CN106420836B - A kind of oviductus ranae dripping pill and preparation method thereof - Google Patents
A kind of oviductus ranae dripping pill and preparation method thereof Download PDFInfo
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- CN106420836B CN106420836B CN201610470694.4A CN201610470694A CN106420836B CN 106420836 B CN106420836 B CN 106420836B CN 201610470694 A CN201610470694 A CN 201610470694A CN 106420836 B CN106420836 B CN 106420836B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/65—Amphibians, e.g. toads, frogs, salamanders or newts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
- A61K9/2036—Silicones; Polysiloxanes
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- General Health & Medical Sciences (AREA)
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- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention provides a kind of oviductus ranae dripping pill and its preparation processes.Oviductus ranae dripping pill is the dropping pill formulation being made by oviductus ranae and dripping pill matrix.The present invention is developed using modern pharmaceutical process solids dispersion technology principle, has the characteristics that good evenness, dissolution rate are high, bioavilability is high, mainly there is strengthen immunity, anti-fatigue active etc..Oviductus ranae dripping pill supplementary product consumption is small, and production cost is low, and compliance is good, convenient to take.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicines, and in particular to arrive a kind of oviductus ranae dripping pill and preparation method thereof.
Background technique
Oviductus ranae refers to the fallopian tubal for winning female wood frog, is process using traditional handicraft and modern advanced
's.Oviductus ranae is gained the name because its shape is like fat, is since ancient times considered as tonic invigorator, can qi-restoratives able-bodied sun by force, support lung
Nourshing kidney benefit liver can treat deficiency of the kidney strain, neurasthenia, flustered insomnia, all deelines such as apogee sweating, in poor health of overflowing.
From ancient times to the present wood frog oil export all over the world, is widely used in medicine and health care product, oviductus ranae is the traditional health care product in China, both
Pharmaceutically acceptable, again edible, the function of tonifying kidney and benefiting sperm moistening lung gos deep into the popular feelings, containing there are many biologies beneficial to human body in oviductus ranae
Active material, wherein main component is protein and its amino acid, fatty acid, inorganic elements, vitamin, hormone etc..There is promotion
Ovarian follicle precocity and ovarian follicle proliferation function, have apparent influence to sexual cycle, can extend excitation period, there is good strong essence effect.Together
When have qi-restoratives, increase essence, the effect of bringing down a fever, can control asthenia of essence and blood, physically weak gas is weak, deficiency syndrome of the lung cough, neurasthenia, hypomnesia, postpartum
The diseases such as agalasisa, hypogalactia and pulmonary tuberculosis, hepatitis.
Traditional Chinese Medicine Dropping Pill is the novel form to grow up on the basis of medicine pill in recent years, it is with traditional Chinese medicine and pharmacy theory
Based on, the chief of modern formulation is drawn, and combine with other preparation techniques, it is (high that Modern preparations " triple effect " can be met substantially
Effect, it is quick-acting, long-acting), " three is small " (small toxicity, reaction is small, dosage is small), " five convenience " (production, transport, use, carrying, keeping)
Developing direction, therefore develop very fast, dripping pill technology is not only widely used in pharmaceutical preparation, but also it is each to can also be used in production
Kind novel healthy food and ordinary food.
Oviductus ranae is prepared into dripping pill, is in the state of high degree of dispersion in carrier (matrix), the dissolution of oviductus ranae can be improved
Degree and dissolution rate improve bioavilability, while can be reduced dosage, reduce toxic side effect, avoid the hair of oxidation, hydrolysis
Stability that is raw, improving drug.
Summary of the invention
It is an object of the invention to supplement the deficiency of present technology, a kind of oviductus ranae dripping pill and preparation method thereof is provided.This
The prepared oviductus ranae dripping pill of invention has bioavilability height, good effect, Small side effects, medicine stability good and preparation
Simply, system easy to control the quality, it is pollution-free in production the features such as, compared compared with wood frog oil product in technology, bioactivity achieves
Unexpected technical effect.
Prescription of the present invention is using oviductus ranae as active material, using dripping pill matrix as auxiliary material, is prepared by suitable technique.
The present invention is 1: 3-1: 10 by the proportion that experiment obtains oviductus ranae and dripping pill matrix, optimum proportioning 1: 3, mixing
Drug viscosity afterwards is moderate, is suitble to the preparation of dripping pill.
