CN1814224A - Chinese medicine capsule for treating cough and asthma and preparing method - Google Patents

Abstract

The invention is a Chinese medicinal soft capsule liquid capsule for curing cough, and their liquid contents are prepared of the following raw materials in weight proportion: Chinese drug extract powder 1 share, menthol 0.00375 share, and medicinal auxiliaries 1.5-3.5 shares, where the Chinese drug extract powder is prepared in weight proportion of Loquat Leaf 345 shares, Poppy Capsule 250 shares, Stemona Root 75 share, Willowleaf Swallowwort Rhizome 45 shares, Cortex Mori 30 shares, and Platycodon Root 30 shares. And its preparing method: adding Chinese drug extract powder and menthol into the substrate made from medicinal auxiliaries to prepare suspension, adding the suspension into the storage cylinder of a liquid capsule pouring machine, preserving the heat, regulating the loading quantity, and making quantitative pouring or pressing the suspension into soft capsules. The invention changes the mixture into soft capsules and liquid capsules, solving the technical difficult problem that the original forms have bad stability and are easy to deposit in the storing period, and does not contain sugar, convenient for patients with diabetes to take and convenient to storage, carrying and transportion.

Description

Chinese medicinal capsule of treatment cough and preparation method thereof

Technical field

The present invention relates to Chinese medicinal capsule for the treatment of cough and preparation method thereof, especially a kind of Chinese medicinal soft capsule for the treatment of cough and liquid capsule and preparation method thereof.

Background technology

Prior dosage form is a mixture, and sugar content is very high, and some patient should not take, and carries, stores, transports inconvenience, the character instability, and the storage life is easily precipitated.

Summary of the invention

Purpose of the present invention just provide a kind ofly have that the technological process of production is simple, disintegration time is short, the Chinese medicinal soft capsule of the treatment cough that do not contain sugar, stable in properties and liquid capsule and preparation method thereof.

Purpose of the present invention can take following method to realize:

A kind of Chinese medicinal capsule for the treatment of cough comprises soft capsule and liquid capsule, it is characterized in that: its capsule liquid is made by following raw material: Chinese medical concrete powder 1 weight portion, Mentholum 0.00375 weight portion, pharmaceutic adjuvant 1.5～3.5 weight portions;

Described Chinese medical concrete is made by Folium Eriobotryae 345 weight portions, Pericarpium Papaveris 250 weight portions, the Radix Stemonae 75 weight portions, Rhizoma Cynanchi Stauntonii 45 weight portions, Cortex Mori 30 weight portions, Radix Platycodonis 30 weight portions;

Described pharmaceutic adjuvant is one or more a compositions in vegetable oil, Polyethylene Glycol-400, propylene glycol, the Cera Flava, and wherein vegetable oil is one or more the mixture in soybean oil, Oleum Arachidis hypogaeae semen, Oleum Brassicae campestris, Oleum Helianthi, Semen Maydis oil, the rapeseed oil.

A kind of preparation method for the treatment of the Chinese medicinal capsule of cough is characterized in that comprising the steps:

Earlier get Folium Eriobotryae, Pericarpium Papaveris, the Radix Stemonae, Rhizoma Cynanchi Stauntonii, Cortex Mori, Radix Platycodonis by proportioning and decoct with water secondary, each 2 hours, collecting decoction filtered, and is evaporated to the clear paste of relative density 1.10～1.15 (60 ℃), and drying is pulverized, and makes Chinese medical concrete medicated powder; With the adjuvant heating, stir, make substrate; Get medicated powder and Mentholum behind the mixing, under stirring condition, join in the substrate, be prepared into suspension, and add in the storage tank of liquid capsule filling machine, loading amount is adjusted in insulation, carries out quantitative filling or suspension is pressed into soft capsule.

In the above-mentioned preparation method, Chinese medical concrete drying process preferred:

Drying process commonly used in industry has constant pressure and dry, drying under reduced pressure, spray drying.Test compares constant pressure and dry, drying under reduced pressure, three kinds of drying modes of spray drying, to having done color and luster, the drying time of gained medicated powder investigation, with this drying mode has been carried out preferably the results are shown in Table 1:

The different drying mode investigation tables of table 1

Mode	Condition	Color and luster	Drying time	Morphine content (mg/g)
					Constant pressure and dry drying under reduced pressure spray drying	80 ℃, 60～70 ℃ of normal pressures, 190 ± 5 ℃ of-0.08MPa inlet temperature, 90 ± 5 ℃ of leaving air temps	Dark-brown light brown light brown	Long period long period time is shorter	0.36 0.41 0.44

According to above result of the test, optimum drying mode of the present invention is a spray drying, 190 ± 5 ℃ of inlet temperature, and secondly 90 ± 5 ℃ of leaving air temps are drying under reduced pressure, temperature is 60～70 ℃.

