CN1823863A - Panacea grass soft capsule and its production method - Google Patents
Panacea grass soft capsule and its production method Download PDFInfo
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- CN1823863A CN1823863A CN 200510048686 CN200510048686A CN1823863A CN 1823863 A CN1823863 A CN 1823863A CN 200510048686 CN200510048686 CN 200510048686 CN 200510048686 A CN200510048686 A CN 200510048686A CN 1823863 A CN1823863 A CN 1823863A
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- lingdancao
- soft capsule
- gelatin
- diluent
- water extract
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Abstract
A Lingdan herb soft capsule is composed of the liquid core containing the aquatic extract of lingdan herb, diluent, antioxidant, suspending aid, antiseptic and beeswax, and the wall containing gelatin and glycerin.
Description
Technical field: the soft capsule oral drugs and the production method thereof that the present invention relates to contain the LINGDANCAO effective dose.
Background technology: LINGDANCAO have another name called Herba laggera [Laggera pterodonta (DC) Benth ", for the Compositae Laggera alata (Roxb.) Sch.-Bip. belongs to herbaceos perennial, only there are three kinds of distributions in this platymiscium China, is distributed widely in ground such as Yunnan, Sichuan, Tibet.Herba laggera bitter in the mouth suffering, cold, be its main function with heat-clearing and toxic substances removing.Be stated from " the southern regions of the Yunnan Province book on Chinese herbal medicine " record the earliest: nature and flavor: hot, bitter, cold, slightly poisonous.Effect: heat-clearing and toxic substances removing, the tired detumescence of loosing.Be used for refreshing and detoxicating, rheumatism skin infection, preventing the attack (or recurrence) of malaria." Yunnan Chinese herbal medicine ": " control upper respiratory tract infection, tonsillitis, stomatitis is prevented and treated influenza ".The LINGDANCAO extract is brown to brown powder, and water soluble is slightly soluble in n-butyl alcohol, is insoluble to chloroform etc., and it has than obvious anti-inflammatory and anti, bacteriostasis.Clinical trial proves: better to disease curative effects such as acute pharyngitis, tonsillitis, upper respiratory tract infection; The heart, liver, brain, lung, kidney are not had obvious damage, do not see obvious toxic-side effects.With the LINGDANCAO extract is that " LINGDANCAO granule ", " the LINGDANCAO mixture " that mainly contains effective constituent reaches " LINGDANCAO oral liquid " by the approval production of medicine prison administrative department, but oral liquid carries inconvenience, granule has effective constituent and is difficult for preserving defectives such as poor stability.
The method that the object of the present invention is to provide a kind of LINGDANCAO soft capsule and produce this LINGDANCAO soft capsule, product are oral administered dosage form, its characteristics: steady quality, effective ingredient keep fully, stripping is fast, carry, easy to use.
Product LINGDANCAO soft capsule of the present invention is made of medicinal liquid and softgel shell two large divisions, it is characterized in that medicinal liquid contains the LINGDANCAO water extract of effective dosage as effective ingredient, medicinal liquid every heavy 0.5 gram by weight contains LINGDANCAO water extract 0.01～0.4 gram (containing volatile oil), and all the other are pharmaceutic adjuvant.Pharmaceutic adjuvant comprises diluent, antioxidant, suspending agent, antiseptic and Cera Flava etc., contains 10 parts in gelatin in the softgel shell, and glycerol is 32.2～33.2% (weight ratios) of gelatin weight.
Diluent can be one or more in Polyethylene Glycol, propylene glycol, vegetable oil, the mineral oil;
Antioxidant can be one or more in ethylenediaminetetraacetic acid, disodium EDTA, dibenzylatiooluene, D～xylose, xylitol, glycine, α～tocopherol, α～tocopheryl acetate, inositol, ascorbic acid, sodium ascorbate, lecithin, malic acid, hydroquinone, citric acid, succinic acid, phytic acid, sodium pyrosulfite, the potassium metabisulfite;
Antiseptic can be one or more in Oleum Caryophylli, propylene glycol, sorbic acid, sorbic acid methyl ester, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, P-hydroxybenzoic acid phenyl ester, butyl p-hydroxybenzoate calcium, Sodium Methyl Hydroxybenzoate, Sodium Propyl Hydroxybenzoate, benzyl alcohol, the benzoic acid etc.;
Suspending agent can be one or more in ethylhydroxyethylcellulose, chitin, chitose, methylcellulose, ethyl cellulose, agar, xanthan gum, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, the Cera Flava etc.
In the process of development LINGDANCAO soft capsule, solved a following main difficult problem.