The matrix of dripping pill can be one of polyethylene glycol, poloxamer, stearic acid sodium, glycerol, gelatin in the present invention
Or it is a variety of.The preferred polyethylene glycol of matrix of the present invention, wherein polyethylene glycol is Macrogol 4000 and Macrogol 6000, is matched
Than being 1: 0.5-1: 1.2, optimum proportioning 1: 0.8.
The present invention uses following technology, and the oviductus ranae dripping pill can be obtained.
[preparation method]
1. raw material: selection color is vivid, without the drying wood frog oil solid of black attachment, is ground into slightly by pulverizer
Powder.
2. matrix: Macrogol 4000 and Macrogol 6000, mixed proportion 1: 0.5-1: 1.2.
3. the proportion of medicine material and matrix: as unit of g, oviductus ranae: matrix=1: 3-1: 10.
4. taking the dripping pill matrix of recipe quantity, 80-100 DEG C of heating water bath is stirred to molten condition, and oviductus ranae is added, sufficiently stirs
It mixes uniformly, and maintains this temperature, pill fluid reservoir is heated to dripping pill substrate temperature, melting medical fluid is added to fluid reservoir
In, it is instilled in coolant liquid with the speed of 30-45 drop per minute, collects molding dripping pill, wipe the coolant on dripping pill surface away, done
It is dry, it packs to obtain the final product.
Note: dripping pill coolant can be one of atoleine, dimethicone edible vegetable oil or a variety of.
One, preparation process tests:
1. the selection of matrix and coolant
With the type of the preferred oviductus ranae dropping pill formulation mesostroma of orthogonal experiment, coolant,
The conditions such as the optimum proportioning and medical fluid dripping temperature of drug and matrix select L9(33) table experiment arrangement.
Each factor level table in the experiment of table 1
Matrix ratios listed in table are selected respectively, it is miscible by different proportion with drug extract, instill 80cm long not
In congener coolant, molding situation and the sedimentation time of dripping pill are observed, with the complexity of dripping, ball shape, Deposition Situation
And the time that leaches of pelletization is inspection target, selects optimum matrix and coolant.It the results are shown in Table 2.
Each factor level table in the experiment of table 2
As can be seen from the above results, oviductus ranae PEG4000: PEG6000 ratio be 1: 0.5,1: 1.2 when solubility slightly
Difference, and have preferable solubility when ratio is 1: 0.8, therefore use PEG4000 and PEG6000 ratio for 1: 0.8 as base
Matter, coolant select dimethicone, made dripping pill shape rounding is smooth, do not trail, and bubble-free generate, roundness compared with
Good, i.e., preferred plan is A2B1C2(PEG4000 and PEG6000 are with 1: 0.8 ratio, oviductus ranae and matrix with 1: 3 ratio, coolant
For dimethicone) when effect it is best.
2. the screening of dripping condition
It is matrix with PEG4000: PEG6000=1: 0.8, the proportion of oviductus ranae and dripping pill matrix is 1: 3, dimethicone
Internal-and external diameter size, the drop speed, drop of water dropper are screened using the weight differential coefficient of variation of pelletization as index for coolant dripping pellet
Away from and coolant temperature, factor level selection be shown in Table 3,4.
The selection of 3 dripping condition of table
4 dripping conditional aspect of table and result
5 analysis of variance table of table
SS | f | S | F | P | |
A | 0.1324 | 2.0000 | 0.0631 | 1.000 | < 0.05 |
B | 3.0011 | 2.0000 | 1.5041 | 22.7293 | |
C | 2.1055 | 2.0000 | 1.0566 | 15.9242 | |
D | 0.8922 | 2.0000 | 0.4421 | 6.7482 | < 0.05 |
SMIN | 0.0664 |
Intuitive and variance analysis is carried out to upper table, the results showed that, best dripping condition are as follows: selecting drip internal-and external diameter is 2.4/
Water dropper, the coolant temperature of 4.0mm is 10 DEG C, drop speed 35-40 drop/min, drip are away from cooling liquid level 6cm.