The selection of diluent of the present invention: the selection of pharmaceutical diluents is the important step of soft capsule and liquid capsule preparation, should be able to guarantee the accuracy and the stability of formulation of content.Among the present invention, all the other are water extraction except that Mentholum.Through test in a small amount, a, be diluent with the vegetable oil, it is difficult for dissolving and disperses in vegetable oil, be gathered into granule, places the back layering, disperses inhomogeneously, can't make soft capsule and liquid capsule; B, be diluent with the vegetable oil, add suspending agent such as Cera Flava after, medicine can disperse preferably, and intersolubility is better, it is not stratified to place the back, stability is better; C, be diluent with PEG-400, it can disperse in PEG-400 preferably, and intersolubility is better, and it is not stratified to place the back, and stability better.So with PEG-400 is diluent, more is applicable to the present invention.Simultaneously, PEG-400 can improve the bioavailability of preparation because of having good water-solubility, is diluent so determine to select for use PEG-400.Because PEG-400 easily absorbs the moisture in the softgel shell, make the softgel shell hardening or become fragile, prolong disintegration, in capsule liquid raw material, add about 8% propylene glycol, substitute the PEG-400 of part, but the moisture between balance softgel shell and the capsule liquid then, suppress the moisture in the capsule liquid absorption softgel shell, after the placement, disintegration basic no change, the hardening or the phenomenon that becomes fragile do not appear in softgel shell.The selection result of diluent sees the following form 2:

The selection of table 2 diluent kind

Diluent	The medicinal liquid situation
		Vegetable oil	Extractum is difficult for disperseing, and is easily agglomerating, puts layering for a long time
Vegetable oil+suspending agent PEG-400 PEG-400+8% propylene glycol	Extractum disperses more even, intersolubility is better, putting not stratified extractum for a long time is uniformly dispersed, intersolubility is good, put not stratified for a long time, softgel shell hardening extractum is uniformly dispersed, and intersolubility is good, puts not stratified for a long time

By above result of the test as can be known, in capsule liquid raw material, be best with PEG-400, substitute the PEG-400 of part with the propylene glycol of about 8% amounts, can guarantee that the soft capsule long-term storage is stable, not hardening of softgel shell (becoming fragile), disintegration is qualified.So determine in soft capsule and liquid capsule with PEG-400 to be diluent, and add the propylene glycol about 8%, prevent that soft capsule and liquid capsule hardening in depositing process (becoming fragile) and disintegration from prolonging.

The selection of diluent ratio of the present invention: the consumption of diluent directly has influence on the loading amount and the content uniformity of soft capsule and liquid capsule, and ratio is low excessively, and then mobile bad, content uniformity is big; Ratio is excessive, and then consumption increases, the inconvenience of taking medicine.Therefore screen the diluent of different proportion, thereby determined optimal proportion.Get two parts in Chinese medical concrete medicated powder of the present invention, add not commensurability PEG-400 (comprising 8% propylene glycol) respectively, fully mix, observe its state, the results are shown in Table 3 after colloid mill ground 10 minutes:

The selection result of the test of table 3 diluent ratio

Diluent: sample	The medicinal liquid situation
		1.5∶1 2.5∶1 3.0∶1	Medicinal liquid is than thickness, and mobile bad medicinal liquid is even, and the good fluidity medicinal liquid is even, and is mobile relatively poor

By above result as can be known, when the ratio of diluent and extractum medicated powder was 1.5: 1, the flowability of medicinal liquid can not satisfy the requirement of soft capsule pressing or liquid capsule fill; When the ratio of diluent and extractum was 2.5: 1, medicinal liquid was even, and good fluidity can satisfy big production requirement, so determine that the ratio of diluent and extractum is 2.5: 1.

The present invention treats after the Chinese medicinal soft capsule of cough and liquid capsule make mixture into soft capsule and liquid capsule, it is poor to have solved former dosage form stability, easy sedimentary technical barrier of storage life, and do not contain sugar, be convenient to diabetics and take, and be convenient to store, carry, transport.It and former dosage form relatively have the following advantages: 1, after taking disintegrate in vivo, can directly absorb at intestinal, absorb soon the bioavailability height; 2, good stability; 3, soft capsule is with gelatin system epithelium, and air-tightness is strong, capsule intensity and film barrier property height, and the gelatin epithelium surpasses polyethylene film more than 30 times to the oxygen barrier property, and is highly stable to oxygen in the air, can prevent the air oxidation moisture absorption, but the content stable for extended periods of time; 4, mostly soft capsule and liquid capsule are medicine dissolution, suspendible, are emulsified in the solvent, are filled in the capsule as content after making its solution that becomes uniformity, and every capsules contained drug error is little; 5, covered the bad smell of medicine, taking convenience.

