CN105166887A - Health care product auxiliary material and applications - Google Patents

Health care product auxiliary material and applications Download PDF

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Publication number
CN105166887A
CN105166887A CN201510500550.4A CN201510500550A CN105166887A CN 105166887 A CN105166887 A CN 105166887A CN 201510500550 A CN201510500550 A CN 201510500550A CN 105166887 A CN105166887 A CN 105166887A
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raw material
health
health care
auxiliary material
care product
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CN105166887B (en
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方念伯
余尚工
陈常绣
王春
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Hubei Kunyan Pharmaceutical Co Ltd
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Hubei Kunyan Pharmaceutical Co Ltd
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Abstract

The invention provides a health care product auxiliary material. The health care product auxiliary material comprises a capsule preparation and contents. The contents comprise rice bran oil, beeswax and iron oxide red. The capsule preparation comprises glycerin, purified water and gelatin. The health care product auxiliary material is a pure traditional Chinese medicine preparation, contains no sugar, and is suitable for old people and diabetics. The contents of effective components are high, and volatile effective components are reserved furthest. The bioavailability is high, the impurity content is low, and the health care product auxiliary material has no raw medicinal powder and is easy to meet hygiene indexes. Absorption is fast and the effective blood concentration is easy to achieve. The health care product auxiliary material is prepared through a pressing method or a dropping preparation method, is formed at one time and has an all-closed dosage form, and unqualified phenomena such as disintegration after long-time storage are avoided. Foreign odor and peculiar smell of some contents can be covered, the traditional Chinese medicine volatile components, traditional Chinese medicine components with adverse smell and traditional Chinese medicine preparations have special smell, after preparation into soft capsules, volatilization is not easy, adverse smell can be covered, and the drug quality is raised. The dose is low and carrying is convenient. The dosage form technology flow is scientific and reasonable.

Description

A kind of health care product auxiliary material and application thereof
Technical field
The present invention relates to a kind of new health care product auxiliary material, belong to technical field of health care food.
Background technology
National Health Foods industry is fast-developing through for many years, grows gradually.Although still face lot of challenges, the development prospect of National Health Foods industry is bright.Under the promotion of the market demand, technological progress and management update, Chinese health products industry development space is huge.Future development will present Consumer groups's diversification, health products sales mode franchiseization, publicity pattern is weeded out the old and bring forth the new and health products become current consumption four main trend.
When preparing novel healthy food, selection and the optimization of diversity when playing health food maximum function always because of the material complexity puzzlement health food formulation of health food of its formulation.
Summary of the invention
The present invention is directed to the problems referred to above, provide a kind of new and effective formulation utilizing health food, i.e. soft capsule.Specific as follows:
A kind of health care product auxiliary material, this health care product auxiliary material comprises capsule preparations and content thereof, and content comprises rice bran oil, beeswax, iron oxide red, and capsule preparations comprises glycerine, purified water, gelatin; Wherein, the extract of rice bran oil and health product raw material adds by weight 1-5:1; Beeswax accounts for the 1-5% of health product raw material gross weight; Glycerine, purified water, gelatin accounts for the 18-25% of health product raw material gross weight, and the weight ratio of gelatin, glycerine, purified water is 1:0.3-0.5:0.8-1.5; Iron oxide red presses the 0.8-2.5 ‰ of gelatin gross weight.
Elect as further, the extract of rice bran oil and health product raw material adds by weight 4:1; Beeswax accounts for 3.6% of health product raw material gross weight; Glycerine, purified water, gelatin accounts for 20% of health product raw material gross weight, and the weight ratio of gelatin, glycerine, purified water is 1.0:0.4:1.0; Iron oxide red presses 2 ‰ of gelatin gross weight.
Described health care product auxiliary material, capsule preparations also comprises konjaku glucomannan, and wherein, konjaku glucomannan accounts for the 1-5% of capsule preparations total amount.
Above-mentioned health care product auxiliary material is applied on the health products of preparation reducing blood lipid by the present invention.Described blood fat reducing health products comprises the raw material composition of following weight portion: Ilex Latifolia Thunb 3-9 part, red sage root 3-8 part, hawthorn 0.3-1.2 part, lotus leaf 2.0-4.5 part, pseudo-ginseng 1.2-2.5 part.More preferably the weight portion of each raw material is Ilex Latifolia Thunb 7.2 parts, the red sage root 5.4 parts, hawthorn 0.6 part, 3.0 parts, lotus leaf, pseudo-ginseng 1.8 parts.