3. confirmatory experiment
With best moulding process progress confirmatory experiment 3 times, weighs appropriate PEG4000, PEG6000 and drug mixes, pour into
In dripping tank, drip internal-and external diameter is the water dropper of 2.4/4.0mm, and drip drips speed 35~40 drops/min, away from cooling liquid level 6cm with two
Methyl-silicone oil is coolant, and cooling temperature is 10 DEG C, carries out dripping, the results are shown in Table 6.
6 dripping pill confirmatory experiment result of table
Experiment number | Average ball weight/mg | The coefficient of variation/% | Yield rate/% | Dissolve time limit/min |
A | 35.2 | 3.02 | 95 | 12 |
B | 35.1 | 3.50 | 94.4 | 11 |
C | 35.0 | 3.49 | 94.1 | 13 |
Average value | 35.1 | 3.37 | 94.5 | 12 |
From the above results, this technique be stablize it is feasible.
Two, strengthen immunity, antifatigue effect experiment
The drug with strengthen immunity has much in the prior art, and the wood frog oil product of good drug efficacy is that Beijing Tongrentang is raw
Tongrentang's board Changbai Mountain Rana temporaria chensinensis oil particles of Tetramune development corporation, Ltd. production.It is prepared to embody the present invention
The technical effect of oviductus ranae dripping pill combines limit food method to obtain model of qi-asthenia, is then prepared into the present invention using swimming strain method
To product and the above product carried out comparative experimental study, to illustrate the significant curative effect of product of the present invention, illustrate the present invention
Significant advantageous effects achieved.Specific experiment is as follows:
(1) material and method
1, experimental animal
SD rat, half male and half female, weight 220-250g are provided, production licence number by Shandong University's Experimental Animal Center
(SCXK (Shandong) 20150001).
2, drug
Oviductus ranae dripping pill of the present invention.
3, main agents
Tongrentang's board Changbai Mountain Rana temporaria chensinensis oil particles, Beijing Tongrentang Biology Product Development Co., Ltd's production, lot number
20140315。
4, method
4.1 modeling
Rat is randomly divided into control group, deficiency of vital energy group, oviductus ranae dripping pill group of the present invention, Tongrentang's board Changbai Mountain Rana temporaria chensinensis
Oil particles group (calls Tongrentang's oviductus ranae granules group in the following text).Control group conventinal breeding, free diet, remaining each group, which is kept on a diet, (feeds
Half when appetite is normal), and carry out power and exhaust swimming, water temperature is controlled at 20 DEG C, rats'swimming, cannot be with shoe in bottom of pond
Rest continuous 14 days, with last sinking of swimming, cannot still return to the water surface after 10s and exhaust for power 1 time a day.After the completion of modeling simultaneously
Observe the activity condition and the state of mind of each group rat.
4.2 experimental group
It is divided into four groups according to randomization, control group, model of qi-asthenia group, oviductus ranae dripping pill group of the present invention, Tongrentang woods
Frog oil particles group, every group 10.Control group, model of qi-asthenia group gavage same amount of normal saline, and oviductus ranae dripping pill group gavages mixed respectively
Suspension (concentration 1.2g/kg), Tongrentang's oviductus ranae granules group gavage oviductus ranae granules suspension (concentration 1.2g/kg), even
It is 14 days continuous.
4.3 statistical analysis
Using 12.0 software statistics of SPSS, method uses one-way analysis of variance, and comparison among groups variance analysis is owned
Data withForm indicate, P < 0.05 be difference it is statistically significant.
4.4 method
(1) there is appetite reduction, after 10 days, successively when the 6th, 7 day in rat Biological Characterization observing and nursing group rat
Occur it is apathetic, it is slow in reacting, curl up and move less, thermophilic sleeping, lazy move, burnout is slow in action, hence it is evident that rolls up, flocks together in groups, encircles
Back, swimming time declines to a great extent, while a mao loss of gloss pool occurs, turns to be yellow, is easy to fall off, and hair is withered, coughs, and asthma is exhaled sometimes
It inhales road secretion to flow out from nose, control group is always without there is the above symptom and sign.