The specific embodiment

Embodiment 1:

Prescription: Folium Eriobotryae 345g, Pericarpium Papaveris 250g, Radix Stemonae 75g, Rhizoma Cynanchi Stauntonii 45g, Cortex Mori 30g, Radix Platycodonis 30g, Mentholum 0.75g, Polyethylene Glycol-400 444g, propylene glycol 56g.

Its preparation method is:

1, gets Six-elements such as Folium Eriobotryae, Pericarpium Papaveris and add 10 times of water gagings decoction secondaries, each 2 hours, collecting decoction, filter,, be evaporated to the clear paste of relative density 1.10～1.15 (60 ℃) under-0.08MPa condition at 65～75 ℃, be preheated to 80 ℃, spray drying (190 ± 5 ℃ of inlet temperature, 90 ± 5 ℃ of leaving air temps), spraying dry powder is standby;

2, with the adjuvant heating, stir, make substrate; Get medicated powder and Mentholum behind the mixing, under stirring condition, join in the substrate, be prepared into suspension, and add in the storage tank of liquid capsule filling machine, loading amount is adjusted in insulation, carries out quantitative filling or suspension is pressed into soft capsule.

Embodiment 2:

Prescription: Folium Eriobotryae 345g, Pericarpium Papaveris 250g, Radix Stemonae 75g, Rhizoma Cynanchi Stauntonii 45g, Cortex Mori 30g, Radix Platycodonis 30g, Mentholum 0.75g, Polyethylene Glycol-400 300g, propylene glycol 24g.

Its preparation method is identical with embodiment 1.

Embodiment 3:

Prescription: Folium Eriobotryae 345g, Pericarpium Papaveris 250g, Radix Stemonae 75g, Rhizoma Cynanchi Stauntonii 45g, Cortex Mori 30g, Radix Platycodonis 30g, Mentholum 0.75g, soybean oil 380g, Cera Flava 20g.

Its preparation method is:

1, step 1 is identical with embodiment 1;

2, get soybean oil 380g, Cera Flava 20g, heating, mix homogeneously adds spray drying powder, Mentholum, and colloid mill ground 10 minutes, made 1000 soft capsules or liquid capsule, promptly.

Embodiment 4:

A kind of Chinese medicinal soft capsule or liquid capsule for the treatment of cough, its capsule liquid is made by following raw material: Folium Eriobotryae 345g, Pericarpium Papaveris 250g, Radix Stemonae 75g, Rhizoma Cynanchi Stauntonii 45g, Cortex Mori 30g, Radix Platycodonis 30g, Mentholum 0.75g, Semen Maydis oil 450g, Cera Flava 30g.

Its preparation method is identical with embodiment 3.

Claims (3)

1, a kind of Chinese medicinal capsule for the treatment of cough comprises soft capsule and liquid capsule, it is characterized in that: its capsule liquid is made by following raw material: Chinese medical concrete powder 1 weight portion, Mentholum 0.00375 weight portion, pharmaceutic adjuvant 1.5～3.5 weight portions;

Described Chinese medical concrete by: Folium Eriobotryae 345 weight portions, Pericarpium Papaveris 250 weight portions, the Radix Stemonae 75 weight portions, Rhizoma Cynanchi Stauntonii 45 weight portions, Cortex Mori 30 weight portions, Radix Platycodonis 30 weight portions are made.

2, the Chinese medicinal capsule of treatment cough according to claim 1, it is characterized in that: described pharmaceutic adjuvant is one or more a compositions in vegetable oil, Polyethylene Glycol-400, propylene glycol, the Cera Flava, and wherein vegetable oil is one or more the mixture in soybean oil, Oleum Arachidis hypogaeae semen, Oleum Brassicae campestris, Oleum Helianthi, Semen Maydis oil, the rapeseed oil.

3, the preparation method of the Chinese medicinal capsule of treatment cough according to claim 1 is characterized in that comprising the steps:

Earlier get Folium Eriobotryae, Pericarpium Papaveris, the Radix Stemonae, Rhizoma Cynanchi Stauntonii, Cortex Mori, Radix Platycodonis by proportioning and decoct with water secondary, each 2 hours, collecting decoction filtered, and is evaporated to the clear paste of relative density 1.10～1.15 (60 ℃), and drying is pulverized, and makes Chinese medical concrete medicated powder; With the adjuvant heating, stir, make substrate; Get medicated powder and Mentholum behind the mixing, under stirring condition, join in the substrate, be prepared into suspension, and add in the storage tank of liquid capsule filling machine, loading amount is adjusted in insulation, carries out quantitative filling or suspension is pressed into soft capsule.