CN1939500A - Kidney-tonifying and bone-strengthening capsules and preparation thereof - Google Patents

Kidney-tonifying and bone-strengthening capsules and preparation thereof Download PDF

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Publication number
CN1939500A
CN1939500A CN 200510105537 CN200510105537A CN1939500A CN 1939500 A CN1939500 A CN 1939500A CN 200510105537 CN200510105537 CN 200510105537 CN 200510105537 A CN200510105537 A CN 200510105537A CN 1939500 A CN1939500 A CN 1939500A
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China
Prior art keywords
fine powder
kidney
strengthening
invigorating
salviae miltiorrhizae
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CN 200510105537
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Chinese (zh)
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张勇
陆兔林
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Individual
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Individual
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Abstract

A Chinese medicine 'Xianling Gubao softgel' for nourishing kidney and strengthening bone is prepared from fine powder of red sage root, the powdered extracts of 5 Chinese-medicinal materials including epimedium, dipsacus root, rehmannia root, etc, and the medicinal auxiliary chosen from vegetative oil, polyethanediol, and glycol monoethylether.

Description

A kind of invigorating the kidney and strengthening the bones soft capsule and preparation method thereof
Technical field
What the present invention relates to is a kind of Chinese medicine novel form and preparation method thereof, especially relates to Chinese medicinal soft capsule of a kind of invigorating the kidney and strengthening the bones and preparation method thereof.
Background technology
The compound preparation that the Chinese medicine XIANLING GUBAO is made up of Six-element Chinese medicines such as Herba Epimedii, Radix Dipsaci, Radix Salviae Miltiorrhizae, the Rhizoma Anemarrhenae, Fructus Psoraleae, Radix Rehmanniae is used for the treatment of deficiency of the liver and kindey, and the osteoporosis due to the obstruction of collaterals by blood stasis is suitable for invigorating the kidney and strengthening the bones.
The product of listing has hard capsule, tablet at present, is Tongjitang Pharmacy Co., Ltd., Guizhou and produces, and tablet is its major product, is coated tablet, and market sale is steady, has higher popularity in the middle at home medicine.2002, capsule and tablet standard transferred national standard to by provincial standard.
Its process characteristic be with the prescription Chinese crude drug through water carry, concentrate, dry, granulate compress tablet coating or encapsulated.Because the Chinese medicinal ingredients complexity, and many water that are insoluble in the active ingredient that proposes, as Fructus Psoraleae extract etc., cause the tablet or the capsule that make, disintegration time is long in vivo, and drug release is slow, thereby influences the curative effect of product.
The preparation method of Xianlinggubao effervescent tablet has been described among " a kind of effervescent tablet for the treatment of orthopaedic disease and preparation method thereof " (publication number CN1583133A), product quality is compared with former preparation be improved to some extent, but the release and the absorption problem of still unresolved indissoluble composition.Simultaneously the pluses and minuses of existing XIANLING GUBAO tablet and capsule are stated among the patent No. CN1583133A, repeated no more here.
Other dosage forms except that tablet and capsule that contained XIANLING GUBAO among " novel Xianlinggubao preparation and its production and use " (publication number CN1634293A); we discover that it does not carry out deep experimentation, and it is unreasonable to disclosed technology preparation (open in national standard) application protection simultaneously.
Summary of the invention
The object of the present invention is to provide a kind of invigorating the kidney and strengthening the bones soft capsule and preparation method thereof, overcome the problem that existing capsule and tablet exist, have that stripping is fast, dosage accurately, the unsuitable moisture absorption, good stability, characteristics that curative effect is high.