Above-mentioned health care product auxiliary material is also promoted the application on the health products of sleep by the present invention in preparation.The health products of described promotion sleep comprise the raw material composition of following weight portion: spina date seed 1-4 part, polygala root 1-3 part, seed of Oriental arborvitae 2-5 part, rhizoma Gastrodiae 0.1-2.0 part.More preferably the weight portion of each raw material is spina date seed 3.2 parts, polygala root 1.6 parts, the seed of Oriental arborvitae 2.4 parts, 0.8 part, rhizoma Gastrodiae.
In the application, soft capsule belongs to the one of capsule, and it is by liquid medicine or juicy fruit body medicine is treated is sealed in a kind of capsule made in soft capsule material.The capsule material of soft capsule is made up of glycerine and gelatin etc., and wall is thicker, and again without gas permeability, therefore soft capsule is the elegant formulations preventing oxidation of drug.
Various oils can be filled or to oily liquids, the suspension of softgel shell without dissolution, capsule 's content generally comprises raw material (Chinese medical extract), diluent, emulsifying agent and suspending agent in soft capsule.When preparing soft capsule, no matter Chinese medicine or its extract are powder or medicinal extract, easily deposit when only mixing with oils matrix, and loading amount can be caused when filling to be forbidden.Therefore; in order to keep suspension to have good mobility, usually adding emulsifying agent, suspending agent and matrix melting, after the equipment such as colloid mill, emulsification instrument mixing dispersion, obtaining comparatively fine and smooth content; thus change the mobility of content, improve the stability that settling ratio guarantees suspension.In the health food of the application, use beeswax, effectively raise the uniformity of liquid.
Rice bran oil is diluent, and rice bran oil itself has good stability, and is a kind of nutritious vegetable oil, and after food, absorptivity reaches more than 90%.The absorption that rice bran oil is made up of aliphatic acid, vitamin E, sterol, oryzanol etc. are conducive to human body, has the cholesterol removed in blood, reduces blood fat, promotes the beneficial effects such as growth in humans's growth, and thus rice bran oil is the nutrient health oil of generally acknowledging both at home and abroad.Its quality meets the requirement of relevant criterion.Production conditional operation is strong, can controlling extent high, better can control product quality.
Beeswax is suspending agent.Worker bee to construct honeycomb and capping honeycomb and from honeybee glandular secretion fatty waxy solid out.It is the organic compound that a kind of chemical composition is very complicated.Generally speaking, the fat of main component synthesized by higher fatty acids and high alcohol of beeswax, accounts for 70% ~ 75%, free fatty accounts for 12% ~ 15%, carbohydrate accounts for 11% ~ 17%, and water accounts for 2.5%, also has a small amount of aromatic substance, pigment and trace element etc.The wax class that beeswax and other plant wax, mineral wax, aliphatic acid, fatty alcohol, glyceride, hydrocarbon and synthetic wax etc. are nearly all and oil and fat product have good intermiscibility.
For adapting to the needs that soft capsule is produced, this technique is using rice bran oil as diluent, and beeswax is as suspending agent.Require to be soluble in homogeneous, good fluidity when rice bran oil, beeswax and Chinese medicine dried cream powder (i.e. raw extract) make suspension.In 3.6% situation that fixing beeswax consumption is content, to the ratio research experiment of Chinese medicine dried cream powder (i.e. raw extract), rice bran oil.Chinese medical extract dried cream powder and rice bran oil mix in the ratio of 1:1-5 respectively, observe mobility and the homogeneity of liquid.
The beneficial effect that soft capsule in the application produces on the health products of the application is as follows:
Pure Chinese medicinal preparation, not sugary, be convenient to the elderly and diabetic takes.Active constituent content is high, and it remains volatile effective component to greatest extent.Bioavilability is high, and impurity content is low, without crude drug powder, more easily meets Hygienic Index.Absorb the advantage such as fast and easily reach effective blood drug concentration.Prepared by pressing or dropping preparation method, one-shot forming, totally-enclosed formulation, after avoiding being long placed in, occur the defective phenomenon of disintegration.Can hide some content foreign odor, peculiar smell, the traditional Chinese medicine ingredients of Chinese medicine volatile ingredient and tool bad smell has special odor containing the Chinese medicine preparation of volatile oil, makes soft capsule not volatile, and can cover bad smell, improves drug quality.Dose is few, easy to carry.Formulation technological process is short, simply.