The medicinal liquid prescription: the LINGDANCAO medicinal ingredient mainly is made up of LINGDANCAO water extract and LINGDANCAO volatile oil, the easy molten vegetable oil of LINGDANCAO volatile oil, but the LINGDANCAO water extract is difficult to be dissolved in vegetable oil.Therefore, we are by a series of test, selected for use a kind ofly can be dissolved in the vegetable oil and the LINGDANCAO extract can be suspended in the vegetable oil, and can for a long time stable material-Cera Flava, solve the dissolving difficult problem of LINGDANCAO water extract well.
An amount of Cera Flava is dissolved in an amount of vegetable oil, again LINGDANCAO water extract (containing volatile oil) is added wherein, add suitable antioxidant afterwards and oxidation deterioration takes place in storage process with the medicinal liquid that prevents soft capsule.
Contain in the optimum formula of product of the present invention: every 0.5 gram
Component amount (gram/grain)
LINGDANCAO water extract (containing volatile oil) 0.01～0.4
Diluent 0.06～0.45
Gelatin 0.04～0.25
32.2～33.2% of glycerin gelatine amount
Suspending agent 0.002～0.01
Antioxidant 0.0005～0.001
Antiseptic 0.00002～0.00007
Cera Flava 0.004～0.035
Annotate: optimum formula is only for the present invention is further illustrated, and the scope of product of the present invention is not subjected to the limitation of this optimum formula.
LINGDANCAO preparation of soft capsule technology may further comprise the steps:
An amount of gelatin is added in the rustless steel NaOH solution tank NaOH, add suitable quantity of water again, airtight, 70 ℃ of insulations added an amount of glycerol in 3 hours again, and antiseptic stirs, vacuumize degassing 2 hours, and it is stand-by to put into 70 ℃ of incubated overnight of gelatin heat-preserving container,
Under the room temperature suspending agent is added in the diluent (vegetable oil), get LINGDANCAO water extract (containing volatile oil), mix with diluent (vegetable oil), treat to add antioxidant and Cera Flava again behind the complete mixing, stir, room temperature leaves standstill,
The medicinal liquid for preparing is poured in the medicinal liquid bucket, pressed soft capsule with mould, every soft capsule contains 10～400 milligrams of LINGDANCAO water extract.
LINGDANCAO soft capsule of the present invention is compared with existing dosage forms such as " LINGDANCAO mixture ", " LINGDANCAO oral liquid ", " LINGDANCAO granules ", has steady quality, and effective ingredient keeps fully, stripping is fast, carries, advantage easy to use.
Product of the present invention prepares as stated above, and its detailed component is provided by the following example, but protection domain of the present invention is not limited to this.
The specific embodiment:
Embodiment 1: every 0.5 gram
Component amount (gram/grain)
LINGDANCAO water extract (containing volatile oil) 0.25
Oleum Arachidis hypogaeae semen 0.15
Gelatin 0.06
Glycerol 0.02
Ethyl cellulose 0.004
Ascorbic acid 0.008
Ethylparaben 0.00005
Cera Flava 0.008
Embodiment 2: every 0.5 gram
Component amount (gram/grain)
LINGDANCAO water extract (containing volatile oil) 0.02
Polyethylene Glycol 0.1
Gelatin 0.05
Glycerol 0.02
Hydroxyethyl-cellulose 0.006
α～tocopheryl acetate 0.0008
Butyl p-hydroxybenzoate 0.00004
Cera Flava 0.008
Embodiment 3: every 0.5 gram
Component amount (gram/grain)
LINGDANCAO water extract (containing volatile oil) 0.15
Oleum Arachidis hypogaeae semen 0.3
Propylene glycol 0.15
Gelatin 0.15
Glycerol 0.05
Hydroxypropyl cellulose 0.006
Inositol 0.0008
Cera Flava 0.025
Embodiment 4: every 0.5 gram
Component amount (gram/grain)
LINGDANCAO water extract (containing volatile oil) 0.2
Polyethylene Glycol 0.15
Propylene glycol 0.14
Gelatin 0.2
Glycerol 0.08
Ascorbic acid 0.0008
Propyl p-hydroxybenzoate 0.00005
Cera Flava 0.015
Embodiment 5: every 0.5 gram
Component amount (gram/grain)
LINGDANCAO water extract (containing volatile oil) 0.4
Polyethylene Glycol 0.2
Propylene glycol 0.25
Gelatin 0.25
Glycerol 0.083
Ascorbic acid 0.001
Propyl p-hydroxybenzoate 0.00007
Cera Flava 0.035
Embodiment 6: every 0.5 gram
Component amount (gram/grain)
LINGDANCAO water extract (containing volatile oil) 0.01
Polyethylene Glycol 0.03
Propylene glycol 0.03
Gelatin 0.04
Glycerol 0.01288
Ascorbic acid 0.0005
Propyl p-hydroxybenzoate 0.00002
Cera Flava 0.004
The production method for preparing above LINGDANCAO soft capsule is:
Taking by weighing 25 kilograms in gelatin adds in the gelatin retort, under stirring, add 25 kg water, after treating that gelatin dissolves fully, add glycerol 8.05～8.34 grams, antiseptic 0.5～1.75 gram again, stir, be evacuated to the degassing 2 hours, put into the gelatin heat-preserving container, in temperature is that 70 ℃ of insulations are left standstill 3 hours, stand-by.