A kind of invigorating the kidney and strengthening the bones soft capsule of the present invention is made up of content and softgel shell two parts, and content comprises Six-element Chinese medicine extract effective ingredient and pharmaceutic adjuvants such as containing Radix Salviae Miltiorrhizae, Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae, Radix Rehmanniae, and the weight proportion of various components is:
Active ingredient 30-70%
The weight proportion of the above-mentioned various components of pharmaceutic adjuvant 30-70% is preferably as follows:
Active ingredient 40-60%
Pharmaceutic adjuvant 40-60%
Pharmaceutic adjuvant of the present invention refers to ethylene glycol monomethyl ether.
Pharmaceutic adjuvant of the present invention can also be the combination of diluent, surfactant, suspending agent, and its weight proportion is 1: 0.016-0.34: 0.016-0.17, preferred 1: 0.066-0.22: 0.044-0.11.Diluent can be one or more in Polyethylene Glycol (PEG) and the vegetable oil, and PEG comprises liquid PEG400, PEG-600 etc., also can cooperate to add a certain amount of solid-state PEG, as PEG6000 etc.; Vegetable oil comprises Semen Maydis oil, soybean oil, salad oil, Oleum Brassicae campestris, tea tree oil, Cortex cocois radicis wet goods.
Surfactant can be one or more in tween, span, lecithin, the polyoxyethylene castor oil.
Suspending agent can be one or more in Cera Flava, ethyl cellulose, hydrogenated palm oil, the mono stearate glyceryl ester etc.
Various components proportioning routinely in the softgel shell among the present invention.
XIANLING GUBAO RUANJIAONANG preparation method among the present invention is as follows:
The content preparation method:
Get Radix Salviae Miltiorrhizae powder and be broken into fine powder, sieve, standby; Four Chinese medicine materials such as Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae are pulverized and are coarse powder, and Radix Rehmanniae is thinly sliced, and decoct with water 3 hours for the first time three times, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, the filtrate spray drying makes fine powder, adds the Radix Salviae Miltiorrhizae fine powder, mixing; Or be concentrated into the clear paste that relative density is 1.20 (50 ℃), and add the Radix Salviae Miltiorrhizae fine powder, mixing, crushed after being dried makes fine powder.The gained fine powder is dissolved in promptly gets content in the ethylene glycol monomethyl ether; Or the heating of surfactant and suspending agent is dissolved in the diluent, and with above-mentioned fine powder or be scattered in the diluent, cross the colloid mill mix homogeneously, or be dissolved in diluent, make content.
The conventional preparation of capsule liquid:
Take by weighing in the pure water input glue jar, when rising to 70~80 ℃, temperature adds gelatin, glycerol, begin after pigment, titanium dioxide, the antiseptic to stir, keep 70~80 ℃ of temperature, vacuum outgas, vacuum outgas, vacuum outgas, vacuum outgas, vacuum outgas, stirred 1 hour, 55~60 ℃ of heat preservation for standby use.
Pelleting technology:
The medicinal liquid for preparing is carried out pelleting.Soft capsule moves into dry of drying room and carries out drying 30 ± 5% times setting of 25 ± 2 ℃, relative humidity 20 hours, and drying condition is that 30 ± 2 ℃, relative humidity are 20%, 8 hours drying times.Exsiccant soft capsule washes ball, pack after picking up ball.
Beneficial effect of the present invention is embodied in following several respects:
(1) in soft capsule, content is the fine particles shape behind colloid mill, and is in uniform suspension state.Owing to the increase of specific surface area, improved the rate of release of medicine; If make uniform liquid, then after the soft capsule disintegrate, medicine is existed in gastric juice with molecularity, compare with hard capsule, can be absorbed more rapidly and fully by body, thereby improve drug bioavailability, reached the purpose that improves drug effect.
(2) capsule shells of making medicine behind the soft capsule and do not had breathability seals, and is isolated with air, is difficult for oxidation reaction takes place, and the active ingredient in the Chinese medicine is more stable.
(3) make the bitterness that can cover medicine behind the soft capsule, and good looking appearance, soft high resilience, swallow than hard capsule is easier, improved the compliance of patient's medication greatly.
The specific embodiment
Embodiment 1:
The content prescription:
Component: every weight (milligram) weight ratio (%)
Radix Salviae Miltiorrhizae fine powder 83 13.8
Concentrate clear paste 217 36.2