Accompanying drawing explanation
Fig. 1 is the preparation technology of the health products soft capsule of embodiment 1 reducing blood lipid.
Fig. 2 is the preparation technology that embodiment 2 promotes the health products of sleep.
Detailed description of the invention
Embodiment 1
Formula:
Content is filled a prescription:
Soft capsule skin is filled a prescription:
1) be broken into fritter according to the raw material meeting States Pharmacopoeia specifications or be broken into granularity and cross 60 object meal, obtain raw material, this raw material 7 times amount 70% edible ethanols are refluxed 2 times, return time is respectively 1.5h and 1h, filter, merging filtrate, again filtrate is reclaimed ethanol at-0.065MPa and 65 DEG C, then at 60 DEG C, be concentrated into relative density is 1.30, obtain cream clearly, further by clear cream at-0.075MPa, drying under reduced pressure at 70 DEG C, pulverize, cross 100 mesh sieves and obtain Chinese medical extract powder, again by rice bran oil, beeswax, gelatin, glycerine, purified water, iron oxide red is in strict accordance with the program entering 100,000 grades of clean areas, clean area is entered for subsequent use through pass-through box,
2) preparation of content, after appropriate rice bran oil beeswax being joined 70 DEG C dissolves completely, then adds residue rice bran oil, mixes, obtained oily wax liquid; Joined in oily wax liquid by Chinese medical extract powder, be uniformly mixed colloid mill 3 times, each 30min, under-0.06Mpa, vacuumize degassing bubble, obtains Contents Fill liquid;
3) preparation of glue, purified water, iron oxide red are mixed well in rear glycerol adding inputization glue tank, after mixing, 70-75 DEG C of heating, adds gelatin after stirring, is stirred to gelatin entirely molten, glue bubble-free is evacuated under-0.08Mpa, after crossing 100 orders, glue is placed in the 55 DEG C of insulations of storage glue tank, stand-by;
4) pelleting, soft capsule filler, glue are pressed into soft capsule by encapsulating machine by 0.5g/ grain, the rotating speed keeping encapsulating machine is that 1.5-3.5 turns/min, the sprinkler body temperature of encapsulating machine keeps 35-50 DEG C, the rubber thickness of soft capsule of compacting is 0.85mm, by the soft capsule that presses in rotating cage, at temperature 18-26 DEG C, shape under relative humidity 30-40% 2-3h, obtains soft capsule;
5) wash ball, pour in soft capsule pot by the capsule and pill after sizing, wash soft capsule twice with 95% ethanol, the time is 4-6 minute, and drop goes out ethanol, is dried by washed capsule and pill uniform spreading on yarn jiggering;
6) dry, select ball, by washed soft capsule temperature 26 DEG C, relative humidity 23.5% carries out drying, 24 hours drying times, be dried to softgel shell moisture control range 12%, can obtain the health products with complementary reducing blood lipid, these health products with complementary reducing blood lipid are capsule preparations.
Contain in every 100g in the said goods: general flavone 0.8g, tanshinone IIA 60mg.
Traditional Chinese Medicine dosage and security
This product is soft capsule, 3 times/day, 4 tablets/time, and without incompatibility between each raw material, consumption per day and reference quantity see attached list.
Raw material consumption per day and the pharmacopeia consumption per day table of comparisons
Ilex Latifolia Thunb The red sage root Hawthorn Lotus leaf Pseudo-ginseng
Product consumption per day (g/ day) 7.2 5.4 0.6 3.0 1.8
Pharmacopeia consumption (g/ day) 3-9 10-15 9-12 3-10 3-9
Can find out from upper table, various Chinese medicine consumption per day does not all exceed pharmacopeia consumption per day.