Below by 100,000:
At room temperature suspending agent 200～1000 grams are added in diluent (vegetable oil) 600～45000 grams, take by weighing LINGDANCAO water extract (containing volatile oil) 1000～4000 grams, pulverize, sieve, with above-mentioned mixing diluents, treat to add antioxidant 2～7 grams, Cera Flava 350～400 grams again behind the complete mixing, stir, room temperature leaves standstill.Guarantee that every soft capsule contains 10～400 milligrams of LINGDANCAO water extract.
The gelatin heat-preserving container is suspended from certain altitude, the medicinal liquid for preparing is poured in the medicinal liquid bucket, change mould and begin to press soft capsule, adjust the soft capsule device to scope of design, drying at room temperature two days, reject the soft gelatin capsule of presentation quality difference, with soft gelatin capsule washing (removing the lubricating oil in the pelleting process), again in 24 ℃ of dryings two days, LINGDANCAO soft capsule semi-finished product, the qualified back packing of quality testing, labeling, packing promptly get LINGDANCAO soft capsule finished product.
Product processes of the present invention: glycerol adding and an amount of antiseptic after gelatin is dissolved in water, vacuum outgas; Suspending agent is added in the vegetable oil, add antioxidant behind LINGDANCAO water extract and the vegetable oil mixing, mould is pressed into soft capsule.
The existing dosage form of the LINGDANCAO that products and marketing of the present invention is sold is compared, and this product advantage is a steady quality, and effective ingredient keeps fully, stripping is fast, carries, easy to use.
Claims (8)
1, a kind of LINGDANCAO soft capsule, constitute by medicinal liquid and softgel shell two large divisions, it is characterized in that LINGDANCAO water extract that medicinal liquid contains effective dosage as effective ingredient, medicinal liquid every heavy 0.5 gram by weight contains LINGDANCAO water extract 0.01～0.4 gram (containing volatile oil), and all the other are pharmaceutic adjuvant.
2, LINGDANCAO soft capsule according to claim 1 is characterized in that:
Pharmaceutic adjuvant comprises diluent, antioxidant, suspending agent, contains 10 parts in gelatin in the softgel shell, and glycerol is 32.2～33.2% (weight ratios) of gelatin weight and antiseptic, Cera Flava.
3, LINGDANCAO soft capsule according to claim 1 and 2 is characterized in that: diluent is one or more in Polyethylene Glycol, propylene glycol, vegetable oil, the mineral oil;
Antioxidant is one or more in ethylenediaminetetraacetic acid, disodium EDTA, dibenzylatiooluene, D～xylose, xylitol, glycine, alpha-tocopherol, α-tocopheryl acetate, inositol, ascorbic acid, sodium ascorbate, lecithin, malic acid, hydroquinone, citric acid, succinic acid, phytic acid, sodium pyrosulfite, the potassium metabisulfite;
Antiseptic is one or more in Oleum Caryophylli, propylene glycol, sorbic acid, sorbic acid methyl ester, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, P-hydroxybenzoic acid phenyl ester, butyl p-hydroxybenzoate calcium, Sodium Methyl Hydroxybenzoate, Sodium Propyl Hydroxybenzoate, benzyl alcohol, the benzoic acid etc.;
Suspending agent is one or more in ethylhydroxyethylcellulose, chitin, chitose, methylcellulose, ethyl cellulose, agar, xanthan gum, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, the Cera Flava etc.
4, LINGDANCAO soft capsule according to claim 1 and 2 is characterized in that containing in the prescription of every heavy 0.5 gram:
Component amount (gram/grain)
LINGDANCAO water extract (containing volatile oil) 0.01～0.4
Diluent 0.06～0.45
Gelatin 0.04～0.25
32.2～33.2% of glycerin gelatine amount
Suspending agent 0.002～0.01
Antioxidant 0.0005～0.001
Antiseptic 0.00002～0.00007
Cera Flava 0.004～0.035
5, LINGDANCAO soft capsule according to claim 3 is characterized in that containing in the prescription of every heavy 0.5 gram:
Component amount (gram/grain)
LINGDANCAO water extract (containing volatile oil) 0.01～0.4
Diluent 0.06～0.45
Gelatin 0.04～0.25
32.2～33.2% of glycerin gelatine amount
Suspending agent 0.002～0.01
Antioxidant 0.0005～0.001
Antiseptic 0.00002～0.00007
Cera Flava 0.004～0.035
6, according to the method for claim 1 or 2 described production panacea grass soft capsules, it is characterized in that may further comprise the steps:
An amount of gelatin is added in the rustless steel NaOH solution tank NaOH, add suitable quantity of water again, airtight, 70 ℃ of insulations added an amount of glycerol in 3 hours again, and antiseptic stirs, vacuumize degassing 2 hours, and it is stand-by to put into 70 ℃ of incubated overnight of gelatin heat-preserving container,
Under the room temperature suspending agent is added in the diluent (vegetable oil), get LINGDANCAO water extract (containing volatile oil), mix with diluent (vegetable oil), treat to add antioxidant and Cera Flava again behind the complete mixing, stir, room temperature leaves standstill,
The medicinal liquid for preparing is poured in the medicinal liquid bucket, pressed soft capsule with mould, every soft capsule contains 10～400 milligrams of LINGDANCAO water extract.