PEG400 275 45.8
Tween 80 15 2.5
Cera Flava 10 1.7
Gross weight 600
The softgel shell prescription:
Component: weight (gram) weight ratio (%)
Gelatin 10,750 43
Glycerol 4,500 18
Water 8,878 38.1
Methyl hydroxybenzoate 20 0.08
Propylparaben 5 0.02
Iron oxide red 160 0.64
Titanium dioxide 25 0.1
Gross weight 25000
Content preparation technology is as follows:
Get Radix Salviae Miltiorrhizae powder and be broken into fine powder, sieve, standby; Four Chinese medicine materials such as Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae are pulverized and are coarse powder, Radix Rehmanniae is thinly sliced, and decocts with water 3 hours for the first time three times, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, filtrate is concentrated into the clear paste that relative density is 1.20 (50 ℃), add the Radix Salviae Miltiorrhizae fine powder, mixing, crushed after being dried or spray drying make fine powder.The heating of surfactant and suspending agent is dissolved in the diluent, and with above-mentioned fine powder or be scattered in the diluent, crosses the colloid mill mix homogeneously; Or be dissolved in diluent, make content.
The capsule liquid making method:
Take by weighing in the pure water input glue jar, add gelatin, glycerol when temperature rises to 70~80 ℃, begin after iron oxide red, titanium dioxide, the antiseptic to stir, keep 70~80 ℃ of temperature, vacuum outgas was stirred 1 hour, 55~60 ℃ of heat preservation for standby use.
Pelleting technology:
The medicinal liquid for preparing is carried out pelleting.Soft capsule moves into drying room and carries out drying 30 ± 5% times setting of 25 ± 2 ℃, relative humidity 20 hours, and drying condition is that 30 ± 2 ℃, relative humidity are 20%, 8 hours drying times.Exsiccant soft capsule washes ball, pack after picking up ball.
Embodiment 2:
The content prescription:
Component: every weight (milligram) weight ratio (%)
Radix Salviae Miltiorrhizae fine powder 83 13.8
Concentrate clear paste 217 36.2
PEG400 240 40
PEG6000 10 1.7
Tween 80 30 5
Cera Flava 20 3.3
Gross weight 600
The softgel shell prescription:
Component: weight (gram) weight ratio (%)
Gelatin 11,250 45
Glycerol 5,500 22
Water 8,020 32
Methyl hydroxybenzoate 30 0.12
Propylparaben 7.5 0.03
Iron oxide red 160 0.64
Titanium dioxide 32. 0.13
Gross weight 25000
Preparation is as embodiment 1.
Embodiment 3:
The content prescription:
Component: every weight (milligram) weight ratio (%)
Radix Salviae Miltiorrhizae fine powder 83 11.9
Extract 178 25.4
Soybean oil 340 48.6
Polyoxyethylene castor oil 63 9
Glyceryl monostearate 36 5.1
Gross weight 700
The softgel shell prescription:
Component: weight (gram) weight ratio (%)
Gelatin 11,750 47
Glycerol 6,750 27
Water 6,258 25
Ethyl hydroxybenzoate 36 0.144
Propylparaben 9 0.036
Iron oxide red 160 0.64
Titanium dioxide 37.5 0.15
Gross weight 25000
Preparation is as embodiment 1.
Embodiment 4:
The content prescription:
Component: every weight (milligram) weight ratio (%)
Radix Salviae Miltiorrhizae fine powder 83 11.9
Extract 178 25.4
Soybean oil 389 55.6
Polyoxyethylene castor oil 30 4.3
Glyceryl monostearate 20 2.8
Gross weight 700
The softgel shell prescription:
Component: weight (gram) weight ratio (%)
Gelatin 11,750 47
Glycerol 6,750 27
Water 6,258 25
Ethyl hydroxybenzoate 36 0.144
Propylparaben 9 0.036
Iron oxide red 160 0.64
Titanium dioxide 37.5 0.15
Gross weight 25000
Preparation is as embodiment 1.
Embodiment 5:
The content prescription:
Component: every weight (milligram) weight ratio (%)
Radix Salviae Miltiorrhizae fine powder 83 16.6
Extract 178 35.6
Ethylene glycol monomethyl ether 239 47.8
Gross weight 500
The softgel shell prescription:
Component: weight (gram) weight ratio (%)
Gelatin 10,750 43
Glycerol 4,500 18
Water 8,878 38.1
Methyl hydroxybenzoate 20 0.08
Propylparaben 5 0.02
Iron oxide red 160 0.64
Titanium dioxide 25 0.1
Gross weight 25000
Content preparation technology is as follows:
Get Radix Salviae Miltiorrhizae powder and be broken into fine powder, sieve, standby; Four Chinese medicine materials such as Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae are pulverized and are coarse powder, and Radix Rehmanniae is thinly sliced, and decoct with water 3 hours for the first time three times, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, the filtrate spray drying makes fine powder, adds the Radix Salviae Miltiorrhizae fine powder, mixing.Mixture is dissolved in the ethylene glycol monomethyl ether.
The same embodiment of later operation.

