53.33 | g |
| Chinese cassia tree | 24 | g |
| Lily | 26.67 | g |
| Cloves | 26.67 | g |
| Beta-cyclodextrin | 10 | g |
| Sorbyl alcohol | 42.42 | g |
| Xylitol | 50.04 | g |
| Microcrystalline Cellulose | 10.05 | g |
| Xylo-Mucine | 5.68 | g |
| Magnesium Stearate | 0.58 | g |
| A Siba is sweet | 1.22 | g |
The bulk drug of above-mentioned weight and pharmaceutical excipient are made 1000 tablets of Chinese medicine lozenges altogether, the heavy 200mg of every sheet.
Method for making]
Get volatile oil and drug extract powder (preparation method is with corresponding contents under embodiment 1 [method for making] item), dissolve by ethanol low-grade fever; Beta-cyclodextrin saturated aqueous solution is prepared under 80 DEG C of conditions; Slowly adding in beta-cyclodextrin saturated aqueous solution by medicine material ethanolic soln under agitation condition, constant temperature stops heating after stirring 1.5h, continues to be stirred to room temperature, obtains white suspension, refrigeration 108h, takes out filter, throw out washing with alcohol 3 times, 50 DEG C of drying under reduced pressure, pulverize, obtain medicinal inclusion compound; By sweet to sorbyl alcohol, Xylitol, Xylo-Mucine, Microcrystalline Cellulose and A Siba, pulverize, mixed even, add medicinal inclusion compound, mixed even, cross 100 order sieves, with 30% ethanol softwood, 30 order sieves are granulated, 70 DEG C of drying under reduced pressure 100min, pellet moisture controls at 5%(W/W) below, 30 orders sieve whole grain, add Magnesium Stearate, compressing tablet, quality inspection, packaging, to obtain final product.
Embodiment 5
[formula]
| Hawthorn | 100 | g |
| Perilla seed | 26.67 | g |
| Japanese Honeysuckle | 60 | g |
| Wolfberry fruit | 20 | g |
| Chinese yam | 50 | g |
| The root of Dahurain angelica | 13.33 | g |
| Chrysanthemum | 40 | g |
| Chinese cassia tree | 10 | g |
| Lily | 6.67 | g |
| Cloves | 6.67 | g |
| Beta-cyclodextrin | 6.5 | g |
| Sorbyl alcohol | 16.36 | g |
| Xylitol | 19.74 | g |
| Microcrystalline Cellulose | 3.88 | g |
| Xylo-Mucine | 2.19 | g |
| Magnesium Stearate | 0.35 | g |
| A Siba is sweet | 0.98 | g |
The bulk drug of above-mentioned weight and pharmaceutical excipient are made 1000 tablets of Chinese medicine lozenges altogether, the heavy 100mg of every sheet.
Method for making]
Get volatile oil and drug extract powder (preparation method is with corresponding contents under embodiment 1 [method for making] item), dissolve by ethanol low-grade fever; Beta-cyclodextrin saturated aqueous solution is prepared under 80 DEG C of conditions; Slowly adding in beta-cyclodextrin saturated aqueous solution by medicine material ethanolic soln under agitation condition, constant temperature stops heating after stirring 2h, continues to be stirred to room temperature, obtains white suspension, refrigeration 120h, takes out filter, throw out washing with alcohol 4 times, 60 DEG C of drying under reduced pressure, pulverize, obtain medicinal inclusion compound; By sweet to sorbyl alcohol, Xylitol, Xylo-Mucine, Microcrystalline Cellulose and A Siba, pulverize, mixed even, add medicinal inclusion compound, mixed even, cross 160 order sieves, with 60% ethanol softwood, 30 order sieves are granulated, 70 DEG C of drying under reduced pressure 60min, pellet moisture controls at 5%(W/W) below, 30 orders sieve whole grain, add Magnesium Stearate, compressing tablet, quality inspection, packaging, to obtain final product.
