CN101700378B - Method for preparing cyperus-amomum stomach soft capsule - Google Patents
Method for preparing cyperus-amomum stomach soft capsule Download PDFInfo
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- CN101700378B CN101700378B CN2009101855881A CN200910185588A CN101700378B CN 101700378 B CN101700378 B CN 101700378B CN 2009101855881 A CN2009101855881 A CN 2009101855881A CN 200910185588 A CN200910185588 A CN 200910185588A CN 101700378 B CN101700378 B CN 101700378B
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Abstract
The invention discloses a method for preparing a cyperus-amomum stomach soft capsule consisting of liquor and capsule wall materials, the liquor is composed of cyperus-amomum stomach extract, thinner, suspending agent and wetting agent, and the capsule wall materials are composed of plastics, plasticizer, antioxidant, organic acid and opaquer. The invention has the characteristics of rapid dissolving speed of active components, high bioavailability, good curative effect, stable liquor, good fluidity, even dispersion and stable quality.
Description
Technical field
The present invention relates to soft capsule preparation method field, be specifically related to a kind of method for preparing of cyperus-amomum stomach soft capsule.
Background technology
" cyperus-amomum stomach soft capsule " records in the 20 in Ministry of Health of the People's Republic of China's " drug standard " Chinese traditional patent formulation preparation, and this article clinical efficacy is definite, and extraction process is reasonable, and process route is clear and definite basically.Primary standard preparation technology is: the Radix Aucklandiae, Fructus Amomi, Pericarpium Citri Reticulatae, Fructus Amomi Rotundus, Herba Pogostemonis adopt steam distillation to extract volatile oil, and distillation back water liquid is subsequent use; Nine flavors such as all the other Rhizoma Atractylodis Macrocephalaes adopt 80% ethanol reflux extraction, collect ethanol extract, reclaim ethanol to there not being the alcohol flavor, merge with water liquid, concentrate, and drying under reduced pressure is ground into fine powder, adds volatile oil such as the vegetable oil and the above-mentioned Radix Aucklandiae, and mixing is processed soft capsule, promptly gets.
This technology is reasonably, but center division technique parameter need be perfect; The present invention selects the adjuvant that is fit to, has improved the active component dissolution rate, and it is high to have improved bioavailability, and therapeutic effect is better, and medicinal liquid is uniformly dispersed, steady quality.
Summary of the invention
The technical problem that the present invention will solve provides a kind of method for preparing of cyperus-amomum stomach soft capsule, improves the bioavailability of cyperus-amomum stomach soft capsule, improves the active component dissolution rate.
Cyperus-amomum stomach soft capsule of the present invention is made up of medicinal liquid and capsule material, and its herb liquid is made up of cyperus-amomum stomach extract, complex stabilizer.The capsule material is by sizing material, plasticizer, antioxidant, organic acid, opacifier.Complex stabilizer is made up of diluent, suspending agent and wetting agent.
Because the complexity of Chinese medicine ingredients; Technological deficiencies such as inhomogeneous, the easy layering of content character often appear in Chinese medicinal soft capsule; Thereby cause loading amount inaccurate; The therapeutic effect that does not reach, and suitable adjuvant can make soft capsule content have good stable property and flowability, it is very important therefore selecting suitable adjuvant.
Diluent in the cyperus-amomum stomach soft capsule of the present invention can be selected the conventional various diluent in this area for use, and diluent of the present invention is preferably one or more vegetable oil in Oleum Sesami, Oleum Arachidis hypogaeae semen, Semen Maydis oil, soybean oil, almond oil, walnut oil, Oleum Gossypii semen, Oleum Helianthi, Oleum Ricini and the olive oil; Further be preferably one or more vegetable oil in Oleum Arachidis hypogaeae semen, Semen Maydis oil, the soybean oil.
Suspending agent of the present invention is one or more in Cera Flava, aluminum monostearate and the ethyl cellulose (100CP); Wetting agent is Tweens or spans, is preferably Arlacel-80.
Sizing material is gelatin or arabic gum in the cyperus-amomum stomach soft capsule of the present invention; Plasticizer is glycerol or sorbitol or both combinations; Antioxidant is Arius acid sodium, NaHSO
3, Vc; Organic acid such as ethylene diacid, L-cysteine, citric acid, maleic acid, glycine; Opacifier is the chocolate palm fibre.Add antioxidant in the sizing material, organic acid can prevent effectively that soft capsule from the disintegrate delay phenomenon occurring at storage, influences the curative effect of product.