7,, it is characterized in that may further comprise the steps according to the method for the described production panacea grass soft capsule of claim 3:
An amount of gelatin is added in the rustless steel NaOH solution tank NaOH, add suitable quantity of water again, airtight, 70 ℃ of insulations added an amount of glycerol in 3 hours again, and antiseptic stirs, vacuumize degassing 2 hours, and it is stand-by to put into 70 ℃ of incubated overnight of gelatin heat-preserving container,
Under the room temperature suspending agent is added in the diluent (vegetable oil), get LINGDANCAO water extract (containing volatile oil), mix with diluent (vegetable oil), treat to add antioxidant and Cera Flava again behind the complete mixing, stir, room temperature leaves standstill,
The medicinal liquid for preparing is poured in the medicinal liquid bucket, pressed soft capsule with mould, every soft capsule contains 10～400 milligrams of LINGDANCAO water extract.
8,, it is characterized in that may further comprise the steps according to the method for the described production panacea grass soft capsule of claim 4:
An amount of gelatin is added in the rustless steel NaOH solution tank NaOH, add suitable quantity of water again, airtight, 70 ℃ of insulations added an amount of glycerol in 3 hours again, and antiseptic stirs, vacuumize degassing 2 hours, and it is stand-by to put into 70 ℃ of incubated overnight of gelatin heat-preserving container,
Under the room temperature suspending agent is added in the diluent (vegetable oil), get LINGDANCAO water extract (containing volatile oil), mix with diluent (vegetable oil), treat to add antioxidant and Cera Flava again behind the complete mixing, stir, room temperature leaves standstill,
The medicinal liquid for preparing is poured in the medicinal liquid bucket, pressed soft capsule with mould, every soft capsule contains 10～400 milligrams of LINGDANCAO water extract.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100486862A CN100544707C (en) | 2005-12-14 | 2005-12-14 | panacea grass soft capsule and production method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100486862A CN100544707C (en) | 2005-12-14 | 2005-12-14 | panacea grass soft capsule and production method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1823863A true CN1823863A (en) | 2006-08-30 |
| CN100544707C CN100544707C (en) | 2009-09-30 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005100486862A Expired - Fee Related CN100544707C (en) | 2005-12-14 | 2005-12-14 | panacea grass soft capsule and production method thereof |
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| Country | Link |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101485707B (en) * | 2009-02-23 | 2011-05-18 | 四川珍珠制药有限公司 | Lingdancao soft capsule and preparation method thereof |
| CN101491549B (en) * | 2009-02-23 | 2011-08-03 | 四川珍珠制药有限公司 | Traditional Chinese medicine soft-capsule and preparation method thereof |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1265913A (en) * | 1999-03-05 | 2000-09-13 | 昆明医学院 | Choulingdan extract and process for preparing same |
| CN1562239A (en) * | 2004-03-30 | 2005-01-12 | 一笑堂（湖南）制药有限公司 | Lingdancao dispersion tablet and preparation method |
| CN1586486A (en) * | 2004-07-12 | 2005-03-02 | 北京瑞伊人科技发展有限公司 | Cefpodoxime proxetil soft capsule preparation and its preparing method |
| CN1634371A (en) * | 2004-11-03 | 2005-07-06 | 赵远 | Pterodontic preparation for treating infectious diseases and preparation method thereof |
-
2005
- 2005-12-14 CN CNB2005100486862A patent/CN100544707C/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101485707B (en) * | 2009-02-23 | 2011-05-18 | 四川珍珠制药有限公司 | Lingdancao soft capsule and preparation method thereof |
| CN101491549B (en) * | 2009-02-23 | 2011-08-03 | 四川珍珠制药有限公司 | Traditional Chinese medicine soft-capsule and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN100544707C (en) | 2009-09-30 |
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Granted publication date: 20090930 Termination date: 20121214 |