Embodiment 6
[formula]
| Hawthorn | 213.33 | g |
| Perilla seed | 512 | g |
| Japanese Honeysuckle | 128 | g |
| Wolfberry fruit | 384 | g |
| Chinese yam | 106.67 | g |
| The root of Dahurain angelica | 256 | g |
| Chrysanthemum | 85.33 | g |
| Chinese cassia tree | 192 | g |
| Lily | 128 | g |
| Cloves | 128 | g |
| Beta-cyclodextrin | 60 | g |
| Sorbyl alcohol | 155.16 | g |
| Xylitol | 181.44 | g |
| Microcrystalline Cellulose | 47.35 | g |
| Xylo-Mucine | 28.93 | g |
| Magnesium Stearate | 2.61 | g |
| A Siba is sweet | 4.5 | g |
The bulk drug of above-mentioned weight and pharmaceutical excipient are made 1000 tablets of Chinese medicine lozenges altogether, the heavy 800mg of every sheet.
Method for making]
Get volatile oil and drug extract powder (preparation method is with corresponding contents under embodiment 1 [method for making] item), dissolve by ethanol low-grade fever; Beta-cyclodextrin saturated aqueous solution is prepared under 80 DEG C of conditions; Slowly adding in beta-cyclodextrin saturated aqueous solution by medicine material ethanolic soln under agitation condition, constant temperature stops heating after stirring 1h, continues to be stirred to room temperature, obtains white suspension, refrigeration 108h, takes out filter, throw out washing with alcohol 2 times, 40 DEG C of drying under reduced pressure, pulverize, obtain medicinal inclusion compound; By sweet to sorbyl alcohol, Xylitol, Xylo-Mucine, Microcrystalline Cellulose and A Siba, pulverize, mixed even, add medicinal inclusion compound, cross 80 order sieves, with water softwood, 20 order sieves are granulated, 60 DEG C of drying under reduced pressure 120min, and pellet moisture controls at 5%(W/W) below, 20 orders sieve whole grain, add Magnesium Stearate, compressing tablet, quality inspection, packaging, to obtain final product.
Embodiment 7
[formula]
| Hawthorn | 210 | g |
| Perilla seed | 252 | g |
| Japanese Honeysuckle | 126 | g |
| Wolfberry fruit | 210 | g |
| Chinese yam | 175 | g |
| The root of Dahurain angelica | 126 | g |
| Chrysanthemum | 84 | g |
| Chinese cassia tree | 105 | g |
| Lily | 56 | g |
| Cloves | 56 | g |
| Beta-cyclodextrin | 59.5 | g |
| Sorbyl alcohol | 160.33 | g |
| Xylitol | 168.22 | g |
| Microcrystalline Cellulose | 53.15 | g |
| Xylo-Mucine | 32.71 | g |
| Magnesium Stearate | 6.14 | g |
| A Siba is sweet | 9.95 | g |
The bulk drug of above-mentioned weight and pharmaceutical excipient are made 1000 tablets of Chinese medicine lozenges altogether, the heavy 700mg of every sheet.
Method for making]
Get volatile oil and drug extract powder (preparation method is with corresponding contents under embodiment 1 [method for making] item), dissolve by ethanol low-grade fever; Beta-cyclodextrin saturated aqueous solution is prepared under 80 DEG C of conditions; Slowly adding in beta-cyclodextrin saturated aqueous solution by medicine material ethanolic soln under agitation condition, constant temperature stops heating after stirring 1h, continues to be stirred to room temperature, obtains white suspension, refrigeration 96h, takes out filter, throw out washing with alcohol 3 times, 60 DEG C of drying under reduced pressure, pulverize, obtain medicinal inclusion compound; By sweet to sorbyl alcohol, Xylitol, Xylo-Mucine, Microcrystalline Cellulose and A Siba, pulverize, mixed even, add medicinal inclusion compound, cross 200 order sieves, with 75% ethanol softwood, 20 order sieves are granulated, 60 DEG C of drying under reduced pressure 60min, and pellet moisture controls at 5%(W/W) below, 20 orders sieve whole grain, add Magnesium Stearate, compressing tablet, quality inspection, packaging, to obtain final product.
Embodiment 8
[formula]
| Hawthorn | 1166.67 | g |
| Perilla seed | 560 | g |
| Japanese Honeysuckle | 700 | g |
| Wolfberry fruit | 466.67 | g |
| Chinese yam | 350 | g |
| The root of Dahurain angelica | 280 | g |
| Chrysanthemum | 466.67 | g |
| Chinese cassia tree | 210 | g |
| Lily | 233.33 | g |
| Cloves | 233.33 | g |
| Beta-cyclodextrin | 100 | g |
| Sorbyl alcohol | 41 | g |
| Xylitol | 51 | g |
| Microcrystalline Cellulose | 42 | g |
| Xylo-Mucine | 30 | g |
| Magnesium Stearate | 13 | g |
| A Siba is sweet | 23 | g |
The bulk drug of above-mentioned weight and pharmaceutical excipient are made 1000 tablets of Chinese medicine lozenges altogether, the heavy 1000mg of every sheet.