Cyperus-amomum stomach extract of the present invention and volatile oil preferably adopt following method to make: the Radix Aucklandiae, Fructus Amomi, Pericarpium Citri Reticulatae, Fructus Amomi Rotundus, Herba Pogostemonis are mixed add 10 times of water gagings immersions 2 hours, extracted volatile oil 3～5 hours with steam distillation, obtain volatile oil; With the device collection in addition of the aqueous solution after the distillation, subsequent use; All the other Chinese medicines adopt 80% alcohol reflux secondary, add 8 times of amount ethanol for the first time, extract 2 hours, filter; Medicinal residues add 6 times of amount ethanol again, extract 1 hour, filter; Merging filtrate, decompression recycling ethanol merges with above-mentioned aqueous solution to there not being the alcohol flavor; Be concentrated into 60 ℃ of following relative densities and be 1.25～1.28 thick paste, drying under reduced pressure becomes dry extract, is ground into fine powder.
Cyperus-amomum stomach extract of the present invention can adopt this area technology commonly used to prepare, and the moisture in the extract of preparation exceeds to be no more than 3%, and the yield of cyperus-amomum stomach extract should be more than 5%.
Preparation of soft capsule technology of the present invention can adopt this area routine techniques to prepare, and in order to reach better technique effect, the present invention preferably adopts and is prepared as follows technology:
Get the cyperus-amomum stomach soft capsule dry extract, be ground into fine powder, subsequent use; Get suspending agent and wetting agent in the complex stabilizer then, in 60 ℃ of heating in water bath fusings, add the diluent in the complex stabilizer again, stirring and evenly mixing is put to room temperature; Add volatile oil such as the above-mentioned Radix Aucklandiae, behind the mixing, add the extract fine powder again, stirring and evenly mixing is regulated the colloid mill fineness between 5～15 μ m, and circulation was milled 0.5 hour, and fully mixing filters, and makes soft capsule content; Get gelatin, glycerol, distilled water, pigment, antioxidant, organic acid, after changing glue, process rubber, adopt oval mould to carry out the embedding pelleting, after dry 12 hours, again through super-dry, choose the ball operation, promptly get cyperus-amomum stomach soft capsule.
The specific embodiment
The preparation technology of cyperus-amomum stomach soft capsule of the present invention: the Radix Aucklandiae, Fructus Amomi, Pericarpium Citri Reticulatae, Fructus Amomi Rotundus, Herba Pogostemonis mixing are added 10 times of water gagings soaked 2 hours, extracted volatile oil 3～5 hours, obtain volatile oil with steam distillation; With the device collection in addition of the aqueous solution after the distillation, subsequent use; All the other Chinese medicines adopt 80% alcohol reflux secondary, add 8 times of amount ethanol for the first time, extract 2 hours, filter; Medicinal residues add 6 times of amount ethanol again, extract 1 hour, filter merging filtrate; Decompression recycling ethanol merges with above-mentioned aqueous solution to there not being the alcohol flavor, is concentrated into 60 ℃ of following relative densities and is 1.25～1.28 thick paste; Drying under reduced pressure becomes dry extract, is ground into fine powder, and is subsequent use; Get the suspending agent in the complex stabilizer then, like Cera Flava and wetting agent, like Arlacel-80, in 60 ℃ of heating in water bath fusings, add diluent in the complex stabilizer, like soybean salad oil, stirring and evenly mixing is put to room temperature; Add volatile oil such as the above-mentioned Radix Aucklandiae, behind the mixing, add the extract fine powder again, stirring and evenly mixing is regulated the colloid mill fineness between 5～15 μ m, adds the medicinal liquid circulation then and mills 0.5 hour, and fully mixing filters, and makes soft capsule content; Get gelatin, glycerol, antioxidant (as: Arius acid sodium), organic acid (as: citric acid), distilled water, pigment and after changing glue, process rubber; Adopt oval mould to carry out the embedding pelleting; Process 1000 of soft capsules; After dry 12 hours, wash ball, drying, choose the ball operation through ethanol again, promptly get cyperus-amomum stomach soft capsule.
Below be embodiments of the invention:
Embodiment 1: the volatile oil extraction process of the Radix Aucklandiae, Fructus Amomi, Pericarpium Citri Reticulatae, Fructus Amomi Rotundus, Herba Pogostemonis
Five tastes medical materials such as the Radix Aucklandiae add 10 times of water yields, soak 1h, adopt steam distillation to extract volatile oil, and carrying the oil time is 5 hours, collects volatile oil, and distillation back water liquid is subsequent use.