Embodiment 1 product sensory
Project Product sensory
Color and luster Soft capsule brownish red is opaque, and content is sepia
Taste, smell There is the distinctive flavour of this product, smell, free from extraneous odour
Proterties Soft capsule is complete bright and clean, crack-free, and content is oily
Impurity Without macroscopic exogenous impurity
Embodiment 1 product physical and chemical index
Project Index
Ash content/(g/100g)≤ 5.0
Plumbous (in Pb)/(mg/kg)≤ 1.5
Arsenic (in As)/(mg/kg)≤ 1.0
Mercury (in Hg)/(mg/kg)≤ 0.3
DDT/(mg/kg)≤ 0.2
BHC/(mg/kg)≤ 0.2
Disintegration time limited/(min)≤ 60
AFB1/(ug/kg)≤ 5
Embodiment 1 product microbiological indicator
Embodiment 2
Formula:
Content is filled a prescription:
Soft capsule skin is filled a prescription:
1) be broken into fritter according to the raw material meeting States Pharmacopoeia specifications or be broken into granularity and cross 60 object meal, obtaining raw material;
2) learn from else's experience the raw material of cutting or pulverizing, reflux 2 times with 6-8 times amount 70% edible ethanol, return time is respectively 1-2h and 1h, filters, merging filtrate;
3) by step 2) in filtrate at-0.065 to-0.075Mpa and 65 DEG C, reclaim ethanol, then at 60 DEG C, being concentrated into relative density is 1.30 to 1.35, obtains medicinal extract;
4) by the clear cream in above-mentioned-0.075 to-0.085Mpa, drying under reduced pressure at 70 DEG C, pulverizes, and crosses 100 mesh sieves, packaging, for subsequent use, the health products with complementary reducing blood lipid can be obtained, this formulation is pulvis, and this programme can be also extract type, namely deletes this step.
Subordinate list: the selection of Chinese medicine ethanol extraction process parameter
General flavone in comprehensive dried cream powder, gastrodin content, production cycle and energy consumption cost, determine above-mentioned Chinese medicine material alcohol reflux 2 times, for the first time alcohol adding amount 7 times, 1.5h; Second time alcohol adding amount 7 times, 1h.
5) preparation of content, by rice bran oil on the basis of above-mentioned steps, beeswax, gelatin, glycerine, purified water, iron oxide red, in strict accordance with the program entering 100,000 grades of clean areas, enter clean area through pass-through box for subsequent use.After appropriate rice bran oil beeswax being joined 70 DEG C dissolves completely, then add residue rice bran oil, mix, obtained oily wax liquid; Joined in oily wax liquid by traditional Chinese medicine extraction medicinal powder, be uniformly mixed colloid mill 3 times, each 30min, under-0.06Mpa, vacuumize degassing bubble, obtains Contents Fill liquid;
6) preparation of glue, purified water, iron oxide red are mixed well in rear glycerol adding inputization glue tank, after mixing, 70-75 DEG C of heating, adds gelatin after stirring, is stirred to gelatin entirely molten, glue bubble-free is evacuated under-0.08Mpa, after crossing 100 orders, glue is placed in the 55 DEG C of insulations of storage glue tank, stand-by;
7) pelleting, soft capsule filler, glue are pressed into soft capsule by encapsulating machine by 0.5g/ grain, the rotating speed keeping encapsulating machine is that 1.5-3.5 turns/min, the sprinkler body temperature of encapsulating machine keeps 35-50 DEG C, the rubber thickness of soft capsule of compacting is 0.85mm, by the soft capsule that presses in rotating cage, at temperature 18-26 DEG C, shape under relative humidity 30-40% 2-3h, obtains soft capsule;
8) wash ball, pour in soft capsule pot by the capsule and pill after sizing, wash soft capsule twice with 95% ethanol, the time is 4-6 minute, and drop goes out ethanol, is dried by washed capsule and pill uniform spreading on yarn jiggering;
9) dry, select ball, by washed soft capsule temperature 26 DEG C, relative humidity 23.5% carries out drying, 24 hours drying times, be dried to softgel shell moisture control range 12%, can obtain the health products promoting sleep of the present invention, the health products of this promotion sleep are capsule preparations.
Contain in every 100g in the said goods: general flavone >=0.3g; Total saposins (in ginsenoside Re g/100g) >=0.2; Gastrodin (mg/100g) >=10.