Method for making]
(preparation method is with in corresponding under embodiment 1 [method for making] item to get volatile oil and drug extract powder
Hold), dissolve by ethanol low-grade fever; Beta-cyclodextrin saturated aqueous solution is prepared under 80 DEG C of conditions; Slowly adding in beta-cyclodextrin saturated aqueous solution by medicine material ethanolic soln under agitation condition, constant temperature stops heating after stirring 1.5h, continues to be stirred to room temperature, obtains white suspension, refrigeration 84h, takes out filter, throw out washing with alcohol 3 times, 50 DEG C of drying under reduced pressure, pulverize, obtain medicinal inclusion compound; By sweet to sorbyl alcohol, Xylitol, Xylo-Mucine, Microcrystalline Cellulose and A Siba, pulverize, mixed even, add medicinal inclusion compound, mixed even, cross 160 order sieves, with 60% ethanol softwood, 30 order sieves are granulated, 70 DEG C of drying under reduced pressure 60min, pellet moisture controls at 5%(W/W) below, 30 orders sieve whole grain, add Magnesium Stearate, compressing tablet, quality inspection, packaging, to obtain final product.
Embodiment 9
[formula]
| Hawthorn | 480 | g |
| Perilla seed | 384 | g |
| Japanese Honeysuckle | 288 | g |
| Wolfberry fruit | 288 | g |
| Chinese yam | 240 | g |
| The root of Dahurain angelica | 192 | g |
| Chrysanthemum | 192 | g |
| Chinese cassia tree | 144 | g |
| Lily | 96 | g |
| Cloves | 96 | g |
| Beta-cyclodextrin | 57 | g |
| Sorbyl alcohol | 71.58 | g |
| Xylitol | 60.7 | g |
| Microcrystalline Cellulose | 24.79 | g |
| Xylo-Mucine | 18.51 | g |
| Magnesium Stearate | 2.38 | g |
| A Siba is sweet | 5.03 | g |
The bulk drug of above-mentioned weight and pharmaceutical excipient are made 1000 tablets of Chinese medicine lozenges altogether, the heavy 600mg of every sheet.
Method for making]
Get volatile oil and drug extract powder (preparation method is with corresponding contents under embodiment 1 [method for making] item), dissolve by ethanol low-grade fever; Beta-cyclodextrin saturated aqueous solution is prepared under 80 DEG C of conditions; Slowly adding in beta-cyclodextrin saturated aqueous solution by medicine material ethanolic soln under agitation condition, constant temperature stops heating after stirring 1.5h, continues to be stirred to room temperature, obtains white suspension, refrigeration 84h, takes out filter, throw out washing with alcohol 2 times, 50 DEG C of drying under reduced pressure, pulverize, obtain medicinal inclusion compound; By sweet to sorbyl alcohol, Xylitol, Xylo-Mucine, Microcrystalline Cellulose and A Siba, pulverize, mixed even, add medicinal inclusion compound, mixed even, cross 200 order sieves, with 75% ethanol softwood, 20 order sieves are granulated, 60 DEG C of drying under reduced pressure 60min, pellet moisture controls at 5%(W/W) below, 20 orders sieve whole grain, add Magnesium Stearate, compressing tablet, quality inspection, packaging, to obtain final product.
Treatment obesity is had good curative effect by Chinese medicine lozenge of the present invention, for illustrating its therapeutic action, we have done a large amount of experiment research, adopt the experimental example of Chinese medicine lozenge pharmacodynamic study of the present invention for further explanation below, and specific experiment data is as follows:
1, experiment material
(1) medicine: Chinese medicine lozenge prepared by the embodiment of the present invention 9, the heavy 0.6g of every sheet, is equivalent to 2.4g crude drug; Sibutramine hydrochloride capsule (company limited of pharmaceutical factory of Taiji Group Fuling Chongqing, the accurate word H20000364 of traditional Chinese medicines).