Embodiment 2: the preparation of cyperus-amomum stomach extract
Nine flavors such as all the other Rhizoma Atractylodis Macrocephalaes extracted 2 hours with 8 times of amount 80% alcohol heating reflux, filtered, and medicinal residues add 6 times of amount 80% ethanol extractions 1 hour again, filter, and merging filtrate, decompression recycling ethanol, subsequent use.The Rhizoma Atractylodis Macrocephalae etc. nine flavor alcohol extracts leave standstill, and make its natural subsidence, draw supernatant again, to remove impurity such as silt.Decompression recycling ethanol is not to there being the alcohol flavor, merges with five tastes medical material distillation back water liquid such as the Radix Aucklandiae, is condensed into the thick paste of 1.25～1.28 (60 ℃ of surveys), again through being dried to dry extract; For avoiding long heat to cause the destruction of part effective ingredient, influence the quality of the pharmaceutical preparations, carry out concentrating under reduced pressure so concentrate the energy-conservation concentrator of appropriate to the occasion employing triple effect, energy-conservation, guarantee the quality, fast.
Drying process can adopt spray drying method, boulton process (60～80 ℃), and equipment is spray drying device and vacuum dryer; Consider that these article are is softgel shell with the gelatin, because the hydrophilic of gelatin has specific (special) requirements to medicinal liquid, moisture must could guarantee soft capsule quality less than 3%, in case softgel shell is out of shape and seepage because of absorbing medicinal liquid moisture.
The employing drying process with atomizing because the clear paste atomizing forms fine mist, increases the gross area of clear paste, can in moment, realize drying, shortens man-hour, improves work efficiency, reduces germ contamination, and is quick, easy, is suitable for industrialized great production; These article adopt boulton process (60～80 ℃) to carry out drying, and trial production is respond well in three batches, the dry extract stable yield about 10%, the dry extract lighter color, the character homogeneous, water content is controlled at below 2.5%; This technology has overcome the long heat drying of clear paste in the traditional handicraft and problems such as complexion changed and ingredient heat loss has taken place.
Embodiment 3: preparations shaping technology
(1) selection of disperse medium (substrate): the ratio of fine drug powder and vegetable oil is that the content density of preparation in 1: 1.0～1: 1.5 is comparatively suitable, mobile better, pelleting is smooth; But consider that soft gelatin capsule is little; Be easy to take, therefore, select fine drug powder: vegetable oil is 1: 1.
(2) selection of suspending agent, wetting agent: Cera Flava, Arlacel-80 account for 2% of oil phase in the pharmaceutical formulation, about 1: 1 of the total amount of vegetable oil and volatile oil and the ratio of dried cream powder.Cera Flava, both ratios of Arlacel-80 are 2%: 2%, and reasonable proportioning increases the stability of soft capsule greatly, make the biphase unlikely separation of solid-liquid.
(3) preparation of content: soybean salad oil, Cera Flava, Arlacel-80 are melted in 60 ℃ of heating in water bath, and stirring and evenly mixing is put to room temperature; Add volatile oil such as the Radix Aucklandiae, mixing adds the extract fine powder again; Stirring and evenly mixing is regulated the colloid mill fineness between 5～15 μ m, adds the medicinal liquid circulation and mills 0.5 hour; Fully mixing filters, and makes soft capsule content.Result of the test shows, through the content that the colloid mill circulation is milled and made in 0.5 hour, and uniform and smooth, stability, good fluidity are placed not stratifiedly, and last machine pelleting does not stop up, and the ball method of double differences is different little, meets the requirement of soft capsule to content.
(4) change glue: get the sizing material of 1 weight portion, the plasticizer of 0.5 weight portion, distilled water and an amount of Arius acid sodium, citric acid, the chocolate palm fibre of 1 weight portion and form.
(5) compacting of soft gelatin capsule: in the above-mentioned ratio that optimizes, get vegetable oil, Cera Flava, Arlacel-80 (1: 0.02: 0.02, W/W) an amount of, vegetable oil, Cera Flava, Arlacel-80 are melted in 60 ℃ of heating in water bath; Stirring and evenly mixing is put to room temperature, adds volatile oil such as the Radix Aucklandiae, mixing; Add 14 flavor dry extract fine powders (100 order) such as the Radix Aucklandiae again, stirring and evenly mixing is regulated the colloid mill fineness between 5～15 μ m, adds the medicinal liquid circulation and mills 0.5 hour; Fully mixing filters, and makes soft capsule content.Last machine carries out the embedding pelleting, every dress 0.45g.