Each supplementary material consumption and security
This product is soft capsule, 2 times/day, 4 tablets/time, and without incompatibility between each raw material, consumption per day and reference quantity see attached list.
Subordinate list: each raw material consumption per day and the pharmacopeia consumption table of comparisons
Raw material Spina date seed The seed of Oriental arborvitae Polygala root Rhizoma Gastrodiae
Medicinal material consumption per day (g/ day) 3.2 2.4 1.6 0.8
Pharmacopeia consumption (g/ day) 9-15 3-9 3-9 3-9
As can be seen from the above, four kinds of Chinese medicine consumption per days are all lower than pharmacopeia lower limit.This product auxiliary material rice bran oil used, beeswax, gelatin, glycerine, iron oxide red all meet healthy food material regulation.This product shows through Disease Prevention Control Center, Hubei Prov's laboratory test, animal safety toxicology test no abnormality seen, shows that product is safe, is applicable to long-term edible.
The physical and chemical index of embodiment 2
Project Index
Ash content (g/100g)≤ 5.0
Plumbous (in Pb)/(mg/kg)≤ 1.5
Arsenic (in As)/(mg/kg)≤ 1.0
Mercury (in Hg)/(mg/kg)≤ 0.3
DDT (DDT)/(mg/kg)≤ 0.2
BHC (HCH)/(mg/kg)≤ 0.2
Disintegration time limited/(min)≤ 60
Flavatin B1/ (ug/kg)≤ 5
The microbiological indicator of embodiment 2
Embodiment 3
Content is filled a prescription:
Soft capsule skin is filled a prescription:
1) be broken into fritter according to the raw material meeting States Pharmacopoeia specifications or be broken into granularity and cross 60 object meal, obtain raw material, this raw material 7 times amount 70% edible ethanols are refluxed 2 times, return time is respectively 1.5h and 1h, filter, merging filtrate, again filtrate is reclaimed ethanol at-0.075Mpa and 65 DEG C, then at 60 DEG C, be concentrated into relative density is 1.30, obtain cream clearly, further by clear cream at-0.085Mpa, drying under reduced pressure at 70 DEG C, pulverize, cross 100 mesh sieves and obtain Chinese medical extract powder, again by rice bran oil, beeswax, gelatin, glycerine, purified water, iron oxide red, konjaku glucomannan is in strict accordance with the program entering 100,000 grades of clean areas, clean area is entered for subsequent use through pass-through box,
2) preparation of content, after appropriate rice bran oil beeswax being joined 70 DEG C dissolves completely, then adds residue rice bran oil and a part of konjaku glucomannan (accounting for 1/2 of konjaku glucomannan total amount), mixes, obtained oily wax liquid; Joined in oily wax liquid by Chinese medical extract powder, be uniformly mixed colloid mill 3 times, each 30min, under-0.07Mpa, vacuumize degassing bubble, obtains Contents Fill liquid;
3) preparation of glue, purified water, iron oxide red are mixed well in rear glycerol adding inputization glue tank, after mixing, 70-75 DEG C of heating, adds gelatin and another part konjaku glucomannan (accounting for 1/2 of konjaku glucomannan total amount), is stirred to gelatin entirely molten after stirring, glue bubble-free is evacuated under-0.07Mpa, after crossing 100 orders, glue is placed in the 55 DEG C of insulations of storage glue tank, stand-by;
4) pelleting, soft capsule filler, glue are pressed into soft capsule by encapsulating machine by 0.5g/ grain, the rotating speed keeping encapsulating machine is that 1.5-3.5 turns/min, the sprinkler body temperature of encapsulating machine keeps 35-50 DEG C, the rubber thickness of soft capsule of compacting is 0.85mm, by the soft capsule that presses in rotating cage, at temperature 18-26 DEG C, shape under relative humidity 30-40% 2-3h, obtains soft capsule;
5) wash ball, pour in soft capsule pot by the capsule and pill after sizing, wash soft capsule twice with 95% ethanol, the time is 4-6 minute, and drop goes out ethanol, is dried by washed capsule and pill uniform spreading on yarn jiggering;
6) dry, select ball, by washed soft capsule temperature 28 DEG C, relative humidity 35% carries out drying, 24 hours drying times, be dried to softgel shell moisture control range 12%, can obtain the health products with complementary reducing blood lipid, these health products with complementary reducing blood lipid are capsule preparations.