(2) animal: SD rat, cleaning grade, body weight 150 �� 10g, male and female half and half, Chongqing Institute of Chinese Medicine institute of lab animals, credit number: SCXK(changes) 2012-0006; Basal feed, Chongqing Institute of Chinese Medicine institute of lab animals, credit number: SCXK(changes) 2012-0007; High lipid food (self-control): basal feed 79.5%, lard 10%, yolk powder 10%, cholesterol 0.5%.
(3) reagent: rat blood serum leptin (LEP) ELISA kit, rat blood serum superoxide-dismutase (SOD) ELISA kit, rat blood serum mda (MDA) ELISA kit, Jiang Lai bio tech ltd, Shanghai; Rat blood serum total antioxidant capacity (T-AOC) test kit, Bioengineering Research Institute is built up in Nanjing.
2, test method and result
Testing according to content described below, quantitative response data represent with mean+SD, adopt t inspection to carry out statistical procedures.
Rat 90, after adaptability is fed, is divided into 2 groups at random, and wherein, blank group (n=10) is fed and raised basal feed, and fat modeling group (n=80) is fed and raised high lipid food, and free diet is drunk water, and timing is weighed 1 time weekly. After 5 weeks, using fat modeling group body weight higher than blank group mean body weight 10%��20% as obesity standard, screen obese rat. Get obese rat 50, it is divided into 5 groups at random, often organizing 10, continue high lipid food and feed, free diet is drunk water, each group presses table 1 gastric infusion, blank group and model control group gavage equal-volume physiological saline, timing administration 1 time every day, timing is weighed 1 time weekly, corresponding adjustment dosage, successive administration 5 weeks. Fasting 12h after last administration, weighs body weight on an empty stomach, measures body long after anesthesia. The coeliac artery blood sampling centrifugal 10min of 4mL, 3000rpm, separation of serum. Collection kidney and surrounding genital fatty tissue are weighed, and calculate fat index [=body weight (kg)/body length (m)2] and Lee ' s index=[body weight (g) �� 1000)]1/3/ body length (cm) }.Serum LEP, SOD, MDA and T-AOC content is measured according to test kit illustration method. The results detailed in Table 1��3.
Table 1 on the impact of rat body weight (
�� SD, n=10)
Note: compare with blank group:1)P 0.001,2)P 0.01,3)P 0.05;
Compare with model control group:4)P 0.001,5)P 0.01,6)P 0.05.
As can be seen from Table 1, model control group rat body weight obviously increases, and compares with Normal group, has pole significant difference (p < 0.001); The body weight of obese rat is increased to have and slows down effect by medicine of the present invention three dosage, wherein, 5,10g(crude drug) kg-1The effect of dosage is obvious, compares with model control group, has pole significance or significant difference (p < 0.01 or p < 0.05).
Table 2 is on the impact of rat body fat, fat index, Lee's exponential sum serum LEP
(
�� SD, n=10)
Note: compare with blank group:1)P 0.001,2)P 0.01,3)P 0.05;
Compare with model control group:4)P 0.001,5)P 0.01,6)P 0.05.
As can be seen from Table 2, the body lipid amount of model control group rat, fat index, Lee's exponential sum serum LEP level all obviously raise, and compare with Normal group, have very significant or significant difference (p < 0.001 or p < 0.05); The These parameters of obese rat is had reducing effect by medicine of the present invention three dosage, wherein, 5,10g(crude drug) kg-1The effect of dosage is obvious, compares with model control group, has very significant or significant difference (p < 0.001 or p < 0.05).
Table 3 on the impact of rat antioxygenation (
�� SD, n=10)
Note: compare with blank group:1)P 0.001,2)P 0.01,3)P 0.05;
Compare with model control group:4)P 0.001,5)P 0.01,6)P 0.05.
As can be seen from Table 3, SOD, T-AOC and MDA level in model control group rat serum all obviously reduces or raises, and compares with Normal group, has very significant or pole significant difference (p < 0.001 or p < 0.05); Medicine of the present invention three dosage the These parameters of obese rat is had rising or reducing effect, wherein, 5,10g(crude drug) kg-1The effect of dosage is obvious, compares with model control group, has very significant or significant difference (p < 0.001 or p < 0.05).