Claims (3)
1. the method for preparing of a cyperus-amomum stomach soft capsule; It is characterized in that cyperus-amomum stomach soft capsule is made up of medicinal liquid and capsule material; Its herb liquid is made up of cyperus-amomum stomach extract, complex stabilizer, and the capsule material is made up of sizing material, plasticizer, antioxidant, organic acid, opacifier;
Complex stabilizer is made up of diluent, suspending agent and wetting agent;
Medicinal liquid is by the cyperus-amomum stomach extract of a weight, the diluent of 1.0～1.5 parts of weight, and the suspending agent that accounts for diluent weight 2%～3% is formed with the wetting agent that accounts for diluent weight 2%～3%;
Diluent is one or more vegetable oil in Oleum Sesami, Oleum Arachidis hypogaeae semen, Semen Maydis oil, soybean oil, almond oil, walnut oil, Oleum Gossypii semen, Oleum Helianthi, Oleum Ricini and the olive oil; Suspending agent is one or more in Cera Flava, aluminum monostearate and the ethyl cellulose, and wetting agent is Tweens or spans;
Sizing material is gelatin or arabic gum; Plasticizer is glycerol or sorbitol or both combinations; Antioxidant is sodium sulfite, NaHSO
3, vitamin C; Opacifier is the chocolate palm fibre; Organic acid is ethylene diacid, L-cysteine, citric acid, maleic acid, glycine;
The concrete preparation technology of said cyperus-amomum stomach soft capsule is: the Radix Aucklandiae, Fructus Amomi, Pericarpium Citri Reticulatae, Fructus Amomi Rotundus, Herba Pogostemonis are mixed add 10 times of water gagings immersions 2 hours, extracted volatile oil 3～5 hours with steam distillation, obtain volatile oil; With the device collection in addition of the aqueous solution after the distillation, subsequent use; All the other Chinese medicines adopt 80% alcohol reflux secondary, add 8 times of amount ethanol for the first time, extract 2 hours, filter; Medicinal residues add 6 times of amount ethanol again, extract 1 hour, filter merging filtrate; Decompression recycling ethanol merges with above-mentioned aqueous solution to there not being the alcohol flavor, is concentrated into 60 ℃ of following relative densities and is 1.25～1.28 thick paste; Drying under reduced pressure becomes dry extract, is ground into fine powder, and is subsequent use;
Get described dry extract, be ground into fine powder, subsequent use; Get suspending agent and wetting agent in the complex stabilizer then, in 60 ℃ of heating in water bath fusings, add the diluent in the complex stabilizer again, stirring and evenly mixing is put to room temperature; Add described volatile oil, behind the mixing, add the extract fine powder again, stirring and evenly mixing is regulated the colloid mill fineness between 5～15 μ m, and circulation was milled 0.5 hour, and fully mixing filters, and makes soft capsule content; Get gelatin, glycerol, distilled water, pigment, after changing glue, process rubber, adopt oval mould to carry out the embedding pelleting, after dry 12 hours, again through super-dry, choose the ball operation, promptly get cyperus-amomum stomach soft capsule.
2. the method for preparing of the cyperus-amomum stomach soft capsule of stating according to claim 1 is characterized in that diluent is one or more vegetable oil in Oleum Arachidis hypogaeae semen, Semen Maydis oil, the soybean oil; Suspending agent is a Cera Flava; Wetting agent is an Arlacel-80.
3. according to the method for preparing of the said cyperus-amomum stomach soft capsule of claim 1, it is characterized in that the capsule material is made up of the sizing material of 1 weight portion, the plasticizer of 0.5 weight portion, distilled water and an amount of antioxidant, opacifier, the organic acid of 1 weight portion.
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| CN116159121A (en) * | 2022-12-23 | 2023-05-26 | 贵州威利德制药有限公司 | Preparation method of stomach-nourishing medicine combination with amomum vilosum |
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Non-Patent Citations (2)
| Title |
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| ，中华人民共和国卫生部药典委员会.香砂养胃软胶囊.《中华人民共和国卫生部药品标准中药成方制剂第二十册》.1998,253. * |
| 时军 程怡.辅料在软胶囊剂型中的应用.《中医药学刊》.2003,第21卷(第9期),1429-1431. * |
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