7 experimental rat Biological Characterization sxemiquantitative of table scoring observation table
Table 8 tests each group rat Biological Characterization and observes table
Group | n | Score value |
Control group | 10 | 1.24±0.33 |
Model of qi-asthenia group | 10 | 4.39±1.14** |
Oviductus ranae dripping pill group | 10 | 1.52±0.11ΔΔ# |
Tongrentang's oviductus ranae granules group | 10 | 1.79±0.23ΔΔ |
Note: compared with the control group, * * P < 0.01;Compared with model of qi-asthenia group, Δ Δ P < 0.01;With Tongrentang's oviductus ranae
Particle group is compared, #P < 0.05
Table 9 is tested each group rat swimming time and is compared
Group | n | Swimming time (s) |
Control group | 10 | 711.5±45.2 |
Model of qi-asthenia group | 10 | 255.7±91.3** |
Oviductus ranae dripping pill group | 10 | 655.6±45.7ΔΔ# |
Tongrentang's oviductus ranae granules group | 10 | 603.1±49.3ΔΔ |
Note: compared with the control group, * * P < 0.01;Compared with model of qi-asthenia group, Δ Δ P < 0.01;With Tongrentang's oviductus ranae
Particle group is compared, #P < 0.05
(2) result
1, each group mouse biological characterization scoring experimental result shows that control group mice is vivaciously active, is quick on the draw;The deficiency of vital energy
Model group mouse then shows burnout lazy move, down in spirits, and four limbs are rolled up, are slow in action, and very then narrows eye, contracting spandrel arch back;Skin pine
It relaxes, back hair color is matt;The light white few profit of tail, nose color;It defecates dilute soft, drains Pyuria, Biological Characterization scoring and control group
Than more significant raising (P < 0.01);Compared with model of qi-asthenia group, Tongrentang's oviductus ranae granules group, oviductus ranae dripping pill group of the present invention
It is slightly blunt to react, and autonomic activities are reduced, and the slightly loose relaxation of skin is soft, the light red few profit of tail, nose color;Stool is dry, tangible, biology
Learning characterization scoring significantly reduces (P < 0.01);Compared with Tongrentang's oviductus ranae granules group, oviductus ranae dripping pill group of the present invention has aobvious
It writes sex differernce (P < 0.05).Referring to table 8.
2, each group rat swimming time experimental result is shown, compared with the control group, model of qi-asthenia group rat power exhausts trip
The swimming time is obviously shortened, and statistics has significant difference (P < 0.01);Compared with model of qi-asthenia group, Tongrentang's oviductus ranae granules group,
Oviductus ranae dripping pill group rat swimming time of the present invention is obviously prolonged, and statistics has significant difference (P < 0.01);With Tongrentang
Oviductus ranae granules group compares, and oviductus ranae dripping pill group of the present invention has significant difference (P < 0.05).Referring to table 9.
Specific embodiment
Embodiment 1
Oviductus ranae 30g
Macrogol 4000 50g
Macrogol 6000 40g
By the Macrogol 4000 of recipe quantity and Macrogol 6000 into evaporating dish, 80 DEG C of heating water baths are stirred to melting
State is stirring evenly and then adding into drug, stirs evenly, and keeps temperature, spare.Pill dripping machine is preheated to 80 DEG C, dimethicone
10 DEG C are cooled to, adjusts drip nozzle to the height of cooling-liquid level to 6cm, drip internal-and external diameter is 2.4/4.0mm, and medical fluid is added to
In fluid reservoir, start valve, with the speed dripping of 35-40 per minute, collects dripping pill in collection port, draw dripping pill surface with filter paper
Dimethicone, it is dry, pack to obtain the final product.
Embodiment 2
Oviductus ranae 30g
Macrogol 4000 200g
Macrogol 6000 100g
By the Macrogol 4000 of recipe quantity and Macrogol 6000 into evaporating dish, 80 DEG C of heating water baths are stirred to melting
State is stirring evenly and then adding into drug, stirs evenly, and keeps temperature, spare.Pill dripping machine is preheated to 80 DEG C, atoleine is cold
But to 12 DEG C, drip nozzle is adjusted to the height of cooling-liquid level to 4cm, and drip internal-and external diameter is 2.6/4.2mm, and medical fluid is added to storage
In liquid chamber, start valve, with the speed dripping of 40-45 per minute, collects dripping pill in collection port, draw dripping pill surface with filter paper
Atoleine, it is dry, it packs to obtain the final product.