Table 1��3 result shows: 1. high lipid food causes obesity rat model and copies successfully; 2. medicine of the present invention can reduce LEP, SOD, T-AOC and MDA level in obese rat body weight, body fat and blood, and alimentary obesity has good antiobesity action, and the resistivity of energy enhancing body.
Above-mentioned pharmacological testing confirms, Chinese medicine lozenge of the present invention has good fat-reducing, falls fat and antioxygenation.
Embodiment 10-18 runs according to following material proportion, Chinese medicine composition and supplementary product consumption, and processing parameter is all with reference to embodiment 9.
| Inclusion agents | Weighting agent | Disintegrating agent | Lubricant | Correctives | |
| Embodiment 10 | Alpha-cylodextrin | Lactose | Xylo-Mucine cross-linked polyvinylpyrrolidone | Magnesium Stearate | Sucrose |
| Embodiment 11 | ��-cyclodextrin | Sorbyl alcohol | Low-substituted hydroxypropyl cellulose | Micropowder silica gel | A Siba is sweet |
| Embodiment 12 | Hydroxyproply-��-cyclodextrin | N.F,USP MANNITOL | Sodium Hydroxymethyl Stalcs | Talcum powder | Stevioside |
| Embodiment 13 | Hydroxypropyl-beta-cyclodextrin | Xylitol | Croscarmellose sodium | Magnesium Stearate | Acesulfame potassium |
| Embodiment 14 | Hydropropyl-y-cyclodextrin | Pregelatinized Starch | Hydroxypropylated starch | Talcum powder | Sodium Cyclamate |
| Embodiment 15 | First group-beta-cyclodextrin | Microcrystalline Cellulose | Micropowder silica gel | Magnesium Stearate | A Siba is sweet |
| Embodiment 16 | Carboxymethyl-beta-cyclodextrin | Dextrin | Low-substituted hydroxypropyl cellulose | Magnesium Stearate | Stevioside |
| Embodiment 17 | One chlorotriazine-beta-cyclodextrin | Sorbyl alcohol | Low-substituted hydroxypropyl cellulose | Magnesium Stearate | A Siba is sweet |
The Chinese medicine lozenge with antiobesity action that embodiment of the present invention 10-17 is obtained, through pharmacodynamics test, its fat-reducing, fat falls and the pharmacological action such as anti-oxidant obvious, this Chinese medicine lozenge slowly dissolves in cheek chamber and plays therapeutic action, therefore absorb fast, treatment concentration can be reached rapidly;After this Chinese medicine lozenge is taken, directly absorb via oral mucosa and enter body circulation, it is not necessary to first arrive liver, it is possible to overcome first pass effect and reduce medicine by metabolic inactivation, it is to increase curative effect.
Although foregoing is with a general description of the specific embodiments to invention has been detailed description, but to those skilled in the art, very likely on the basis of the present invention, it being made some amendments or improves. Therefore, modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.
Claims (8)
1. one kind has the Chinese medicine lozenge of antiobesity action, it is characterised in that: it is made up of the extract of Chinese medicine composition and pharmaceutical excipient; Described Chinese medicine composition is hawthorn 10��30 parts, perilla seed 8��24 parts, Japanese Honeysuckle 6��18 parts, wolfberry fruit 6��18 parts, Chinese yam 5��15 parts, the root of Dahurain angelica 4��12 parts, chrysanthemum 4��12 parts, Chinese cassia tree 3��9 parts, lily 2��6 parts, cloves 2��6 parts.
2. Chinese medicine lozenge as claimed in claim 1, it is characterised in that: described pharmaceutical excipient is the combination of inclusion agents 0.632��4.211 part, weighting agent 2.105��14.737 parts, disintegrating agent 0.316��2.105 part, lubricant 0.021��0.316 part, correctives 0.042��0.589 part.
3. Chinese medicine lozenge according to claim 1, it is characterised in that: the one or more combination that described inclusion agents is selected from alpha-cylodextrin, beta-cyclodextrin, ��-cyclodextrin, Hydroxyproply-��-cyclodextrin, hydroxypropyl-beta-cyclodextrin, hydropropyl-y-cyclodextrin, first group-beta-cyclodextrin, carboxymethyl-beta-cyclodextrin or one chlorotriazine-beta-cyclodextrin.
4. Chinese medicine lozenge according to claim 1 and 2, it is characterised in that: one or more combinations that described disintegrating agent is selected from Xylo-Mucine cross-linked polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, Sodium Hydroxymethyl Stalcs, croscarmellose sodium, hydroxypropylated starch or micropowder silica gel.