Contain in every 100g in the said goods: general flavone 0.81g, tanshinone IIA 65mg.
Embodiment 2 product sensory
Project Product sensory
Color and luster Soft capsule brownish red is opaque, and content is sepia
Taste, smell There is the distinctive flavour of this product, smell, free from extraneous odour
Proterties Soft capsule is complete bright and clean, crack-free, and content is oily
Impurity Without macroscopic exogenous impurity
Embodiment 2 product physical and chemical index
Project Index
Ash content/(g/100g)≤ 5.0
Plumbous (in Pb)/(mg/kg)≤ 1.5
Arsenic (in As)/(mg/kg)≤ 1.0
Mercury (in Hg)/(mg/kg)≤ 0.3
DDT/(mg/kg)≤ 0.2
BHC/(mg/kg)≤ 0.2
Disintegration time limited/(min)≤ 60
AFB1/(ug/kg)≤ 5
Embodiment 2 product microbiological indicator
Konjaku glucomannan, has higher water absorbing capacity, in the process of soft capsules rupture and health product raw material stripping or spilling, because of, the adsorption capacity of konjaku glucomannan, can effectively slow down health product raw material stripping or spilling, make to be absorbed with order.Because of the gelling performance of konjaku glucomannan, the rupture process of soft capsule can be slowed down, make soft capsule slowly stripping break.Moreover konjaku glucomannan can regulate the balance of diet, keep body fluids.

Claims (9)

1. a health care product auxiliary material, is characterized in that, this health care product auxiliary material comprises capsule preparations and content thereof, and content comprises rice bran oil, beeswax, iron oxide red, and capsule preparations comprises glycerine, purified water, gelatin; Wherein, the extract of rice bran oil and health product raw material adds by weight 1-5:1; Beeswax accounts for the 1-5% of health product raw material gross weight; Glycerine, purified water, gelatin accounts for the 18-25% of health product raw material gross weight, and the weight ratio of gelatin, glycerine, purified water is 1:0.3-0.5:0.8-1.5; Iron oxide red presses the 0.8-2.5 ‰ of gelatin gross weight.
2. health care product auxiliary material according to claim 1, is characterized in that, the extract of rice bran oil and health product raw material adds by weight 4:1; Beeswax accounts for 3.6% of health product raw material gross weight; Glycerine, purified water, gelatin accounts for 20% of health product raw material gross weight, and the weight ratio of gelatin, glycerine, purified water is 1.0:0.4:1.0; Iron oxide red presses 2 ‰ of gelatin gross weight.
3. the health care product auxiliary material described in claim 1 or 2, is characterized in that, capsule preparations also comprises konjaku glucomannan, and wherein, konjaku glucomannan accounts for the 1-5% of capsule preparations total amount.
4. claim 1 or the health care product auxiliary material described in 2 or 3 are preparing the application on blood fat reducing health products.
5. application according to claim 4, is characterized in that, described blood fat reducing health products comprises the raw material composition of following weight portion: Ilex Latifolia Thunb 3-9 part, red sage root 3-8 part, hawthorn 0.3-1.2 part, lotus leaf 2.0-4.5 part, pseudo-ginseng 1.2-2.5 part.
6. application according to claim 5, is characterized in that, the weight portion of each raw material is Ilex Latifolia Thunb 7.2 parts, the red sage root 5.4 parts, hawthorn 0.6 part, 3.0 parts, lotus leaf, pseudo-ginseng 1.8 parts.
7. claim 1 or the health care product auxiliary material described in 2 or 3 promote the application on the health products of sleep in preparation.
8. application according to claim 7, is characterized in that, the health products of described promotion sleep comprise the raw material composition of following weight portion: spina date seed 1-4 part, polygala root 1-3 part, seed of Oriental arborvitae 2-5 part, rhizoma Gastrodiae 0.1-2.0 part.
9. application according to claim 8, is characterized in that, the weight portion of each raw material is spina date seed 3.2 parts, polygala root 1.6 parts, the seed of Oriental arborvitae 2.4 parts, 0.8 part, rhizoma Gastrodiae.
CN201510500550.4A 2015-08-14 2015-08-14 A kind of health care product auxiliary material and its application Expired - Fee Related CN105166887B (en)

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