Embodiment 3
Oviductus ranae 30g
Macrogol 4000 109g
Macrogol 6000 131g
By the Macrogol 4000 of recipe quantity and Macrogol 6000 into evaporating dish, 80 DEG C of heating water baths are stirred to melting
State is stirring evenly and then adding into drug, stirs evenly, and keeps temperature, spare.Pill dripping machine is preheated to 80 DEG C, edible vegetable oil
8 DEG C are cooled to, adjusts drip nozzle to the height of cooling-liquid level to 8cm, drip internal-and external diameter is 2.8/3.8mm, and medical fluid is added to
In fluid reservoir, start valve, with the speed dripping of 30-35 per minute, collects dripping pill in collection port, draw dripping pill surface with filter paper
Edible vegetable oil, it is dry, pack to obtain the final product.
Claims (2)
1. a kind of oviductus ranae dripping pill, it is characterised in that be made of oviductus ranae and dripping pill matrix, the preparation side of the oviductus ranae dripping pill
Method includes the following steps:
(1) selection color is vivid, without the drying wood frog oil solid of black attachment, is ground into coarse powder by pulverizer;
(2) the dripping pill matrix of recipe quantity is taken according to the ratio that oviductus ranae and matrix weight ratio are 1: 3, matrix is Macrogol 4000
And Macrogol 6000, weight ratio 1: 0.8,80-100 DEG C of heating water bath are stirred to molten condition, are stirring evenly and then adding into
Drug stirs, and keeps this temperature, spare;
(3) pill dripping machine fluid reservoir is heated to 80-100 DEG C, the drug of molten condition is added in fluid reservoir, with per minute
The speed dripping of 35-40 drop collects molding dripping pill, wipes the coolant liquid on surface away, be drying to obtain, wherein dripping pill is cold into condensate liquid
But agent is dimethicone, and drip internal-and external diameter is the water dropper of 2.4/4.0mm, drip away from cooling liquid level 6cm, coolant temperature 10
℃。
2. a kind of preparation method of oviductus ranae dripping pill, it is characterised in that include the following steps:
(1) selection color is vivid, without the drying wood frog oil solid of black attachment, is ground into coarse powder by pulverizer;
(2) the dripping pill matrix of recipe quantity is taken according to the ratio that oviductus ranae and matrix weight ratio are 1: 3, matrix is Macrogol 4000
And Macrogol 6000, weight ratio 1: 0.8,80-100 DEG C of heating water bath are stirred to molten condition, are stirring evenly and then adding into
Drug stirs, and keeps this temperature, spare;
(3) pill dripping machine fluid reservoir is heated to 80-100 DEG C, the drug of molten condition is added in fluid reservoir, with per minute
The speed dripping of 35-40 drop collects molding dripping pill, wipes the coolant liquid on surface away, be drying to obtain, wherein dripping pill is cold into condensate liquid
But agent can be atoleine, dimethicone or edible vegetable oil, drip internal-and external diameter be the water dropper of 2.4/4.0mm, drip away from
Cooling liquid level 6cm, coolant temperature are 10 DEG C.
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Citations (3)
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CN104189283A (en) * | 2014-09-04 | 2014-12-10 | 上海浦东高星生物技术研究所 | Pomegranate seed oil drop pill |
CN105395496A (en) * | 2015-12-02 | 2016-03-16 | 孙彪 | Ginseng dropping pill and preparation method thereof |
CN105663690A (en) * | 2016-03-11 | 2016-06-15 | 孙彪 | Health-aiding compound dropping pills and preparing method thereof |
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US20110195136A1 (en) * | 2008-10-06 | 2011-08-11 | Jianming Chen | Drop pill for treating coronary heart disease and preparation thereof |
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Publication number | Priority date | Publication date | Assignee | Title |
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CN104189283A (en) * | 2014-09-04 | 2014-12-10 | 上海浦东高星生物技术研究所 | Pomegranate seed oil drop pill |
CN105395496A (en) * | 2015-12-02 | 2016-03-16 | 孙彪 | Ginseng dropping pill and preparation method thereof |
CN105663690A (en) * | 2016-03-11 | 2016-06-15 | 孙彪 | Health-aiding compound dropping pills and preparing method thereof |
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