5. Chinese medicine lozenge according to claim 1 or 3, it is characterised in that: one or more combinations that described weighting agent is selected from lactose, sorbyl alcohol, N.F,USP MANNITOL, Xylitol, pregelatinized Starch, Microcrystalline Cellulose or dextrin.
6. Chinese medicine lozenge according to claim 1 or 2 or 3, it is characterised in that: described lubricant be selected from Magnesium Stearate, micropowder silica gel or talcum powder one or more.
7. Chinese medicine lozenge according to claim 1 or 2 or 3, it is characterised in that: described correctives is selected from that sucrose, A Siba are sweet, one or more in stevioside, acesulfame potassium or Sodium Cyclamate.
8. the preparation method of Chinese medicine lozenge as described in an item as arbitrary in claim 1-7, it is characterised in that, comprise the following steps:
(1) perilla seed, Japanese Honeysuckle, the root of Dahurain angelica, Chinese cassia tree and cloves meal, add water soaking 4��12h, and heating is extracted, and collects volatile oil, filter residue I and the aqueous solution;
(2) filter residue I by step (1) gained adds 6��10 times amount water, decocts and boils 1��2 hour, filters, and collects filtrate and obtains filtrate I, gets filtrate I and merge with the aqueous solution of step (1) gained, obtain amalgamation liquid;
(3) by hawthorn, wolfberry fruit, lily three taste medicine, add 6��10 times amount 70%��75% alcohol reflux 2 times, each 1��1.5 hour, filter, get filter residue and merge to obtain filter residue II, get filtrate and merge to obtain filtrate II, by filtrate II decompression recycling ethanol to the greatest extent;
(4) Chinese yam and chrysanthemum meal is got, mix even with the filter residue II of step (3) gained, add 10��12 times amount water, decoct and boil 2 times, each 1��2 hour, filter, get filtrate and merge to obtain filtrate II I, the amalgamation liquid of filtrate II I and step (2) gained is mixed even, being evaporated to relative density is 1.02��1.04(50 DEG C��60 DEG C) liquid time, every 100mL liquid adds 1% II type ZTC1+1 natural clarifying agent component A 4.5��5.5mL, add 1% II type ZTC1+1 natural clarifying agent B component 2.5��3.5mL again, stir even, 60 DEG C��70 DEG C water bath heat preservations 1��1.5 hour, 2��4 DEG C leave standstill 20��24 hours, filter, collect filtrate and obtain filtrate IV, add the filtrate II of step (3) gained, concentrated, dry, pulverize, cross 40 order sieves, obtain drug extract powder,
(5) get the volatile oil of step (1) gained and the drug extract powder of step (4) gained, dissolve by ethanol low-grade fever; Under 80 DEG C of conditions, inclusion agents water is made saturated solution; Under agitation condition, medicine material ethanolic soln is slowly added in inclusion agents saturated solution, constant temperature stops heating after stirring 1��2h, continue to be stirred to room temperature, obtaining white suspension, refrigeration 72��120h, takes out filter, throw out washing with alcohol 2��4 times, 40��60 DEG C of drying under reduced pressure, pulverize, obtain medicine material inclusion compound; By weighting agent, disintegrating agent and correctives, pulverize, mixed even, add medicine material inclusion compound, mixed even, cross 60��200 order sieves, with water or 20��80% ethanol softwoods, 20��30 order sieves are granulated, 60��70 DEG C of drying under reduced pressure 60��120min, pellet moisture controls below 5%, and 20��30 orders sieve whole grain, add lubricant, compressing tablet, quality inspection, packaging, obtains Chinese medicine lozenge.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108813605A (en) * | 2018-04-17 | 2018-11-16 | 北京佑众全椒制药有限公司 | A kind of toxin expelling, weight reducing chu chrysanthemum lozenge |
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2014
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Non-Patent Citations (1)
| Title |
|---|
| 谭小春等: "《图解家庭食用药茶大全》", 31 January 2014, 中医古籍出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108813605A (en) * | 2018-04-17 | 2018-11-16 | 北京佑众全椒制药有限公司 | A kind of toxin expelling, weight reducing chu chrysanthemum lozenge |
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Application publication date: 20160608 |