Claims (8)

1. invigorating the kidney and strengthening the bones soft capsule, content comprises Six-element Chinese medicine extract effective ingredient and pharmaceutic adjuvants such as containing Radix Salviae Miltiorrhizae, Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae, Radix Rehmanniae, wherein the weight proportion of various components is: active ingredient 30-70%, pharmaceutic adjuvant 30-70%.
2. invigorating the kidney and strengthening the bones soft capsule, content comprises Six-element Chinese medicine extract effective ingredient and pharmaceutic adjuvants such as containing Radix Salviae Miltiorrhizae, Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae, Radix Rehmanniae, wherein the weight proportion of various components is: active ingredient 40-60%, pharmaceutic adjuvant 40-60%.
3. as claim 1,2 described invigorating the kidney and strengthening the bones soft capsules, it is characterized in that: described pharmaceutic adjuvant is an ethylene glycol monomethyl ether.
4. as claim 1,2 described invigorating the kidney and strengthening the bones soft capsules, it is characterized in that: described pharmaceutic adjuvant can be the combination of diluent, surfactant, suspending agent, and its weight proportion is 1: 0.016-0.34: 0.016-0.17.
5. as claim 1,2 described invigorating the kidney and strengthening the bones soft capsules, it is characterized in that: described pharmaceutic adjuvant can be the combination of diluent, surfactant, suspending agent, and its weight proportion is 1: 0.066-0.22: 0.044-0.11.
6. as claim 4,5 described invigorating the kidney and strengthening the bones soft capsules, it is characterized in that: described diluent is one or more in Polyethylene Glycol (PEG) and the vegetable oil; Surfactant is one or more in tween, span, lecithin, the polyoxyethylene castor oil; Suspending agent is one or more in Cera Flava, ethyl cellulose, hydrogenated palm oil, the mono stearate glyceryl ester etc.
7 one kinds of invigorating the kidney and strengthening the bones preparation of soft capsule methods, the content preparation process is as follows: gets Radix Salviae Miltiorrhizae powder and is broken into fine powder, sieve, standby; Four Chinese medicine materials such as Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae are pulverized and are coarse powder, Radix Rehmanniae is thinly sliced, and decocts with water 3 hours for the first time three times, 2 hours for the second time, 1 hour for the third time, collecting decoction filtered, the filtrate spray drying makes fine powder, add the Radix Salviae Miltiorrhizae fine powder, mixing is dissolved in the gained fine powder that mixing promptly gets content in the ethylene glycol monomethyl ether.
8. invigorating the kidney and strengthening the bones preparation of soft capsule method, preparation process is as follows: gets Radix Salviae Miltiorrhizae powder and is broken into fine powder, sieve, standby; Four Chinese medicine materials such as Herba Epimedii, Radix Dipsaci, the Rhizoma Anemarrhenae, Fructus Psoraleae are pulverized and are coarse powder, and Radix Rehmanniae is thinly sliced, and decocts with water three times, 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, collecting decoction filters, and the filtrate spray drying makes fine powder, add the Radix Salviae Miltiorrhizae fine powder, mixing, or be concentrated into the clear paste that relative density is 1.20 (50 ℃), add the Radix Salviae Miltiorrhizae fine powder, mixing, crushed after being dried makes fine powder.The heating of surfactant and/or suspending agent is dissolved in the diluent, and with above-mentioned fine powder or be scattered in the diluent, crosses the colloid mill mix homogeneously; Or be dissolved in diluent, promptly get content.Be raw material, prepared rubber routinely with gelatin, glycerol, water again, will obtain the content fill then and make soft capsule, through typing, dry, wash ball, after promptly get product.
CN 200510105537 2005-09-27 2005-09-27 Kidney-tonifying and bone-strengthening capsules and preparation thereof Pending CN1939500A (en)

Priority Applications (1)

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Application Number Priority Date Filing Date Title
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CN1939500A true CN1939500A (en) 2007-04-04

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103083521A (en) * 2013-02-20 2013-05-08 贵州同济堂制药有限公司 Extraction method, separated extract and preparation of Xianlinggubao
CN104352741A (en) * 2014-10-17 2015-02-18 磐安县道地磐药中药研究所 Xianlinggubao Chinese herbal piece composite preparation as well as preparation method and application package thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103083521A (en) * 2013-02-20 2013-05-08 贵州同济堂制药有限公司 Extraction method, separated extract and preparation of Xianlinggubao
CN103083521B (en) * 2013-02-20 2015-04-15 贵州同济堂制药有限公司 Extraction method, separated extract and preparation of Xianlinggubao
CN104352741A (en) * 2014-10-17 2015-02-18 磐安县道地磐药中药研究所 Xianlinggubao Chinese herbal piece composite preparation as well as preparation method and application package thereof

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